{ "article": { "LEGIARTI000006685848": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "L1121-10", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2004-08-11", "DATE_DEBUT": "2000-06-22" } }, "META_COMMUN": { "ID": "LEGIARTI000006685848", "URL": "article/LEGI/ARTI/00/00/06/68/58/LEGIARTI000006685848.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SPANXXXXXXX1X1121L10XXAA" } }, "LIENS": { "LIEN": [ { "@id": "JORFTEXT000000508831", "#text": "Loi 88-1138 1988-12-20 art. 6 5°", "@sens": "source", "@cidtexte": "JORFTEXT000000508831", "@nortexte": "SPSX8810045L", "@numtexte": "88-1138", "@typelien": "CONCORDANCE", "@naturetexte": "LOI", "@datesignatexte": "1988-12-20" }, { "@id": "LEGIARTI000006275437", "@num": "6", "#text": "Loi n°88-1138 du 20 décembre 1988 - art. 6 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000508831", "@nortexte": "SPSX8810045L", "@numtexte": "88-1138", "@typelien": "CONCORDE", "@naturetexte": "LOI", "@datesignatexte": "1988-12-20" }, { "@id": "JORFTEXT000000217229", "#text": "Ordonnance 2000-548 2000-06-15", "@sens": "source", "@cidtexte": "JORFTEXT000000217229", "@nortexte": "MESX0000036P", "@typelien": "CODIFICATION", "@naturetexte": "RAPPORT", "@datesignatexte": "2999-01-01" }, { "@id": "JORFTEXT000000227015", "#text": "Loi 2002-303 2002-03-04 art. 92 JORF 5 mars 2002", "@sens": "source", "@cidtexte": "JORFTEXT000000227015", "@nortexte": "MESX0100092L", "@numtexte": "2002-303", "@typelien": "CODIFICATION", "@naturetexte": "LOI", "@datesignatexte": "2002-03-04" }, { "@id": "LEGIARTI000020320259", "@num": "3", "#text": "Arrêté du 24 mai 2006 - art. 3 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000457818", "@nortexte": "SANP0622223A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-05-24" }, { "@id": "LEGIARTI000020338799", "@num": "3", "#text": "Arrêté du 16 août 2006 - art. 3 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000459553", "@nortexte": "SANP0623377A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000020320295", "@num": "3", "#text": "Arrêté du 16 août 2006 - art. 3 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000459554", "@nortexte": "SANP0623381A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000006254253", "@num": "3", "#text": "Arrêté du 16 août 2006 - art. 3 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000640165", "@nortexte": "SANP0623371A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000020317472", "@num": "3", "#text": "Arrêté du 16 août 2006 - art. 3 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000639975", "@nortexte": "SANP0623370A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000020338811", "@num": "3", "#text": "Arrêté du 16 août 2006 - art. 3 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000640166", "@nortexte": "SANP0623375A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000020326611", "@num": "3", "#text": "Arrêté du 16 août 2006 - art. 3 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000270592", "@nortexte": "SANP0623380A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000020350765", "@num": "3", "#text": "Arrêté du 23 octobre 2006 - art. 3 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000459238", "@nortexte": "SANP0624375A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-10-23" }, { "@id": "LEGIARTI000035971526", "#text": "DÉCRET n°2014-1286 du 23 octobre 2014 - art. (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000029675991", "@nortexte": "AFSX1419046D", "@numtexte": "2014-1286", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2014-10-23" }, { "@id": "LEGIARTI000033546931", "@num": "3", "#text": "Arrêté du 2 décembre 2016 - art. 3 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000033545400", "@nortexte": "AFSP1635538A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2016-12-02" }, { "@id": "LEGIARTI000033547020", "@num": "3", "#text": "Arrêté du 2 décembre 2016 - art. 3 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000033545436", "@nortexte": "AFSP1635568A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2016-12-02" }, { "@id": "LEGIARTI000033547085", "@num": "3", "#text": "Arrêté du 2 décembre 2016 - art. 3 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000033545461", "@nortexte": "AFSP1635571A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2016-12-02" }, { "@id": "LEGIARTI000033554483", "@num": "3", "#text": "Arrêté du 2 décembre 2016 - art. 3 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000033553349", "@nortexte": "AFSP1635656A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2016-12-02" }, { "@id": "LEGIARTI000043124098", "@num": "3", "#text": "Arrêté du 26 janvier 2021 - art. 3 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000043121591", "@nortexte": "SSAP2102968A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2021-01-26" }, { "@id": "LEGIARTI000043507358", "@num": "1", "#text": "Arrêté du 17 mai 2021 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000043507013", "@nortexte": "SSAP2115206A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2021-05-17" }, { "@id": "LEGIARTI000006685857", "@num": "L1121-17", "#text": "Code de la santé publique - art. L1121-17 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006685839", "@num": "L1121-7", "#text": "Code de la santé publique - art. L1121-7 (T)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006685839", "@num": "L1121-7", "#text": "Code de la santé publique - art. L1121-7 (T)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006685839", "@num": "L1121-7", "#text": "Code de la santé publique - art. L1121-7 (T)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000046125661", "@num": "L1124-1", "#text": "Code de la santé publique - art. L1124-1 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000046125917", "@num": "L1126-6", "#text": "Code de la santé publique - art. L1126-6 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000025454406", "@num": "L1142-3", "#text": "Code de la santé publique - art. L1142-3 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000033281988", "@num": "L1221-8-1", "#text": "Code de la santé publique - art. L1221-8-1 (VT)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006170998", "@fin": "2016-12-31", "#text": "Chapitre Ier : Principes généraux", "@debut": "2000-06-22" }, { "@id": "LEGISCTA000032722874", "@fin": "2999-01-01", "#text": "Chapitre Ier : Principes généraux relatifs aux recherches impliquant la personne humaine", "@debut": "2016-12-31" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006154978", "@fin": "2012-03-07", "#text": "Titre II : Recherches biomédicales", "@debut": "2000-06-22" }, { "@id": "LEGISCTA000025457387", "@fin": "2999-01-01", "#text": "Titre II : Recherches impliquant la personne humaine", "@debut": "2012-03-07" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006140603", "@fin": "2999-01-01", "#text": "Livre Ier : Protection des personnes en matière de santé", "@debut": "2000-06-22" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006125345", "@fin": "2999-01-01", "#text": "Première partie : Protection générale de la santé", "@debut": "2000-06-22" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006103419", "@fin": "2999-01-01", "#text": "Partie législative", "@debut": "2000-06-22" } ] }, "@cid": "LEGITEXT000006072665", "@nature": "CODE", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Code de la santé publique", "@debut": "1953-10-07", "@id_txt": "LEGITEXT000006072665", "@c_titre_court": "Code de la santé publique" } ], "@date_publi": "2999-01-01", "@date_signature": "2999-01-01" } }, "VERSIONS": { "VERSION": [ { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006685848", "@fin": "2004-08-11", "@num": "L1121-10", "@etat": "MODIFIE", "@debut": "2000-06-22", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006685849", "@fin": "2012-03-07", "@num": "L1121-10", "@etat": "MODIFIE", "@debut": "2004-08-11", "@origine": "LEGI" } }, { "@etat": "VIGUEUR", "LIEN_ART": { "@id": "LEGIARTI000025457525", "@fin": "2999-01-01", "@num": "L1121-10", "@etat": "VIGUEUR", "@debut": "2012-03-07", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
Les modalités d'application des dispositions du présent chapitre sont déterminées par décret en Conseil d'Etat et notamment les minima de garanties pour l'assurance prévue au troisième alinéa de l'article L. 1121-7.
\n
" } }, "LEGIARTI000006254244": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "3", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2009-02-28", "DATE_DEBUT": "2006-08-26" } }, "META_COMMUN": { "ID": "LEGIARTI000006254244", "URL": "article/LEGI/ARTI/00/00/06/25/42/LEGIARTI000006254244.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SRIE3XXXXXX003AAXXXXXXAA" } }, "LIENS": { "LIEN": [ { "#text": "Arrêté 2000-10-18", "@sens": "source", "@typelien": "CITATION" }, { "#text": "Arrêté 2006-08-16 art. 4, annexe", "@sens": "source", "@typelien": "CITATION" }, { "@id": "LEGIARTI000006685848", "@num": "L1121-10", "#text": "Code de la santé publique - art. L1121-10 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006685833", "@num": "L1121-4", "#text": "Code de la santé publique - art. L1121-4 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006685895", "@num": "L1123-14", "#text": "Code de la santé publique - art. L1123-14 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006685883", "@num": "L1123-8", "#text": "Code de la santé publique - art. L1123-8 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006690281", "@num": "L5211-1", "#text": "Code de la santé publique - art. L5211-1 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006690312", "@num": "L5221-1", "#text": "Code de la santé publique - art. L5221-1 (T)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006908378", "@num": "R1123-20", "#text": "Code de la santé publique - art. R1123-20 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006908399", "@num": "R1123-29", "#text": "Code de la santé publique - art. R1123-29 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "@cid": "JORFTEXT000000639975", "@nor": "SANP0623370A", "@nature": "ARRETE", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Arrêté du 16 août 2006 fixant le contenu, le format et les modalités de présentation à l'Agence française de sécurité sanitaire des produits de santé du dossier de demande d'autorisation de recherche biomédicale portant sur un dispositif médical ou sur un dispositif médical de diagnostic in vitro", "@debut": "2999-01-01", "@id_txt": "JORFTEXT000000639975", "@c_titre_court": "Arrêté du 16 août 2006" }, { "@fin": "2999-01-01", "#text": "Arrêté du 16 août 2006 fixant le contenu, le format et les modalités de présentation à l'Agence française de sécurité sanitaire des produits de santé du dossier de demande d'autorisation de recherche biomédicale portant sur un dispositif médical ou sur un dispositif médical de diagnostic in vitro", "@debut": "2006-08-26", "@id_txt": "LEGITEXT000006054291", "@c_titre_court": "Arrêté du 16 août 2006" } ], "@ministere": "MINISTERE DE LA SANTE ET DES SOLIDARITES", "@date_publi": "2006-08-26", "@date_signature": "2006-08-16" } }, "VERSIONS": { "VERSION": [ { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006254244", "@fin": "2009-02-28", "@num": "3", "@etat": "MODIFIE", "@debut": "2006-08-26", "@origine": "LEGI" } }, { "@etat": "VIGUEUR", "LIEN_ART": { "@id": "LEGIARTI000020317472", "@fin": "2999-01-01", "@num": "3", "@etat": "VIGUEUR", "@debut": "2009-02-28", "@origine": "LEGI" } }, { "LIEN_ART": { "@id": "JORFARTI000001494454", "@fin": "2999-01-01", "@num": "3", "@debut": "2999-01-01", "@origine": "JORF" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
Le dossier de demande d'autorisation d'une recherche biomédicale portant sur un dispositif médical ou sur un dispositif médical de diagnostic in vitro, tels que définis aux articles L. 5211-1 et L. 5221-1 du code de la santé publique, se compose des quatre parties suivantes :
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I. - Un dossier administratif contenant les informations suivantes :
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1° Un courrier de demande d'autorisation, daté et signé, disponible en version électronique sur le site internet de l'Agence française de sécurité sanitaire des produits de santé ou en version papier, sur demande auprès de l'Agence française de sécurité sanitaire des produits de santé ;
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2° Le formulaire de demande d'autorisation, daté et signé, disponible en version électronique sur le site internet de l'Agence française de sécurité sanitaire des produits de santé ou en version papier, sur demande auprès de l'Agence française de sécurité sanitaire des produits de santé ;
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3° Le cas échéant, la liste des autorités compétentes des Etats membres de la Communauté européenne auxquelles la demande a été soumise et la nature de leurs décisions finales, si elles sont disponibles ;
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4° Si le demandeur n'est pas le promoteur, l'autorisation écrite lui permettant d'agir pour le compte du promoteur ;
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5° Le cas échéant, une copie de la ou des autorisations requises en application des dispositions du code de la santé publique, pour la mise en place de la recherche ou pour l'utilisation du dispositif médical ou du dispositif médical de diagnostic in vitro ;
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6° En cas de soumission de données relatives à un dispositif médical ou un dispositif médical de diagnostic in vitro sur lequel porte la recherche, appartenant à un tiers, en application du 4° de l'article 4 du présent arrêté, l'autorisation délivrée par ce dernier au promoteur pour communiquer ces données ;
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7° Le justificatif du versement des taxes prévues à l'article L. 1123-8 du code de la santé publique.
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II. - Un dossier sur la recherche biomédicale contenant les informations suivantes :
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1° Le protocole de la recherche, tel que défini à l'article R. 1123-20 du code de la santé publique, daté et comportant un numéro de version ;
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2° Le résumé du protocole de la recherche ;
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3° La brochure pour l'investigateur ou la notice d'instruction pour tout dispositif pourvu du marquage CE, ou la notice d'utilisation pour tout dispositif médical de diagnostic in vitro pourvu du marquage CE, accompagnée, s'il est utilisé dans une destination autre que celle figurant sur cette notice, de la synthèse des données justifiant l'utilisation et la sécurité d'emploi du dispositif médical ou du dispositif médical de diagnostic in vitro dans le cadre de la recherche ;
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4° Si la brochure pour l'investigateur appartient à un tiers, l'autorisation du tiers délivrée au promoteur pour l'utiliser ;
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5° La copie de l'attestation d'assurance mentionnée à l'article L. 1121-10 du code de la santé publique ;
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6° Le cas échéant, l'avis d'un comité scientifique consulté par le promoteur ;
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7° Le document de référence permettant de déterminer le caractère attendu ou inattendu d'une suspicion d'effet indésirable grave.
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III. - Un dossier technique relatif aux produits utilisés dans le cadre de la recherche :
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1° Pour chaque dispositif médical ou dispositif médical de diagnostic in vitro sur lequel porte la recherche, le promoteur transmet un dossier technique, comprenant les informations suivantes :
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a) La déclaration que le dispositif concerné est conforme aux exigences essentielles à la seule exception des aspects qui doivent faire l'objet de l'investigation, pour lesquels le fabricant doit certifier que toutes les précautions ont été prises pour protéger la santé et la sécurité des personnes qui se prêtent à la recherche. La déclaration est documentée par les résultats de l'analyse des risques et la liste des référentiels appliqués.
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Toutefois, lorsque le promoteur est un promoteur mentionné à l'article L. 1123-14 (12°) du code de la santé publique, il fournit les données permettant d'établir que ces risques éventuels ne sont pas hors de proportion avec le bénéfice escompté pour les personnes qui se prêtent à la recherche, et les résultats de l'analyse des risques ou, à défaut, les résultats de l'évaluation des risques éventuels générés par l'utilisation envisagée dans la recherche ;
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b) Les résumés des données non cliniques pour les dispositifs médicaux et des données de performance pour les dispositifs de diagnostic in vitro ;
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c) Le cas échéant, les données relatives à la sécurité virale conformément à l'annexe du présent arrêté ;
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d) Le cas échéant, les données relatives à l'évaluation des risques pour la santé publique et l'environnement conformément aux dispositions de l'arrêté du 18 octobre 2000 susvisé lorsque la recherche porte sur un dispositif ou un dispositif médical de diagnostic in vitro contenant des organismes génétiquement modifiés ;
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e) Le cas échéant, les données relatives aux radioéléments ;
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f) Les résumés de toutes les données disponibles des recherches biomédicales préalablement menées avec le même dispositif médical ou dispositif médical de diagnostic in vitro ou avec un dispositif équivalent. Dans ce dernier cas, les éléments justifiant l'équivalence avec le dispositif faisant l'objet de la recherche sont apportés ;
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g) Une analyse critique, au regard de l'évaluation des bénéfices et des risques de la recherche, des données non cliniques et, le cas échéant, cliniques relatives au dispositif médical ou dispositif médical de diagnostic in vitro faisant l'objet de la recherche.
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Le promoteur peut faire référence aux données non cliniques et cliniques présentées dans la brochure pour l'investigateur, lorsque celles-ci sont suffisamment détaillées pour permettre une appréciation précise de la sécurité d'emploi du dispositif médical ou du dispositif médical de diagnostic in vitro sur lequel porte la recherche.
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Le promoteur tient à la disposition de l'Agence française de sécurité sanitaire des produits de santé, à sa demande, les données complètes des études référencées dans le dossier technique, sauf exception dûment justifiée.
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2° Si la recherche biomédicale implique l'utilisation d'un dispositif médical qui incorpore comme partie intégrante une substance qui, si elle est utilisée séparément, est susceptible d'être considérée comme un médicament, le dossier technique est complété par les informations suivantes relatives à cette substance :
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a) La justification scientifique de l'ajout de la substance active au dispositif médical tant au plan qualitatif que quantitatif ;
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b) Des données non cliniques et, le cas échéant, des données cliniques portant notamment sur la cinétique locale et les effets locaux de la substance incorporée dans le dispositif médical ;
\n
c) Si la substance active incorporée dans le dispositif médical sur lequel porte la recherche est celle contenue dans un médicament disposant d'une autorisation de mise sur le marché en France ou dans un Etat membre de la Communauté européenne : le résumé des caractéristiques du produit en vigueur à la date de soumission de la demande d'autorisation de recherche. Dans ce cas, les données relatives à la qualité pharmaceutique du médicament sont constituées par l'attestation délivrée par le fabricant de la substance active incorporée dans le dispositif médical spécifiant que celle-ci est en tout point identique à celle utilisée pour la préparation du médicament disposant d'une autorisation de mise sur le marché. Le promoteur fournit au titre des données non cliniques et cliniques celles appuyant la démonstration de l'absence d'altération du rapport efficacité/sécurité par rapport à l'administration habituelle du médicament, notamment celles se rapportant à la cinétique locale et aux effets locaux de la substance active ;
\n
d) Si la substance active incorporée dans le dispositif médical sur lequel porte la recherche n'est pas contenue dans un médicament disposant d'une autorisation de mise sur le marché en France ou dans un Etat membre de la Communauté européenne : une synthèse des données relatives à la qualité pharmaceutique, chimique ou biologique de la substance active conformément aux exigences de la Pharmacopée européenne pour les substances à usage pharmaceutique et, le cas échéant, pour les produits de fermentation.
\n
3° Si la recherche portant sur un dispositif médical ou un dispositif médical de diagnostic in vitro prévoit d'utiliser ou d'étudier d'autres produits que ceux mentionnés respectivement au 1° et au 2° du III du présent article, il appartient au demandeur de fournir la documentation adaptée relative à ces produits, telle que définie dans les arrêtés relatifs à la demande d'autorisation de recherche biomédicale soumise à l'autorité compétente portant sur de tels produits, permettant à l'Agence française de sécurité sanitaire des produits de santé d'apprécier la sécurité des personnes qui se prêtent à la recherche conformément aux dispositions de l'article R. 1123-29 du code de la santé publique.
\n
IV. - La copie de l'avis final du comité de protection des personnes mentionné à l'article L. 1121-4 du code de la santé publique, s'il est disponible.
" } }, "LEGIARTI000006254253": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "3", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2009-03-07", "DATE_DEBUT": "2006-08-26" } }, "META_COMMUN": { "ID": "LEGIARTI000006254253", "URL": "article/LEGI/ARTI/00/00/06/25/42/LEGIARTI000006254253.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SRIE4XXXXXX003AAXXXXXXAA" } }, "LIENS": { "LIEN": [ { "#text": "Arrêté 2006-08-16 annexe", "@sens": "source", "@typelien": "CITATION" }, { "@id": "LEGIARTI000006685848", "@num": "L1121-10", "#text": "Code de la santé publique - art. L1121-10 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006685852", "@num": "L1121-13", "#text": "Code de la santé publique - art. L1121-13 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006685859", "@num": "L1122-1", "#text": "Code de la santé publique - art. L1122-1 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006685883", "@num": "L1123-8", "#text": "Code de la santé publique - art. L1123-8 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006690281", "@num": "L5211-1", "#text": "Code de la santé publique - art. L5211-1 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006690312", "@num": "L5221-1", "#text": "Code de la santé publique - art. L5221-1 (T)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006908378", "@num": "R1123-20", "#text": "Code de la santé publique - art. R1123-20 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "@cid": "JORFTEXT000000640165", "@nor": "SANP0623371A", "@nature": "ARRETE", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Arrêté du 16 août 2006 fixant le contenu, le format et les modalités de présentation du dossier de demande d'avis au comité de protection des personnes sur un projet de recherche biomédicale portant sur un dispositif médical ou sur un dispositif médical de diagnostic in vitro", "@debut": "2999-01-01", "@id_txt": "JORFTEXT000000640165", "@c_titre_court": "Arrêté du 16 août 2006" }, { "@fin": "2016-12-08", "#text": "Arrêté du 16 août 2006 fixant le contenu, le format et les modalités de présentation du dossier de demande d'avis au comité de protection des personnes sur un projet de recherche biomédicale portant sur un dispositif médical ou sur un dispositif médical de diagnostic in vitro", "@debut": "2006-08-26", "@id_txt": "LEGITEXT000006054292", "@c_titre_court": "Arrêté du 16 août 2006" } ], "@ministere": "MINISTERE DE LA SANTE ET DES SOLIDARITES", "@date_publi": "2006-08-26", "@date_signature": "2006-08-16" } }, "VERSIONS": { "VERSION": [ { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006254253", "@fin": "2009-03-07", "@num": "3", "@etat": "MODIFIE", "@debut": "2006-08-26", "@origine": "LEGI" } }, { "@etat": "ABROGE", "LIEN_ART": { "@id": "LEGIARTI000020350738", "@fin": "2016-12-08", "@num": "3", "@etat": "ABROGE", "@debut": "2009-03-07", "@origine": "LEGI" } }, { "LIEN_ART": { "@id": "JORFARTI000001106174", "@fin": "2999-01-01", "@num": "3", "@debut": "2999-01-01", "@origine": "JORF" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
Le dossier de demande d'avis sur un projet de recherche biomédicale portant sur un dispositif médical ou sur un dispositif médical de diagnostic in vitro, tels que définis aux articles L. 5211-1 et L. 5221-1 du code de la santé publique, adressé au comité de protection des personnes concerné, comprend :
\n
I. - Un dossier administratif contenant les informations suivantes :
\n
1° Un courrier de demande d'avis, daté et signé ;
\n
2° Le formulaire de demande d'avis, daté et signé, disponible en version électronique sur le site internet de l'Agence française de sécurité sanitaire des produits de santé ou en version papier sur demande auprès de l'Agence française de sécurité sanitaire des produits de santé ;
\n
3° Le document additionnel à la demande d'avis au comité de protection des personnes décrit en annexe du présent arrêté (document non reproduit, voir fac similé), daté et signé, accompagné des supports susceptible d'être utilisés en vue du recrutement des personnes ;
\n
4° Le cas échéant, la liste des autorités compétentes des Etats membres de la Communauté européenne auxquelles la demande a été soumise et la nature de leurs décisions finales, si elles sont disponibles ;
\n
5° Si le demandeur n'est pas le promoteur, l'autorisation écrite lui permettant d'agir pour le compte du promoteur ;
\n
6° Le cas échéant, la copie de la ou des autorisations de lieux de recherches biomédicales mentionnées à l'article L. 1121-13 du code de la santé publique ;
\n
7° Le justificatif du versement des taxes prévues à l'article L. 1123-8 du code de la santé publique.
\n
II. - Un dossier sur la recherche biomédicale contenant les informations suivantes :
\n
1° Le protocole de la recherche tel que défini à l'article R. 1123-20 du code de la santé publique, daté et comportant un numéro de version ;
\n
2° Le résumé du protocole ;
\n
3° La brochure pour l'investigateur ou la notice d'instruction pour tout dispositif médical pourvu du marquage CE, ou la notice d'utilisation pour tout dispositif médical de diagnostic in vitro pourvu du marquage CE, accompagnée, s'il est utilisé dans une destination autre que celle figurant sur cette notice, de la synthèse des données justifiant l'utilisation et la sécurité d'emploi du dispositif médical ou du dispositif médical de diagnostic in vitro dans le cadre de la recherche ;
\n
4° Si la brochure pour l'investigateur appartient à un tiers, l'autorisation du tiers délivrée au promoteur pour l'utiliser ;
\n
5° Le document d'information destiné aux personnes qui se prêtent à la recherche prévu à l'article L. 1122-1 du code de la santé publique. Ce document décrit notamment les contre-indications, les effets indésirables graves et les précautions d'utilisation du dispositif sur lequel porte la recherche.
\n
Si le dispositif médical ou le dispositif médical de diagnostic in vitro sur lequel porte la recherche n'est pas pourvu du marquage CE, ce document précise également les risques éventuels liés au dispositif médical et dispositif médical de diagnostic in vitro et, le cas échéant, ceux liés à la procédure de mise en oeuvre du dispositif médical.
\n
Si le dispositif médical ou le dispositif médical de diagnostic in vitro sur lequel porte la recherche est pourvu du marquage CE, le dossier sur la recherche biomédicale comprend également une comparaison et la justification des divergences pertinentes en termes de sécurité des personnes, entre le document d'information destiné aux personnes qui se prêtent à la recherche et la notice d'instruction pour les dispositifs médicaux, ou la notice d'utilisation pour les dispositifs médicaux de diagnostic in vitro ;
\n
6° Le formulaire de recueil de consentement des personnes se prêtant à la recherche ;
\n
7° La copie de l'attestation d'assurance prévue à l'article L. 1121-10 du code de la santé publique ;
\n
8° Le cas échéant, l'avis d'un comité scientifique consulté par le promoteur ;
\n
9° Une justification de l'adéquation des moyens humains, matériels et techniques au projet de recherche biomédicale et de leur compatibilité avec les impératifs de sécurité des personnes qui s'y prêtent, sauf si le lieu bénéficie d'une autorisation mentionnée à l'article L. 1121-13 du code de la santé publique ;
\n
10° Les curriculum vitae du ou des investigateurs ;
\n
11° La nature de la décision finale de l'Agence française de sécurité sanitaire des produits de santé mentionnée à l'article L. 1123-8 du code de la santé publique, si cette décision est disponible.
" } }, "LEGIARTI000006254281": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "3", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2009-03-05", "DATE_DEBUT": "2006-08-26" } }, "META_COMMUN": { "ID": "LEGIARTI000006254281", "URL": "article/LEGI/ARTI/00/00/06/25/42/LEGIARTI000006254281.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SRIE8XXXXXX003AAXXXXXXAA" } }, "LIENS": { "LIEN": [ { "#text": "Arrêté 2001-02-06", "@sens": "source", "@typelien": "CITATION" }, { "@id": "LEGIARTI000006685848", "@num": "L1121-10", "#text": "Code de la santé publique - art. L1121-10 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006685852", "@num": "L1121-13", "#text": "Code de la santé publique - art. L1121-13 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006685833", "@num": "L1121-4", "#text": "Code de la santé publique - art. L1121-4 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006685883", "@num": "L1123-8", "#text": "Code de la santé publique - art. L1123-8 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006908378", "@num": "R1123-20", "#text": "Code de la santé publique - art. R1123-20 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006908399", "@num": "R1123-29", "#text": "Code de la santé publique - art. R1123-29 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006915505", "@num": "R5131-4", "#text": "Code de la santé publique - art. R5131-4 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "@cid": "JORFTEXT000000640166", "@nor": "SANP0623375A", "@nature": "ARRETE", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Arrêté du 16 août 2006 fixant le contenu, le format et les modalités de présentation à l'Agence française de sécurité sanitaire des produits de santé du dossier de demande d'autorisation de recherche biomédicale portant sur un produit cosmétique ou de tatouage", "@debut": "2999-01-01", "@id_txt": "JORFTEXT000000640166", "@c_titre_court": "Arrêté du 16 août 2006" }, { "@fin": "2999-01-01", "#text": "Arrêté du 16 août 2006 fixant le contenu, le format et les modalités de présentation à l'Agence française de sécurité sanitaire des produits de santé du dossier de demande d'autorisation de recherche biomédicale portant sur un produit cosmétique ou de tatouage", "@debut": "2006-08-26", "@id_txt": "LEGITEXT000006054296", "@c_titre_court": "Arrêté du 16 août 2006" } ], "@ministere": "MINISTERE DE LA SANTE ET DES SOLIDARITES", "@date_publi": "2006-08-26", "@date_signature": "2006-08-16" } }, "VERSIONS": { "VERSION": [ { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006254281", "@fin": "2009-03-05", "@num": "3", "@etat": "MODIFIE", "@debut": "2006-08-26", "@origine": "LEGI" } }, { "@etat": "VIGUEUR", "LIEN_ART": { "@id": "LEGIARTI000020338811", "@fin": "2999-01-01", "@num": "3", "@etat": "VIGUEUR", "@debut": "2009-03-05", "@origine": "LEGI" } }, { "LIEN_ART": { "@id": "JORFARTI000001301214", "@fin": "2999-01-01", "@num": "3", "@debut": "2999-01-01", "@origine": "JORF" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
Le dossier de demande d'autorisation de recherche biomédicale portant sur un produit cosmétique ou de tatouage se compose des quatre parties suivantes :
\n
I. - Un dossier administratif contenant les informations suivantes :
\n
1° Un courrier de demande d'autorisation, daté et signé, disponible en version électronique sur le site internet de l'Agence française de sécurité sanitaire des produits de santé ou en version papier, sur demande auprès de l'Agence française de sécurité sanitaire des produits de santé ;
\n
2° Le formulaire de demande d'autorisation, daté et signé, disponible en version électronique sur le site internet de l'Agence française de sécurité sanitaire des produits de santé ou en version papier, sur demande auprès de l'Agence française de sécurité sanitaire des produits de santé ;
\n
3° Le cas échéant, la liste des autorités compétentes des Etats membres de la Communauté européenne auxquelles la demande a été soumise et la nature de leurs décisions finales, si elles sont disponibles ;
\n
4° Si le demandeur n'est pas le promoteur, l'autorisation écrite lui permettant d'agir pour le compte du promoteur ;
\n
5° Le cas échéant, une copie de la ou des autorisations de lieux de recherches biomédicales mentionnées à l'article L. 1121-13 du code de la santé publique ;
\n
6° En cas de soumission de données relatives aux produits cosmétiques ou de tatouage sur lesquels porte la recherche et appartenant à un tiers, l'autorisation délivrée par ce dernier au promoteur pour communiquer ces données ;
\n
7° Le justificatif du versement de la taxe prévue à l'article L. 1123-8 du code de la santé publique.
\n
II. - Un dossier sur la recherche biomédicale contenant les informations suivantes :
\n
1° Le protocole de la recherche tel que défini à l'article R. 1123-20 du code de la santé publique, daté et comportant un numéro de version ;
\n
2° Le résumé du protocole de la recherche ;
\n
3° La brochure pour l'investigateur ;
\n
4° Si la brochure pour l'investigateur appartient à un tiers, l'autorisation du tiers délivrée au promoteur pour l'utiliser ;
\n
5° La copie de l'attestation d'assurance mentionnée à l'article L. 1121-10 du code de la santé publique ;
\n
6° Le cas échéant, l'avis d'un comité scientifique consulté par le promoteur.
\n
III. - Un dossier technique relatif aux produits utilisés dans le cadre de la recherche :
\n
1° Pour chaque produit cosmétique ou de tatouage sur lequel porte la recherche, le promoteur transmet un dossier technique contenant les informations suivantes :
\n
a) La composition qualitative exprimée conformément aux dispositions du dernier alinéa de l'article R. 5131-4 du code de la santé publique, y compris pour les parfums et les compositions parfumantes dont la mention sur l'étiquetage est exigée au 8° de l'article R. 5131-4 du code de la santé publique. Pour les autres parfums et compositions parfumantes, les informations suivantes devront être fournies : la dénomination des parfums et des compositions parfumantes, leurs numéros de code indiqués par le fournisseur et l'identité de ce dernier ;
\n
b) L'origine de toute matière première d'origine bovine, ovine ou caprine entrant dans la composition du produit testé, telle que prévue dans l'arrêté du 6 février 2001 fixant la liste des substances qui ne peuvent entrer dans la composition des produits cosmétiques ;
\n
c) Les spécifications et les résultats des essais physico-chimiques et microbiologiques du produit cosmétique ou de tatouage faisant l'objet de la recherche ;
\n
d) Le cas échéant, les précautions d'emploi et avertissements prévus sur l'étiquetage ;
\n
e) Le cas échéant, une brève description du matériel utilisé pour la recherche ainsi que les documents attestant la conformité de ce matériel aux exigences essentielles de sécurité et de santé ;
\n
f) Le dossier de sécurité du produit cosmétique ou de tatouage faisant l'objet de la recherche qui comprend les informations suivantes ;
\n
- l'attestation d'innocuité établie par la personne qualifiée responsable de l'évaluation de la sécurité pour la santé humaine du produit faisant l'objet de la recherche ;
\n
- si elles ont été effectuées, la liste et les résultats des études de sécurité menées sur chacun des ingrédients du produit faisant l'objet de la recherche permettant d'attester de leur innocuité ;
\n
- si elles ont été effectuées, la liste et les résultats des études de sécurité menées sur le produit fini faisant l'objet de la recherche ;
\n
g) Le cas échéant, les résumés de toutes les données disponibles des études et des recherches biomédicales préalablement menées avec un ou des produits similaires au produit étudié.
\n
2° Si la recherche portant sur un produit cosmétique ou de tatouage prévoit d'utiliser ou d'étudier d'autres produits que ces produits cosmétiques ou de tatouage, il appartient au demandeur de fournir la documentation adaptée relative à ces produits, telle que définie dans les arrêtés relatifs à la demande d'autorisation de recherche biomédicale soumise à l'autorité compétente portant sur de tels produits, permettant à l'Agence française de sécurité sanitaire des produits de santé d'apprécier la sécurité des personnes qui se prêtent à la recherche conformément aux dispositions de l'article R. 1123-29 du code de la santé publique.
\n
IV. - La copie de l'avis final du comité de protection des personnes, mentionné à l'article L. 1121-4 du code de la santé publique, s'il est disponible.
" } }, "LEGIARTI000006254291": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "3", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2009-03-05", "DATE_DEBUT": "2006-08-26" } }, "META_COMMUN": { "ID": "LEGIARTI000006254291", "URL": "article/LEGI/ARTI/00/00/06/25/42/LEGIARTI000006254291.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SRIFAXXXXXX003AAXXXXXXAA" } }, "LIENS": { "LIEN": [ { "#text": "Arrêté 2006-08-16 annexe", "@sens": "source", "@typelien": "CITATION" }, { "@id": "LEGIARTI000006685848", "@num": "L1121-10", "#text": "Code de la santé publique - art. L1121-10 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006685852", "@num": "L1121-13", "#text": "Code de la santé publique - art. L1121-13 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006685859", "@num": "L1122-1", "#text": "Code de la santé publique - art. L1122-1 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006685883", "@num": "L1123-8", "#text": "Code de la santé publique - art. L1123-8 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006908378", "@num": "R1123-20", "#text": "Code de la santé publique - art. R1123-20 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "@cid": "JORFTEXT000000459553", "@nor": "SANP0623377A", "@nature": "ARRETE", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Arrêté du 16 août 2006 fixant le contenu, le format et les modalités de présentation du dossier de demande d'avis au comité de protection des personnes sur un projet de recherche biomédicale portant sur un produit cosmétique ou de tatouage", "@debut": "2999-01-01", "@id_txt": "JORFTEXT000000459553", "@c_titre_court": "Arrêté du 16 août 2006" }, { "@fin": "2016-12-08", "#text": "Arrêté du 16 août 2006 fixant le contenu, le format et les modalités de présentation du dossier de demande d'avis au comité de protection des personnes sur un projet de recherche biomédicale portant sur un produit cosmétique ou de tatouage", "@debut": "2006-08-26", "@id_txt": "LEGITEXT000006054298", "@c_titre_court": "Arrêté du 16 août 2006" } ], "@ministere": "MINISTERE DE LA SANTE ET DES SOLIDARITES", "@date_publi": "2006-08-26", "@date_signature": "2006-08-16" } }, "VERSIONS": { "VERSION": [ { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006254291", "@fin": "2009-03-05", "@num": "3", "@etat": "MODIFIE", "@debut": "2006-08-26", "@origine": "LEGI" } }, { "@etat": "ABROGE", "LIEN_ART": { "@id": "LEGIARTI000020338799", "@fin": "2016-12-08", "@num": "3", "@etat": "ABROGE", "@debut": "2009-03-05", "@origine": "LEGI" } }, { "LIEN_ART": { "@id": "JORFARTI000001301216", "@fin": "2999-01-01", "@num": "3", "@debut": "2999-01-01", "@origine": "JORF" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
Le dossier de demande d'avis sur un projet de recherche biomédicale portant sur un produit cosmétique ou un produit de tatouage, adressé au comité de protection des personnes concerné, comprend :
\n
I. - Un dossier administratif contenant les informations suivantes :
\n
1. Un courrier de demande d'avis, daté et signé ;
\n
2. Le formulaire de demande d'avis, daté et signé, disponible en version électronique sur le site internet de l'Agence française de sécurité sanitaire des produits de santé ou en version papier sur demande auprès de l'Agence française de sécurité sanitaire des produits de santé ;
\n
3. Le document additionnel à la demande d'avis au comité de protection des personnes décrit en annexe du présent arrêté, daté et signé, accompagné des supports susceptibles d'être utilisés en vue du recrutement des personnes ;
\n
4. Le cas échéant, la liste des autorités compétentes des Etats membres de la Communauté européenne auxquelles la demande a été soumise et la nature de leurs décisions finales, si elles sont disponibles ;
\n
5. Si le demandeur n'est pas le promoteur, l'autorisation écrite lui permettant d'agir pour le compte du promoteur ;
\n
6. Le cas échéant, la copie de la ou des autorisations de lieux de recherches biomédicales mentionnées à l'article L. 1121-13 du code de la santé publique ;
\n
7. Le justificatif du versement de la taxe prévue à l'article L. 1123-8 du code de la santé publique.
\n
II. - Un dossier sur la recherche biomédicale contenant les informations suivantes :
\n
1. Le protocole de la recherche tel que défini à l'article R. 1123-20 du code de la santé publique, daté et comportant un numéro de version ;
\n
2. Le résumé du protocole ;
\n
3. La brochure pour l'investigateur ;
\n
4. Si la brochure pour l'investigateur appartient à un tiers, l'autorisation du tiers délivrée au promoteur pour l'utiliser ;
\n
5. Le document d'information destiné aux personnes qui se prêtent à la recherche, prévu à l'article L. 1122-1 du code de la santé publique. Ce document décrit notamment les risques encourus avec le(s) produit(s) étudié(s) mais également liés à la méthodologie de la recherche ;
\n
6. Le formulaire de recueil du consentement des personnes se prêtant à la recherche ;
\n
7. La copie de l'attestation d'assurance prévue à l'article L. 1121-10 du code de la santé publique ;
\n
8. Le cas échéant, l'avis d'un comité scientifique consulté par le promoteur ;
\n
9. Une justification de l'adéquation des moyens humains, matériels et techniques au projet de recherche biomédicale et de leur compatibilité avec les impératifs de sécurité des personnes qui s'y prêtent, sauf si le lieu bénéficie de l'autorisation mentionnée à l'article L. 1121-13 du code de la santé publique ;
\n
10. Les curriculum vitae du ou des investigateurs ;
\n
11. La nature de la décision finale de l'Agence française de sécurité sanitaire des produits de santé mentionnée à l'article L. 1123-8 du code de la santé publique, si cette décision est disponible.
\n
" } }, "LEGIARTI000006254309": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "3", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2009-03-01", "DATE_DEBUT": "2006-08-26" } }, "META_COMMUN": { "ID": "LEGIARTI000006254309", "URL": "article/LEGI/ARTI/00/00/06/25/43/LEGIARTI000006254309.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SRIFDXXXXXX003AAXXXXXXAA" } }, "LIENS": { "LIEN": [ { "@id": "LEGIARTI000006685848", "@num": "L1121-10", "#text": "Code de la santé publique - art. L1121-10 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006685833", "@num": "L1121-4", "#text": "Code de la santé publique - art. L1121-4 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006685883", "@num": "L1123-8", "#text": "Code de la santé publique - art. L1123-8 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006690344", "@num": "L5311-1", "#text": "Code de la santé publique - art. L5311-1 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006908378", "@num": "R1123-20", "#text": "Code de la santé publique - art. R1123-20 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "@cid": "JORFTEXT000000270592", "@nor": "SANP0623380A", "@nature": "ARRETE", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Arrêté du 16 août 2006 fixant le contenu, le format et les modalités de présentation au ministre chargé de la santé du dossier de demande d'autorisation de recherche biomédicale ne portant pas sur un produit mentionné à l'article L. 5311-1 du code de la santé publique", "@debut": "2999-01-01", "@id_txt": "JORFTEXT000000270592", "@c_titre_court": "Arrêté du 16 août 2006" }, { "@fin": "2999-01-01", "#text": "Arrêté du 16 août 2006 fixant le contenu, le format et les modalités de présentation au ministre chargé de la santé du dossier de demande d'autorisation de recherche biomédicale ne portant pas sur un produit mentionné à l'article L. 5311-1 du code de la santé publique", "@debut": "2006-08-26", "@id_txt": "LEGITEXT000006054301", "@c_titre_court": "Arrêté du 16 août 2006" } ], "@ministere": "MINISTERE DE LA SANTE ET DES SOLIDARITES", "@date_publi": "2006-08-26", "@date_signature": "2006-08-16" } }, "VERSIONS": { "VERSION": [ { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006254309", "@fin": "2009-03-01", "@num": "3", "@etat": "MODIFIE", "@debut": "2006-08-26", "@origine": "LEGI" } }, { "@etat": "VIGUEUR", "LIEN_ART": { "@id": "LEGIARTI000020326611", "@fin": "2999-01-01", "@num": "3", "@etat": "VIGUEUR", "@debut": "2009-03-01", "@origine": "LEGI" } }, { "LIEN_ART": { "@id": "JORFARTI000002283290", "@fin": "2999-01-01", "@num": "3", "@debut": "2999-01-01", "@origine": "JORF" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
Le dossier de demande d'autorisation d'une recherche biomédicale ne portant pas sur un produit mentionné à l'article L. 5311-1 du code de la santé publique se compose des quatre parties suivantes :
\n
I. - Un dossier administratif contenant les informations suivantes :
\n
1° Un courrier de demande d'autorisation, daté et signé, disponible en version électronique sur le site internet du ministère chargé de la santé ou en version papier, sur demande auprès du ministère chargé de la santé, direction générale de la santé ;
\n
2° Le formulaire de demande d'autorisation, daté et signé, disponible en version électronique sur le site internet du ministère chargé de la santé ou en version papier, sur demande auprès du ministère chargé de la santé, direction générale de la santé ;
\n
3° Si le demandeur n'est pas le promoteur, l'autorisation écrite lui permettant d'agir pour le compte du promoteur ;
\n
4° Le justificatif du versement des taxes prévues à l'article L. 1123-8 du code de la santé publique.
\n
II. - Un dossier sur la recherche biomédicale contenant les informations suivantes :
\n
1° Le protocole de la recherche, tel que défini à l'article R. 1123-20 du code de la santé publique, daté et comportant un numéro de version ;
\n
2° Le résumé du protocole de la recherche ;
\n
3° La brochure pour l'investigateur lorsque la recherche porte sur des produits autres que ceux mentionnés à l'article L. 5311-1 du code de la santé publique ;
\n
4° La copie de l'attestation d'assurance telle que prévue à l'article L. 1121-10 du code de la santé publique ;
\n
5° Le cas échéant, l'avis d'un comité scientifique consulté par le promoteur.
\n
III. - Le cas échéant, un dossier technique relatif aux produits utilisés dans le cadre de la recherche :
\n
1. Lorsque l'objet de la recherche porte sur un produit autre que ceux mentionnés à l'article L. 5311-1 du code de la santé publique, le promoteur transmet un dossier technique comportant les informations suivantes :
\n
a) La composition du produit ;
\n
b) La qualité, chimique ou biologique, du produit ;
\n
c) Les données non cliniques obtenues à partir des études toxicologiques ;
\n
d) Les données cliniques obtenues à partir des recherches biomédicales préalablement menées avec le même produit ou correspondant à des effets médicaux antérieurement connus.
\n
Ce dossier comporte également, le cas échéant, le certificat d'analyse du produit expérimenté dans les cas où sont détectées soit des impuretés qui ne sont pas justifiées par les spécifications précisées dans le dossier du produit expérimental relatif aux données sur la qualité, chimique et biologique, soit des impuretés inattendues qui ne sont pas couvertes par ces spécifications.
\n
Le promoteur tient à la disposition du ministre chargé de la santé, à sa demande, les données complètes des études référencées dans le dossier du produit expérimental, sauf exception dûment justifiée.
\n
2. Si la recherche biomédicale ne portant pas sur un produit mentionné à l'article L. 5311-1 du code de la santé publique implique l'utilisation d'un médicament, le promoteur transmet les informations suivantes :
\n
a) Si ce médicament dispose d'une autorisation de mise sur le marché en France ou dans un autre Etat membre de la Communauté européenne ou d'une autorisation équivalente délivrée par une autorité compétente aux Etats-Unis ou au Japon : le résumé des caractéristiques du produit tel que prévu dans cette autorisation de mise sur le marché ;
\n
b) Si le promoteur souhaite importer un médicament nécessaire à la réalisation de la recherche une fois celle-ci autorisée par le ministre chargé de la santé, le promoteur joint au dossier de demande d'autorisation : une demande d'attestation en vue de l'importation de médicaments, disponible en version électronique sur le site internet de l'Agence française de sécurité sanitaire des produits de santé ou en version papier sur demande auprès de l'Agence française de sécurité sanitaire des produits de santé.
\n
3. Si la recherche biomédicale ne portant pas sur un produit mentionné à l'article L. 5311-1 du code de la santé publique implique l'utilisation d'un dispositif médical ne disposant pas d'un marquage CE ou disposant d'un marquage CE mais utilisé dans une autre destination que celle prévue par le marquage CE, le promoteur transmet les informations suivantes relatives à ce dispositif :
\n
a) La description du dispositif et la notice d'instruction ;
\n
b) Lorsque le promoteur est le fabricant du dispositif, la déclaration de conformité aux exigences essentielles, documentée par les résultats de l'analyse des risques ainsi que la liste des référentiels appliqués ;
\n
c) Lorsque le promoteur n'est pas le fabricant du dispositif, les résultats de l'analyse des risques ou, le cas échéant, les résultats de l'évaluation des risques éventuels générés par l'utilisation envisagée dans la recherche ;
\n
d) Les données non cliniques et, le cas échéant, cliniques relatives au dispositif utilisé dans la recherche.
\n
IV. - La copie de l'avis du comité de protection des personnes mentionné à l'article L. 1121-4 du code de la santé publique, s'il est disponible.
" } }, "LEGIARTI000006254320": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "3", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2009-03-01", "DATE_DEBUT": "2006-08-26" } }, "META_COMMUN": { "ID": "LEGIARTI000006254320", "URL": "article/LEGI/ARTI/00/00/06/25/43/LEGIARTI000006254320.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SRIFEXXXXXX003AAXXXXXXAA" } }, "LIENS": { "LIEN": [ { "#text": "Arrêté 2006-08-16 annexe", "@sens": "source", "@typelien": "CITATION" }, { "@id": "LEGIARTI000006685848", "@num": "L1121-10", "#text": "Code de la santé publique - art. L1121-10 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006685852", "@num": "L1121-13", "#text": "Code de la santé publique - art. L1121-13 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006685883", "@num": "L1123-8", "#text": "Code de la santé publique - art. L1123-8 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006690344", "@num": "L5311-1", "#text": "Code de la santé publique - art. L5311-1 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006908378", "@num": "R1123-20", "#text": "Code de la santé publique - art. R1123-20 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "@cid": "JORFTEXT000000459554", "@nor": "SANP0623381A", "@nature": "ARRETE", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Arrêté du 16 août 2006 fixant le contenu, le format et les modalités de présentation du dossier de demande d'avis au comité de protection des personnes sur un projet de recherche biomédicale ne portant pas sur un produit mentionné à l'article L. 5311-1 du code de la santé publique", "@debut": "2999-01-01", "@id_txt": "JORFTEXT000000459554", "@c_titre_court": "Arrêté du 16 août 2006" }, { "@fin": "2016-12-10", "#text": "Arrêté du 16 août 2006 fixant le contenu, le format et les modalités de présentation du dossier de demande d'avis au comité de protection des personnes sur un projet de recherche biomédicale ne portant pas sur un produit mentionné à l'article L. 5311-1 du code de la santé publique", "@debut": "2006-08-26", "@id_txt": "LEGITEXT000006054302", "@c_titre_court": "Arrêté du 16 août 2006" } ], "@ministere": "MINISTERE DE LA SANTE ET DES SOLIDARITES", "@date_publi": "2006-08-26", "@date_signature": "2006-08-16" } }, "VERSIONS": { "VERSION": [ { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006254320", "@fin": "2009-03-01", "@num": "3", "@etat": "MODIFIE", "@debut": "2006-08-26", "@origine": "LEGI" } }, { "@etat": "ABROGE", "LIEN_ART": { "@id": "LEGIARTI000020320295", "@fin": "2016-12-10", "@num": "3", "@etat": "ABROGE", "@debut": "2009-03-01", "@origine": "LEGI" } }, { "LIEN_ART": { "@id": "JORFARTI000002470844", "@fin": "2999-01-01", "@num": "3", "@debut": "2999-01-01", "@origine": "JORF" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
Le dossier de demande d'avis sur un projet de recherche biomédicale ne portant pas sur un produit mentionné à l'article L. 5311-1 du code de la santé, adressé au comité de protection des personnes concerné, comprend :
\n
I. - Un dossier administratif contenant les informations suivantes :
\n
1° Un courrier de demande d'avis, daté et signé ;
\n
2° Le formulaire de demande d'avis, daté et signé, disponible en version électronique sur le site internet du ministère chargé de la santé ou en version papier, sur demande auprès du ministère chargé de la santé, direction générale de la santé ;
\n
3° Le document additionnel à la demande d'avis au comité de protection des personnes, décrit en annexe du présent arrêté, daté et signé, accompagné, le cas échéant, des supports susceptibles d'être utilisés en vue du recrutement des personnes ;
\n
4° Si le demandeur n'est pas le promoteur, l'autorisation écrite lui permettant d'agir pour le compte du promoteur ;
\n
5° Si nécessaire, la copie de la ou des autorisations de lieux de recherches biomédicales mentionnées à l'article L. 1121-13 du code de la santé publique ;
\n
6° Le justificatif du versement des taxes prévues à l'article L. 1123-8 du code de la santé publique.
\n
II. - Un dossier sur la recherche biomédicale contenant les informations suivantes :
\n
1° Le protocole de la recherche tel que défini à l'article R. 1123-20 du code de la santé publique, daté et comportant un numéro de version ;
\n
2° Le résumé du protocole ;
\n
3° La brochure pour l'investigateur lorsque la recherche porte sur un produit autre que ceux mentionnés à l'article L. 5311-1 du code de la santé publique ;
\n
4° Le cas échéant, le résumé des caractéristiques du produit comparateur ;
\n
5° Si la brochure pour l'investigateur appartient à un tiers, l'autorisation du tiers délivrée au promoteur pour l'utiliser ;
\n
6° Le document d'information destiné aux personnes qui se prêtent à la recherche ;
\n
7° Le formulaire de recueil du consentement des personnes se prêtant à la recherche ou d'autorisation dans les cas prévus à l'article L. 1122-2 ;
\n
8° La copie de l'attestation d'assurance prévue à l'article L. 1121-10 du code de la santé publique ;
\n
9° Le cas échéant, l'avis d'un comité scientifique consulté par le promoteur ;
\n
10° Une justification de l'adéquation des moyens humains, matériels et techniques au projet de recherche biomédicale et de leur compatibilité avec les impératifs de sécurité des personnes qui s'y prêtent, sauf si le lieu bénéficie de l'autorisation mentionnée à l'article L. 1121-13 du code de la santé publique ;
\n
11° Les curriculum vitae du ou des investigateurs ;
\n
12° La nature de la décision finale du ministre chargé de la santé, mentionnée à l'article L. 1123-8 du code de la santé publique, si cette décision est disponible.
" } }, "LEGIARTI000006256267": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "3", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2009-03-07", "DATE_DEBUT": "2006-11-04" } }, "META_COMMUN": { "ID": "LEGIARTI000006256267", "URL": "article/LEGI/ARTI/00/00/06/25/62/LEGIARTI000006256267.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SRIFXXXXXXX003AAXXXXXXAA" } }, "LIENS": { "LIEN": [ { "#text": "Arrêté 2006-10-23 annexe", "@sens": "source", "@typelien": "CITATION" }, { "@id": "LEGIARTI000006685848", "@num": "L1121-10", "#text": "Code de la santé publique - art. L1121-10 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006685852", "@num": "L1121-13", "#text": "Code de la santé publique - art. L1121-13 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006685859", "@num": "L1122-1", "#text": "Code de la santé publique - art. L1122-1 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006685883", "@num": "L1123-8", "#text": "Code de la santé publique - art. L1123-8 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006908378", "@num": "R1123-20", "#text": "Code de la santé publique - art. R1123-20 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "@cid": "JORFTEXT000000459238", "@nor": "SANP0624375A", "@nature": "ARRETE", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Arrêté du 23 octobre 2006 fixant le contenu, le format et les modalités de présentation du dossier de demande d'avis au comité de protection des personnes sur un projet de recherche biomédicale portant sur les produits sanguins labiles, les organes, les tissus d'origine humaine ou animale et les préparations de thérapie cellulaire mentionnées à l'article L. 1243-1 du code de la santé publique", "@debut": "2999-01-01", "@id_txt": "JORFTEXT000000459238", "@c_titre_court": "Arrêté du 23 octobre 2006" }, { "@fin": "2021-02-13", "#text": "Arrêté du 23 octobre 2006 fixant le contenu, le format et les modalités de présentation du dossier de demande d'avis au comité de protection des personnes sur un projet de recherche biomédicale portant sur les produits sanguins labiles, les organes, les tissus d'origine humaine ou animale et les préparations de thérapie cellulaire mentionnées à l'article L. 1243-1 du code de la santé publique", "@debut": "2006-11-04", "@id_txt": "LEGITEXT000006054654", "@c_titre_court": "Arrêté du 23 octobre 2006" } ], "@ministere": "MINISTERE DE LA SANTE ET DES SOLIDARITES", "@date_publi": "2006-11-04", "@date_signature": "2006-10-23", "@num_parution_jo": "0256" } }, "VERSIONS": { "VERSION": [ { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006256267", "@fin": "2009-03-07", "@num": "3", "@etat": "MODIFIE", "@debut": "2006-11-04", "@origine": "LEGI" } }, { "@etat": "ABROGE", "LIEN_ART": { "@id": "LEGIARTI000020350765", "@fin": "2021-02-13", "@num": "3", "@etat": "ABROGE", "@debut": "2009-03-07", "@origine": "LEGI" } }, { "LIEN_ART": { "@id": "JORFARTI000002282763", "@fin": "2999-01-01", "@num": "3", "@debut": "2999-01-01", "@origine": "JORF" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
Le dossier de demande d'avis sur un projet de recherche biomédicale portant sur les produits sanguins labiles, les organes, les tissus d'origine humaine ou animale et les préparations de thérapie cellulaire, adressé au comité de protection des personnes concerné, comprend :
\n
I. - Un dossier administratif contenant les informations suivantes :
\n
1° Un courrier de demande d'avis daté et signé ;
\n
2° Le formulaire de demande d'avis, daté et signé, disponible en version électronique sur le site internet de l'Agence française de sécurité des produits de santé ou en version papier, sur demande auprès de l'Agence française de sécurité sanitaire des produits de santé ;
\n
3° Le document additionnel à la demande d'avis au comité de protection des personnes décrit en annexe du présent arrêté, daté et signé, accompagné des supports susceptibles d'être utilisés en vue du recrutement des personnes ;
\n
4° Le cas échéant, la liste des autorités compétentes des Etats membres de la Communauté européenne auxquelles la demande a été soumise et la nature de leurs décisions finales, si elles sont disponibles ;
\n
5° Si le demandeur n'est pas le promoteur, l'autorisation écrite lui permettant d'agir pour le compte du promoteur ;
\n
6° Le cas échéant, la copie de la ou des autorisations de lieux de recherches biomédicales mentionnées à l'article L. 1121-13 du code de la santé publique ;
\n
7° Le justificatif du versement des taxes prévues à l'article L. 1123-8 du code de la santé publique.
\n
II. - Un dossier sur la recherche biomédicale contenant les informations suivantes :
\n
1° Le protocole de la recherche tel que défini à l'article R. 1123-20 du code de la santé publique, daté et comportant un numéro de version ;
\n
2° Le résumé du protocole ;
\n
3° La brochure pour l'investigateur ;
\n
4° Si la brochure pour l'investigateur appartient à un tiers, l'autorisation du tiers délivrée au promoteur pour l'utiliser ;
\n
5° Le document d'information destiné aux personnes qui se prêtent à la recherche prévu à l'article L. 1122-1 du code de la santé publique.
\n
Lorsque la recherche porte sur un tissu préparé selon un procédé autorisé ou sur une préparation de thérapie cellulaire disposant d'une autorisation en France, le dossier comprend :
\n
- une comparaison du document d'information destiné aux personnes qui se prêtent à la recherche et des éléments de l'autorisation du produit portant sur des contre-indications et des effets indésirables graves ou des mises en garde ou précautions d'emploi particulières ;
\n
- et, le cas échéant, la description et la justification des divergences pertinentes en termes de sécurité des personnes entre le document d'information destiné aux personnes qui se prêtent à la recherche et les éléments de l'autorisation du produit portant sur des contre-indications et des effets indésirables graves ou des mises en garde ou précautions d'emploi particulières ;
\n
6° Le formulaire de recueil du consentement des personnes se prêtant à la recherche ;
\n
7° La copie de l'attestation d'assurance prévue à l'article L. 1121-10 du code de la santé publique ;
\n
8° Le cas échéant, l'avis d'un comité scientifique consulté par le promoteur ;
\n
9° Une justification de l'adéquation des moyens humains, matériels et techniques au projet de recherche biomédicale et de leur compatibilité avec les impératifs de sécurité des personnes qui s'y prêtent, sauf si le lieu bénéficie de l'autorisation mentionnée à l'article L. 1121-13 du code de la santé publique ;
\n
10° Les curriculum vitae du ou des investigateurs ;
\n
11° La nature de la décision finale de l'Agence française de sécurité sanitaire des produits de santé mentionnée à l'article L. 1123-8 du code de la santé publique, si cette décision est disponible.
" } }, "LEGIARTI000006275436": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "6", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2000-06-22", "DATE_DEBUT": "1990-07-05" } }, "META_COMMUN": { "ID": "LEGIARTI000006275436", "URL": "article/LEGI/ARTI/00/00/06/27/54/LEGIARTI000006275436.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SPEAJXXXXXX006AAXXXXXXAC" } }, "LIENS": { "LIEN": [ { "@id": "LEGIARTI000006696432", "@num": "1", "#text": "Loi n°90-549 du 2 juillet 1990 - art. 1 () JORF 5 juillet 1990", "@sens": "source", "@cidtexte": "JORFTEXT000000715844", "@nortexte": "SPSX9010213L", "@numtexte": "90-549", "@typelien": "MODIFICATION", "@naturetexte": "LOI", "@datesignatexte": "1990-07-02" }, { "@id": "LEGIARTI000006685848", "@num": "L1121-10", "#text": "Code de la santé publique - art. L1121-10 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006685891", "@num": "L1123-11", "#text": "Code de la santé publique - art. L1123-11 (T)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006685904", "@num": "L1124-7", "#text": "Code de la santé publique - art. L1124-7 (Ab)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006692620", "@num": "L209-11", "#text": "Code de la santé publique - art. L209-11 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006692624", "@num": "L209-12", "#text": "Code de la santé publique - art. L209-12 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006692643", "@num": "L209-17", "#text": "Code de la santé publique - art. L209-17 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006692645", "@num": "L209-18", "#text": "Code de la santé publique - art. L209-18 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006692658", "@num": "L209-20", "#text": "Code de la santé publique - art. L209-20 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006692609", "@num": "L209-7", "#text": "Code de la santé publique - art. L209-7 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "@cid": "JORFTEXT000000508831", "@nor": "SPSX8810045L", "@num": "88-1138", "@nature": "LOI", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Loi n°88-1138 du 20 décembre 1988 DITE HURIET RELATIVE A LA PROTECTION DES PERSONNES QUI SE PRETENT A DES RECHERCHES BIOMEDICALES", "@debut": "2999-01-01", "@id_txt": "JORFTEXT000000508831", "@c_titre_court": "Loi n°88-1138 du 20 décembre 1988" }, { "@fin": "2999-01-01", "#text": "Loi n° 88-1138 du 20 décembre 1988 relative à la protection des personnes qui se prêtent à des recherches biomédicales", "@debut": "1988-12-22", "@id_txt": "LEGITEXT000006069027", "@c_titre_court": "Loi n° 88-1138 du 20 décembre 1988" } ], "@date_publi": "1988-12-22", "@date_signature": "1988-12-20" } }, "VERSIONS": { "VERSION": [ { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006275434", "@fin": "1990-01-25", "@num": "6", "@etat": "MODIFIE", "@debut": "1988-12-22", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006275435", "@fin": "1990-07-05", "@num": "6", "@etat": "MODIFIE", "@debut": "1990-01-25", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006275436", "@fin": "2000-06-22", "@num": "6", "@etat": "MODIFIE", "@debut": "1990-07-05", "@origine": "LEGI" } }, { "@etat": "VIGUEUR", "LIEN_ART": { "@id": "LEGIARTI000006275437", "@fin": "2999-01-01", "@num": "6", "@etat": "VIGUEUR", "@debut": "2000-06-22", "@origine": "LEGI" } }, { "LIEN_ART": { "@id": "JORFARTI000002279309", "@fin": "2999-01-01", "@num": "6", "@debut": "2999-01-01", "@origine": "JORF" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
Des décrets en Conseil d'Etat fixent les modalités d'application de la présente loi et notamment :
\n
1° La composition et les conditions d'agrément, de financement, de fonctionnement et de nomination des membres des comités consultatifs de protection des personnes dans la recherche biomédicale ainsi que la nature des informations qui doivent leur être communiquées par l'investigateur et sur lesquelles ils sont appelés à émettre leur avis ;
\n
2° Les conditions de la constitution, de la gestion et de la consultation du fichier national prévu à l'article L. 209-17 du code de la santé publique ;
\n
3° Les conditions de l'autorisation prévue à l'article L. 209-18 du même code ;
\n
4° La nature des informations qui doivent être communiquées par le promoteur au ministre chargé de la santé, dans la lettre d'intention mentionnée à l'article L. 209-12 du code de la santé publique.
\n
5° Les minima de garanties pour l'assurance prévue au troisième alinéa de l'article L. 209-7 du code de la santé publique.
\n
Les articles L. 209-11, L. 209-12, L. 209-17, L. 209-18 et L. 209-20 (premier à troisième et dernier alinéas) du code de la santé publique entreront en vigueur aux dates fixées par les textes pris pour leur application et au plus tard le 31 décembre 1990.
" } }, "LEGIARTI000006275437": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "6", "ETAT": "VIGUEUR", "TYPE": "AUTONOME", "DATE_FIN": "2999-01-01", "DATE_DEBUT": "2000-06-22" } }, "META_COMMUN": { "ID": "LEGIARTI000006275437", "URL": "article/LEGI/ARTI/00/00/06/27/54/LEGIARTI000006275437.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SPEAJXXXXXX006AAXXXXXXAD" } }, "LIENS": { "LIEN": [ { "@id": "JORFTEXT000000217229", "#text": "Ordonnance 2000-548 2000-06-15 art. 4 II JORF 22 juin 2000", "@sens": "source", "@cidtexte": "JORFTEXT000000217229", "@nortexte": "MESX0000036R", "@typelien": "MODIFICATION", "@naturetexte": "RAPPORT", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006685848", "@num": "L1121-10", "#text": "Code de la santé publique - art. L1121-10 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006685891", "@num": "L1123-11", "#text": "Code de la santé publique - art. L1123-11 (T)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006685904", "@num": "L1124-7", "#text": "Code de la santé publique - art. L1124-7 (Ab)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006692620", "@num": "L209-11", "#text": "Code de la santé publique - art. L209-11 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006692624", "@num": "L209-12", "#text": "Code de la santé publique - art. L209-12 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006692643", "@num": "L209-17", "#text": "Code de la santé publique - art. L209-17 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006692645", "@num": "L209-18", "#text": "Code de la santé publique - art. L209-18 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006692658", "@num": "L209-20", "#text": "Code de la santé publique - art. L209-20 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "@cid": "JORFTEXT000000508831", "@nor": "SPSX8810045L", "@num": "88-1138", "@nature": "LOI", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Loi n°88-1138 du 20 décembre 1988 DITE HURIET RELATIVE A LA PROTECTION DES PERSONNES QUI SE PRETENT A DES RECHERCHES BIOMEDICALES", "@debut": "2999-01-01", "@id_txt": "JORFTEXT000000508831", "@c_titre_court": "Loi n°88-1138 du 20 décembre 1988" }, { "@fin": "2999-01-01", "#text": "Loi n° 88-1138 du 20 décembre 1988 relative à la protection des personnes qui se prêtent à des recherches biomédicales", "@debut": "1988-12-22", "@id_txt": "LEGITEXT000006069027", "@c_titre_court": "Loi n° 88-1138 du 20 décembre 1988" } ], "@date_publi": "1988-12-22", "@date_signature": "1988-12-20" } }, "VERSIONS": { "VERSION": [ { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006275434", "@fin": "1990-01-25", "@num": "6", "@etat": "MODIFIE", "@debut": "1988-12-22", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006275435", "@fin": "1990-07-05", "@num": "6", "@etat": "MODIFIE", "@debut": "1990-01-25", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006275436", "@fin": "2000-06-22", "@num": "6", "@etat": "MODIFIE", "@debut": "1990-07-05", "@origine": "LEGI" } }, { "@etat": "VIGUEUR", "LIEN_ART": { "@id": "LEGIARTI000006275437", "@fin": "2999-01-01", "@num": "6", "@etat": "VIGUEUR", "@debut": "2000-06-22", "@origine": "LEGI" } }, { "LIEN_ART": { "@id": "JORFARTI000002279309", "@fin": "2999-01-01", "@num": "6", "@debut": "2999-01-01", "@origine": "JORF" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
Des décrets en Conseil d'Etat fixent les modalités d'application de la présente loi et notamment :
\n
1° à 5° Abrogés
\n
Les articles L. 209-11, L. 209-12, L. 209-17, L. 209-18 et L. 209-20 (premier à troisième et dernier alinéas) du code de la santé publique entreront en vigueur aux dates fixées par les textes pris pour leur application et au plus tard le 31 décembre 1990.
" } }, "LEGIARTI000006685839": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "L1121-7", "ETAT": "TRANSFERE", "TYPE": "AUTONOME", "DATE_FIN": "2004-08-11", "DATE_DEBUT": "2000-06-22" } }, "META_COMMUN": { "ID": "LEGIARTI000006685839", "URL": "article/LEGI/ARTI/00/00/06/68/58/LEGIARTI000006685839.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SPANXXXXXXX1X1121L07XXAA" } }, "LIENS": { "LIEN": [ { "@id": "JORFTEXT000000217229", "#text": "Ordonnance 2000-548 2000-06-15", "@sens": "source", "@cidtexte": "JORFTEXT000000217229", "@nortexte": "MESX0000036P", "@typelien": "CODIFICATION", "@naturetexte": "RAPPORT", "@datesignatexte": "2999-01-01" }, { "@id": "JORFTEXT000000227015", "#text": "Loi 2002-303 2002-03-04 art. 92 JORF 5 mars 2002", "@sens": "source", "@cidtexte": "JORFTEXT000000227015", "@nortexte": "MESX0100092L", "@numtexte": "2002-303", "@typelien": "CODIFICATION", "@naturetexte": "LOI", "@datesignatexte": "2002-03-04" }, { "@id": "LEGIARTI000006697709", "@num": "88", "#text": "Loi n°2004-806 du 9 août 2004 - art. 88 () JORF 11 août 2004", "@sens": "source", "@cidtexte": "JORFTEXT000000787078", "@nortexte": "SANX0300055L", "@numtexte": "2004-806", "@typelien": "TRANSFERT", "@naturetexte": "LOI", "@datesignatexte": "2004-08-09" }, { "@id": "LEGIARTI000006685848", "@num": "L1121-10", "#text": "Code de la santé publique - art. L1121-10 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006685848", "@num": "L1121-10", "#text": "Code de la santé publique - art. L1121-10 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006685849", "@num": "L1121-10", "#text": "Code de la santé publique - art. L1121-10 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006685933", "@num": "L1126-6", "#text": "Code de la santé publique - art. L1126-6 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006685999", "@num": "L1142-3", "#text": "Code de la santé publique - art. L1142-3 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006686091", "@num": "L1221-8-1", "#text": "Code de la santé publique - art. L1221-8-1 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006692611", "@num": "L209-7", "#text": "Code de la santé publique - art. L209-7 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006692609", "@num": "L209-7", "#text": "Code de la santé publique - art. L209-7 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006908316", "@num": "R1121-2", "#text": "Code de la santé publique - art. R1121-2 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006170998", "@fin": "2016-12-31", "#text": "Chapitre Ier : Principes généraux", "@debut": "2000-06-22" }, { "@id": "LEGISCTA000032722874", "@fin": "2999-01-01", "#text": "Chapitre Ier : Principes généraux relatifs aux recherches impliquant la personne humaine", "@debut": "2016-12-31" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006154978", "@fin": "2012-03-07", "#text": "Titre II : Recherches biomédicales", "@debut": "2000-06-22" }, { "@id": "LEGISCTA000025457387", "@fin": "2999-01-01", "#text": "Titre II : Recherches impliquant la personne humaine", "@debut": "2012-03-07" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006140603", "@fin": "2999-01-01", "#text": "Livre Ier : Protection des personnes en matière de santé", "@debut": "2000-06-22" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006125345", "@fin": "2999-01-01", "#text": "Première partie : Protection générale de la santé", "@debut": "2000-06-22" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006103419", "@fin": "2999-01-01", "#text": "Partie législative", "@debut": "2000-06-22" } ] }, "@cid": "LEGITEXT000006072665", "@nature": "CODE", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Code de la santé publique", "@debut": "1953-10-07", "@id_txt": "LEGITEXT000006072665", "@c_titre_court": "Code de la santé publique" } ], "@date_publi": "2999-01-01", "@date_signature": "2999-01-01" } }, "VERSIONS": { "VERSION": [ { "@etat": "TRANSFERE", "LIEN_ART": { "@id": "LEGIARTI000006685839", "@fin": "2004-08-11", "@num": "L1121-7", "@etat": "TRANSFERE", "@debut": "2000-06-22", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006685840", "@fin": "2012-03-07", "@num": "L1121-7", "@etat": "MODIFIE", "@debut": "2004-08-11", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000025457542", "@fin": "2019-03-11", "@num": "L1121-7", "@etat": "MODIFIE", "@debut": "2012-03-07", "@origine": "LEGI" } }, { "@etat": "VIGUEUR", "LIEN_ART": { "@id": "LEGIARTI000038219268", "@fin": "2999-01-01", "@num": "L1121-7", "@etat": "VIGUEUR", "@debut": "2019-03-11", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
Pour les recherches biomédicales sans bénéfice individuel direct, le promoteur assume, même sans faute, l'indemnisation des conséquences dommageables de la recherche pour la personne qui s'y prête et celle de ses ayants droit, sans que puisse être opposé le fait d'un tiers ou le retrait volontaire de la personne qui avait initialement consenti à se prêter à la recherche.
\n
Pour les recherches biomédicales avec bénéfice individuel direct, le promoteur assume l'indemnisation des conséquences dommageables de la recherche pour la personne qui s'y prête et celle de ses ayants droit, sauf preuve à sa charge que le dommage n'est pas imputable à sa faute, ou à celle de tout intervenant sans que puisse être opposé le fait d'un tiers ou le retrait volontaire de la personne qui avait initialement consenti à se prêter à la recherche.
\n
La recherche biomédicale exige la souscription préalable, par son promoteur, d'une assurance garantissant sa responsabilité civile telle qu'elle résulte du présent article et celle de tout intervenant, indépendamment de la nature des liens existant entre les intervenants et le promoteur. Les dispositions du présent article sont d'ordre public.
" } }, "LEGIARTI000006685840": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "L1121-7", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2012-03-07", "DATE_DEBUT": "2004-08-11" } }, "META_COMMUN": { "ID": "LEGIARTI000006685840", "URL": "article/LEGI/ARTI/00/00/06/68/58/LEGIARTI000006685840.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SPANXXXXXXX1X1121L07XXAB" } }, "LIENS": { "LIEN": [ { "@id": "JORFTEXT000000217229", "#text": "Ordonnance 2000-548 2000-06-15", "@sens": "source", "@cidtexte": "JORFTEXT000000217229", "@nortexte": "MESX0000036P", "@typelien": "CODIFICATION", "@naturetexte": "RAPPORT", "@datesignatexte": "2999-01-01" }, { "@id": "JORFTEXT000000227015", "#text": "Loi 2002-303 2002-03-04 art. 92 JORF 5 mars 2002", "@sens": "source", "@cidtexte": "JORFTEXT000000227015", "@nortexte": "MESX0100092L", "@numtexte": "2002-303", "@typelien": "CODIFICATION", "@naturetexte": "LOI", "@datesignatexte": "2002-03-04" }, { "@id": "LEGIARTI000006697709", "@num": "88", "#text": "Loi n°2004-806 du 9 août 2004 - art. 88 () JORF 11 août 2004", "@sens": "source", "@cidtexte": "JORFTEXT000000787078", "@nortexte": "SANX0300055L", "@numtexte": "2004-806", "@typelien": "MODIFICATION", "@naturetexte": "LOI", "@datesignatexte": "2004-08-09" }, { "@id": "LEGIARTI000006685848", "@num": "L1121-10", "#text": "Code de la santé publique - art. L1121-10 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006685848", "@num": "L1121-10", "#text": "Code de la santé publique - art. L1121-10 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006685849", "@num": "L1121-10", "#text": "Code de la santé publique - art. L1121-10 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006685933", "@num": "L1126-6", "#text": "Code de la santé publique - art. L1126-6 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006685999", "@num": "L1142-3", "#text": "Code de la santé publique - art. L1142-3 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006686091", "@num": "L1221-8-1", "#text": "Code de la santé publique - art. L1221-8-1 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006692611", "@num": "L209-7", "#text": "Code de la santé publique - art. L209-7 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006692609", "@num": "L209-7", "#text": "Code de la santé publique - art. L209-7 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006908316", "@num": "R1121-2", "#text": "Code de la santé publique - art. R1121-2 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006170998", "@fin": "2016-12-31", "#text": "Chapitre Ier : Principes généraux", "@debut": "2000-06-22" }, { "@id": "LEGISCTA000032722874", "@fin": "2999-01-01", "#text": "Chapitre Ier : Principes généraux relatifs aux recherches impliquant la personne humaine", "@debut": "2016-12-31" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006154978", "@fin": "2012-03-07", "#text": "Titre II : Recherches biomédicales", "@debut": "2000-06-22" }, { "@id": "LEGISCTA000025457387", "@fin": "2999-01-01", "#text": "Titre II : Recherches impliquant la personne humaine", "@debut": "2012-03-07" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006140603", "@fin": "2999-01-01", "#text": "Livre Ier : Protection des personnes en matière de santé", "@debut": "2000-06-22" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006125345", "@fin": "2999-01-01", "#text": "Première partie : Protection générale de la santé", "@debut": "2000-06-22" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006103419", "@fin": "2999-01-01", "#text": "Partie législative", "@debut": "2000-06-22" } ] }, "@cid": "LEGITEXT000006072665", "@nature": "CODE", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Code de la santé publique", "@debut": "1953-10-07", "@id_txt": "LEGITEXT000006072665", "@c_titre_court": "Code de la santé publique" } ], "@date_publi": "2999-01-01", "@date_signature": "2999-01-01" } }, "VERSIONS": { "VERSION": [ { "@etat": "TRANSFERE", "LIEN_ART": { "@id": "LEGIARTI000006685839", "@fin": "2004-08-11", "@num": "L1121-7", "@etat": "TRANSFERE", "@debut": "2000-06-22", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006685840", "@fin": "2012-03-07", "@num": "L1121-7", "@etat": "MODIFIE", "@debut": "2004-08-11", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000025457542", "@fin": "2019-03-11", "@num": "L1121-7", "@etat": "MODIFIE", "@debut": "2012-03-07", "@origine": "LEGI" } }, { "@etat": "VIGUEUR", "LIEN_ART": { "@id": "LEGIARTI000038219268", "@fin": "2999-01-01", "@num": "L1121-7", "@etat": "VIGUEUR", "@debut": "2019-03-11", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
Les mineurs ne peuvent être sollicités pour se prêter à des recherches biomédicales que si des recherches d'une efficacité comparable ne peuvent être effectuées sur des personnes majeures et dans les conditions suivantes :
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- soit l'importance du bénéfice escompté pour ces personnes est de nature à justifier le risque prévisible encouru ;
\n
- soit ces recherches se justifient au regard du bénéfice escompté pour d'autres mineurs. Dans ce cas, les risques prévisibles et les contraintes que comporte la recherche doivent présenter un caractère minimal.
" } }, "LEGIARTI000006685857": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "L1121-17", "ETAT": "VIGUEUR", "TYPE": "AUTONOME", "DATE_FIN": "2999-01-01", "DATE_DEBUT": "2004-08-11" } }, "META_COMMUN": { "ID": "LEGIARTI000006685857", "URL": "article/LEGI/ARTI/00/00/06/68/58/LEGIARTI000006685857.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SPANXXXXXXX1X1121L17XXAA" } }, "LIENS": { "LIEN": [ { "@id": "JORFTEXT000000217229", "#text": "Ordonnance 2000-548 2000-06-15", "@sens": "source", "@cidtexte": "JORFTEXT000000217229", "@nortexte": "MESX0000036P", "@typelien": "CODIFICATION", "@naturetexte": "RAPPORT", "@datesignatexte": "2999-01-01" }, { "@id": "JORFTEXT000000227015", "#text": "Loi 2002-303 2002-03-04 art. 92 JORF 5 mars 2002", "@sens": "source", "@cidtexte": "JORFTEXT000000227015", "@nortexte": "MESX0100092L", "@numtexte": "2002-303", "@typelien": "CODIFICATION", "@naturetexte": "LOI", "@datesignatexte": "2002-03-04" }, { "@id": "LEGIARTI000006697709", "@num": "88", "#text": "Loi n°2004-806 du 9 août 2004 - art. 88 () JORF 11 août 2004", "@sens": "source", "@cidtexte": "JORFTEXT000000787078", "@nortexte": "SANX0300055L", "@numtexte": "2004-806", "@typelien": "CREATION", "@naturetexte": "LOI", "@datesignatexte": "2004-08-09" }, { "@id": "LEGIARTI000025442824", "@num": "11", "#text": "LOI n°2012-300 du 5 mars 2012 - art. 11 (VT)", "@sens": "cible", "@cidtexte": "JORFTEXT000025441587", "@nortexte": "SASX0901817L", "@numtexte": "2012-300", "@typelien": "CITATION", "@naturetexte": "LOI", "@datesignatexte": "2012-03-05" }, { "@id": "LEGIARTI000006685848", "@num": "L1121-10", "#text": "Code de la santé publique - art. L1121-10 (VT)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006685852", "@num": "L1121-13", "#text": "Code de la santé publique - art. L1121-13 (VT)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006685854", "@num": "L1121-15", "#text": "Code de la santé publique - art. L1121-15 (VT)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006170998", "@fin": "2016-12-31", "#text": "Chapitre Ier : Principes généraux", "@debut": "2000-06-22" }, { "@id": "LEGISCTA000032722874", "@fin": "2999-01-01", "#text": "Chapitre Ier : Principes généraux relatifs aux recherches impliquant la personne humaine", "@debut": "2016-12-31" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006154978", "@fin": "2012-03-07", "#text": "Titre II : Recherches biomédicales", "@debut": "2000-06-22" }, { "@id": "LEGISCTA000025457387", "@fin": "2999-01-01", "#text": "Titre II : Recherches impliquant la personne humaine", "@debut": "2012-03-07" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006140603", "@fin": "2999-01-01", "#text": "Livre Ier : Protection des personnes en matière de santé", "@debut": "2000-06-22" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006125345", "@fin": "2999-01-01", "#text": "Première partie : Protection générale de la santé", "@debut": "2000-06-22" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006103419", "@fin": "2999-01-01", "#text": "Partie législative", "@debut": "2000-06-22" } ] }, "@cid": "LEGITEXT000006072665", "@nature": "CODE", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Code de la santé publique", "@debut": "1953-10-07", "@id_txt": "LEGITEXT000006072665", "@c_titre_court": "Code de la santé publique" } ], "@date_publi": "2999-01-01", "@date_signature": "2999-01-01" } }, "VERSIONS": { "VERSION": [ { "@etat": "VIGUEUR", "LIEN_ART": { "@id": "LEGIARTI000006685857", "@fin": "2999-01-01", "@num": "L1121-17", "@etat": "VIGUEUR", "@debut": "2004-08-11", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
Les modalités d'application des dispositions du présent chapitre sont déterminées par décret en Conseil d'Etat et notamment :
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1° Les minima de garanties pour l'assurance prévue au troisième alinéa de l'article L. 1121-10 ;
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2° Les conditions de l'autorisation prévue à l'article L. 1121-13 ;
\n
3° Les conditions d'établissement et de publication des répertoires prévus à l'article L. 1121-15.
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Le promoteur dont la responsabilité civile n'est pas garantie par l'assurance prévue à l'article L. 1121-10 est puni d'un an d'emprisonnement et de 15 000 euros d'amende.

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Le sang et ses composants peuvent être utilisés dans le cadre d'une activité de recherche, qu'ils aient été ou non prélevés par un établissement de transfusion sanguine. Dans ce cas, la recherche est menée à partir de prélèvements réalisés soit dans une finalité médicale, soit dans le cadre d'une recherche biomédicale, soit dans une finalité de constitution de collection d'échantillons biologiques humains. Dans ce dernier cas, les prélèvements de sang ne doivent comporter que des risques négligeables. Dans tous les cas, les principes mentionnés aux articles L. 1221-3, L. 1221-4 et L. 1221-6 sont applicables, sans préjudice des dispositions du titre II du livre Ier de la présente partie lorsque le sang ou ses composants sont prélevés ou utilisés dans le cadre d'une activité de recherche biomédicale.
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Lorsque le sang ou ses composants sont prélevés pour constituer directement une collection d'échantillons biologiques humains, les dispositions mentionnées aux articles L. 1243-3 et L. 1243-4 sont applicables ainsi que les principes de l'indemnisation des conséquences dommageables et de l'obligation d'assurance tels que définis, pour les recherches biomédicales, à l'article L. 1121-10.
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Lorsque des prélèvements de sang visés à l'alinéa précédent sont effectués, à des fins de constitution d'une collection d'échantillons biologiques humains, sur des femmes enceintes, des parturientes ou des mères qui allaitent, sur des mineurs ou des majeurs faisant l'objet d'une mesure de protection légale ou hors d'état d'exprimer leur consentement, sur des personnes privées de liberté, des personnes hospitalisées sans leur consentement, des personnes admises dans un établissement sanitaire ou social à d'autres fins que la recherche, le comité mentionné au troisième alinéa de l'article L. 1243-3 s'assure, en outre, que la collection est destinée à des recherches qui ne pourraient pas être effectuées sur une autre catégorie de la population avec une efficacité comparable.
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Le sang et ses composants peuvent être utilisés dans le cadre d'une activité de recherche, qu'ils aient été ou non prélevés par un établissement de transfusion sanguine. Dans ce cas, la recherche est menée à partir de prélèvements réalisés soit dans une finalité médicale, soit dans le cadre d'une recherche visant à évaluer les soins courants mentionnée au 2° de l'article L. 1121-1, soit dans le cadre d'une recherche biomédicale, soit dans une finalité de constitution de collection d'échantillons biologiques humains. Dans ce dernier cas, les prélèvements de sang ne doivent comporter que des risques négligeables. Dans tous les cas, les principes mentionnés aux articles L. 1221-3, L. 1221-4 et L. 1221-6 sont applicables, sans préjudice des dispositions du titre II du livre Ier de la présente partie lorsque le sang ou ses composants sont prélevés ou utilisés dans le cadre d'une activité de recherche biomédicale.
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Lorsque le sang ou ses composants sont prélevés pour constituer directement une collection d'échantillons biologiques humains, les dispositions mentionnées aux articles L. 1243-3 et L. 1243-4 sont applicables ainsi que les principes de l'indemnisation des conséquences dommageables et de l'obligation d'assurance tels que définis, pour les recherches biomédicales, à l'article L. 1121-10.
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Lorsque des prélèvements de sang visés à l'alinéa précédent sont effectués, à des fins de constitution d'une collection d'échantillons biologiques humains, sur des femmes enceintes, des parturientes ou des mères qui allaitent, sur des mineurs ou des majeurs faisant l'objet d'une mesure de protection légale ou hors d'état d'exprimer leur consentement, sur des personnes privées de liberté, des personnes hospitalisées sans leur consentement, des personnes admises dans un établissement sanitaire ou social à d'autres fins que la recherche, le comité mentionné au troisième alinéa de l'article L. 1243-3 s'assure, en outre, que la collection est destinée à des recherches qui ne pourraient pas être effectuées sur une autre catégorie de la population avec une efficacité comparable.
" } }, "LEGIARTI000020317472": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "3", "ETAT": "VIGUEUR", "TYPE": "AUTONOME", "DATE_FIN": "2999-01-01", "DATE_DEBUT": "2009-02-28" } }, "META_COMMUN": { "ID": "LEGIARTI000020317472", "URL": "article/LEGI/ARTI/00/00/20/31/74/LEGIARTI000020317472.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "LIENS": { "LIEN": [ { "@id": "LEGIARTI000020316810", "@num": "1", "#text": "Arrêté du 19 février 2009 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000020315166", "@nortexte": "SASP0904393A", "@typelien": "MODIFIE", "@naturetexte": "ARRETE", "@datesignatexte": "2009-02-19" }, { "@id": "LEGITEXT000006072665", "#text": "Code de la santé publique", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006685848", "@num": "L1121-10", "#text": "Code de la santé publique - art. L1121-10", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006685833", "@num": "L1121-4", "#text": "Code de la santé publique - art. L1121-4", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006685895", "@num": "L1123-14", "#text": "Code de la santé publique - art. L1123-14", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006690281", "@num": "L5211-1", "#text": "Code de la santé publique - art. L5211-1", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006908378", "@num": "R1123-20", "#text": "Code de la santé publique - art. R1123-20", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006908399", "@num": "R1123-29", "#text": "Code de la santé publique - art. R1123-29", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "@cid": "JORFTEXT000000639975", "@nor": "SANP0623370A", "@nature": "ARRETE", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Arrêté du 16 août 2006 fixant le contenu, le format et les modalités de présentation à l'Agence française de sécurité sanitaire des produits de santé du dossier de demande d'autorisation de recherche biomédicale portant sur un dispositif médical ou sur un dispositif médical de diagnostic in vitro", "@debut": "2999-01-01", "@id_txt": "JORFTEXT000000639975", "@c_titre_court": "Arrêté du 16 août 2006" }, { "@fin": "2999-01-01", "#text": "Arrêté du 16 août 2006 fixant le contenu, le format et les modalités de présentation à l'Agence française de sécurité sanitaire des produits de santé du dossier de demande d'autorisation de recherche biomédicale portant sur un dispositif médical ou sur un dispositif médical de diagnostic in vitro", "@debut": "2006-08-26", "@id_txt": "LEGITEXT000006054291", "@c_titre_court": "Arrêté du 16 août 2006" } ], "@ministere": "MINISTERE DE LA SANTE ET DES SOLIDARITES", "@date_publi": "2006-08-26", "@date_signature": "2006-08-16" } }, "VERSIONS": { "VERSION": [ { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006254244", "@fin": "2009-02-28", "@num": "3", "@etat": "MODIFIE", "@debut": "2006-08-26", "@origine": "LEGI" } }, { "@etat": "VIGUEUR", "LIEN_ART": { "@id": "LEGIARTI000020317472", "@fin": "2999-01-01", "@num": "3", "@etat": "VIGUEUR", "@debut": "2009-02-28", "@origine": "LEGI" } }, { "LIEN_ART": { "@id": "JORFARTI000001494454", "@fin": "2999-01-01", "@num": "3", "@debut": "2999-01-01", "@origine": "JORF" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "

Le dossier de demande d'autorisation d'une recherche biomédicale portant sur un dispositif médical ou sur un dispositif médical de diagnostic in vitro, tels que définis aux articles L. 5211-1 et L. 5221-1 du code de la santé publique, se compose des quatre parties suivantes :

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I. - Un dossier administratif contenant les informations suivantes :

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1° Un courrier de demande d'autorisation, daté et signé, disponible en version électronique sur le site internet de l'Agence française de sécurité sanitaire des produits de santé ou en version papier, sur demande auprès de l'Agence française de sécurité sanitaire des produits de santé ;

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2° Le formulaire de demande d'autorisation, daté et signé, disponible en version électronique sur le site internet de l'Agence française de sécurité sanitaire des produits de santé ou en version papier, sur demande auprès de l'Agence française de sécurité sanitaire des produits de santé ;

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3° Le cas échéant, la liste des autorités compétentes des Etats membres de la Communauté européenne auxquelles la demande a été soumise et la nature de leurs décisions finales, si elles sont disponibles ;

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4° Si le demandeur n'est pas le promoteur, l'autorisation écrite lui permettant d'agir pour le compte du promoteur ;

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5° Le cas échéant, une copie de la ou des autorisations requises en application des dispositions du code de la santé publique, pour la mise en place de la recherche ou pour l'utilisation du dispositif médical ou du dispositif médical de diagnostic in vitro ;

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6° En cas de soumission de données relatives à un dispositif médical ou un dispositif médical de diagnostic in vitro sur lequel porte la recherche, appartenant à un tiers, en application du 4° de l'article 4 du présent arrêté, l'autorisation délivrée par ce dernier au promoteur pour communiquer ces données.

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II. - Un dossier sur la recherche biomédicale contenant les informations suivantes :

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1° Le protocole de la recherche, tel que défini à l'article R. 1123-20 du code de la santé publique, daté et comportant un numéro de version ;

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2° Le résumé du protocole de la recherche ;

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3° La brochure pour l'investigateur ou la notice d'instruction pour tout dispositif pourvu du marquage CE, ou la notice d'utilisation pour tout dispositif médical de diagnostic in vitro pourvu du marquage CE, accompagnée, s'il est utilisé dans une destination autre que celle figurant sur cette notice, de la synthèse des données justifiant l'utilisation et la sécurité d'emploi du dispositif médical ou du dispositif médical de diagnostic in vitro dans le cadre de la recherche ;

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4° Si la brochure pour l'investigateur appartient à un tiers, l'autorisation du tiers délivrée au promoteur pour l'utiliser ;

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5° La copie de l'attestation d'assurance mentionnée à l'article L. 1121-10 du code de la santé publique ;

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6° Le cas échéant, l'avis d'un comité scientifique consulté par le promoteur ;

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7° Le document de référence permettant de déterminer le caractère attendu ou inattendu d'une suspicion d'effet indésirable grave.

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III. - Un dossier technique relatif aux produits utilisés dans le cadre de la recherche :

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1° Pour chaque dispositif médical ou dispositif médical de diagnostic in vitro sur lequel porte la recherche, le promoteur transmet un dossier technique, comprenant les informations suivantes :

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a) La déclaration que le dispositif concerné est conforme aux exigences essentielles à la seule exception des aspects qui doivent faire l'objet de l'investigation, pour lesquels le fabricant doit certifier que toutes les précautions ont été prises pour protéger la santé et la sécurité des personnes qui se prêtent à la recherche. La déclaration est documentée par les résultats de l'analyse des risques et la liste des référentiels appliqués.

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Toutefois, lorsque le promoteur est un promoteur mentionné à l'article L. 1123-14 (12°) du code de la santé publique, il fournit les données permettant d'établir que ces risques éventuels ne sont pas hors de proportion avec le bénéfice escompté pour les personnes qui se prêtent à la recherche, et les résultats de l'analyse des risques ou, à défaut, les résultats de l'évaluation des risques éventuels générés par l'utilisation envisagée dans la recherche ;

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b) Les résumés des données non cliniques pour les dispositifs médicaux et des données de performance pour les dispositifs de diagnostic in vitro ;

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c) Le cas échéant, les données relatives à la sécurité virale conformément à l'annexe du présent arrêté ;

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d) Le cas échéant, les données relatives à l'évaluation des risques pour la santé publique et l'environnement conformément aux dispositions de l'arrêté du 18 octobre 2000 susvisé lorsque la recherche porte sur un dispositif ou un dispositif médical de diagnostic in vitro contenant des organismes génétiquement modifiés ;

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e) Le cas échéant, les données relatives aux radioéléments ;

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f) Les résumés de toutes les données disponibles des recherches biomédicales préalablement menées avec le même dispositif médical ou dispositif médical de diagnostic in vitro ou avec un dispositif équivalent. Dans ce dernier cas, les éléments justifiant l'équivalence avec le dispositif faisant l'objet de la recherche sont apportés ;

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g) Une analyse critique, au regard de l'évaluation des bénéfices et des risques de la recherche, des données non cliniques et, le cas échéant, cliniques relatives au dispositif médical ou dispositif médical de diagnostic in vitro faisant l'objet de la recherche.

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Le promoteur peut faire référence aux données non cliniques et cliniques présentées dans la brochure pour l'investigateur, lorsque celles-ci sont suffisamment détaillées pour permettre une appréciation précise de la sécurité d'emploi du dispositif médical ou du dispositif médical de diagnostic in vitro sur lequel porte la recherche.

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Le promoteur tient à la disposition de l'Agence française de sécurité sanitaire des produits de santé, à sa demande, les données complètes des études référencées dans le dossier technique, sauf exception dûment justifiée.

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2° Si la recherche biomédicale implique l'utilisation d'un dispositif médical qui incorpore comme partie intégrante une substance qui, si elle est utilisée séparément, est susceptible d'être considérée comme un médicament, le dossier technique est complété par les informations suivantes relatives à cette substance :

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a) La justification scientifique de l'ajout de la substance active au dispositif médical tant au plan qualitatif que quantitatif ;

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b) Des données non cliniques et, le cas échéant, des données cliniques portant notamment sur la cinétique locale et les effets locaux de la substance incorporée dans le dispositif médical ;

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c) Si la substance active incorporée dans le dispositif médical sur lequel porte la recherche est celle contenue dans un médicament disposant d'une autorisation de mise sur le marché en France ou dans un Etat membre de la Communauté européenne : le résumé des caractéristiques du produit en vigueur à la date de soumission de la demande d'autorisation de recherche. Dans ce cas, les données relatives à la qualité pharmaceutique du médicament sont constituées par l'attestation délivrée par le fabricant de la substance active incorporée dans le dispositif médical spécifiant que celle-ci est en tout point identique à celle utilisée pour la préparation du médicament disposant d'une autorisation de mise sur le marché. Le promoteur fournit au titre des données non cliniques et cliniques celles appuyant la démonstration de l'absence d'altération du rapport efficacité/sécurité par rapport à l'administration habituelle du médicament, notamment celles se rapportant à la cinétique locale et aux effets locaux de la substance active ;

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d) Si la substance active incorporée dans le dispositif médical sur lequel porte la recherche n'est pas contenue dans un médicament disposant d'une autorisation de mise sur le marché en France ou dans un Etat membre de la Communauté européenne : une synthèse des données relatives à la qualité pharmaceutique, chimique ou biologique de la substance active conformément aux exigences de la Pharmacopée européenne pour les substances à usage pharmaceutique et, le cas échéant, pour les produits de fermentation.

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3° Si la recherche portant sur un dispositif médical ou un dispositif médical de diagnostic in vitro prévoit d'utiliser ou d'étudier d'autres produits que ceux mentionnés respectivement au 1° et au 2° du III du présent article, il appartient au demandeur de fournir la documentation adaptée relative à ces produits, telle que définie dans les arrêtés relatifs à la demande d'autorisation de recherche biomédicale soumise à l'autorité compétente portant sur de tels produits, permettant à l'Agence française de sécurité sanitaire des produits de santé d'apprécier la sécurité des personnes qui se prêtent à la recherche conformément aux dispositions de l'article R. 1123-29 du code de la santé publique.

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IV. - La copie de l'avis final du comité de protection des personnes mentionné à l'article L. 1121-4 du code de la santé publique, s'il est disponible.

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" } }, "LEGIARTI000020320259": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "3", "ETAT": "ABROGE", "TYPE": "AUTONOME", "DATE_FIN": "2011-10-06", "DATE_DEBUT": "2009-03-01" } }, "META_COMMUN": { "ID": "LEGIARTI000020320259", "URL": "article/LEGI/ARTI/00/00/20/32/02/LEGIARTI000020320259.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "LIENS": { "LIEN": [ { "@id": "LEGIARTI000020319414", "@num": "1", "#text": "Arrêté du 19 février 2009 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000020318421", "@nortexte": "SASP0904413A", "@typelien": "MODIFIE", "@naturetexte": "ARRETE", "@datesignatexte": "2009-02-19" }, { "@id": "LEGIARTI000024629824", "@num": "2", "#text": "Arrêté du 22 septembre 2011 - art. 2", "@sens": "cible", "@cidtexte": "JORFTEXT000024629111", "@nortexte": "ETSP1125979A", "@typelien": "ABROGE", "@naturetexte": "ARRETE", "@datesignatexte": "2011-09-22" }, { "@id": "LEGIARTI000006685848", "@num": "L1121-10", "#text": "Code de la santé publique - art. L1121-10", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006685833", "@num": "L1121-4", "#text": "Code de la santé publique - art. L1121-4", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006689881", "@num": "L5121-5", "#text": "Code de la santé publique - art. L5121-5", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006908378", "@num": "R1123-20", "#text": "Code de la santé publique - art. R1123-20", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "@cid": "JORFTEXT000000457818", "@nor": "SANP0622223A", "@nature": "ARRETE", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Arrêté du 24 mai 2006 fixant le contenu, le format et les modalités de présentation à l'Agence française de sécurité sanitaire des produits de santé du dossier de demande d'autorisation de recherche biomédicale portant sur un médicament à usage humain", "@debut": "2999-01-01", "@id_txt": "JORFTEXT000000457818", "@c_titre_court": "Arrêté du 24 mai 2006" }, { "@fin": "2011-10-06", "#text": "Arrêté du 24 mai 2006 fixant le contenu, le format et les modalités de présentation à l'Agence française de sécurité sanitaire des produits de santé du dossier de demande d'autorisation de recherche biomédicale portant sur un médicament à usage humain", "@debut": "2006-05-31", "@id_txt": "LEGITEXT000020140259", "@c_titre_court": "Arrêté du 24 mai 2006" } ], "@ministere": "MINISTERE DE LA SANTE ET DES SOLIDARITES", "@date_publi": "2006-05-30", "@date_signature": "2006-05-24" } }, "VERSIONS": { "VERSION": [ { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000020140273", "@fin": "2006-09-30", "@num": "3", "@etat": "MODIFIE", "@debut": "2006-05-31", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000020140360", "@fin": "2009-03-01", "@num": "3", "@etat": "MODIFIE", "@debut": "2006-09-30", "@origine": "LEGI" } }, { "@etat": "ABROGE", "LIEN_ART": { "@id": "LEGIARTI000020320259", "@fin": "2011-10-06", "@num": "3", "@etat": "ABROGE", "@debut": "2009-03-01", "@origine": "LEGI" } }, { "LIEN_ART": { "@id": "JORFARTI000002281761", "@fin": "2999-01-01", "@num": "3", "@debut": "2999-01-01", "@origine": "JORF" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "

Le dossier de demande d'autorisation d'une recherche biomédicale portant sur un médicament à usage humain se compose des quatre parties suivantes :
I.-Un dossier administratif contenant les informations suivantes :
1° Un courrier de demande d'autorisation daté et signé, disponible en version électronique sur le site internet de l'Agence française de sécurité sanitaire des produits de santé, ou en version papier, sur demande auprès de l'Agence française de sécurité sanitaire des produits de santé, comprenant notamment :
a) Si le médicament expérimental dispose d'une autorisation de mise sur le marché en France, une comparaison et, le cas échéant, la description et la justification des divergences pertinentes en terme de sécurité des personnes entre le protocole et le résumé des caractéristiques du produit tel que prévu dans cette autorisation de mise sur le marché ;
b) Le cas échéant, les raisons pour lesquelles le promoteur ne considère pas comme un médicament expérimental un traitement mentionné dans le protocole de la recherche ;
2° Le formulaire de demande d'autorisation, daté et signé, disponible en version électronique sur le site internet de la base de données EudraCT, ou en version papier, sur demande auprès de l'Agence française de sécurité sanitaire des produits de santé ;
3° Le reçu de confirmation du numéro EudraCT ;
4° Le cas échéant, la liste des autorités compétentes des Etats membres de la Communauté européenne auxquelles la demande a été soumise et la nature de leur décision finale, si elle est disponible ;
5° Si le demandeur n'est pas le promoteur, l'autorisation écrite lui permettant d'agir pour le compte du promoteur ;
6° Le cas échéant, une copie de la ou des autorisations requises, en application des dispositions du code de la santé publique, pour la mise en place de la recherche ou pour l'utilisation du médicament ;
7° Le cas échéant, une copie de tout avis scientifique rendu au promoteur, sur le médicament expérimental ou sur la recherche, par l'Agence française de sécurité sanitaire des produits de santé, par l'Agence européenne des médicaments, ou par toute autorité compétente d'un Etat membre de la Communauté européenne ;
8° En cas de soumission de données relatives à un médicament expérimental appartenant à un tiers, en application du 4° de l'article 4 du présent arrêté, l'autorisation délivrée par ce dernier au promoteur pour communiquer ces données.
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II.-Un dossier sur la recherche biomédicale contenant les informations suivantes :
1° Le protocole de la recherche tel que défini à l'article R. 1123-20 du code de la santé publique, daté et comportant un numéro de version ;
2° Le résumé du protocole de la recherche ;
3° La brochure pour l'investigateur ou le résumé des caractéristiques du produit pour tout médicament expérimental disposant d'une autorisation de mise sur le marché en France ou dans un autre Etat membre de la Communauté européenne, accompagné, s'il est utilisé dans des conditions différentes de celles prévues par cette autorisation, de la synthèse des données justifiant l'utilisation et la sécurité d'emploi du médicament dans le cadre de la recherche ;
4° La copie de l'attestation d'assurance telle que prévue à l'article L. 1121-10 du code de la santé publique ;
5° Le cas échéant, l'avis d'un comité scientifique consulté par le promoteur ;
6° Le document de référence permettant de déterminer le caractère attendu ou inattendu d'une suspicion d'effet indésirable grave ;

7° Si la brochure pour l'investigateur appartient à un tiers, l'autorisation du tiers délivrée au promoteur pour l'utiliser.
III.-Un dossier technique relatif aux produits utilisés dans le cadre de la recherche :
1° Pour chaque médicament expérimental, le promoteur transmet un dossier technique dénommé dossier du médicament expérimental.
Ce dossier, dont le format est décrit en annexe 1 du présent arrêté, comporte trois parties composées d'une synthèse de toutes les informations disponibles sur le médicament expérimental relatives :
a) A la qualité pharmaceutique, chimique ou biologique de la substance active et du produit fini ;
b) Aux données non cliniques obtenues à partir des études pharmacologiques et de toxicité ;
c) Le cas échéant, aux données cliniques obtenues à partir des recherches biomédicales préalablement menées avec le même médicament expérimental ou liées à son utilisation en thérapeutique.
Ce dossier comprend également une analyse critique, au regard de l'évaluation des bénéfices et des risques de la recherche, des données non cliniques et, le cas échéant, cliniques relatives au médicament expérimental.
La partie du dossier mentionnée au a est complétée, le cas échéant, par les informations suivantes :
-si le médicament est fabriqué dans un autre Etat membre de la Communauté européenne ou partie à l'accord sur l'Espace économique européen et s'il ne bénéficie pas d'une autorisation de mise sur le marché dans un Etat membre de la Communauté européenne, la copie de l'autorisation d'ouverture de l'établissement de fabrication du médicament expérimental indiquant les opérations, les types de médicaments et les formes pharmaceutiques auxquels cette autorisation s'applique ;
-si le médicament n'est pas fabriqué dans un Etat membre de la Communauté européenne ou partie à l'accord sur l'Espace économique européen et s'il ne bénéficie pas d'une autorisation de mise sur le marché dans un Etat membre de la Communauté européenne, la copie de l'autorisation d'ouverture de l'établissement importateur du médicament expérimental indiquant les opérations, les types de médicaments et les formes pharmaceutiques auxquels cette autorisation s'applique et une attestation établie par la personne qualifiée de l'établissement importateur établissant que le médicament expérimental a été fabriqué selon des normes au moins équivalentes aux bonnes pratiques de fabrication mentionnées à l'article L. 5121-5 du code de la santé publique ;
-le certificat d'analyse du médicament expérimenté dans les cas où sont détectées soit des impuretés qui ne sont pas justifiées par les spécifications précisées dans le dossier du médicament expérimental relatif aux données sur la qualité pharmaceutique, chimique et biologique, soit des impuretés inattendues qui ne sont pas couvertes par ces spécifications.
Pour la constitution du dossier du médicament expérimental, le promoteur tient compte des lignes directrices et des indications détaillées sur la réglementation des médicaments dans la Communauté européenne, publiées par la Commission européenne, ainsi que des recommandations spécifiques de l'Agence européenne des médicaments.
Le promoteur peut faire référence aux données non cliniques et cliniques présentées dans la brochure pour l'investigateur lorsque celles-ci sont suffisamment détaillées pour permettre une appréciation précise de la sécurité d'emploi du médicament expérimental dans la recherche biomédicale.
Le promoteur atteste que les études servant de base aux données non cliniques et cliniques présentées dans le dossier du médicament expérimental ont été menées conformément aux principes de bonnes pratiques de laboratoire et aux principes de bonnes pratiques cliniques.A défaut, le promoteur présente les raisons pour lesquelles il ne peut pas fournir cette attestation.
Le promoteur tient à la disposition de l'Agence française de sécurité sanitaire des produits de santé, à sa demande, les données complètes des études référencées dans le dossier du médicament expérimental, sauf exception dûment justifiée.
2° Si le protocole de la recherche prévoit l'utilisation d'un médicament non expérimental nécessaire à la réalisation de la recherche, le promoteur transmet les informations suivantes :
a) Si ce médicament dispose d'une autorisation de mise sur le marché en France ou dans un autre Etat membre de la Communauté européenne ou d'une autorisation équivalente délivrée par une autorité compétente aux Etats-Unis ou au Japon et s'il est utilisé conformément à cette autorisation : le résumé des caractéristiques du produit tel que prévu dans cette autorisation de mise sur le marché ;
b) Si ce médicament est utilisé dans des conditions différentes de celles prévues par son autorisation de mise sur le marché en France ou dans un autre Etat membre de la Communauté européenne : le résumé des caractéristiques du produit tel que prévu dans cette autorisation de mise sur le marché ainsi qu'un dossier permettant de justifier de la qualité pharmaceutique, chimique et biologique, le cas échéant, et de la sécurité d'emploi de ce médicament dans le cadre de la recherche concernée ;
c) Si ce médicament ne dispose pas d'une autorisation de mise sur le marché en France ou dans un autre Etat membre de la Communauté européenne : un dossier permettant de justifier de la qualité pharmaceutique, chimique et biologique et de la sécurité d'emploi de ce médicament dans le cadre de la recherche concernée.
3° Si la recherche biomédicale portant sur un médicament implique l'utilisation d'un dispositif médical ne disposant pas d'un marquage CE ou disposant d'un marquage CE, mais utilisé dans une autre destination que celle prévue par le marquage CE, le promoteur transmet les informations suivantes relatives à ce dispositif :
a) La description du dispositif et la notice d'instruction ;
b) Lorsque le promoteur est le fabricant du dispositif, la déclaration de conformité aux exigences essentielles, documentée par les résultats de l'analyse des risques ainsi que la liste des référentiels appliqués ;
c) Lorsque le promoteur n'est pas le fabricant du dispositif, les résultats de l'analyse des risques ou, le cas échéant, les résultats de l'évaluation des risques éventuels générés par l'utilisation envisagée dans la recherche ;
d) Les données non cliniques et, le cas échéant, cliniques relatives au dispositif utilisé dans la recherche.
4° Si la recherche portant sur le médicament prévoit d'utiliser ou d'étudier d'autres produits que les médicaments non expérimentaux et les dispositifs médicaux mentionnés respectivement aux 2° et 3° du III du présent article, il appartient au demandeur de fournir la documentation adaptée relative à ces produits, telle que définie dans les arrêtés relatifs à la demande d'autorisation de recherche biomédicale soumise à l'autorité compétente portant sur de tels produits, permettant à l'Agence française de sécurité sanitaire des produits de santé d'apprécier la sécurité des personnes qui se prêtent à la recherche conformément aux dispositions de l'article R. 1123-29 du code de la santé publique.
IV.-La copie de l'avis final du comité de protection des personnes mentionné à l'article L. 1121-4 du code de la santé publique, s'il est disponible.

" } }, "LEGIARTI000020320295": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "3", "ETAT": "ABROGE", "TYPE": "AUTONOME", "DATE_FIN": "2016-12-10", "DATE_DEBUT": "2009-03-01" } }, "META_COMMUN": { "ID": "LEGIARTI000020320295", "URL": "article/LEGI/ARTI/00/00/20/32/02/LEGIARTI000020320295.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "LIENS": { "LIEN": [ { "@id": "LEGIARTI000020319423", "@num": "1", "#text": "Arrêté du 19 février 2009 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000020318429", "@nortexte": "SASP0904387A", "@typelien": "MODIFIE", "@naturetexte": "ARRETE", "@datesignatexte": "2009-02-19" }, { "@id": "LEGIARTI000033554491", "@num": "5", "#text": "Arrêté du 2 décembre 2016 - art. 5", "@sens": "cible", "@cidtexte": "JORFTEXT000033553349", "@nortexte": "AFSP1635656A", "@typelien": "ABROGE", "@naturetexte": "ARRETE", "@datesignatexte": "2016-12-02" }, { "@id": "LEGIARTI000006685848", "@num": "L1121-10", "#text": "Code de la santé publique - art. L1121-10", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006685852", "@num": "L1121-13", "#text": "Code de la santé publique - art. L1121-13", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006685862", "@num": "L1122-2", "#text": "Code de la santé publique - art. L1122-2", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006685883", "@num": "L1123-8", "#text": "Code de la santé publique - art. L1123-8", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006690344", "@num": "L5311-1", "#text": "Code de la santé publique - art. L5311-1", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006908378", "@num": "R1123-20", "#text": "Code de la santé publique - art. R1123-20", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "@cid": "JORFTEXT000000459554", "@nor": "SANP0623381A", "@nature": "ARRETE", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Arrêté du 16 août 2006 fixant le contenu, le format et les modalités de présentation du dossier de demande d'avis au comité de protection des personnes sur un projet de recherche biomédicale ne portant pas sur un produit mentionné à l'article L. 5311-1 du code de la santé publique", "@debut": "2999-01-01", "@id_txt": "JORFTEXT000000459554", "@c_titre_court": "Arrêté du 16 août 2006" }, { "@fin": "2016-12-10", "#text": "Arrêté du 16 août 2006 fixant le contenu, le format et les modalités de présentation du dossier de demande d'avis au comité de protection des personnes sur un projet de recherche biomédicale ne portant pas sur un produit mentionné à l'article L. 5311-1 du code de la santé publique", "@debut": "2006-08-26", "@id_txt": "LEGITEXT000006054302", "@c_titre_court": "Arrêté du 16 août 2006" } ], "@ministere": "MINISTERE DE LA SANTE ET DES SOLIDARITES", "@date_publi": "2006-08-26", "@date_signature": "2006-08-16" } }, "VERSIONS": { "VERSION": [ { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006254320", "@fin": "2009-03-01", "@num": "3", "@etat": "MODIFIE", "@debut": "2006-08-26", "@origine": "LEGI" } }, { "@etat": "ABROGE", "LIEN_ART": { "@id": "LEGIARTI000020320295", "@fin": "2016-12-10", "@num": "3", "@etat": "ABROGE", "@debut": "2009-03-01", "@origine": "LEGI" } }, { "LIEN_ART": { "@id": "JORFARTI000002470844", "@fin": "2999-01-01", "@num": "3", "@debut": "2999-01-01", "@origine": "JORF" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "

Le dossier de demande d'avis sur un projet de recherche biomédicale ne portant pas sur un produit mentionné à l'article L. 5311-1 du code de la santé, adressé au comité de protection des personnes concerné, comprend :

I.-Un dossier administratif contenant les informations suivantes :

1° Un courrier de demande d'avis, daté et signé ;

2° Le formulaire de demande d'avis, daté et signé, disponible en version électronique sur le site internet du ministère chargé de la santé ou en version papier, sur demande auprès de l'Agence française de sécurité sanitaire des produits de santé ;

3° Le document additionnel à la demande d'avis au comité de protection des personnes, décrit en annexe du présent arrêté, daté et signé, accompagné, le cas échéant, des supports susceptibles d'être utilisés en vue du recrutement des personnes ;

4° Si le demandeur n'est pas le promoteur, l'autorisation écrite lui permettant d'agir pour le compte du promoteur ;

5° Si nécessaire, la copie de la ou des autorisations de lieux de recherches biomédicales mentionnées à l'article L. 1121-13 du code de la santé publique.

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II.-Un dossier sur la recherche biomédicale contenant les informations suivantes :

1° Le protocole de la recherche tel que défini à l'article R. 1123-20 du code de la santé publique, daté et comportant un numéro de version ;

2° Le résumé du protocole ;

3° La brochure pour l'investigateur lorsque la recherche porte sur un produit autre que ceux mentionnés à l'article L. 5311-1 du code de la santé publique ;

4° Le cas échéant, le résumé des caractéristiques du produit comparateur ;

5° Si la brochure pour l'investigateur appartient à un tiers, l'autorisation du tiers délivrée au promoteur pour l'utiliser ;

6° Le document d'information destiné aux personnes qui se prêtent à la recherche ;

7° Le formulaire de recueil du consentement des personnes se prêtant à la recherche ou d'autorisation dans les cas prévus à l'article L. 1122-2 ;

8° La copie de l'attestation d'assurance prévue à l'article L. 1121-10 du code de la santé publique ;

9° Le cas échéant, l'avis d'un comité scientifique consulté par le promoteur ;

10° Une justification de l'adéquation des moyens humains, matériels et techniques au projet de recherche biomédicale et de leur compatibilité avec les impératifs de sécurité des personnes qui s'y prêtent, sauf si le lieu bénéficie de l'autorisation mentionnée à l'article L. 1121-13 du code de la santé publique ;

11° Les curriculum vitae du ou des investigateurs ;

12° La nature de la décision finale de l'Agence française de sécurité sanitaire des produits de santé, mentionnée à l'article L. 1123-8 du code de la santé publique, si cette décision est disponible.

" } }, "LEGIARTI000020326611": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "3", "ETAT": "VIGUEUR", "TYPE": "AUTONOME", "DATE_FIN": "2999-01-01", "DATE_DEBUT": "2009-03-01" } }, "META_COMMUN": { "ID": "LEGIARTI000020326611", "URL": "article/LEGI/ARTI/00/00/20/32/66/LEGIARTI000020326611.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "LIENS": { "LIEN": [ { "@id": "LEGIARTI000020319432", "@num": "1", "#text": "Arrêté du 19 février 2009 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000020318439", "@nortexte": "SASP0904427A", "@typelien": "MODIFIE", "@naturetexte": "ARRETE", "@datesignatexte": "2009-02-19" }, { "@id": "LEGIARTI000006685848", "@num": "L1121-10", "#text": "Code de la santé publique - art. L1121-10 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006685833", "@num": "L1121-4", "#text": "Code de la santé publique - art. L1121-4 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006690344", "@num": "L5311-1", "#text": "Code de la santé publique - art. L5311-1 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006908378", "@num": "R1123-20", "#text": "Code de la santé publique - art. R1123-20 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "@cid": "JORFTEXT000000270592", "@nor": "SANP0623380A", "@nature": "ARRETE", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Arrêté du 16 août 2006 fixant le contenu, le format et les modalités de présentation au ministre chargé de la santé du dossier de demande d'autorisation de recherche biomédicale ne portant pas sur un produit mentionné à l'article L. 5311-1 du code de la santé publique", "@debut": "2999-01-01", "@id_txt": "JORFTEXT000000270592", "@c_titre_court": "Arrêté du 16 août 2006" }, { "@fin": "2999-01-01", "#text": "Arrêté du 16 août 2006 fixant le contenu, le format et les modalités de présentation au ministre chargé de la santé du dossier de demande d'autorisation de recherche biomédicale ne portant pas sur un produit mentionné à l'article L. 5311-1 du code de la santé publique", "@debut": "2006-08-26", "@id_txt": "LEGITEXT000006054301", "@c_titre_court": "Arrêté du 16 août 2006" } ], "@ministere": "MINISTERE DE LA SANTE ET DES SOLIDARITES", "@date_publi": "2006-08-26", "@date_signature": "2006-08-16" } }, "VERSIONS": { "VERSION": [ { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006254309", "@fin": "2009-03-01", "@num": "3", "@etat": "MODIFIE", "@debut": "2006-08-26", "@origine": "LEGI" } }, { "@etat": "VIGUEUR", "LIEN_ART": { "@id": "LEGIARTI000020326611", "@fin": "2999-01-01", "@num": "3", "@etat": "VIGUEUR", "@debut": "2009-03-01", "@origine": "LEGI" } }, { "LIEN_ART": { "@id": "JORFARTI000002283290", "@fin": "2999-01-01", "@num": "3", "@debut": "2999-01-01", "@origine": "JORF" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "

Le dossier de demande d'autorisation d'une recherche biomédicale ne portant pas sur un produit mentionné à l'article L. 5311-1 du code de la santé publique se compose des quatre parties suivantes :

I.-Un dossier administratif contenant les informations suivantes :

1° Un courrier de demande d'autorisation, daté et signé, disponible en version électronique sur le site internet du ministère chargé de la santé ou en version papier, sur demande auprès de l'Agence française de sécurité sanitaire des produits de santé ;

2° Le formulaire de demande d'autorisation, daté et signé, disponible en version électronique sur le site internet du ministère chargé de la santé ou en version papier, sur demande auprès de l'Agence française de sécurité sanitaire des produits de santé ;

3° Si le demandeur n'est pas le promoteur, l'autorisation écrite lui permettant d'agir pour le compte du promoteur.

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II.-Un dossier sur la recherche biomédicale contenant les informations suivantes :

1° Le protocole de la recherche, tel que défini à l'article R. 1123-20 du code de la santé publique, daté et comportant un numéro de version ;

2° Le résumé du protocole de la recherche ;

3° La brochure pour l'investigateur lorsque la recherche porte sur des produits autres que ceux mentionnés à l'article L. 5311-1 du code de la santé publique ;

4° La copie de l'attestation d'assurance telle que prévue à l'article L. 1121-10 du code de la santé publique ;

5° Le cas échéant, l'avis d'un comité scientifique consulté par le promoteur.

III.-Le cas échéant, un dossier technique relatif aux produits utilisés dans le cadre de la recherche :

1. Lorsque l'objet de la recherche porte sur un produit autre que ceux mentionnés à l'article L. 5311-1 du code de la santé publique, le promoteur transmet un dossier technique comportant les informations suivantes :

a) La composition du produit ;

b) La qualité, chimique ou biologique, du produit ;

c) Les données non cliniques obtenues à partir des études toxicologiques ;

d) Les données cliniques obtenues à partir des recherches biomédicales préalablement menées avec le même produit ou correspondant à des effets médicaux antérieurement connus.

Ce dossier comporte également, le cas échéant, le certificat d'analyse du produit expérimenté dans les cas où sont détectées soit des impuretés qui ne sont pas justifiées par les spécifications précisées dans le dossier du produit expérimental relatif aux données sur la qualité, chimique et biologique, soit des impuretés inattendues qui ne sont pas couvertes par ces spécifications.

Le promoteur tient à la disposition du Agence française de sécurité sanitaire des produits de santé, à sa demande, les données complètes des études référencées dans le dossier du produit expérimental, sauf exception dûment justifiée.

2. Si la recherche biomédicale ne portant pas sur un produit mentionné à l'article L. 5311-1 du code de la santé publique implique l'utilisation d'un médicament, le promoteur transmet les informations suivantes :

a) Si ce médicament dispose d'une autorisation de mise sur le marché en France ou dans un autre Etat membre de la Communauté européenne ou d'une autorisation équivalente délivrée par une autorité compétente aux Etats-Unis ou au Japon : le résumé des caractéristiques du produit tel que prévu dans cette autorisation de mise sur le marché ;

b) Si le promoteur souhaite importer un médicament nécessaire à la réalisation de la recherche une fois celle-ci autorisée par l'Agence française de sécurité sanitaire des produits de santé, le promoteur joint au dossier de demande d'autorisation : une demande d'attestation en vue de l'importation de médicaments, disponible en version électronique sur le site internet de l'Agence française de sécurité sanitaire des produits de santé ou en version papier sur demande auprès de l'Agence française de sécurité sanitaire des produits de santé.

3. Si la recherche biomédicale ne portant pas sur un produit mentionné à l'article L. 5311-1 du code de la santé publique implique l'utilisation d'un dispositif médical ne disposant pas d'un marquage CE ou disposant d'un marquage CE mais utilisé dans une autre destination que celle prévue par le marquage CE, le promoteur transmet les informations suivantes relatives à ce dispositif :

a) La description du dispositif et la notice d'instruction ;

b) Lorsque le promoteur est le fabricant du dispositif, la déclaration de conformité aux exigences essentielles, documentée par les résultats de l'analyse des risques ainsi que la liste des référentiels appliqués ;

c) Lorsque le promoteur n'est pas le fabricant du dispositif, les résultats de l'analyse des risques ou, le cas échéant, les résultats de l'évaluation des risques éventuels générés par l'utilisation envisagée dans la recherche ;

d) Les données non cliniques et, le cas échéant, cliniques relatives au dispositif utilisé dans la recherche.

IV.-La copie de l'avis du comité de protection des personnes mentionné à l'article L. 1121-4 du code de la santé publique, s'il est disponible.

" } }, "LEGIARTI000020338799": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "3", "ETAT": "ABROGE", "TYPE": "AUTONOME", "DATE_FIN": "2016-12-08", "DATE_DEBUT": "2009-03-05" } }, "META_COMMUN": { "ID": "LEGIARTI000020338799", "URL": "article/LEGI/ARTI/00/00/20/33/87/LEGIARTI000020338799.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "LIENS": { "LIEN": [ { "@id": "LEGIARTI000020338511", "@num": "1", "#text": "Arrêté du 19 février 2009 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000020337585", "@nortexte": "SASP0904437A", "@typelien": "MODIFIE", "@naturetexte": "ARRETE", "@datesignatexte": "2009-02-19" }, { "@id": "LEGIARTI000033547089", "@num": "5", "#text": "Arrêté du 2 décembre 2016 - art. 5", "@sens": "cible", "@cidtexte": "JORFTEXT000033545461", "@nortexte": "AFSP1635571A", "@typelien": "ABROGE", "@naturetexte": "ARRETE", "@datesignatexte": "2016-12-02" }, { "@id": "LEGIARTI000006685848", "@num": "L1121-10", "#text": "Code de la santé publique - art. L1121-10", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006685852", "@num": "L1121-13", "#text": "Code de la santé publique - art. L1121-13", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006685859", "@num": "L1122-1", "#text": "Code de la santé publique - art. L1122-1", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006685883", "@num": "L1123-8", "#text": "Code de la santé publique - art. L1123-8", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006908378", "@num": "R1123-20", "#text": "Code de la santé publique - art. R1123-20", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "@cid": "JORFTEXT000000459553", "@nor": "SANP0623377A", "@nature": "ARRETE", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Arrêté du 16 août 2006 fixant le contenu, le format et les modalités de présentation du dossier de demande d'avis au comité de protection des personnes sur un projet de recherche biomédicale portant sur un produit cosmétique ou de tatouage", "@debut": "2999-01-01", "@id_txt": "JORFTEXT000000459553", "@c_titre_court": "Arrêté du 16 août 2006" }, { "@fin": "2016-12-08", "#text": "Arrêté du 16 août 2006 fixant le contenu, le format et les modalités de présentation du dossier de demande d'avis au comité de protection des personnes sur un projet de recherche biomédicale portant sur un produit cosmétique ou de tatouage", "@debut": "2006-08-26", "@id_txt": "LEGITEXT000006054298", "@c_titre_court": "Arrêté du 16 août 2006" } ], "@ministere": "MINISTERE DE LA SANTE ET DES SOLIDARITES", "@date_publi": "2006-08-26", "@date_signature": "2006-08-16" } }, "VERSIONS": { "VERSION": [ { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006254291", "@fin": "2009-03-05", "@num": "3", "@etat": "MODIFIE", "@debut": "2006-08-26", "@origine": "LEGI" } }, { "@etat": "ABROGE", "LIEN_ART": { "@id": "LEGIARTI000020338799", "@fin": "2016-12-08", "@num": "3", "@etat": "ABROGE", "@debut": "2009-03-05", "@origine": "LEGI" } }, { "LIEN_ART": { "@id": "JORFARTI000001301216", "@fin": "2999-01-01", "@num": "3", "@debut": "2999-01-01", "@origine": "JORF" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "

Le dossier de demande d'avis sur un projet de recherche biomédicale portant sur un produit cosmétique ou un produit de tatouage, adressé au comité de protection des personnes concerné, comprend :

I.-Un dossier administratif contenant les informations suivantes :

1. Un courrier de demande d'avis, daté et signé ;

2. Le formulaire de demande d'avis, daté et signé, disponible en version électronique sur le site internet de l'Agence française de sécurité sanitaire des produits de santé ou en version papier sur demande auprès de l'Agence française de sécurité sanitaire des produits de santé ;

3. Le document additionnel à la demande d'avis au comité de protection des personnes décrit en annexe du présent arrêté, daté et signé, accompagné des supports susceptibles d'être utilisés en vue du recrutement des personnes ;

4. Le cas échéant, la liste des autorités compétentes des Etats membres de la Communauté européenne auxquelles la demande a été soumise et la nature de leurs décisions finales, si elles sont disponibles ;

5. Si le demandeur n'est pas le promoteur, l'autorisation écrite lui permettant d'agir pour le compte du promoteur ;

6. Le cas échéant, la copie de la ou des autorisations de lieux de recherches biomédicales mentionnées à l'article L. 1121-13 du code de la santé publique ;

II.-Un dossier sur la recherche biomédicale contenant les informations suivantes :

1. Le protocole de la recherche tel que défini à l'article R. 1123-20 du code de la santé publique, daté et comportant un numéro de version ;

2. Le résumé du protocole ;

3. La brochure pour l'investigateur ;

4. Si la brochure pour l'investigateur appartient à un tiers, l'autorisation du tiers délivrée au promoteur pour l'utiliser ;

5. Le document d'information destiné aux personnes qui se prêtent à la recherche, prévu à l'article L. 1122-1 du code de la santé publique. Ce document décrit notamment les risques encourus avec le (s) produit (s) étudié (s) mais également liés à la méthodologie de la recherche ;

6. Le formulaire de recueil du consentement des personnes se prêtant à la recherche ;

7. La copie de l'attestation d'assurance prévue à l'article L. 1121-10 du code de la santé publique ;

8. Le cas échéant, l'avis d'un comité scientifique consulté par le promoteur ;

9. Une justification de l'adéquation des moyens humains, matériels et techniques au projet de recherche biomédicale et de leur compatibilité avec les impératifs de sécurité des personnes qui s'y prêtent, sauf si le lieu bénéficie de l'autorisation mentionnée à l'article L. 1121-13 du code de la santé publique ;

10. Les curriculum vitae du ou des investigateurs ;

11. La nature de la décision finale de l'Agence française de sécurité sanitaire des produits de santé mentionnée à l'article L. 1123-8 du code de la santé publique, si cette décision est disponible.

\n
\n
" } }, "LEGIARTI000020338811": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "3", "ETAT": "VIGUEUR", "TYPE": "AUTONOME", "DATE_FIN": "2999-01-01", "DATE_DEBUT": "2009-03-05" } }, "META_COMMUN": { "ID": "LEGIARTI000020338811", "URL": "article/LEGI/ARTI/00/00/20/33/88/LEGIARTI000020338811.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "LIENS": { "LIEN": [ { "@id": "LEGIARTI000020338533", "@num": "1", "#text": "Arrêté du 19 février 2009 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000020337593", "@nortexte": "SASP0904456A", "@typelien": "MODIFIE", "@naturetexte": "ARRETE", "@datesignatexte": "2009-02-19" }, { "@id": "LEGIARTI000006685848", "@num": "L1121-10", "#text": "Code de la santé publique - art. L1121-10 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006685852", "@num": "L1121-13", "#text": "Code de la santé publique - art. L1121-13 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006685833", "@num": "L1121-4", "#text": "Code de la santé publique - art. L1121-4 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006908378", "@num": "R1123-20", "#text": "Code de la santé publique - art. R1123-20 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006908399", "@num": "R1123-29", "#text": "Code de la santé publique - art. R1123-29 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006915505", "@num": "R5131-4", "#text": "Code de la santé publique - art. R5131-4 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "@cid": "JORFTEXT000000640166", "@nor": "SANP0623375A", "@nature": "ARRETE", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Arrêté du 16 août 2006 fixant le contenu, le format et les modalités de présentation à l'Agence française de sécurité sanitaire des produits de santé du dossier de demande d'autorisation de recherche biomédicale portant sur un produit cosmétique ou de tatouage", "@debut": "2999-01-01", "@id_txt": "JORFTEXT000000640166", "@c_titre_court": "Arrêté du 16 août 2006" }, { "@fin": "2999-01-01", "#text": "Arrêté du 16 août 2006 fixant le contenu, le format et les modalités de présentation à l'Agence française de sécurité sanitaire des produits de santé du dossier de demande d'autorisation de recherche biomédicale portant sur un produit cosmétique ou de tatouage", "@debut": "2006-08-26", "@id_txt": "LEGITEXT000006054296", "@c_titre_court": "Arrêté du 16 août 2006" } ], "@ministere": "MINISTERE DE LA SANTE ET DES SOLIDARITES", "@date_publi": "2006-08-26", "@date_signature": "2006-08-16" } }, "VERSIONS": { "VERSION": [ { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006254281", "@fin": "2009-03-05", "@num": "3", "@etat": "MODIFIE", "@debut": "2006-08-26", "@origine": "LEGI" } }, { "@etat": "VIGUEUR", "LIEN_ART": { "@id": "LEGIARTI000020338811", "@fin": "2999-01-01", "@num": "3", "@etat": "VIGUEUR", "@debut": "2009-03-05", "@origine": "LEGI" } }, { "LIEN_ART": { "@id": "JORFARTI000001301214", "@fin": "2999-01-01", "@num": "3", "@debut": "2999-01-01", "@origine": "JORF" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "

Le dossier de demande d'autorisation de recherche biomédicale portant sur un produit cosmétique ou de tatouage se compose des quatre parties suivantes :

I.-Un dossier administratif contenant les informations suivantes :

4° Si le demandeur n'est pas le promoteur, l'autorisation écrite lui permettant d'agir pour le compte du promoteur ;

5° Le cas échéant, une copie de la ou des autorisations de lieux de recherches biomédicales mentionnées à l'article L. 1121-13 du code de la santé publique ;

6° En cas de soumission de données relatives aux produits cosmétiques ou de tatouage sur lesquels porte la recherche et appartenant à un tiers, l'autorisation délivrée par ce dernier au promoteur pour communiquer ces données ;

II.-Un dossier sur la recherche biomédicale contenant les informations suivantes :

1° Le protocole de la recherche tel que défini à l'article R. 1123-20 du code de la santé publique, daté et comportant un numéro de version ;

2° Le résumé du protocole de la recherche ;

3° La brochure pour l'investigateur ;

4° Si la brochure pour l'investigateur appartient à un tiers, l'autorisation du tiers délivrée au promoteur pour l'utiliser ;

5° La copie de l'attestation d'assurance mentionnée à l'article L. 1121-10 du code de la santé publique ;

6° Le cas échéant, l'avis d'un comité scientifique consulté par le promoteur.

III.-Un dossier technique relatif aux produits utilisés dans le cadre de la recherche :

1° Pour chaque produit cosmétique ou de tatouage sur lequel porte la recherche, le promoteur transmet un dossier technique contenant les informations suivantes :

a) La composition qualitative exprimée conformément aux dispositions du dernier alinéa de l'article R. 5131-4 du code de la santé publique, y compris pour les parfums et les compositions parfumantes dont la mention sur l'étiquetage est exigée au 8° de l'article R. 5131-4 du code de la santé publique. Pour les autres parfums et compositions parfumantes, les informations suivantes devront être fournies : la dénomination des parfums et des compositions parfumantes, leurs numéros de code indiqués par le fournisseur et l'identité de ce dernier ;

b) L'origine de toute matière première d'origine bovine, ovine ou caprine entrant dans la composition du produit testé, telle que prévue dans l'arrêté du 6 février 2001 fixant la liste des substances qui ne peuvent entrer dans la composition des produits cosmétiques ;

c) Les spécifications et les résultats des essais physico-chimiques et microbiologiques du produit cosmétique ou de tatouage faisant l'objet de la recherche ;

d) Le cas échéant, les précautions d'emploi et avertissements prévus sur l'étiquetage ;

e) Le cas échéant, une brève description du matériel utilisé pour la recherche ainsi que les documents attestant la conformité de ce matériel aux exigences essentielles de sécurité et de santé ;

f) Le dossier de sécurité du produit cosmétique ou de tatouage faisant l'objet de la recherche qui comprend les informations suivantes ;

-l'attestation d'innocuité établie par la personne qualifiée responsable de l'évaluation de la sécurité pour la santé humaine du produit faisant l'objet de la recherche ;

-si elles ont été effectuées, la liste et les résultats des études de sécurité menées sur chacun des ingrédients du produit faisant l'objet de la recherche permettant d'attester de leur innocuité ;

-si elles ont été effectuées, la liste et les résultats des études de sécurité menées sur le produit fini faisant l'objet de la recherche ;

g) Le cas échéant, les résumés de toutes les données disponibles des études et des recherches biomédicales préalablement menées avec un ou des produits similaires au produit étudié.

2° Si la recherche portant sur un produit cosmétique ou de tatouage prévoit d'utiliser ou d'étudier d'autres produits que ces produits cosmétiques ou de tatouage, il appartient au demandeur de fournir la documentation adaptée relative à ces produits, telle que définie dans les arrêtés relatifs à la demande d'autorisation de recherche biomédicale soumise à l'autorité compétente portant sur de tels produits, permettant à l'Agence française de sécurité sanitaire des produits de santé d'apprécier la sécurité des personnes qui se prêtent à la recherche conformément aux dispositions de l'article R. 1123-29 du code de la santé publique.

IV.-La copie de l'avis final du comité de protection des personnes, mentionné à l'article L. 1121-4 du code de la santé publique, s'il est disponible.

\n
" } }, "LEGIARTI000020350765": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "3", "ETAT": "ABROGE", "TYPE": "AUTONOME", "DATE_FIN": "2021-02-13", "DATE_DEBUT": "2009-03-07" } }, "META_COMMUN": { "ID": "LEGIARTI000020350765", "URL": "article/LEGI/ARTI/00/00/20/35/07/LEGIARTI000020350765.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "LIENS": { "LIEN": [ { "@id": "LEGIARTI000020349117", "@num": "1", "#text": "Arrêté du 19 février 2009 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000020348138", "@nortexte": "SASP0904439A", "@typelien": "MODIFIE", "@naturetexte": "ARRETE", "@datesignatexte": "2009-02-19" }, { "@id": "LEGIARTI000043124104", "@num": "5", "#text": "Arrêté du 26 janvier 2021 - art. 5", "@sens": "cible", "@cidtexte": "JORFTEXT000043121591", "@nortexte": "SSAP2102968A", "@typelien": "ABROGE", "@naturetexte": "ARRETE", "@datesignatexte": "2021-01-26" }, { "@id": "LEGIARTI000006685848", "@num": "L1121-10", "#text": "Code de la santé publique - art. L1121-10", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006685852", "@num": "L1121-13", "#text": "Code de la santé publique - art. L1121-13", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006685859", "@num": "L1122-1", "#text": "Code de la santé publique - art. L1122-1", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006685883", "@num": "L1123-8", "#text": "Code de la santé publique - art. L1123-8", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006908378", "@num": "R1123-20", "#text": "Code de la santé publique - art. R1123-20", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "@cid": "JORFTEXT000000459238", "@nor": "SANP0624375A", "@nature": "ARRETE", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Arrêté du 23 octobre 2006 fixant le contenu, le format et les modalités de présentation du dossier de demande d'avis au comité de protection des personnes sur un projet de recherche biomédicale portant sur les produits sanguins labiles, les organes, les tissus d'origine humaine ou animale et les préparations de thérapie cellulaire mentionnées à l'article L. 1243-1 du code de la santé publique", "@debut": "2999-01-01", "@id_txt": "JORFTEXT000000459238", "@c_titre_court": "Arrêté du 23 octobre 2006" }, { "@fin": "2021-02-13", "#text": "Arrêté du 23 octobre 2006 fixant le contenu, le format et les modalités de présentation du dossier de demande d'avis au comité de protection des personnes sur un projet de recherche biomédicale portant sur les produits sanguins labiles, les organes, les tissus d'origine humaine ou animale et les préparations de thérapie cellulaire mentionnées à l'article L. 1243-1 du code de la santé publique", "@debut": "2006-11-04", "@id_txt": "LEGITEXT000006054654", "@c_titre_court": "Arrêté du 23 octobre 2006" } ], "@ministere": "MINISTERE DE LA SANTE ET DES SOLIDARITES", "@date_publi": "2006-11-04", "@date_signature": "2006-10-23", "@num_parution_jo": "0256" } }, "VERSIONS": { "VERSION": [ { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006256267", "@fin": "2009-03-07", "@num": "3", "@etat": "MODIFIE", "@debut": "2006-11-04", "@origine": "LEGI" } }, { "@etat": "ABROGE", "LIEN_ART": { "@id": "LEGIARTI000020350765", "@fin": "2021-02-13", "@num": "3", "@etat": "ABROGE", "@debut": "2009-03-07", "@origine": "LEGI" } }, { "LIEN_ART": { "@id": "JORFARTI000002282763", "@fin": "2999-01-01", "@num": "3", "@debut": "2999-01-01", "@origine": "JORF" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "

Le dossier de demande d'avis sur un projet de recherche biomédicale portant sur les produits sanguins labiles, les organes, les tissus d'origine humaine ou animale et les préparations de thérapie cellulaire, adressé au comité de protection des personnes concerné, comprend :

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\n

I. - Un dossier administratif contenant les informations suivantes :

\n
\n

1° Un courrier de demande d'avis daté et signé ;

\n
\n

2° Le formulaire de demande d'avis, daté et signé, disponible en version électronique sur le site internet de l'Agence française de sécurité des produits de santé ou en version papier, sur demande auprès de l'Agence française de sécurité sanitaire des produits de santé ;

\n
\n

3° Le document additionnel à la demande d'avis au comité de protection des personnes décrit en annexe du présent arrêté, daté et signé, accompagné des supports susceptibles d'être utilisés en vue du recrutement des personnes ;

\n
\n

4° Le cas échéant, la liste des autorités compétentes des Etats membres de la Communauté européenne auxquelles la demande a été soumise et la nature de leurs décisions finales, si elles sont disponibles ;

\n
\n

5° Si le demandeur n'est pas le promoteur, l'autorisation écrite lui permettant d'agir pour le compte du promoteur ;

\n
\n

6° Le cas échéant, la copie de la ou des autorisations de lieux de recherches biomédicales mentionnées à l'article L. 1121-13 du code de la santé publique.

\n
\n

II. - Un dossier sur la recherche biomédicale contenant les informations suivantes :

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1° Le protocole de la recherche tel que défini à l'article R. 1123-20 du code de la santé publique, daté et comportant un numéro de version ;

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2° Le résumé du protocole ;

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3° La brochure pour l'investigateur ;

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4° Si la brochure pour l'investigateur appartient à un tiers, l'autorisation du tiers délivrée au promoteur pour l'utiliser ;

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5° Le document d'information destiné aux personnes qui se prêtent à la recherche prévu à l'article L. 1122-1 du code de la santé publique.

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Lorsque la recherche porte sur un tissu préparé selon un procédé autorisé ou sur une préparation de thérapie cellulaire disposant d'une autorisation en France, le dossier comprend :

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- une comparaison du document d'information destiné aux personnes qui se prêtent à la recherche et des éléments de l'autorisation du produit portant sur des contre-indications et des effets indésirables graves ou des mises en garde ou précautions d'emploi particulières ;

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- et, le cas échéant, la description et la justification des divergences pertinentes en termes de sécurité des personnes entre le document d'information destiné aux personnes qui se prêtent à la recherche et les éléments de l'autorisation du produit portant sur des contre-indications et des effets indésirables graves ou des mises en garde ou précautions d'emploi particulières ;

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6° Le formulaire de recueil du consentement des personnes se prêtant à la recherche ;

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7° La copie de l'attestation d'assurance prévue à l'article L. 1121-10 du code de la santé publique ;

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8° Le cas échéant, l'avis d'un comité scientifique consulté par le promoteur ;

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9° Une justification de l'adéquation des moyens humains, matériels et techniques au projet de recherche biomédicale et de leur compatibilité avec les impératifs de sécurité des personnes qui s'y prêtent, sauf si le lieu bénéficie de l'autorisation mentionnée à l'article L. 1121-13 du code de la santé publique ;

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10° Les curriculum vitae du ou des investigateurs ;

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11° La nature de la décision finale de l'Agence française de sécurité sanitaire des produits de santé mentionnée à l'article L. 1123-8 du code de la santé publique, si cette décision est disponible.

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" } }, "LEGIARTI000024316813": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "L1221-8-1", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2012-03-07", "DATE_DEBUT": "2011-08-01" } }, "META_COMMUN": { "ID": "LEGIARTI000024316813", "URL": "article/LEGI/ARTI/00/00/24/31/68/LEGIARTI000024316813.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "LIENS": { "LIEN": [ { "@id": "JORFTEXT000000217229", "#text": "Rapport relatif à l'ordonnance n° 2000-548 du 15 juin 2000", "@sens": "source", "@cidtexte": "JORFTEXT000000217229", "@nortexte": "MESX0000036P", "@typelien": "CODIFICATION", "@naturetexte": "RAPPORT", "@datesignatexte": "2999-01-01" }, { "@id": "JORFTEXT000000227015", "#text": "Loi n°2002-303 du 4 mars 2002", "@sens": "source", "@cidtexte": "JORFTEXT000000227015", "@nortexte": "MESX0100092L", "@numtexte": "2002-303", "@typelien": "CODIFICATION", "@naturetexte": "LOI", "@datesignatexte": "2002-03-04" }, { "@id": "LEGIARTI000024313721", "@num": "9", "#text": "LOI n°2011-803\n du 5 juillet 2011 - art. 9", "@sens": "cible", "@cidtexte": "JORFTEXT000024312722", "@nortexte": "ETSX1117295L", "@numtexte": "2011-803", "@typelien": "MODIFIE", "@naturetexte": "LOI", "@datesignatexte": "2011-07-05" }, { "@id": "LEGIARTI000018165471", "@num": "706-135", "#text": "Code de procédure pénale - art. 706-135 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006071154", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000044588896", "@num": "L222-1", "#text": "Code de la recherche - art. 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R1223-14 (T)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006171018", "@fin": "2999-01-01", "#text": "Chapitre Ier : Collecte, préparation et conservation du sang, de ses composants et des produits sanguins labiles.", "@debut": "2000-06-22" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006154985", "@fin": "2999-01-01", "#text": "Titre II : Sang humain", "@debut": "2000-06-22" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006140604", "@fin": "2999-01-01", "#text": "Livre II : Don et utilisation des éléments et produits du corps humain", "@debut": "2000-06-22" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006125345", "@fin": "2999-01-01", "#text": "Première partie : Protection générale de la santé", "@debut": "2000-06-22" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006103419", "@fin": "2999-01-01", "#text": "Partie législative", "@debut": "2000-06-22" } ] }, "@cid": "LEGITEXT000006072665", "@nature": "CODE", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Code de la santé publique", "@debut": "1953-10-07", "@id_txt": "LEGITEXT000006072665", "@c_titre_court": "Code de la santé publique" } ], "@date_publi": "2999-01-01", "@date_signature": "2999-01-01" } }, "VERSIONS": { "VERSION": [ { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006686091", "@fin": "2004-08-11", "@num": "L1221-8-1", "@etat": "MODIFIE", "@debut": "2004-08-07", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006686092", "@fin": "2006-04-19", "@num": "L1221-8-1", "@etat": "MODIFIE", "@debut": "2004-08-11", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006686093", "@fin": "2011-08-01", "@num": "L1221-8-1", "@etat": "MODIFIE", "@debut": "2006-04-19", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000024316813", "@fin": "2012-03-07", "@num": "L1221-8-1", "@etat": "MODIFIE", "@debut": "2011-08-01", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000033281988", "@fin": "2016-10-22", "@num": "L1221-8-1", "@etat": "MODIFIE", "@debut": "2012-03-07", "@origine": "LEGI" } }, { "@etat": "VIGUEUR", "LIEN_ART": { "@id": "LEGIARTI000025457509", "@fin": "2999-01-01", "@num": "L1221-8-1", "@etat": "VIGUEUR", "@debut": "2016-10-22", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "

Le sang et ses composants peuvent être utilisés dans le cadre d'une activité de recherche, qu'ils aient été ou non prélevés par un établissement de transfusion sanguine. Dans ce cas, la recherche est menée à partir de prélèvements réalisés soit dans une finalité médicale, soit dans le cadre d'une recherche visant à évaluer les soins courants mentionnée au 2° de l'article L. 1121-1, soit dans le cadre d'une recherche biomédicale, soit dans une finalité de constitution de collection d'échantillons biologiques humains. Dans ce dernier cas, les prélèvements de sang ne doivent comporter que des risques négligeables. Dans tous les cas, les principes mentionnés aux articles L. 1221-3, L. 1221-4 et L. 1221-6 sont applicables, sans préjudice des dispositions du titre II du livre Ier de la présente partie lorsque le sang ou ses composants sont prélevés ou utilisés dans le cadre d'une activité de recherche biomédicale.

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Lorsque le sang ou ses composants sont prélevés pour constituer directement une collection d'échantillons biologiques humains, les dispositions mentionnées aux articles L. 1243-3 et L. 1243-4 sont applicables ainsi que les principes de l'indemnisation des conséquences dommageables et de l'obligation d'assurance tels que définis, pour les recherches biomédicales, à l'article L. 1121-10.

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Lorsque des prélèvements de sang visés à l'alinéa précédent sont effectués, à des fins de constitution d'une collection d'échantillons biologiques humains, sur des femmes enceintes, des parturientes ou des mères qui allaitent, sur des mineurs ou des majeurs faisant l'objet d'une mesure de protection légale ou hors d'état d'exprimer leur consentement, sur des personnes privées de liberté, des personnes faisant l'objet de soins psychiatriques en application des chapitres II à IV du titre Ier du livre II de la troisième partie du présent code ou de l'article 706-135 du code de procédure pénale, des personnes admises dans un établissement sanitaire ou social à d'autres fins que la recherche, le comité mentionné au troisième alinéa de l'article L. 1243-3 s'assure, en outre, que la collection est destinée à des recherches qui ne pourraient pas être effectuées sur une autre catégorie de la population avec une efficacité comparable.

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" } }, "LEGIARTI000025457542": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "L1121-7", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2019-03-11", "DATE_DEBUT": "2012-03-07" } }, "META_COMMUN": { "ID": "LEGIARTI000025457542", "URL": "article/LEGI/ARTI/00/00/25/45/75/LEGIARTI000025457542.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "NOTA": { "CONTENU": "
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" }, "LIENS": { "LIEN": [ { "@id": "JORFTEXT000000217229", "#text": "Rapport relatif à l'ordonnance n° 2000-548 du 15 juin 2000", "@sens": "source", "@cidtexte": "JORFTEXT000000217229", "@nortexte": "MESX0000036P", "@typelien": "CODIFICATION", "@naturetexte": "RAPPORT", "@datesignatexte": "2999-01-01" }, { "@id": "JORFTEXT000000227015", "#text": "Loi n°2002-303 du 4 mars 2002", "@sens": "source", "@cidtexte": "JORFTEXT000000227015", "@nortexte": "MESX0100092L", "@numtexte": "2002-303", "@typelien": "CODIFICATION", "@naturetexte": "LOI", "@datesignatexte": "2002-03-04" }, { "@id": "LEGIARTI000025442828", "@num": "1", "#text": "LOI n°2012-300 du 5 mars 2012 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000025441587", "@nortexte": "SASX0901817L", "@numtexte": "2012-300", "@typelien": "MODIFIE", "@naturetexte": "LOI", "@datesignatexte": "2012-03-05" }, { "@id": "LEGIARTI000006685825", "@num": "L1121-1", "#text": "Code de la santé publique - art. 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Les mineurs ne peuvent être sollicités pour se prêter à des recherches mentionnées aux 1° ou 2° de l'article L. 1121-1 que si des recherches d'une efficacité comparable ne peuvent être effectuées sur des personnes majeures et dans les conditions suivantes :

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-soit l'importance du bénéfice escompté pour ces personnes est de nature à justifier le risque prévisible encouru ;

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-soit ces recherches se justifient au regard du bénéfice escompté pour d'autres mineurs. Dans ce cas, les risques prévisibles et les contraintes que comporte la recherche doivent présenter un caractère minimal.

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L313-8 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006074069", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006797671", "@num": "L342-4", "#text": "Code de l'action sociale et des familles - art. L342-4 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006074069", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006798076", "@num": "L471-2", "#text": "Code de l'action sociale et des familles - art. L471-2 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006074069", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006798086", "@num": "L472-1", "#text": "Code de l'action sociale et des familles - art. L472-1 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006074069", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000026568308", "@num": "L554-5", "#text": "Code de l'action sociale et des familles - art. L554-5 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006074069", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000026568490", "@num": "L564-5", "#text": "Code de l'action sociale et des familles - art. L564-5 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006074069", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000026568917", "@num": "L574-5", "#text": "Code de l'action sociale et des familles - art. L574-5 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006074069", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006906904", "@num": "R314-87", "#text": "Code de l'action sociale et des familles - art. R314-87 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006074069", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006906919", "@num": "R314-97", "#text": "Code de l'action sociale et des familles - art. R314-97 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006074069", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000029678511", "@fin": "2999-01-01", "#text": "Annexe", "@debut": "2014-11-12" } ] }, "@cid": "JORFTEXT000029675991", "@nor": "AFSX1419046D", "@num": "2014-1286", "@nature": "DECRET", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Décret n° 2014-1286 du 23 octobre 2014 relatif aux exceptions à l'application du principe « silence vaut acceptation » sur le fondement du II de l'article 21 de la loi n° 2000-321 du 12 avril 2000 relative aux droits des citoyens dans leurs relations avec les administrations (ministère des affaires sociales, de la santé et des droits des femmes)", "@debut": "2999-01-01", "@id_txt": "JORFTEXT000029675991", "@c_titre_court": "DÉCRET n°2014-1286 du 23 octobre 2014" }, { "@fin": "2999-01-01", "#text": "Décret n° 2014-1286 du 23 octobre 2014 relatif aux exceptions à l'application du principe « silence vaut acceptation » sur le fondement du II de l'article 21 de la loi n° 2000-321 du 12 avril 2000 relative aux droits des citoyens dans leurs relations avec les administrations (ministère des affaires sociales, de la santé et des droits des femmes)", "@debut": "2014-11-12", "@id_txt": "LEGITEXT000029678507", "@c_titre_court": "DÉCRET n°2014-1286 du 23 octobre 2014" } ], "@ministere": "Ministère des affaires sociales, de la santé et des droits des femmes", "@date_publi": "2014-11-01", "@date_signature": "2014-10-23", "@num_parution_jo": "0254" } }, "VERSIONS": { "VERSION": [ { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000029678512", "@fin": "2017-11-04", "@etat": "MODIFIE", "@debut": "2014-11-12", "@origine": "LEGI" } }, { "@etat": "VIGUEUR", "LIEN_ART": { "@id": "LEGIARTI000035971526", "@fin": "2999-01-01", "@etat": "VIGUEUR", "@debut": "2017-11-04", "@origine": "LEGI" } }, { "LIEN_ART": { "@id": "JORFARTI000029676005", "@fin": "2999-01-01", "@debut": "2999-01-01", "@origine": "JORF" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "

\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n

\n OBJET DE LA DEMANDE \n \n	\n DISPOSITIONS APPLICABLES \n	\n DÉLAI À L'EXPIRATION duquel la décision de rejet est acquise, lorsqu'il est différent du délai de 2 mois \n \n
Code de la santé publique \n
Avis du comité de protection des personnes sur les conditions de validité de la recherche \n	\nArticle L. 1123-7 \n \n	Trente-cinq jours \n
Autorisation de modification substantielle de la recherche \n	\nArticle L. 1123-9 \n \n	Trente-cinq jours \n
Agrément des praticiens seuls habilités à procéder à des examens des caractéristiques génétiques d'une personne ou de son identification par empreintes génétiques à des fins médicales \n	\nArticle L. 1131-3 \n \n	\n
Autorisation d'exercer la profession de conseiller génétique accordée individuellement aux ressortissants d'un Etat membre de l'Union européenne ou d'un autre Etat partie à l'accord sur l'Espace économique européen \n	\nArticle L. 1132-3 \n \n	Quatre mois \n
Dérogation à l'obligation d'assurance prévue au premier alinéa de l'article L. 1142-2 accordée aux établissements publics de santé disposant des ressources financières leur permettant d'indemniser les dommages dans des conditions équivalentes à celles qui résulteraient d'un contrat d'assurance \n	Article L. 1142-2 \n	\n
Autorisation de conservation des produits sanguins labiles destinés à une utilisation thérapeutique directe délivrée aux établissements de santé et groupements de coopération sanitaire \n	\nArticle L. 1221-10 \n \n	Quatre mois \n
Autorisation d'importation, par quelque organisme que ce soit, d'un produit sanguin labile ou d'une pâte plasmatique, à usage thérapeutique direct ou destiné à la préparation de produits de santé \n	\nArticle L. 1221-12, premier alinéa \n	\n
Autorisation des établissements de santé pour les prélèvements d'organes en vue d'un don \n	\nArticle L. 1233-1 \n \n	Six mois \n
Autorisation d'effectuer le prélèvement de cellules hématopoïétiques accordée par le comité d'experts mentionné à l'article L. 1231-3, sur un mineur au bénéfice de son frère ou de sa sœur \n	\nArticle L. 1241-3 \n \n	\n
Autorisation d'effectuer le prélèvement de cellules hématopoïétiques accordée par le comité d'experts mentionné à l'article L. 1231-3, sur un majeur faisant l'objet d'une mesure de protection légale, au bénéfice de son frère ou de sa sœur \n	\nArticle L. 1241-4 \n \n	\n
Autorisation de prélèvement de tissus du corps humain en vue de don à des fins thérapeutiques accordée aux établissements de santé \n	\nArticle L. 1242-1, premier alinéa \n	\n
Autorisation accordée aux établissements de santé de prélèvement de cellules à des fins d'administration autologue ou allogénique et à l'Etablissement français du sang, ses établissements de transfusion sanguine ou aux établissements de santé de prélèvement de cellules du sang destinées à la préparation de produits cellulaires à finalité thérapeutique \n	Article L. 1242-1, deuxième alinéa \n	\n
Autorisation accordée aux établissements et organismes pour assurer la préparation, la conservation, la distribution et la cession, à des fins thérapeutiques autologues ou allogéniques, des tissus et de leurs dérivés et des préparations de thérapie cellulaire \n	\nArticle L. 1243-2, premier alinéa \n	Six mois \n
Autorisation de modification substantielle des éléments figurant sur la demande initiale d'autorisation, qui affecte une ou plusieurs des activités exercées par l'établissement ou l'organisme autorisé \n	Article L. 1243-2, troisième alinéa \n	Quatre mois \n
Autorisation d'importer ou exporter à des fins thérapeutiques des tissus, leurs dérivés, des cellules issus du corps humain et des préparations de thérapie cellulaire préparés et conservés dans un Etat membre de l'Union européenne ou un Etat partie à l'accord sur l'Espace économique européen \n	Article L. 1245-5, premier alinéa \n	Trois mois \n
Autorisation spécifique d'importation et d'exportation des tissus, leurs dérivés, des cellules issus du corps humain et des préparations de thérapie cellulaire en provenance ou à destination d'un Etat non membre de l'Union européenne ou n'étant pas partie à l'accord sur l'Espace économique européen \n	Article L. 1245-5, deuxième alinéa \n	Trois mois \n
Autorisation d'importer ou d'exporter à des fins thérapeutiques des tissus, cellules, quel que soit le niveau de préparation, et des préparations de thérapie cellulaires destinés aux patients, accordée, dans des situations d'urgence, aux établissements ou organismes ne bénéficiant pas de l'autorisation d'exercer les activités d'importation et d'exportation des trois premiers alinéas de l'article L. 1245-5 \n \n	Article L. 1245-5, dernier alinéa \n	\n
Autorisation des produits thérapeutiques annexes, préalablement à leur mise sur le marché \n	\nArticle L. 1261-2 \n \n	Quatre-vingt-dix jours \n
Autorisation préalable de sondage, travail souterrain, et des autres activités, dépôts ou installations de nature à nuire directement ou indirectement à la qualité des eaux, dans le périmètre de protection d'une source d'eau minérale naturelle \n	\nArticle L. 1322-4 \n \n	Quatre mois, ou six mois en cas d'expertise d'un organisme compétent à l'échelon national \n
Interdiction prise par le préfet, sur demande du propriétaire de la source, de travaux, dépôts ou installation mentionnés à l'article L. 1322-4 et entrepris, soit en vertu d'une autorisation régulière, soit après une déclaration préalable, si leur résultat constaté est d'altérer ou de diminuer la source d'eau minérale naturelle \n	\nArticle L. 1322-5 \n \n	\n
Suspension provisoire des travaux ou activité sur demande du propriétaire de la source, lorsque, à raison de sondage ou de travaux souterrains ou à raison d'autres activités, dépôts ou installation entrepris en dehors du périmètre jugé de nature à altérer ou à diminuer une source d'eau minérale naturelle d'intérêt public, l'extension de celui-ci paraît nécessaire \n	\nArticle L. 1322-6 \n \n	\n
Autorisation d'occupation d'un terrain compris dans le périmètre de protection d'une source d'eau minérale naturelle déclarée d'intérêt public pour l'exécution de travaux \n	\nArticle L. 1322-10 \n \n	\n
Autorisation de publicité relative à l'emploi de radionucléides ou de produits en contenant, hors des domaines de la médecine humaine ou vétérinaire \n	\nArticle L. 1333-14 \n \n	\n
Autorisation de création de centres pluridisciplinaires de diagnostics prénatals, dans des établissements et organismes de santé publics et privés d'intérêt collectif \n	\nArticle L. 2131-1 VIII \n	\n
Autorisation spécifique accordée aux établissements réalisant le diagnostic préimplantatoire \n	\nArticle L. 2131-4 \n \n	\n
Autorisation d'un diagnostic préimplantatoire à titre dérogatoire \n	\nArticle L. 2131-4-1 \n \n	\n
Agrément des praticiens seuls habilités à procéder au diagnostic biologique effectué à partir de cellules prélevées sur l'embryon in vitro \n	\nArticle L. 2131-4-2 \n \n	\n
Autorisation délivrée avant la mise en œuvre de toute nouvelle technique visant à améliorer l'efficacité, la reproductibilité et la sécurité des procédés biologiques utilisés en assistance médicale à la procréation \n	\nArticle L. 2141-1 \n \n	\n
Autorisation de déplacement d'embryons conçus avec les gamètes de l'un au moins des membres d'un couple et dans le respect des principes fondamentaux prévus par les articles 16 à 16-8 du code civil et exclusivement destinés à permettre la poursuite du projet parental de ce couple \n	\nArticle L. 2141-9 \n \n	\n
Autorisation délivrée aux établissements, organismes ou laboratoires titulaires de l'autorisation prévue à l'article L. 2142-1 d'exercer une activité d'assistance médicale à la procréation leur permettant d'importer ou d'exporter des gamètes ou tissus germinaux issus du corps humain \n	\nArticle L. 2141-11-1 \n \n	\n
Autorisation accordée pour la recherche sur l'embryon humain et les cellules souches embryonnaires \n	\nArticle L. 2151-5 \n \n	\n
Autorisation préalable accordée par l'Agence de la biomédecine pour l'importation et l'exportation de cellules souches embryonnaires aux fins de recherche \n	\nArticle L. 2151-6 \n \n	\n
Autorisation délivrée à tout organisme qui assure, à des fins scientifiques, la conservation de cellules souches embryonnaires \n	\nArticle L. 2151-7 \n \n	\n
Autorisation de fonctionnement des lactariums gérés, par des établissements publics de santé, des collectivités publiques ou des organismes sans but lucratif assurant la collecte, la préparation, la qualification, le traitement, la conservation, la distribution et la délivrance, sur prescription médicale du lait maternel mentionné au 8° de l'article L. 5311-1 \n \n	\nArticle L. 2323-1 \n \n	\n
Agrément des appareils de désinfection obligatoire \n	\nArticle L. 3114-1 \n \n	Quatre mois \n
Autorisation de mise en œuvre des protocoles de coopération et des adhésions des professionnels de santé à ces protocoles \n	\nArticle L. 4011-2 \n \n	Quatre mois \n
Autorisation à exercer la profession de préparateur en pharmacie accordée individuellement aux ressortissants d'un Etat membre de l'Union européenne ou d'un autre Etat partie à l'accord sur l'Espace économique européen \n	\nArticle L. 4241-7 \n \n	Quatre mois \n
Autorisation d'exercer la profession de préparateur en pharmacie hospitalière accordée individuellement aux ressortissants d'un Etat membre de l'Union européenne ou d'un autre Etat partie à l'accord sur l'Espace économique européen \n	\nArticle L. 4241-14 \n \n	Quatre mois \n
Autorisation d'exercer la profession d'infirmier ou d'infirmière accordée individuellement aux ressortissants d'un Etat membre de l'Union européenne ou d'un autre Etat partie à l'accord sur l'Espace économique européen \n	\nArticle L. 4311-4 \n \n	Quatre mois \n
Obtention du diplôme d'Etat d'infirmier du secteur psychiatrique par les candidats infirmiers titulaires du diplôme d'Etat de secteur psychiatrique qui ont suivi un complément de formation \n	\nArticle L. 4311-5 \n \n	\n
Autorisation d'exercer la profession de masseur-kinésithérapeute accordée individuellement aux ressortissants d'un Etat membre de l'Union européenne ou d'un autre Etat partie à l'accord sur l'Espace économique européen \n	\nArticle L. 4321-4 \n \n	Quatre mois \n
Autorisation d'exercer la profession de pédicure podologue accordée individuellement aux ressortissants d'un Etat membre de l'Union européenne ou d'un autre Etat partie à l'accord sur l'Espace économique européen \n	\nArticle L. 4322-4 \n \n	Quatre mois \n
Autorisation d'exercer la profession de psychomotricien accordée individuellement aux ressortissants d'un Etat membre de l'Union européenne ou d'un autre Etat partie à l'accord sur l'Espace économique européen \n	\nArticle L. 4332-4 \n \n	Quatre mois \n
Autorisation d'exercer la profession d'orthophoniste accordée individuellement aux ressortissants d'un Etat membre de l'Union européenne ou d'un autre Etat partie à l'accord sur l'Espace économique européen \n	\nArticle L. 4341-4 \n \n	Quatre mois \n
Autorisation d'exercer la profession d'orthoptiste accordée individuellement aux ressortissants d'un Etat membre de l'Union européenne ou d'un autre Etat partie à l'accord sur l'Espace économique européen \n	\nArticle L. 4342-4 \n \n	Quatre mois \n
Autorisation d'exercer la profession de manipulateur d'électroradiologie médicale accordée individuellement aux ressortissants d'un Etat membre de l'Union européenne ou d'un autre Etat partie à l'accord sur l'Espace économique européen \n	\nArticle L. 4351-4 \n \n	Quatre mois \n
Autorisation d'exercer la profession d'audioprothésiste accordée individuellement aux ressortissants d'un Etat membre de l'Union européenne ou d'un autre Etat partie à l'accord sur l'Espace économique européen \n	\nArticle L. 4361-4 \n \n	Quatre mois \n
Autorisation d'exercice pour les auxiliaires médicaux ainsi que les préparateurs en pharmacie et préparateurs en pharmacie hospitalière accordée individuellement aux ressortissants d'un Etat non membre de l'Union européenne ou non partie à l'accord sur l'Espace économique européen, sans préjudice des engagements internationaux de la France en matière de coopération sanitaire, et notamment de ses engagements en faveur du développement solidaire \n	\nArticle L. 4381-4 \n \n	Quatre mois \n
Autorisation d'exercer la profession d'aide-soignant accordée individuellement aux ressortissants d'un Etat membre de l'Union européenne ou d'un autre Etat partie à l'accord sur l'Espace économique européen \n	\nArticle L. 4391-2 \n \n	Quatre mois \n
Autorisation d'exercer la profession d'auxiliaire puériculture accordée individuellement aux ressortissants d'un Etat membre de l'Union européenne ou d'un autre Etat partie à l'accord sur l'Espace économique européen \n	\nArticle L. 4392-2 \n \n	Quatre mois \n
Octroi d'une licence en cas de création d'une nouvelle officine de pharmacie, transfert d'une officine d'un lieu dans un autre et tout regroupement d'officines \n	\nArticle L. 5125-4 \n \n	Quatre mois \n
Autorisation de mise en service de véhicules affectés aux transports sanitaires terrestres \n	\nArticle L. 6312-4 \n \n	\n
Validation du domaine de spécialisation permettant l'exercice de la biologie médicale lorsque la reconnaissance de ce domaine de spécialisation ne résulte pas soit d'un diplôme ou d'un concours, soit d'une autorisation ou d'un agrément délivré par l'autorité compétente \n	\nArticle L. 6213-2 (1°) \n	\n
Autorisation d'exercice de la profession de biologiste médical accordée aux directeurs ou directeur adjoint d'un centre national de référence pour la lutte contre les maladies transmissibles \n	Article L. 6213-2 (3°) \n	\n
Autorisation d'exercice des fonctions de biologiste médical, dans les centres hospitaliers et universitaires et les établissements liés par convention en application de l'article L. 6142-5, des professionnels médecins ou pharmaciens, non qualifiés en biologie médicale et recrutés dans une discipline mixte, lorsqu'il justifient d'un exercice effectif d'une durée de trois ans dans des structures et laboratoires de biologie médicale. \n	\nArticle L. 6213-2-1 \n \n	\n
Autorisation pour la création d'installations de chirurgie esthétique \n	\nArticle L. 6322-1 \n \n	Quatre mois \n
Dispense de tout ou partie des enseignements, des stages cliniques et éventuellement, du ou des examens de passage pour l'obtention du diplôme de masseur-kinésithérapeute \n	\nArticle D. 4321-17 \n \n	\n
Dérogation aux dispositions de l'article D. 4364-7 à D. 4364-10 pour exercer les professions d'orthoprothésiste, podo-orthésiste, oculariste, épithésiste ou orthopédiste-orthésiste \n	\nArticle D. 4364-10-1 \n \n	Huit mois \n
Autorisation d'exercer les professions d'orthoprothésiste, de podo-orthésiste, d'oculariste, d'épithésiste ou d'orthopédiste-orthésiste accordée aux ressortissants d'un Etat membre de l'Union européenne ou d'un autre Etat partie à l'accord sur l'Espace économique européen \n	\nArticle D. 4364-11 \n \n	Quatre mois \n
Code de l'action sociale et des familles \n
Agrément des organismes procédant à la domiciliation \n	\nArticle L. 264-6 \n \n	\n
Agrément des organismes assurant l'accueil et l'hébergement de personnes en difficulté et qui ne relèvent pas de l'article L. 312-1 \n \n	\nArticle L. 265-1 \n \n	\n
Accord pour la cession de l'autorisation des établissements et services sociaux et médico-sociaux et des lieux de vie et d'accueil, lorsque la décision relève notamment de l'Etat \n	\nArticle L. 313-1, troisième alinéa \n	\n
Autorisation de création, d'extension et de transformation des établissements et services sociaux et médico-sociaux et des lieux de vie et d'accueil soumis à la procédure d'appel à projet, lorsque la décision relève notamment de l'Etat \n	\nArticle L. 313-1-1 \n \n	Six mois \n
Habilitation à recevoir des bénéficiaires de l'aide sociale et autorisation à dispenser des prestations prises en charge par l'Etat ou l'assurance-maladie, lorsque la décision relève notamment de l'Etat \n	\nArticle L. 313-8 \n \n	\n
Habilitation à recevoir des mineurs confiés par l'autorité judiciaire \n	\nArticle L. 313-10 \n \n	\n
Accord sur le choix par le gestionnaire de l'établissement ou du service fermé de l'attributaire des sommes affectées à l'établissement ou service fermé, apportées par l'Etat, par l'agence régionale de santé, les collectivités territoriales et leurs établissements publics ou par les organismes de sécurité sociale, énumérées à l'article L. 313-19, lorsque la décision relève notamment de l'Etat \n	Article L. 313-19, neuvième alinéa \n	\n
Accord de l'autorité de tarification sur les conditions de mise en œuvre de l'obligation de reversement des sommes affectées à l'établissement ou service fermé, apportées par l'Etat, par l'agence régionale de santé, les collectivités territoriales et leurs établissements publics ou par les organismes de sécurité sociale, énumérées à l'article L. 313-19 \n	Article L. 313-19, dernier alinéa \n	\n
Fixation d'un pourcentage supérieur de bénéficiaires de l'aide sociale en cas d'augmentation importante des coûts d'exploitation résultant d'améliorations de prestations existantes ou de la modification des conditions de gestion ou d'exploitation \n	\nArticle L. 342-4 \n \n	\n
Agrément en qualité de mandataire judiciaire à la protection des majeurs des personnes physiques qui exercent à titre individuel et habituel les mesures de protection des majeurs ordonnées par l'autorité judiciaire au titre du mandat spécial auquel il peut être recouru dans le cadre de la sauvegarde de justice ou au titre de la curatelle, de la tutelle ou de la mesure d'accompagnement judiciaire, préalablement à leur inscription sur la liste prévue à l'article L. 471-2\n \n	\nArticle L. 472-1 \n \n	Quatre mois \n
Autorisation d'exercice, dans les îles Wallis-et-Futuna, des mandats de protection des majeurs par les services mandataires par les services sociaux \n	\nArticle L. 554-5 \n \n	\n
Autorisation d'exercice, en Polynésie française, des mandats de protection des majeurs par les services sociaux \n	\nArticle L. 564-5 \n \n	\n
Autorisation d'exercice, en Nouvelle-Calédonie, des mandats de protection des majeurs par les services sociaux \n	\nArticle L. 574-5 \n \n	\n
Autorisation de prise en compte de frais de siège social de l'organisme gestionnaire, lorsque la décision relève de l'Etat \n	\nArticle R. 314-87 \n \n	\n
Accord de l'autorité tarifaire sur les conditions de mise en œuvre de l'obligation de reversement des montants des amortissements cumulés des biens, des provisions non utilisées et des réserves de trésorerie apparaissant au bilan de clôture, en cas de fermeture ou de cessation d'activité totale ou partielle d'un établissement ou d'un service \n	\nArticle R. 314-97, \n quatrième alinéa \n	\n
Loi n° 2002-303 du 4 mars 2002 relative aux droits des malades et à la qualité du système de santé \n
Agrément des établissements autorisés à dispenser la formation en chiropraxie \n	\nArticle 75, premier alinéa \n	Six mois \n
Agrément des établissements de formation pour délivrer une formation en ostéopathie \n	Article 75, premier alinéa \n	\n
Loi n° 2004-806 du 9 août 2004 relative à la politique de santé publique \n
Inscription sur la liste départementale mentionnée au deuxième alinéa de l'article 52 de la loi n° 2004-806 du 9 août 2004 relative à la politique de santé publique permettant l'usage du titre de psychothérapeute \n	Article 52, deuxième alinéa \n	\n
Agrément des établissements de formation pour délivrer une formation en psychopathologie clinique \n	Article 52, troisième alinéa \n	Six mois \n
Inscription sur la liste départementale des psychothérapeutes aux professionnels justifiant d'au moins cinq ans de pratique de la psychothérapie à la date de publication du décret n° 2010-534 du 20 mai 2010 relatif à l'usage du titre de psychothérapeute, alors même qu'ils ne remplissent pas les conditions de formation et de diplôme prévues aux articles 1er et 6 du décret \n	Article 52, dernier alinéa \n	Six mois \n
Ordonnance n° 2010-49 du 13 janvier 2010 relative à la biologie médicale \n
Autorisation d'exercice des fonctions de biologiste médical par les personnes ayant déposé auprès du ministre chargé de la santé, avant la date de publication de l'ordonnance n° 2010-49 du 13 janvier 2010 relative à la biologie médicale, une demande d'autorisation d'exercice des fonctions de directeur ou directeur adjoint de laboratoire sans qu'une décision leur ait été notifiée au plus tard à cette même date \n	\nArticle 9 v \n	Quatre mois \n
Autorisation, jusqu'au 31 octobre 2020, des laboratoires de biologie médicale non accrédités au sens de l'article L. 6221-1 du code de la santé publique \n \n	\nArticle 7 I \n	\n
Décret n° 2007-435 du 25 mars 2007 relatif aux actes et aux conditions d'exercice de l'ostéopathie \n
Autorisation aux ressortissants d'un Etat membre de l'Union européenne ou d'un autre Etat partie à l'Espace économique européen à faire usage professionnel du titre d'ostéopathe \n	\nArticle 6 \n \n	Quatre mois \n
Décret n° 2011-32 du 7 janvier 2011 relatif aux actes et aux conditions d'exercice de la chiropraxie \n
Autorisation des ressortissants d'un Etats membres de l'Union européenne ou d'un autre Etat partie à l'accord sur l'Espace économique européen, à user du titre de chiropracteur \n	\nArticle 6 \n \n	Quatre mois \n
Arrêté du 25 janvier 2005 relatif aux modalités d'organisation de la validation des acquis de l'expérience pour l'obtention du diplôme professionnel d'aide-soignant \n
Recevabilité du dossier de demande de validation des acquis de l'expérience pour acquérir le diplôme professionnel d'aide-soignant \n	\nArticle 2 \n \n	\n
Arrêté du 16 janvier 2006 relatif aux modalités d'organisation de la validation des acquis de l'expérience pour l'obtention du diplôme professionnel d'auxiliaire de puériculture \n
Recevabilité du dossier de demande de validation des acquis de l'expérience pour acquérir le diplôme d'Etat d'auxiliaire de puériculture \n	\nArticle 2 \n \n	\n
Arrêté du 31 juillet 2006 relatif aux modalités d'organisation de la validation des acquis de l'expérience pour l'obtention du diplôme de préparateur en pharmacie hospitalière \n
Recevabilité du dossier de demande de validation des acquis de l'expérience pour acquérir le diplôme de préparateur en pharmacie hospitalière \n	\nArticle 2 \n \n	\n
Arrêté du 18 août 2010 relatif aux modalités d'organisation de la validation des acquis de l'expérience pour l'obtention du diplôme d'Etat d'ergothérapeute \n
Recevabilité du dossier de demande de validation des acquis de l'expérience pour acquérir le diplôme d'Etat d'ergothérapeute \n	\nArticle 2 \n \n	\n
Arrêté du 6 décembre 2011 relatif à la formation et aux missions de la personne spécialisée en radiophysique médicale et à la reconnaissance des qualifications professionnelles des ressortissants étrangers pour l'exercice de ces missions en France \n
Autorisation à exercer les fonctions de la personne spécialisée en radiophysique médicale accordée individuellement aux ressortissants d'un Etat membre de l'Union européenne ou d'un autre Etat partie à l'accord sur l'Espace économique européen \n	\nArticle 6 \n \n	Quatre mois \n
Arrêté du 24 février 2014 relatif aux modalités d'organisation de la validation des acquis de l'expérience pour l'obtention du diplôme d'Etat d'infirmier du bloc opératoire \n
Recevabilité du dossier de demande de validation des acquis de l'expérience pour acquérir le diplôme d'Etat d'infirmier de bloc opératoire \n	\nArticle 2\n \n	\n

\n\n

" } }, "LEGIARTI000032722995": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "L1124-1", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2018-01-19", "DATE_DEBUT": "2016-12-31" } }, "META_COMMUN": { "ID": "LEGIARTI000032722995", "URL": "article/LEGI/ARTI/00/00/32/72/29/LEGIARTI000032722995.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "NOTA": { "CONTENU": "

Conformément au II de l'article 8 de l'ordonnance n° 2016-800 du 16 juin 2016, ces dispositions entrent en vigueur à la date d'entrée en vigueur des dispositions du règlement européen (UE) n° 536/2014.

" }, "LIENS": { "LIEN": [ { "@id": "LEGIARTI000006528193", "@num": "54", "#text": "LOI n° 78-17 du 6 janvier 1978 - art. 54 (V)", "@sens": "source", "@cidtexte": "JORFTEXT000000886460", "@numtexte": "78-17", "@typelien": "CITATION", "@naturetexte": "LOI", "@datesignatexte": "1978-01-06" }, { "@id": "JORFTEXT000000217229", "#text": "Rapport relatif à l'ordonnance n° 2000-548 du 15 juin 2000", "@sens": "source", "@cidtexte": "JORFTEXT000000217229", "@nortexte": "MESX0000036P", "@typelien": "CODIFICATION", "@naturetexte": "RAPPORT", "@datesignatexte": "2999-01-01" }, { "@id": "JORFTEXT000000227015", "#text": "Loi n°2002-303 du 4 mars 2002", "@sens": "source", "@cidtexte": "JORFTEXT000000227015", "@nortexte": "MESX0100092L", "@numtexte": "2002-303", "@typelien": "CODIFICATION", "@naturetexte": "LOI", "@datesignatexte": "2002-03-04" }, { "@id": "LEGIARTI000047718215", "@num": "2", "#text": "Arrêté du 23 janvier 2009 - art. 2 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000020214008", "@nortexte": "SASP0902336A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2009-01-23" }, { "@id": "LEGIARTI000047718206", "@num": "3", "#text": "Arrêté du 23 janvier 2009 - art. 3 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000020214008", "@nortexte": "SASP0902336A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2009-01-23" }, { "@id": "LEGIARTI000032720821", "@num": "4", "#text": "Ordonnance n°2016-800 du 16 juin 2016 - art. 4", "@sens": "cible", "@cidtexte": "JORFTEXT000032719520", "@nortexte": "AFSP1608692R", "@numtexte": "2016-800", "@typelien": "MODIFIE", "@naturetexte": "ORDONNANCE", "@datesignatexte": "2016-06-16" }, { "@id": "LEGIARTI000045163027", "@num": "1", "#text": "Arrêté du 26 janvier 2022 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000045159601", "@nortexte": "SSAP2203907A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2022-01-26" }, { "@id": "LEGIARTI000044946523", "@num": "R532-35", "#text": "Code de l'environnement - art. 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\n

I.-Les essais cliniques de médicaments sont régis par les dispositions du règlement (UE) n° 536/2014 du Parlement européen et du Conseil du 16 avril 2014.

L'autorité compétente pour effectuer l'évaluation de la partie I du rapport d'évaluation prévue à l'article 6 de ce règlement est l'Agence nationale de sécurité du médicament et des produits de santé.

L'évaluation de la partie II prévue à l'article 7 de ce règlement relève de la compétence et de la responsabilité des comités de protection des personnes mentionnés à l'article L. 1123-1.

L'Agence nationale de sécurité du médicament et des produits de santé notifie au promoteur la décision unique relative à l'essai clinique mentionnée au paragraphe 1 de l'article 8 de ce règlement.

II.-En cas de refus d'autorisation d'un essai prévu au paragraphe 4 de l'article 8 du règlement précité, le promoteur peut saisir d'une demande de réexamen les autorités suivantes :

1° L'Agence nationale de sécurité du médicament et des produits de santé, lorsque cette demande porte sur des éléments relevant de la partie I prévue à l'article 6 du règlement mentionné ci-dessus ;

2° Le ministre chargé de la santé lorsque cette demande porte sur des éléments relevant de la partie II prévue à l'article 7 du règlement mentionné ci-dessus.

La demande de réexamen est présentée et instruite dans des délais et selon des modalités fixées par décret en Conseil d'Etat.

III.-La première administration d'un médicament à l'homme ne peut être effectuée que dans des lieux ayant été autorisés conformément au deuxième alinéa de l'article L. 1121-13.

Les essais cliniques de médicaments de thérapie innovante tels que définis à l'article 2 du règlement (CE) n° 1394/2007 du Parlement européen et du Conseil, du 13 novembre 2007, concernant les médicaments de thérapie innovante et modifiant la directive 2001/83/ CE ainsi que le règlement (CE) n° 726/2004 et les essais cliniques de médicaments de thérapie innovante tels que définis au 17° de l'article L. 5121-1 ne peuvent être réalisés que dans des établissements de santé ou de transfusion sanguine, dans les services de santé des armées ou dans le centre de transfusion sanguine des armées.

IV.-Sont applicables aux essais cliniques mentionnés au I les dispositions du présent chapitre ainsi que les dispositions des articles L. 1121-10, L. 1121-11, L. 1121-13, L. 1121-14, L. 1121-16, L. 1121-16-1, L. 1123-10, L. 1126-1 à L. 1126-12, L. 5121-1-1, L. 5125-1 et L. 5126-1. Ces essais sont interdits sur une personne qui n'est pas affiliée à un régime de sécurité sociale ou bénéficiaire d'un tel régime.

Leur sont également applicables les dispositions du 1° du II de l'article 54 de la loi n° 78-17 du 6 janvier 1978 modifiée relative à l'informatique et aux libertés.

\n
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Le dossier de demande d'avis mentionné à l'article 2 comprend :
I. - Un dossier administratif contenant les informations suivantes :
1° Un courrier de demande, daté et signé ;
2° Le formulaire de demande d'avis, daté et signé, disponible en version électronique sur le site internet de la base de données EudraCT ;
3° Le document additionnel à la demande d'avis au comité de protection des personnes décrit en annexe au présent arrêté, daté et signé, accompagné des supports susceptibles d'être utilisés en vue du recrutement des personnes ;
4° Le cas échéant, la copie de la ou des autorisations de lieux de recherches mentionnées à l'article L. 1121-13 du code de la santé publique.
II. - Un dossier sur la recherche contenant les informations suivantes :
1° Le protocole de la recherche tel que défini à l'article R. 1123-20 du code de la santé publique, daté et comportant un numéro de version ;
2° Le résumé du protocole, daté et comportant un numéro de version ;
3° La brochure pour l'investigateur ou le résumé des caractéristiques du produit pour tout médicament expérimental disposant d'une autorisation de mise sur le marché en France ou dans un autre Etat membre de l'Union européenne accompagné, s'il est utilisé dans des conditions différentes de celles prévues par cette autorisation, de la synthèse des données justifiant l'utilisation et la sécurité d'emploi du médicament dans la recherche ;
4° Si la brochure pour l'investigateur appartient à un tiers, l'autorisation du tiers délivrée au promoteur pour l'utiliser ;
5° Le document d'information destiné aux personnes qui se prêtent à la recherche prévu à l'article L. 1122-1 du code de la santé publique. Si le médicament expérimental dispose d'une autorisation de mise sur le marché en France, le dossier comprend une comparaison et, le cas échéant, la description et la justification des divergences pertinentes en terme de sécurité des personnes entre le document d'information destiné aux personnes qui se prêtent à la recherche et la notice prévue à l'article R. 5121-148 du code de la santé publique, au regard des contre-indications et des effets indésirables graves ou des mises en garde ou précautions d'emploi particulières ;
6° Le formulaire de recueil du consentement des personnes se prêtant à la recherche ;
7° La copie de l'attestation d'assurance prévue à l'article L. 1121-10 du code de la santé publique ;
8° Le cas échéant, l'avis d'un comité scientifique consulté par le promoteur ;
9° Une justification de l'adéquation des moyens humains, matériels et techniques au projet de recherche et de leur compatibilité avec les impératifs de sécurité des personnes qui s'y prêtent, sauf si le lieu bénéficie de l'autorisation mentionnée à l'article L. 1121-13 du code de la santé publique ;
10° Les curriculum vitae du ou des investigateurs ;
11° La nature de la décision finale de l'Agence nationale de sécurité du médicament et des produits de santé mentionnée à l'article L. 1123-8 du code de la santé publique, si cette décision est disponible.
Les documents mentionnés aux 2°, 5°, 6° et 9° du II du présent article sont rédigés en français.

" } }, "LEGIARTI000033547020": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "3", "ETAT": "VIGUEUR", "TYPE": "AUTONOME", "DATE_FIN": "2999-01-01", "DATE_DEBUT": "2016-12-08" } }, "META_COMMUN": { "ID": "LEGIARTI000033547020", "URL": "article/LEGI/ARTI/00/00/33/54/70/LEGIARTI000033547020.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "LIENS": { "LIEN": [ { "@id": "LEGIARTI000006685848", "@num": "L1121-10", "#text": "Code de la santé publique - art. L1121-10", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006685852", "@num": "L1121-13", "#text": "Code de la santé publique - art. L1121-13", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006685859", "@num": "L1122-1", "#text": "Code de la santé publique - art. L1122-1", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000032721696", "@num": "L1122-1-4", "#text": "Code de la santé publique - art. L1122-1-4", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006685883", "@num": "L1123-8", "#text": "Code de la santé publique - art. L1123-8", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006908378", "@num": "R1123-20", "#text": "Code de la santé publique - art. R1123-20", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "@cid": "JORFTEXT000033545436", "@nor": "AFSP1635568A", "@nature": "ARRETE", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Arrêté du 2 décembre 2016 fixant le contenu, le format et les modalités de présentation du dossier de demande d'avis au comité de protection des personnes sur un projet de recherche mentionnée au 1° et au 2° de l'article L. 1121-1 du code de la santé publique portant sur un dispositif médical ou sur un dispositif médical de diagnostic in vitro", "@debut": "2999-01-01", "@id_txt": "JORFTEXT000033545436", "@c_titre_court": "Arrêté du 2 décembre 2016" }, { "@fin": "2999-01-01", "#text": "Arrêté du 2 décembre 2016 fixant le contenu, le format et les modalités de présentation du dossier de demande d'avis au comité de protection des personnes sur un projet de recherche mentionnée au 1° et au 2° de l'article L. 1121-1 du code de la santé publique portant sur un dispositif médical ou sur un dispositif médical de diagnostic in vitro", "@debut": "2016-12-08", "@id_txt": "LEGITEXT000033547014", "@c_titre_court": "Arrêté du 2 décembre 2016" } ], "@ministere": "Ministère des affaires sociales et de la santé", "@date_publi": "2016-12-07", "@date_signature": "2016-12-02" } }, "VERSIONS": { "VERSION": [ { "@etat": "VIGUEUR", "LIEN_ART": { "@id": "LEGIARTI000033547020", "@fin": "2999-01-01", "@num": "3", "@etat": "VIGUEUR", "@debut": "2016-12-08", "@origine": "LEGI" } }, { "LIEN_ART": { "@id": "JORFARTI000033545443", "@fin": "2999-01-01", "@num": "3", "@debut": "2999-01-01", "@origine": "JORF" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "

\n
Le dossier de demande d'avis comprend :
I. - Un dossier administratif contenant :
1° Un courrier de demande, daté et signé ;
2° Le formulaire de demande d'avis auprès du comité de protection des personnes désigné et d'autorisation auprès de l'Agence nationale de sécurité du médicament et des produits de santé, renseigné, daté et signé, disponible en version électronique sur le site internet de l'Agence nationale de sécurité du médicament et des produits de santé ;
3° Le document additionnel à la demande d'avis au comité de protection des personnes décrit en annexe du présent arrêté, daté et signé, accompagné des supports susceptibles d'être utilisés en vue du recrutement des personnes ;
4° Pour les recherches mentionnées au 1° de l'article L.1121-1, le cas échéant, la copie de la ou des autorisations de lieux de recherches mentionnées à l'article L. 1121-13 du code de la santé publique.
II. - Un dossier sur la recherche contenant :
1° Le protocole de la recherche tel que défini à l'article R. 1123-20 du code de la santé publique, daté et comportant un numéro de version ;
2° Le résumé du protocole rédigé en français, daté et comportant le numéro de version mentionné au 1° ;
3° La brochure pour l'investigateur mentionnée à l'article R. 1123-20 du code de la santé publique, ou la notice d'instruction en vigueur pour tout dispositif médical pourvu du marquage CE, ou la notice d'utilisation en vigueur pour tout dispositif médical de diagnostic in vitro pourvu du marquage CE, accompagnée, pour les recherches mentionnées au 1° de l'article L.1121-1 dans le cadre desquelles le dispositif est utilisé dans une destination autre que celle figurant sur cette notice, de la synthèse des données justifiant son utilisation et sa sécurité d'emploi dans le cadre de la recherche ;
4° Si la brochure pour l'investigateur appartient à un tiers, l'autorisation du tiers délivrée au promoteur pour l'utiliser ;
5° Le document d'information destiné aux personnes qui se prêtent à la recherche prévu à l'article L. 1122-1 du code de la santé publique sauf lorsque les exigences méthodologiques de la recherche ne sont pas compatible avec le recueil du consentement et que l'information est collective conformément à l'article L.1122-1-4 du code de la santé publique. Ce document décrit notamment les contre-indications, les effets indésirables graves et les précautions d'utilisation du dispositif sur lequel porte la recherche.
Si le dispositif médical ou le dispositif médical de diagnostic in vitro sur lequel porte la recherche n'est pas pourvu du marquage CE, ce document précise également les risques éventuels liés au dispositif médical et dispositif médical de diagnostic in vitro et, le cas échéant, ceux liés à la procédure de mise en oeuvre du dispositif médical.
Si le dispositif médical ou le dispositif médical de diagnostic in vitro sur lequel porte la recherche est pourvu du marquage CE, le dossier sur la recherche comprend également une comparaison et la justification des divergences pertinentes en termes de sécurité des personnes, entre le document d'information destiné aux personnes qui se prêtent à la recherche et la notice d'instruction pour les dispositifs médicaux, ou la notice d'utilisation pour les dispositifs médicaux de diagnostic in vitro ;
6° Le formulaire de recueil de consentement des personnes se prêtant à la recherche sauf lorsqu'il est fait application de l'article L.1122-1-4 du code de la santé publique ;
7° La copie de l'attestation d'assurance prévue à l'article L. 1121-10 du code de la santé publique ;
8° Une justification de l'adéquation des moyens humains, matériels et techniques au projet de recherche et de leur compatibilité avec les impératifs de sécurité des personnes qui s'y prêtent, sauf si le lieu bénéficie d'une autorisation mentionnée à l'article L. 1121-13 du code de la santé publique ;
9° Les curriculum vitae du ou des investigateurs ;
10° Le cas échéant la nature de la décision finale de l'Agence nationale de sécurité du médicament et des produits de santé mentionnée à l'article L. 1123-8 du code de la santé publique, si cette décision est disponible.

" } }, "LEGIARTI000033547085": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "3", "ETAT": "VIGUEUR", "TYPE": "AUTONOME", "DATE_FIN": "2999-01-01", "DATE_DEBUT": "2016-12-08" } }, "META_COMMUN": { "ID": "LEGIARTI000033547085", "URL": "article/LEGI/ARTI/00/00/33/54/70/LEGIARTI000033547085.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "LIENS": { "LIEN": [ { "@id": "LEGIARTI000006685825", "@num": "L1121-1", "#text": "Code de la santé publique - art. L1121-1", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006685848", "@num": "L1121-10", "#text": "Code de la santé publique - art. L1121-10", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006685852", "@num": "L1121-13", "#text": "Code de la santé publique - art. L1121-13", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006685859", "@num": "L1122-1", "#text": "Code de la santé publique - art. L1122-1", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006685862", "@num": "L1122-2", "#text": "Code de la santé publique - art. L1122-2", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006685883", "@num": "L1123-8", "#text": "Code de la santé publique - art. L1123-8", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006908378", "@num": "R1123-20", "#text": "Code de la santé publique - art. R1123-20", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "@cid": "JORFTEXT000033545461", "@nor": "AFSP1635571A", "@nature": "ARRETE", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Arrêté du 2 décembre 2016 fixant le contenu, le format et les modalités de présentation du dossier de demande d'avis au comité de protection des personnes sur un projet de recherche mentionnée au 1° ou au 2° de l'article L. 1121-1 du code de la santé publique portant sur un produit cosmétique ou de tatouage", "@debut": "2999-01-01", "@id_txt": "JORFTEXT000033545461", "@c_titre_court": "Arrêté du 2 décembre 2016" }, { "@fin": "2999-01-01", "#text": "Arrêté du 2 décembre 2016 fixant le contenu, le format et les modalités de présentation du dossier de demande d'avis au comité de protection des personnes sur un projet de recherche mentionnée au 1° ou au 2° de l'article L. 1121-1 du code de la santé publique portant sur un produit cosmétique ou de tatouage", "@debut": "2016-12-08", "@id_txt": "LEGITEXT000033547075", "@c_titre_court": "Arrêté du 2 décembre 2016" } ], "@ministere": "Ministère des affaires sociales et de la santé", "@date_publi": "2016-12-07", "@date_signature": "2016-12-02" } }, "VERSIONS": { "VERSION": [ { "@etat": "VIGUEUR", "LIEN_ART": { "@id": "LEGIARTI000033547085", "@fin": "2999-01-01", "@num": "3", "@etat": "VIGUEUR", "@debut": "2016-12-08", "@origine": "LEGI" } }, { "LIEN_ART": { "@id": "JORFARTI000033545468", "@fin": "2999-01-01", "@num": "3", "@debut": "2999-01-01", "@origine": "JORF" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "

\n
Le dossier de demande d'avis comprend :
I. - Un dossier administratif contenant :
1. Un courrier de demande d'avis, daté et signé ;
2. Le formulaire de demande d'avis, renseigné, daté et signé, disponible en version électronique sur le site internet de l'Agence nationale de sécurité du médicament et des produits de santé ;
3. Le document additionnel à la demande d'avis au comité de protection des personnes décrit en annexe du présent arrêté, daté et signé, accompagné des supports susceptibles d'être utilisés en vue du recrutement des personnes ;
4. En cas de soumission de données relatives à un produit cosmétique ou de tatouage sur lequel porte la recherche, appartenant à un tiers, l'autorisation délivrée par ce dernier au promoteur pour communiquer ces données ;
5. Pour les recherches mentionnées au 1° de l'article L. 1121-1 du code de la santé publique, le cas échéant, la copie de la ou des autorisations de lieux de recherches mentionnées à l'article L. 1121-13 du code de la santé publique.
II. - Un dossier sur la recherche contenant :
1. Le protocole de la recherche tel que défini à l'article R. 1123-20 du code de la santé publique, daté et comportant un numéro de version ;
2. Le résumé du protocole rédigé en français, daté et comportant un numéro de version ;
3. La brochure pour l'investigateur mentionnée à l'article R. 1123-20 du code de la santé publique datée et comportant un numéro de version ;
4. Le document d'information destiné aux personnes qui se prêtent à la recherche prévu à l'article L. 1122-1 du code de la santé publique sauf lorsque les exigences méthodologiques de la recherche ne sont pas compatible avec le recueil du consentement et que l'information est collective conformément à l'article L. 1122-1-4. Ce document décrit notamment les risques encourus avec le(s) produit(s) faisant l'objet de la recherche mais également liés à la méthodologie de la recherche ;
5. Le formulaire de recueil du consentement des personnes se prêtant à la recherche ou d'autorisation dans les cas prévus à l'article L. 1122-2 du code de la santé publique sauf lorsqu'il est fait application de l'article L. 1122-1-4 ;
6. La copie de l'attestation d'assurance prévue à l'article L. 1121-10 du code de la santé publique ;
7. Une justification de l'adéquation des moyens humains, matériels et techniques au projet de recherche et de leur compatibilité avec les impératifs de sécurité des personnes qui s'y prêtent, sauf si le lieu bénéficie de l'autorisation mentionnée à l'article L. 1121-13 du code de la santé publique ;
8. Les curriculum vitae du ou des investigateurs ;
9. Le cas échéant, la nature de la décision finale de l'Agence nationale de sécurité du médicament et des produits de santé mentionnée à l'article L. 1123-8 du code de la santé publique, si cette décision est disponible.

" } }, "LEGIARTI000033554483": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "3", "ETAT": "VIGUEUR", "TYPE": "AUTONOME", "DATE_FIN": "2999-01-01", "DATE_DEBUT": "2016-12-10" } }, "META_COMMUN": { "ID": "LEGIARTI000033554483", "URL": "article/LEGI/ARTI/00/00/33/55/44/LEGIARTI000033554483.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "NOTA": { "CONTENU": "
" }, "LIENS": { "LIEN": [ { "@id": "LEGIARTI000006685848", "@num": "L1121-10", "#text": "Code de la santé publique - art. L1121-10", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006685852", "@num": "L1121-13", "#text": "Code de la santé publique - art. L1121-13", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006685862", "@num": "L1122-2", "#text": "Code de la santé publique - art. L1122-2", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006685883", "@num": "L1123-8", "#text": "Code de la santé publique - art. L1123-8", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006690344", "@num": "L5311-1", "#text": "Code de la santé publique - art. L5311-1", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006908378", "@num": "R1123-20", "#text": "Code de la santé publique - art. R1123-20", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "@cid": "JORFTEXT000033553349", "@nor": "AFSP1635656A", "@nature": "ARRETE", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Arrêté du 2 décembre 2016 fixant le contenu et les modalités de présentation du dossier de demande d'avis au comité de protection des personnes sur un projet de recherche mentionnée au 1° ou au 2° de l'article L. 1121-1 du code de la santé publique ne portant pas sur un produit mentionné à l'article L. 5311-1 du même code", "@debut": "2999-01-01", "@id_txt": "JORFTEXT000033553349", "@c_titre_court": "Arrêté du 2 décembre 2016" }, { "@fin": "2999-01-01", "#text": "Arrêté du 2 décembre 2016 fixant le contenu et les modalités de présentation du dossier de demande d'avis au comité de protection des personnes sur un projet de recherche mentionnée au 1° ou au 2° de l'article L. 1121-1 du code de la santé publique ne portant pas sur un produit mentionné à l'article L. 5311-1 du même code", "@debut": "2016-12-10", "@id_txt": "LEGITEXT000033554478", "@c_titre_court": "Arrêté du 2 décembre 2016" } ], "@ministere": "Ministère des affaires sociales et de la santé", "@date_publi": "2016-12-09", "@date_signature": "2016-12-02" } }, "VERSIONS": { "VERSION": [ { "@etat": "VIGUEUR", "LIEN_ART": { "@id": "LEGIARTI000033554483", "@fin": "2999-01-01", "@num": "3", "@etat": "VIGUEUR", "@debut": "2016-12-10", "@origine": "LEGI" } }, { "LIEN_ART": { "@id": "JORFARTI000033553355", "@fin": "2999-01-01", "@num": "3", "@debut": "2999-01-01", "@origine": "JORF" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "

\n
Le dossier de demande d'avis mentionné à l'article 2 comprend :
I. - Un dossier administratif contenant les informations suivantes :
1° Un courrier de demande d'avis, daté et signé ;
2° Le formulaire de demande d'avis, daté et signé, conformément à l'annexe 1 du présent arrêté ;
3° Le document additionnel à la demande d'avis au comité de protection des personnes, décrit en annexe 2 du présent arrêté, daté et signé, accompagné, le cas échéant, des supports susceptibles d'être utilisés en vue du recrutement des personnes ;
4° Pour les recherches mentionnées au 1° de l'article L. 1121-1, si nécessaire, la copie de la ou des autorisations de lieux de recherches mentionnées à l'article L. 1121-13 du code de la santé publique.
II. - Un dossier sur la recherche contenant les informations suivantes :
1° Le protocole de la recherche tel que défini à l'article R. 1123-20 du code de la santé publique, daté et comportant un numéro de version ;
2° Le résumé du protocole rédigé en français, daté et comportant un numéro de version ;
3° Le cas échéant, la brochure pour l'investigateur mentionnée à l'article R. 1123-20 du code de la santé publique, datée et comportant un numéro de version, lorsque la recherche porte sur un produit autre que ceux mentionnés à l'article L. 5311-1 du code de la santé publique ;
4° Si la brochure pour l'investigateur appartient à un tiers, l'autorisation du tiers délivrée au promoteur pour l'utiliser ;
5° Le document d'information destiné aux personnes qui se prêtent à la recherche, sauf lorsque les exigences méthodologiques de la recherche ne sont pas compatibles avec le recueil du consentement et que l'information est collective conformément à l'article L. 1122-1-4 ;
6° Le formulaire de recueil du consentement des personnes se prêtant à la recherche ou d'autorisation dans les cas prévus à l'article L. 1122-2 du code de la santé publique sauf lorsqu'il est fait application de l'article L. 1122-1-4 ;
7° La copie de l'attestation d'assurance prévue à l'article L. 1121-10 du code de la santé publique ;
8° Une justification de l'adéquation des moyens humains, matériels et techniques au projet de recherche et de leur compatibilité avec les impératifs de sécurité des personnes qui s'y prêtent, sauf si le lieu bénéficie de l'autorisation mentionnée à l'article L. 1121-13 du code de la santé publique ;
9° Les curriculum vitae du ou des investigateurs ;
10° Le cas échéant, la nature de la décision finale de l'Agence nationale de sécurité du médicament et des produits de santé, mentionnée à l'article L. 1123-8 du code de la santé publique, si cette décision est disponible.

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L264-6", "@sens": "source", "@cidtexte": "LEGITEXT000006074069", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000019864230", "@num": "L265-1", "#text": "Code de l'action sociale et des familles - art. L265-1", "@sens": "source", "@cidtexte": "LEGITEXT000006074069", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006797382", "@num": "L312-1", "#text": "Code de l'action sociale et des familles - art. L312-1", "@sens": "source", "@cidtexte": "LEGITEXT000006074069", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006797433", "@num": "L313-1", "#text": "Code de l'action sociale et des familles - art. L313-1", "@sens": "source", "@cidtexte": "LEGITEXT000006074069", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006797757", "@num": "L313-1-1", "#text": "Code de l'action sociale et des familles - art. L313-1-1", "@sens": "source", "@cidtexte": "LEGITEXT000006074069", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006797477", "@num": "L313-10", "#text": "Code de l'action sociale et des familles - art. L313-10", "@sens": "source", "@cidtexte": "LEGITEXT000006074069", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006797774", "@num": "L313-19", "#text": "Code de l'action sociale et des familles - art. L313-19", "@sens": "source", "@cidtexte": "LEGITEXT000006074069", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006797469", "@num": "L313-8", "#text": "Code de l'action sociale et des familles - art. L313-8", "@sens": "source", "@cidtexte": "LEGITEXT000006074069", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006797671", "@num": "L342-4", "#text": "Code de l'action sociale et des familles - art. L342-4", "@sens": "source", "@cidtexte": "LEGITEXT000006074069", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006798076", "@num": "L471-2", "#text": "Code de l'action sociale et des familles - art. L471-2", "@sens": "source", "@cidtexte": "LEGITEXT000006074069", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006798086", "@num": "L472-1", "#text": "Code de l'action sociale et des familles - art. L472-1", "@sens": "source", "@cidtexte": "LEGITEXT000006074069", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000026568308", "@num": "L554-5", "#text": "Code de l'action sociale et des familles - art. L554-5", "@sens": "source", "@cidtexte": "LEGITEXT000006074069", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000026568490", "@num": "L564-5", "#text": "Code de l'action sociale et des familles - art. L564-5", "@sens": "source", "@cidtexte": "LEGITEXT000006074069", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000026568917", "@num": "L574-5", "#text": "Code de l'action sociale et des familles - art. L574-5", "@sens": "source", "@cidtexte": "LEGITEXT000006074069", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006906904", "@num": "R314-87", "#text": "Code de l'action sociale et des familles - art. R314-87", "@sens": "source", "@cidtexte": "LEGITEXT000006074069", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006906919", "@num": "R314-97", "#text": "Code de l'action sociale et des familles - art. R314-97", "@sens": "source", "@cidtexte": "LEGITEXT000006074069", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000029678511", "@fin": "2999-01-01", "#text": "Annexe", "@debut": "2014-11-12" } ] }, "@cid": "JORFTEXT000029675991", "@nor": "AFSX1419046D", "@num": "2014-1286", "@nature": "DECRET", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Décret n° 2014-1286 du 23 octobre 2014 relatif aux exceptions à l'application du principe « silence vaut acceptation » sur le fondement du II de l'article 21 de la loi n° 2000-321 du 12 avril 2000 relative aux droits des citoyens dans leurs relations avec les administrations (ministère des affaires sociales, de la santé et des droits des femmes)", "@debut": "2999-01-01", "@id_txt": "JORFTEXT000029675991", "@c_titre_court": "DÉCRET n°2014-1286 du 23 octobre 2014" }, { "@fin": "2999-01-01", "#text": "Décret n° 2014-1286 du 23 octobre 2014 relatif aux exceptions à l'application du principe « silence vaut acceptation » sur le fondement du II de l'article 21 de la loi n° 2000-321 du 12 avril 2000 relative aux droits des citoyens dans leurs relations avec les administrations (ministère des affaires sociales, de la santé et des droits des femmes)", "@debut": "2014-11-12", "@id_txt": "LEGITEXT000029678507", "@c_titre_court": "DÉCRET n°2014-1286 du 23 octobre 2014" } ], "@ministere": "Ministère des affaires sociales, de la santé et des droits des femmes", "@date_publi": "2014-11-01", "@date_signature": "2014-10-23", "@num_parution_jo": "0254" } }, "VERSIONS": { "VERSION": [ { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000029678512", "@fin": "2017-11-04", "@etat": "MODIFIE", "@debut": "2014-11-12", "@origine": "LEGI" } }, { "@etat": "VIGUEUR", "LIEN_ART": { "@id": "LEGIARTI000035971526", "@fin": "2999-01-01", "@etat": "VIGUEUR", "@debut": "2017-11-04", "@origine": "LEGI" } }, { "LIEN_ART": { "@id": "JORFARTI000029676005", "@fin": "2999-01-01", "@debut": "2999-01-01", "@origine": "JORF" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n

\n OBJET DE LA DEMANDE \n	\n DISPOSITIONS APPLICABLES \n	\n DÉLAI À L'EXPIRATION \n\t\t\tduquel la décision de rejet est acquise, \n\t\t\tlorsqu'il est différent du délai de 2 mois \n
Code de la santé publique
Avis du comité de protection des personnes sur les conditions de validité de la recherche	\nArticle L. 1123-7 \n	Trente-cinq jours
Autorisation de modification substantielle de la recherche	\nArticle L. 1123-9 \n	Trente-cinq jours
Agrément des praticiens seuls habilités à procéder à des examens des caractéristiques génétiques d'une personne ou de son identification par empreintes génétiques à des fins médicales	\nArticle L. 1131-3 \n	\n
Autorisation d'exercer la profession de conseiller génétique accordée individuellement aux ressortissants d'un Etat membre de l'Union européenne ou d'un autre Etat partie à l'accord sur l'Espace économique européen	\nArticle L. 1132-3 \n	Quatre mois
Dérogation à l'obligation d'assurance prévue au premier alinéa de l'article L. 1142-2 accordée aux établissements publics de santé disposant des ressources financières leur permettant d'indemniser les dommages dans des conditions équivalentes à celles qui résulteraient d'un contrat d'assurance	Article L. 1142-2	\n
Autorisation de conservation des produits sanguins labiles destinés à une utilisation thérapeutique directe délivrée aux établissements de santé et groupements de coopération sanitaire	\nArticle L. 1221-10 \n	Quatre mois
Autorisation d'importation, par quelque organisme que ce soit, d'un produit sanguin labile ou d'une pâte plasmatique, à usage thérapeutique direct ou destiné à la préparation de produits de santé	\nArticle L. 1221-12, premier alinéa	\n
Autorisation des établissements de santé pour les prélèvements d'organes en vue d'un don	\nArticle L. 1233-1 \n	Six mois
Autorisation d'effectuer le prélèvement de cellules hématopoïétiques accordée par le comité d'experts mentionné à l'article L. 1231-3, sur un mineur au bénéfice de son frère ou de sa sœur	\nArticle L. 1241-3 \n	\n
Autorisation d'effectuer le prélèvement de cellules hématopoïétiques accordée par le comité d'experts mentionné à l'article L. 1231-3, sur un majeur faisant l'objet d'une mesure de protection légale, au bénéfice de son frère ou de sa sœur	\nArticle L. 1241-4 \n	\n
Autorisation de prélèvement de tissus du corps humain en vue de don à des fins thérapeutiques accordée aux établissements de santé	\nArticle L. 1242-1, premier alinéa	\n
Autorisation accordée aux établissements de santé de prélèvement de cellules à des fins d'administration autologue ou allogénique et à l'Etablissement français du sang, ses établissements de transfusion sanguine ou aux établissements de santé de prélèvement de cellules du sang destinées à la préparation de produits cellulaires à finalité thérapeutique	Article L. 1242-1, deuxième alinéa	\n
Autorisation accordée aux établissements et organismes pour assurer la préparation, la conservation, la distribution et la cession, à des fins thérapeutiques autologues ou allogéniques, des tissus et de leurs dérivés et des préparations de thérapie cellulaire	\nArticle L. 1243-2, premier alinéa	Six mois
Autorisation de modification substantielle des éléments figurant sur la demande initiale d'autorisation, qui affecte une ou plusieurs des activités exercées par l'établissement ou l'organisme autorisé	Article L. 1243-2, troisième alinéa	Quatre mois
Autorisation d'importer ou exporter à des fins thérapeutiques des tissus, leurs dérivés, des cellules issus du corps humain et des préparations de thérapie cellulaire préparés et conservés dans un Etat membre de l'Union européenne ou un Etat partie à l'accord sur l'Espace économique européen	Article L. 1245-5, premier alinéa	Trois mois
Autorisation spécifique d'importation et d'exportation des tissus, leurs dérivés, des cellules issus du corps humain et des préparations de thérapie cellulaire en provenance ou à destination d'un Etat non membre de l'Union européenne ou n'étant pas partie à l'accord sur l'Espace économique européen	Article L. 1245-5, deuxième alinéa	Trois mois
Autorisation d'importer ou d'exporter à des fins thérapeutiques des tissus, cellules, quel que soit le niveau de préparation, et des préparations de thérapie cellulaires destinés aux patients, accordée, dans des situations d'urgence, aux établissements ou organismes ne bénéficiant pas de l'autorisation d'exercer les activités d'importation et d'exportation des trois premiers alinéas de l'article L. 1245-5 \n	Article L. 1245-5, dernier alinéa	\n
Autorisation des produits thérapeutiques annexes, préalablement à leur mise sur le marché	\nArticle L. 1261-2 \n	Quatre-vingt-dix jours
Autorisation préalable de sondage, travail souterrain, et des autres activités, dépôts ou installations de nature à nuire directement ou indirectement à la qualité des eaux, dans le périmètre de protection d'une source d'eau minérale naturelle	\nArticle L. 1322-4 \n	Quatre mois, ou six mois en cas d'expertise d'un organisme compétent à l'échelon national
Interdiction prise par le préfet, sur demande du propriétaire de la source, de travaux, dépôts ou installation mentionnés à l'article L. 1322-4 et entrepris, soit en vertu d'une autorisation régulière, soit après une déclaration préalable, si leur résultat constaté est d'altérer ou de diminuer la source d'eau minérale naturelle	\nArticle L. 1322-5 \n	\n
Suspension provisoire des travaux ou activité sur demande du propriétaire de la source, lorsque, à raison de sondage ou de travaux souterrains ou à raison d'autres activités, dépôts ou installation entrepris en dehors du périmètre jugé de nature à altérer ou à diminuer une source d'eau minérale naturelle d'intérêt public, l'extension de celui-ci paraît nécessaire	\nArticle L. 1322-6 \n	\n
Autorisation d'occupation d'un terrain compris dans le périmètre de protection d'une source d'eau minérale naturelle déclarée d'intérêt public pour l'exécution de travaux	\nArticle L. 1322-10 \n	\n
Autorisation de publicité relative à l'emploi de radionucléides ou de produits en contenant, hors des domaines de la médecine humaine ou vétérinaire	\nArticle L. 1333-14 \n	\n
Autorisation de création de centres pluridisciplinaires de diagnostics prénatals, dans des établissements et organismes de santé publics et privés d'intérêt collectif	\nArticle L. 2131-1 VIII	\n
Autorisation spécifique accordée aux établissements réalisant le diagnostic préimplantatoire	\nArticle L. 2131-4 \n	\n
Autorisation d'un diagnostic préimplantatoire à titre dérogatoire	\nArticle L. 2131-4-1 \n	\n
Agrément des praticiens seuls habilités à procéder au diagnostic biologique effectué à partir de cellules prélevées sur l'embryon in vitro	\nArticle L. 2131-4-2 \n	\n
Autorisation délivrée avant la mise en œuvre de toute nouvelle technique visant à améliorer l'efficacité, la reproductibilité et la sécurité des procédés biologiques utilisés en assistance médicale à la procréation	\nArticle L. 2141-1 \n	\n
Autorisation de déplacement d'embryons conçus avec les gamètes de l'un au moins des membres d'un couple et dans le respect des principes fondamentaux prévus par les articles 16 à 16-8 du code civil et exclusivement destinés à permettre la poursuite du projet parental de ce couple	\nArticle L. 2141-9 \n	\n
Autorisation délivrée aux établissements, organismes ou laboratoires titulaires de l'autorisation prévue à l'article L. 2142-1 d'exercer une activité d'assistance médicale à la procréation leur permettant d'importer ou d'exporter des gamètes ou tissus germinaux issus du corps humain	\nArticle L. 2141-11-1 \n	\n
Autorisation accordée pour la recherche sur l'embryon humain et les cellules souches embryonnaires	\nArticle L. 2151-5 \n	\n
Autorisation préalable accordée par l'Agence de la biomédecine pour l'importation et l'exportation de cellules souches embryonnaires aux fins de recherche	\nArticle L. 2151-6 \n	\n
Autorisation délivrée à tout organisme qui assure, à des fins scientifiques, la conservation de cellules souches embryonnaires	\nArticle L. 2151-7 \n	\n
Autorisation de fonctionnement des lactariums gérés, par des établissements publics de santé, des collectivités publiques ou des organismes sans but lucratif assurant la collecte, la préparation, la qualification, le traitement, la conservation, la distribution et la délivrance, sur prescription médicale du lait maternel mentionné au 8° de l'article L. 5311-1 \n	\nArticle L. 2323-1 \n	\n
Agrément des appareils de désinfection obligatoire	\nArticle L. 3114-1 \n	Quatre mois
Autorisation de mise en œuvre des protocoles de coopération et des adhésions des professionnels de santé à ces protocoles	\nArticle L. 4011-2 \n	Quatre mois
Autorisation à exercer la profession de préparateur en pharmacie accordée individuellement aux ressortissants d'un Etat membre de l'Union européenne ou d'un autre Etat partie à l'accord sur l'Espace économique européen	\nArticle L. 4241-7 \n	Quatre mois
Autorisation d'exercer la profession de préparateur en pharmacie hospitalière accordée individuellement aux ressortissants d'un Etat membre de l'Union européenne ou d'un autre Etat partie à l'accord sur l'Espace économique européen	\nArticle L. 4241-14 \n	Quatre mois
Autorisation à exercer la profession de physicien médical accordée individuellement aux ressortissants d'un Etat membre de l'Union européenne ou d'un autre Etat partie à l'accord sur l'Espace économique européen	Article \n \n\t\t\tL. 4251-5	Quatre mois
Autorisation d'exercer la profession d'infirmier ou d'infirmière accordée individuellement aux ressortissants d'un Etat membre de l'Union européenne ou d'un autre Etat partie à l'accord sur l'Espace économique européen	\nArticle L. 4311-4 \n	Quatre mois
Obtention du diplôme d'Etat d'infirmier du secteur psychiatrique par les candidats infirmiers titulaires du diplôme d'Etat de secteur psychiatrique qui ont suivi un complément de formation	\nArticle L. 4311-5 \n	\n
Autorisation d'exercer la profession de masseur-kinésithérapeute accordée individuellement aux ressortissants d'un Etat membre de l'Union européenne ou d'un autre Etat partie à l'accord sur l'Espace économique européen	\nArticle L. 4321-4 \n	Quatre mois
Autorisation d'exercer la profession de pédicure podologue accordée individuellement aux ressortissants d'un Etat membre de l'Union européenne ou d'un autre Etat partie à l'accord sur l'Espace économique européen	\nArticle L. 4322-4 \n	Quatre mois
Autorisation d'exercer la profession de psychomotricien accordée individuellement aux ressortissants d'un Etat membre de l'Union européenne ou d'un autre Etat partie à l'accord sur l'Espace économique européen	\nArticle L. 4332-4 \n	Quatre mois
Autorisation d'exercer la profession d'orthophoniste accordée individuellement aux ressortissants d'un Etat membre de l'Union européenne ou d'un autre Etat partie à l'accord sur l'Espace économique européen	\nArticle L. 4341-4 \n	Quatre mois
Autorisation d'exercer la profession d'orthoptiste accordée individuellement aux ressortissants d'un Etat membre de l'Union européenne ou d'un autre Etat partie à l'accord sur l'Espace économique européen	\nArticle L. 4342-4 \n	Quatre mois
Autorisation d'exercer la profession de manipulateur d'électroradiologie médicale accordée individuellement aux ressortissants d'un Etat membre de l'Union européenne ou d'un autre Etat partie à l'accord sur l'Espace économique européen	\nArticle L. 4351-4 \n	Quatre mois
Autorisation d'exercer la profession d'audioprothésiste accordée individuellement aux ressortissants d'un Etat membre de l'Union européenne ou d'un autre Etat partie à l'accord sur l'Espace économique européen	\nArticle L. 4361-4 \n	Quatre mois
Autorisation d'exercer les professions d'orthoprothésiste, de podo-orthésiste, d'oculariste, d'épithésiste ou d'orthopédiste-orthésiste accordée individuellement aux ressortissants d'un Etat membre de l'Union européenne ou d'un autre Etat partie à l'accord sur l'Espace économique européen	Article \n \n\t\t\tL. 4364-5	Quatre mois
Autorisation d'exercice pour les auxiliaires médicaux ainsi que les préparateurs en pharmacie et préparateurs en pharmacie hospitalière accordée individuellement aux ressortissants d'un Etat non membre de l'Union européenne ou non partie à l'accord sur l'Espace économique européen, sans préjudice des engagements internationaux de la France en matière de coopération sanitaire, et notamment de ses engagements en faveur du développement solidaire	\nArticle L. 4381-4 \n	Quatre mois
Autorisation d'exercer la profession d'aide-soignant accordée individuellement aux ressortissants d'un Etat membre de l'Union européenne ou d'un autre Etat partie à l'accord sur l'Espace économique européen	\nArticle L. 4391-2 \n	Quatre mois
Autorisation d'exercer la profession d'auxiliaire puériculture accordée individuellement aux ressortissants d'un Etat membre de l'Union européenne ou d'un autre Etat partie à l'accord sur l'Espace économique européen	\nArticle L. 4392-2 \n	Quatre mois
Octroi d'une licence en cas de création d'une nouvelle officine de pharmacie, transfert d'une officine d'un lieu dans un autre et tout regroupement d'officines	\nArticle L. 5125-4 \n	Quatre mois
Autorisation de mise en service de véhicules affectés aux transports sanitaires terrestres	\nArticle L. 6312-4 \n	\n
Validation du domaine de spécialisation permettant l'exercice de la biologie médicale lorsque la reconnaissance de ce domaine de spécialisation ne résulte pas soit d'un diplôme ou d'un concours, soit d'une autorisation ou d'un agrément délivré par l'autorité compétente	\nArticle L. 6213-2 (1°)	\n
Autorisation d'exercice de la profession de biologiste médical accordée aux directeurs ou directeur adjoint d'un centre national de référence pour la lutte contre les maladies transmissibles	Article L. 6213-2 (3°)	\n
Autorisation d'exercice des fonctions de biologiste médical, dans les centres hospitaliers et universitaires et les établissements liés par convention en application de l'article L. 6142-5, des professionnels médecins ou pharmaciens, non qualifiés en biologie médicale et recrutés dans une discipline mixte, lorsqu'il justifient d'un exercice effectif d'une durée de trois ans dans des structures et laboratoires de biologie médicale.	\nArticle L. 6213-2-1 \n	\n
Autorisation pour la création d'installations de chirurgie esthétique	\nArticle L. 6322-1 \n	Quatre mois
Dispense de tout ou partie des enseignements, des stages cliniques et éventuellement, du ou des examens de passage pour l'obtention du diplôme de masseur-kinésithérapeute	\nArticle D. 4321-17 \n	\n
Dérogation aux dispositions de l'article D. 4364-7 à D. 4364-10 pour exercer les professions d'orthoprothésiste, podo-orthésiste, oculariste, épithésiste ou orthopédiste-orthésiste	\nArticle D. 4364-10-1 \n	Huit mois
Code de l'action sociale et des familles
Agrément des organismes procédant à la domiciliation	\nArticle L. 264-6 \n	\n
Agrément des organismes assurant l'accueil et l'hébergement de personnes en difficulté et qui ne relèvent pas de l'article L. 312-1 \n	\nArticle L. 265-1 \n	\n
Accord pour la cession de l'autorisation des établissements et services sociaux et médico-sociaux et des lieux de vie et d'accueil, lorsque la décision relève notamment de l'Etat	\nArticle L. 313-1, troisième alinéa	\n
Autorisation de création, d'extension et de transformation des établissements et services sociaux et médico-sociaux et des lieux de vie et d'accueil soumis à la procédure d'appel à projet, lorsque la décision relève notamment de l'Etat	\nArticle L. 313-1-1 \n	Six mois
Habilitation à recevoir des bénéficiaires de l'aide sociale et autorisation à dispenser des prestations prises en charge par l'Etat ou l'assurance-maladie, lorsque la décision relève notamment de l'Etat	\nArticle L. 313-8 \n	\n
Habilitation à recevoir des mineurs confiés par l'autorité judiciaire	\nArticle L. 313-10 \n	\n
Accord sur le choix par le gestionnaire de l'établissement ou du service fermé de l'attributaire des sommes affectées à l'établissement ou service fermé, apportées par l'Etat, par l'agence régionale de santé, les collectivités territoriales et leurs établissements publics ou par les organismes de sécurité sociale, énumérées à l'article L. 313-19, lorsque la décision relève notamment de l'Etat	Article L. 313-19, neuvième alinéa	\n
Accord de l'autorité de tarification sur les conditions de mise en œuvre de l'obligation de reversement des sommes affectées à l'établissement ou service fermé, apportées par l'Etat, par l'agence régionale de santé, les collectivités territoriales et leurs établissements publics ou par les organismes de sécurité sociale, énumérées à l'article L. 313-19	Article L. 313-19, dernier alinéa	\n
Fixation d'un pourcentage supérieur de bénéficiaires de l'aide sociale en cas d'augmentation importante des coûts d'exploitation résultant d'améliorations de prestations existantes ou de la modification des conditions de gestion ou d'exploitation	\nArticle L. 342-4 \n	\n
Agrément en qualité de mandataire judiciaire à la protection des majeurs des personnes physiques qui exercent à titre individuel et habituel les mesures de protection des majeurs ordonnées par l'autorité judiciaire au titre du mandat spécial auquel il peut être recouru dans le cadre de la sauvegarde de justice ou au titre de la curatelle, de la tutelle ou de la mesure d'accompagnement judiciaire, préalablement à leur inscription sur la liste prévue à l'article L. 471-2\n	\nArticle L. 472-1 \n	Quatre mois
Autorisation d'exercice, dans les îles Wallis-et-Futuna, des mandats de protection des majeurs par les services mandataires par les services sociaux	\nArticle L. 554-5 \n	\n
Autorisation d'exercice, en Polynésie française, des mandats de protection des majeurs par les services sociaux	\nArticle L. 564-5 \n	\n
Autorisation d'exercice, en Nouvelle-Calédonie, des mandats de protection des majeurs par les services sociaux	\nArticle L. 574-5 \n	\n
Autorisation de prise en compte de frais de siège social de l'organisme gestionnaire, lorsque la décision relève de l'Etat	\nArticle R. 314-87 \n	\n
Accord de l'autorité tarifaire sur les conditions de mise en œuvre de l'obligation de reversement des montants des amortissements cumulés des biens, des provisions non utilisées et des réserves de trésorerie apparaissant au bilan de clôture, en cas de fermeture ou de cessation d'activité totale ou partielle d'un établissement ou d'un service	\nArticle R. 314-97, \n \n\t\t\tquatrième alinéa	\n
Loi n° 2002-303 du 4 mars 2002 relative aux droits des malades et à la qualité du système de santé
Agrément des établissements autorisés à dispenser la formation en chiropraxie	\nArticle 75, premier alinéa	Six mois
Agrément des établissements de formation pour délivrer une formation en ostéopathie	Article 75, premier alinéa	\n
Loi n° 2004-806 du 9 août 2004 relative à la politique de santé publique
Inscription sur la liste départementale mentionnée au deuxième alinéa de l'article 52 de la loi n° 2004-806 du 9 août 2004 relative à la politique de santé publique permettant l'usage du titre de psychothérapeute	Article 52, deuxième alinéa	\n
Agrément des établissements de formation pour délivrer une formation en psychopathologie clinique	Article 52, troisième alinéa	Six mois
Inscription sur la liste départementale des psychothérapeutes aux professionnels justifiant d'au moins cinq ans de pratique de la psychothérapie à la date de publication du décret n° 2010-534 du 20 mai 2010 relatif à l'usage du titre de psychothérapeute, alors même qu'ils ne remplissent pas les conditions de formation et de diplôme prévues aux articles 1er et 6 du décret	Article 52, dernier alinéa	Six mois
Autorisation à user du titre de psychothérapeute accordée individuellement aux ressortissants d'un Etat membre de l'Union européenne ou d'un autre Etat partie à l'accord sur l'Espace économique européen	Article 52-1, I	Quatre mois
Ordonnance n° 2010-49 du 13 janvier 2010 relative à la biologie médicale
Autorisation d'exercice des fonctions de biologiste médical par les personnes ayant déposé auprès du ministre chargé de la santé, avant la date de publication de l'ordonnance n° 2010-49 du 13 janvier 2010 relative à la biologie médicale, une demande d'autorisation d'exercice des fonctions de directeur ou directeur adjoint de laboratoire sans qu'une décision leur ait été notifiée au plus tard à cette même date	\nArticle 9 v	Quatre mois
Autorisation, jusqu'au 31 octobre 2020, des laboratoires de biologie médicale non accrédités au sens de l'article L. 6221-1 du code de la santé publique \n	\nArticle 7 I	\n
Décret n° 2007-435 du 25 mars 2007 relatif aux actes et aux conditions d'exercice de l'ostéopathie
Autorisation aux ressortissants d'un Etat membre de l'Union européenne ou d'un autre Etat partie à l'Espace économique européen à faire usage professionnel du titre d'ostéopathe	\nArticle 6 \n	Quatre mois
Décret n° 2011-32 du 7 janvier 2011 relatif aux actes et aux conditions d'exercice de la chiropraxie
Autorisation des ressortissants d'un Etats membres de l'Union européenne ou d'un autre Etat partie à l'accord sur l'Espace économique européen, à user du titre de chiropracteur	\nArticle 6 \n	Quatre mois
Arrêté du 25 janvier 2005 relatif aux modalités d'organisation de la validation des acquis de l'expérience pour l'obtention du diplôme professionnel d'aide-soignant
Recevabilité du dossier de demande de validation des acquis de l'expérience pour acquérir le diplôme professionnel d'aide-soignant	\nArticle 2 \n	\n
Arrêté du 16 janvier 2006 relatif aux modalités d'organisation de la validation des acquis de l'expérience pour l'obtention du diplôme professionnel d'auxiliaire de puériculture
Recevabilité du dossier de demande de validation des acquis de l'expérience pour acquérir le diplôme d'Etat d'auxiliaire de puériculture	\nArticle 2 \n	\n
Arrêté du 31 juillet 2006 relatif aux modalités d'organisation de la validation des acquis de l'expérience pour l'obtention du diplôme de préparateur en pharmacie hospitalière
Recevabilité du dossier de demande de validation des acquis de l'expérience pour acquérir le diplôme de préparateur en pharmacie hospitalière	\nArticle 2 \n	\n
Arrêté du 18 août 2010 relatif aux modalités d'organisation de la validation des acquis de l'expérience pour l'obtention du diplôme d'Etat d'ergothérapeute
Recevabilité du dossier de demande de validation des acquis de l'expérience pour acquérir le diplôme d'Etat d'ergothérapeute	\nArticle 2 \n	\n
Arrêté du 24 février 2014 relatif aux modalités d'organisation de la validation des acquis de l'expérience pour l'obtention du diplôme d'Etat d'infirmier du bloc opératoire
Recevabilité du dossier de demande de validation des acquis de l'expérience pour acquérir le diplôme d'Etat d'infirmier de bloc opératoire	\nArticle 2\n	\n

\n\n
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" }, "LIENS": { "LIEN": [ { "@id": "LEGIARTI000006528193", "@num": "54", "#text": "LOI n° 78-17 du 6 janvier 1978 - art. 54", "@sens": "source", "@cidtexte": "JORFTEXT000000886460", "@numtexte": "78-17", "@typelien": "CITATION", "@naturetexte": "LOI", "@datesignatexte": "1978-01-06" }, { "@id": "JORFTEXT000000217229", "#text": "Rapport relatif à l'ordonnance n° 2000-548 du 15 juin 2000", "@sens": "source", "@cidtexte": "JORFTEXT000000217229", "@nortexte": "MESX0000036P", "@typelien": "CODIFICATION", "@naturetexte": "RAPPORT", "@datesignatexte": "2999-01-01" }, { "@id": "JORFTEXT000000227015", "#text": "Loi n°2002-303 du 4 mars 2002", "@sens": "source", "@cidtexte": "JORFTEXT000000227015", "@nortexte": "MESX0100092L", "@numtexte": "2002-303", "@typelien": "CODIFICATION", "@naturetexte": "LOI", "@datesignatexte": "2002-03-04" }, { "@id": "LEGIARTI000047718215", "@num": "2", "#text": "Arrêté du 23 janvier 2009 - art. 2 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000020214008", "@nortexte": "SASP0902336A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2009-01-23" }, { "@id": "LEGIARTI000047718206", "@num": "3", "#text": "Arrêté du 23 janvier 2009 - art. 3 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000020214008", "@nortexte": "SASP0902336A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2009-01-23" }, { "@id": "LEGIARTI000036505765", "@num": "4", "#text": "Ordonnance n° 2018-21 du 17 janvier 2018 - art. 4", "@sens": "cible", "@cidtexte": "JORFTEXT000036504763", "@nortexte": "SSAZ1731251R", "@numtexte": "2018-21", "@typelien": "MODIFIE", "@naturetexte": "ORDONNANCE", "@datesignatexte": "2018-01-17" }, { "@id": "LEGIARTI000036505464", "@num": "3", "#text": "Ordonnance n°2018-20 du 17 janvier 2018 - art. 3", "@sens": "cible", "@cidtexte": "JORFTEXT000036504646", "@nortexte": "ARMD1726559R", "@numtexte": "2018-20", "@typelien": "MODIFIE", "@naturetexte": "ORDONNANCE", "@datesignatexte": "2018-01-17" }, { "@id": "LEGIARTI000045163027", "@num": "1", "#text": "Arrêté du 26 janvier 2022 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000045159601", "@nortexte": "SSAP2203907A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2022-01-26" }, { "@id": "LEGIARTI000044946523", "@num": "R532-35", "#text": "Code de l'environnement - art. 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R1123-71 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000032723038", "@num": "223-8", "#text": "Code pénal - art. 223-8 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006070719", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006171004", "@fin": "2004-08-11", "#text": "Chapitre IV : Recherches sans bénéfice individuel direct.", "@debut": "2000-06-22" }, { "@id": "LEGISCTA000032722999", "@fin": "2999-01-01", "#text": "Chapitre IV : Dispositions particulières applicables aux essais cliniques de médicaments", "@debut": "2016-12-31" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006154978", "@fin": "2012-03-07", "#text": "Titre II : Recherches biomédicales", "@debut": "2000-06-22" }, { "@id": "LEGISCTA000025457387", "@fin": "2999-01-01", "#text": "Titre II : Recherches impliquant la personne humaine", "@debut": "2012-03-07" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006140603", "@fin": "2999-01-01", "#text": "Livre Ier : Protection des personnes en matière de santé", "@debut": "2000-06-22" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006125345", "@fin": "2999-01-01", "#text": "Première partie : Protection générale de la santé", "@debut": "2000-06-22" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006103419", "@fin": "2999-01-01", "#text": "Partie législative", "@debut": "2000-06-22" } ] }, "@cid": "LEGITEXT000006072665", "@nature": "CODE", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Code de la santé publique", "@debut": "1953-10-07", "@id_txt": "LEGITEXT000006072665", "@c_titre_court": "Code de la santé publique" } ], "@date_publi": "2999-01-01", "@date_signature": "2999-01-01" } }, "VERSIONS": { "VERSION": [ { "@etat": "ABROGE", "LIEN_ART": { "@id": "LEGIARTI000006685897", "@fin": "2004-08-11", "@num": "L1124-1", "@etat": "ABROGE", "@debut": "2000-06-22", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000032722995", "@fin": "2018-01-19", "@num": "L1124-1", "@etat": "MODIFIE", "@debut": "2016-12-31", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000036515077", "@fin": "2018-05-25", "@num": "L1124-1", "@etat": "MODIFIE", "@debut": "2018-01-19", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000037964261", "@fin": "2019-06-01", "@num": "L1124-1", "@etat": "MODIFIE", "@debut": "2018-05-25", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000037090318", "@fin": "2022-04-22", "@num": "L1124-1", "@etat": "MODIFIE", "@debut": "2019-06-01", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000045629928", "@fin": "2022-07-31", "@num": "L1124-1", "@etat": "MODIFIE", "@debut": "2022-04-22", "@origine": "LEGI" } }, { "@etat": "VIGUEUR", "LIEN_ART": { "@id": "LEGIARTI000046125661", "@fin": "2999-01-01", "@num": "L1124-1", "@etat": "VIGUEUR", "@debut": "2022-07-31", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "

I.-Les essais cliniques de médicaments sont régis par les dispositions du règlement (UE) n° 536/2014 du Parlement européen et du Conseil du 16 avril 2014.

L'évaluation de la partie II prévue à l'article 7 de ce règlement relève de la compétence et de la responsabilité des comités de protection des personnes mentionnés aux articles L. 1123-1 et L. 1123-16.

II.-En cas de refus d'autorisation d'un essai prévu au paragraphe 4 de l'article 8 du règlement précité, le promoteur peut saisir d'une demande de réexamen les autorités suivantes :

2° Le ministre chargé de la santé lorsque cette demande porte sur des éléments relevant de la partie II prévue à l'article 7 du règlement mentionné ci-dessus.

La demande de réexamen est présentée et instruite dans des délais et selon des modalités fixées par décret en Conseil d'Etat.

III.-La première administration d'un médicament à l'homme ne peut être effectuée que dans des lieux ayant été autorisés conformément au deuxième alinéa de l'article L. 1121-13.

Les essais cliniques de médicaments de thérapie innovante tels que définis à l'article 2 du règlement (CE) n° 1394/2007 du Parlement européen et du Conseil, du 13 novembre 2007, concernant les médicaments de thérapie innovante et modifiant la directive 2001/83/ CE ainsi que le règlement (CE) n° 726/2004 et les essais cliniques de médicaments de thérapie innovante tels que définis au 17° de l'article L. 5121-1 ne peuvent être réalisés que dans des établissements de santé, à l'Établissement français du sang, dans les hôpitaux des armées ou les autres éléments du service de santé des armées mentionnés à l'article L. 6147-7 ou à l'Institution nationale des invalides.

Leur sont également applicables les dispositions du 1° du II de l'article 54 de la loi n° 78-17 du 6 janvier 1978 modifiée relative à l'informatique et aux libertés.

" } }, "LEGIARTI000037090318": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "L1124-1", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2022-04-22", "DATE_DEBUT": "2019-06-01" } }, "META_COMMUN": { "ID": "LEGIARTI000037090318", "URL": "article/LEGI/ARTI/00/00/37/09/03/LEGIARTI000037090318.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "NOTA": { "CONTENU": "

Conformément à l'article 29 de l’ordonnance n° 2018-1125 du 12 décembre 2018, ces dispositions entrent en vigueur en même temps que le décret n° 2019-536 du 29 mai 2019 pris pour l'application de la loi n° 78-17 du 6 janvier 1978 relative à l'informatique, aux fichiers et aux libertés au 1er juin 2019.

" }, "LIENS": { "LIEN": [ { "@id": "LEGIARTI000006528193", "@num": "54", "#text": "LOI n° 78-17 du 6 janvier 1978 - art. 54", "@sens": "source", "@cidtexte": "JORFTEXT000000886460", "@numtexte": "78-17", "@typelien": "CITATION", "@naturetexte": "LOI", "@datesignatexte": "1978-01-06" }, { "@id": "JORFTEXT000000217229", "#text": "Rapport relatif à l'ordonnance n° 2000-548 du 15 juin 2000", "@sens": "source", "@cidtexte": "JORFTEXT000000217229", "@nortexte": "MESX0000036P", "@typelien": "CODIFICATION", "@naturetexte": "RAPPORT", "@datesignatexte": "2999-01-01" }, { "@id": "JORFTEXT000000227015", "#text": "Loi n°2002-303 du 4 mars 2002", "@sens": "source", "@cidtexte": "JORFTEXT000000227015", "@nortexte": "MESX0100092L", "@numtexte": "2002-303", "@typelien": "CODIFICATION", "@naturetexte": "LOI", "@datesignatexte": "2002-03-04" }, { "@id": "LEGIARTI000047718215", "@num": "2", "#text": "Arrêté du 23 janvier 2009 - art. 2 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000020214008", "@nortexte": "SASP0902336A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2009-01-23" }, { "@id": "LEGIARTI000047718206", "@num": "3", "#text": "Arrêté du 23 janvier 2009 - art. 3 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000020214008", "@nortexte": "SASP0902336A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2009-01-23" }, { "@id": "LEGIARTI000037801538", "@num": "21", "#text": "Ordonnance n° 2018-1125 du 12 décembre 2018 - art. 21", "@sens": "cible", "@cidtexte": "JORFTEXT000037800506", "@nortexte": "JUSC1829503R", "@numtexte": "2018-1125", "@typelien": "MODIFIE", "@naturetexte": "ORDONNANCE", "@datesignatexte": "2018-12-12" }, { "@id": "LEGIARTI000045163027", "@num": "1", "#text": "Arrêté du 26 janvier 2022 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000045159601", "@nortexte": "SSAP2203907A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2022-01-26" }, { "@id": "LEGIARTI000044946523", "@num": "R532-35", "#text": "Code de l'environnement - art. R532-35 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006074220", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000044962501", "@num": "R536-11", "#text": "Code de l'environnement - art. R536-11 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006074220", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006685848", "@num": "L1121-10", "#text": "Code de la santé publique - art. L1121-10", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006685850", "@num": "L1121-11", "#text": "Code de la santé publique - art. L1121-11", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006685852", "@num": "L1121-13", "#text": "Code de la santé publique - art. 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L1123-1", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006685889", "@num": "L1123-10", "#text": "Code de la santé publique - art. L1123-10", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000036505929", "@num": "L1123-16", "#text": "Code de la santé publique - art. L1123-16", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000034477966", "@num": "L1123-7-2", "#text": "Code de la santé publique - art. L1123-7-2 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000032723034", "@num": "L1126-1", "#text": "Code de la santé publique - art. 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L5126-1", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000049986826", "@num": "R1123-20-1", "#text": "Code de la santé publique - art. R1123-20-1 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000049986731", "@num": "R1123-71", "#text": "Code de la santé publique - art. R1123-71 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000032723038", "@num": "223-8", "#text": "Code pénal - art. 223-8 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006070719", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006171004", "@fin": "2004-08-11", "#text": "Chapitre IV : Recherches sans bénéfice individuel direct.", "@debut": "2000-06-22" }, { "@id": "LEGISCTA000032722999", "@fin": "2999-01-01", "#text": "Chapitre IV : Dispositions particulières applicables aux essais cliniques de médicaments", "@debut": "2016-12-31" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006154978", "@fin": "2012-03-07", "#text": "Titre II : Recherches biomédicales", "@debut": "2000-06-22" }, { "@id": "LEGISCTA000025457387", "@fin": "2999-01-01", "#text": "Titre II : Recherches impliquant la personne humaine", "@debut": "2012-03-07" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006140603", "@fin": "2999-01-01", "#text": "Livre Ier : Protection des personnes en matière de santé", "@debut": "2000-06-22" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006125345", "@fin": "2999-01-01", "#text": "Première partie : Protection générale de la santé", "@debut": "2000-06-22" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006103419", "@fin": "2999-01-01", "#text": "Partie législative", "@debut": "2000-06-22" } ] }, "@cid": "LEGITEXT000006072665", "@nature": "CODE", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Code de la santé publique", "@debut": "1953-10-07", "@id_txt": "LEGITEXT000006072665", "@c_titre_court": "Code de la santé publique" } ], "@date_publi": "2999-01-01", "@date_signature": "2999-01-01" } }, "VERSIONS": { "VERSION": [ { "@etat": "ABROGE", "LIEN_ART": { "@id": "LEGIARTI000006685897", "@fin": "2004-08-11", "@num": "L1124-1", "@etat": "ABROGE", "@debut": "2000-06-22", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000032722995", "@fin": "2018-01-19", "@num": "L1124-1", "@etat": "MODIFIE", "@debut": "2016-12-31", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000036515077", "@fin": "2018-05-25", "@num": "L1124-1", "@etat": "MODIFIE", "@debut": "2018-01-19", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000037964261", "@fin": "2019-06-01", "@num": "L1124-1", "@etat": "MODIFIE", "@debut": "2018-05-25", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000037090318", "@fin": "2022-04-22", "@num": "L1124-1", "@etat": "MODIFIE", "@debut": "2019-06-01", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000045629928", "@fin": "2022-07-31", "@num": "L1124-1", "@etat": "MODIFIE", "@debut": "2022-04-22", "@origine": "LEGI" } }, { "@etat": "VIGUEUR", "LIEN_ART": { "@id": "LEGIARTI000046125661", "@fin": "2999-01-01", "@num": "L1124-1", "@etat": "VIGUEUR", "@debut": "2022-07-31", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "

I.-Les essais cliniques de médicaments sont régis par les dispositions du règlement (UE) n° 536/2014 du Parlement européen et du Conseil du 16 avril 2014.

II.-En cas de refus d'autorisation d'un essai prévu au paragraphe 4 de l'article 8 du règlement précité, le promoteur peut saisir d'une demande de réexamen les autorités suivantes :

2° Le ministre chargé de la santé lorsque cette demande porte sur des éléments relevant de la partie II prévue à l'article 7 du règlement mentionné ci-dessus.

La demande de réexamen est présentée et instruite dans des délais et selon des modalités fixées par décret en Conseil d'Etat.

III.-La première administration d'un médicament à l'homme ne peut être effectuée que dans des lieux ayant été autorisés conformément au deuxième alinéa de l'article L. 1121-13.

Les essais cliniques de médicaments de thérapie innovante tels que définis à l'article 2 du règlement (CE) n° 1394/2007 du Parlement européen et du Conseil, du 13 novembre 2007, concernant les médicaments de thérapie innovante et modifiant la directive 2001/83/ CE ainsi que le règlement (CE) n° 726/2004 et les essais cliniques de médicaments de thérapie innovante tels que définis au 17° de l'article L. 5121-1 ne peuvent être réalisés que dans des établissements de santé, à l'Établissement français du sang, dans les hôpitaux des armées ou les autres éléments du service de santé des armées mentionnés à l'article L. 6147-7 ou à l'Institution nationale des invalides.

Leur sont également applicables les dispositions du 1° de l'article 76 de la loi n° 78-17 du 6 janvier 1978 modifiée relative à l'informatique et aux libertés.

" } }, "LEGIARTI000038219268": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "L1121-7", "ETAT": "VIGUEUR", "TYPE": "AUTONOME", "DATE_FIN": "2999-01-01", "DATE_DEBUT": "2019-03-11" } }, "META_COMMUN": { "ID": "LEGIARTI000038219268", "URL": "article/LEGI/ARTI/00/00/38/21/92/LEGIARTI000038219268.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "NOTA": { "CONTENU": "
\n
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Les mineurs peuvent être sollicités pour se prêter à des recherches mentionnées aux 1° ou 2° de l'article L. 1121-1 seulement si des recherches d'une efficacité comparable ne peuvent être effectuées sur des personnes majeures et dans les conditions suivantes :

-soit l'importance du bénéfice escompté pour ces personnes est de nature à justifier le risque prévisible encouru ;

" } }, "LEGIARTI000043124098": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "3", "ETAT": "VIGUEUR", "TYPE": "AUTONOME", "DATE_FIN": "2999-01-01", "DATE_DEBUT": "2021-02-13" } }, "META_COMMUN": { "ID": "LEGIARTI000043124098", "URL": "article/LEGI/ARTI/00/00/43/12/40/LEGIARTI000043124098.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "NOTA": { "CONTENU": "
" }, "LIENS": { "LIEN": [ { "@id": "LEGIARTI000006685848", "@num": "L1121-10", "#text": "Code de la santé publique - art. L1121-10", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006685852", "@num": "L1121-13", "#text": "Code de la santé publique - art. L1121-13", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006685859", "@num": "L1122-1", "#text": "Code de la santé publique - art. L1122-1", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006685883", "@num": "L1123-8", "#text": "Code de la santé publique - art. L1123-8", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006908378", "@num": "R1123-20", "#text": "Code de la santé publique - art. R1123-20", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "@cid": "JORFTEXT000043121591", "@nor": "SSAP2102968A", "@nature": "ARRETE", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Arrêté du 26 janvier 2021 fixant le contenu et les modalités de présentation du dossier de demande d'avis au comité de protection des personnes sur un projet de recherche mentionné au 1° de l'article L. 1121-1 du code de la santé publique portant sur les produits sanguins labiles, les organes, les tissus d'origine humaine ou animale et les préparations de thérapie cellulaire mentionnées à l'article L. 1243-1 du code de la santé publique", "@debut": "2999-01-01", "@id_txt": "JORFTEXT000043121591", "@c_titre_court": "Arrêté du 26 janvier 2021" }, { "@fin": "2999-01-01", "#text": "Arrêté du 26 janvier 2021 fixant le contenu et les modalités de présentation du dossier de demande d'avis au comité de protection des personnes sur un projet de recherche mentionné au 1° de l'article L. 1121-1 du code de la santé publique portant sur les produits sanguins labiles, les organes, les tissus d'origine humaine ou animale et les préparations de thérapie cellulaire mentionnées à l'article L. 1243-1 du code de la santé publique", "@debut": "2021-02-13", "@id_txt": "LEGITEXT000043124086", "@c_titre_court": "Arrêté du 26 janvier 2021" } ], "@ministere": "Ministère des solidarités et de la santé", "@date_publi": "2021-02-12", "@date_signature": "2021-01-26", "@num_parution_jo": "0037" } }, "VERSIONS": { "VERSION": [ { "@etat": "VIGUEUR", "LIEN_ART": { "@id": "LEGIARTI000043124098", "@fin": "2999-01-01", "@num": "3", "@etat": "VIGUEUR", "@debut": "2021-02-13", "@origine": "LEGI" } }, { "LIEN_ART": { "@id": "JORFARTI000043121599", "@fin": "2999-01-01", "@num": "3", "@debut": "2999-01-01", "@origine": "JORF" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "

\n
- une comparaison du document d'information destiné aux personnes qui se prêtent à la recherche et des éléments de l'autorisation du produit portant sur des contre-indications et des effets indésirables graves ou des mises en garde ou précautions d'emploi particulières ;
- et, le cas échéant, la description et la justification des divergences pertinentes en termes de sécurité des personnes entre le document d'information destiné aux personnes qui se prêtent à la recherche et les éléments de l'autorisation du produit portant sur des contre-indications et des effets indésirables graves ou des mises en garde ou précautions d'emploi particulières ;

\n
6° Le formulaire de recueil du consentement des personnes se prêtant à la recherche ;
7° La copie de l'attestation d'assurance prévue à l'article L. 1121-10 du code de la santé publique ;
8° Une justification de l'adéquation des moyens humains, matériels et techniques au projet de recherche et de leur compatibilité avec les impératifs de sécurité des personnes qui s'y prêtent, sauf si le lieu bénéficie de l'autorisation mentionnée à l'article L. 1121-13 du code de la santé publique ;
9° Les curriculum vitae du ou des investigateurs ;
10° La nature de la décision finale de l'Agence nationale de sécurité du médicament et des produits de santé mentionnée à l'article L. 1123-8 du code de la santé publique, si cette décision est disponible.

" } }, "LEGIARTI000045629928": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "L1124-1", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2022-07-31", "DATE_DEBUT": "2022-04-22" } }, "META_COMMUN": { "ID": "LEGIARTI000045629928", "URL": "article/LEGI/ARTI/00/00/45/62/99/LEGIARTI000045629928.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "NOTA": { "CONTENU": "

Se reporter aux modalités d'application prévues aux I, II, III et VI de l'article 17 de l'ordonnance n° 2022-582 du 20 avril 2022.

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L209-14 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006692635", "@num": "L209-14", "#text": "Code de la santé publique - art. L209-14 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006689870", "@num": "L5121-1", "#text": "Code de la santé publique - art. L5121-1", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006689877", "@num": "L5121-1-1", "#text": "Code de la santé publique - art. L5121-1-1", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006690015", "@num": "L5125-1", "#text": "Code de la santé publique - art. 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R1123-71 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000032723038", "@num": "223-8", "#text": "Code pénal - art. 223-8 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006070719", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006171004", "@fin": "2004-08-11", "#text": "Chapitre IV : Recherches sans bénéfice individuel direct.", "@debut": "2000-06-22" }, { "@id": "LEGISCTA000032722999", "@fin": "2999-01-01", "#text": "Chapitre IV : Dispositions particulières applicables aux essais cliniques de médicaments", "@debut": "2016-12-31" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006154978", "@fin": "2012-03-07", "#text": "Titre II : Recherches biomédicales", "@debut": "2000-06-22" }, { "@id": "LEGISCTA000025457387", "@fin": "2999-01-01", "#text": "Titre II : Recherches impliquant la personne humaine", "@debut": "2012-03-07" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006140603", "@fin": "2999-01-01", "#text": "Livre Ier : Protection des personnes en matière de santé", "@debut": "2000-06-22" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006125345", "@fin": "2999-01-01", "#text": "Première partie : Protection générale de la santé", "@debut": "2000-06-22" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006103419", "@fin": "2999-01-01", "#text": "Partie législative", "@debut": "2000-06-22" } ] }, "@cid": "LEGITEXT000006072665", "@nature": "CODE", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Code de la santé publique", "@debut": "1953-10-07", "@id_txt": "LEGITEXT000006072665", "@c_titre_court": "Code de la santé publique" } ], "@date_publi": "2999-01-01", "@date_signature": "2999-01-01" } }, "VERSIONS": { "VERSION": [ { "@etat": "ABROGE", "LIEN_ART": { "@id": "LEGIARTI000006685897", "@fin": "2004-08-11", "@num": "L1124-1", "@etat": "ABROGE", "@debut": "2000-06-22", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000032722995", "@fin": "2018-01-19", "@num": "L1124-1", "@etat": "MODIFIE", "@debut": "2016-12-31", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000036515077", "@fin": "2018-05-25", "@num": "L1124-1", "@etat": "MODIFIE", "@debut": "2018-01-19", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000037964261", "@fin": "2019-06-01", "@num": "L1124-1", "@etat": "MODIFIE", "@debut": "2018-05-25", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000037090318", "@fin": "2022-04-22", "@num": "L1124-1", "@etat": "MODIFIE", "@debut": "2019-06-01", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000045629928", "@fin": "2022-07-31", "@num": "L1124-1", "@etat": "MODIFIE", "@debut": "2022-04-22", "@origine": "LEGI" } }, { "@etat": "VIGUEUR", "LIEN_ART": { "@id": "LEGIARTI000046125661", "@fin": "2999-01-01", "@num": "L1124-1", "@etat": "VIGUEUR", "@debut": "2022-07-31", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "

I.-Les essais cliniques de médicaments sont régis par les dispositions du règlement (UE) n° 536/2014 du Parlement européen et du Conseil du 16 avril 2014.

II.-En cas de refus d'autorisation d'un essai prévu au paragraphe 4 de l'article 8 du règlement précité, le promoteur peut saisir d'une demande de réexamen les autorités suivantes :

2° Le ministre chargé de la santé lorsque cette demande porte sur des éléments relevant de la partie II prévue à l'article 7 du règlement mentionné ci-dessus.

La demande de réexamen est présentée et instruite dans des délais et selon des modalités fixées par décret en Conseil d'Etat.

III.-La première administration d'un médicament à l'homme ne peut être effectuée que dans des lieux ayant été autorisés conformément au deuxième alinéa de l'article L. 1121-13.

Les essais cliniques de médicaments de thérapie innovante tels que définis à l'article 2 du règlement (CE) n° 1394/2007 du Parlement européen et du Conseil, du 13 novembre 2007, concernant les médicaments de thérapie innovante et modifiant la directive 2001/83/ CE ainsi que le règlement (CE) n° 726/2004 et les essais cliniques de médicaments de thérapie innovante tels que définis au 17° de l'article L. 5121-1 ne peuvent être réalisés que dans des établissements de santé, à l'Établissement français du sang, dans les hôpitaux des armées ou les autres éléments du service de santé des armées mentionnés à l'article L. 6147-7 ou à l'Institution nationale des invalides.

IV.-Sont applicables aux essais cliniques mentionnés au I les dispositions du présent chapitre ainsi que les dispositions des articles L. 1121-10, L. 1121-11, L. 1121-13, L. 1121-14, L. 1121-16, L. 1121-16-1, L. 1123-10, L. 1127-1 à L. 1127-12, L. 5121-1-1, L. 5125-1 et L. 5126-1. Ces essais sont interdits sur une personne qui n'est pas affiliée à un régime de sécurité sociale ou bénéficiaire d'un tel régime.

Leur sont également applicables les dispositions du 1° de l'article 76 de la loi n° 78-17 du 6 janvier 1978 modifiée relative à l'informatique et aux libertés.

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R532-35 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006074220", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000044962501", "@num": "R536-11", "#text": "Code de l'environnement - art. R536-11 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006074220", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006685848", "@num": "L1121-10", "#text": "Code de la santé publique - art. L1121-10", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006685850", "@num": "L1121-11", "#text": "Code de la santé publique - art. L1121-11", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006685852", "@num": "L1121-13", "#text": "Code de la santé publique - art. 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L1123-1", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006685889", "@num": "L1123-10", "#text": "Code de la santé publique - art. L1123-10", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000046125731", "@num": "L1123-16", "#text": "Code de la santé publique - art. L1123-16 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000034477966", "@num": "L1123-7-2", "#text": "Code de la santé publique - art. L1123-7-2 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000045630090", "@num": "L1126-1", "#text": "Code de la santé publique - art. L1126-1 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000046125901", "@num": "L1126-10", "#text": "Code de la santé publique - art. L1126-10 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000046125923", "@num": "L1126-5", "#text": "Code de la santé publique - art. L1126-5 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000046121769", "@num": "L1128-1", "#text": "Code de la santé publique - art. L1128-1 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006692637", "@num": "L209-14", "#text": "Code de la santé publique - art. 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I.-Les essais cliniques de médicaments sont régis par les dispositions du règlement (UE) n° 536/2014 du Parlement européen et du Conseil du 16 avril 2014.

II.-En cas de refus d'autorisation d'un essai prévu au paragraphe 4 de l'article 8 du règlement précité, le promoteur peut saisir d'une demande de réexamen les autorités suivantes :

2° Le ministre chargé de la santé lorsque cette demande porte sur des éléments relevant de la partie II prévue à l'article 7 du règlement mentionné ci-dessus.

La demande de réexamen est présentée et instruite dans des délais et selon des modalités fixées par décret en Conseil d'Etat.

III.-La première administration d'un médicament à l'homme ne peut être effectuée que dans des lieux ayant été autorisés conformément au deuxième alinéa de l'article L. 1121-13.

Les essais cliniques de médicaments de thérapie innovante tels que définis à l'article 2 du règlement (CE) n° 1394/2007 du Parlement européen et du Conseil, du 13 novembre 2007, concernant les médicaments de thérapie innovante et modifiant la directive 2001/83/ CE ainsi que le règlement (CE) n° 726/2004 et les essais cliniques de médicaments de thérapie innovante tels que définis au 17° de l'article L. 5121-1 ne peuvent être réalisés que dans des établissements de santé, à l'Établissement français du sang, dans les hôpitaux des armées ou les autres éléments du service de santé des armées mentionnés à l'article L. 6147-7 ou à l'Institution nationale des invalides.

IV.-Sont applicables aux essais cliniques mentionnés au I les dispositions du présent chapitre ainsi que les dispositions des articles L. 1121-10, L. 1121-11, L. 1121-13, L. 1121-14, L. 1121-16, L. 1121-16-1, L. 1123-10, L. 1128-1 à L. 1128-12, L. 5121-1-1, L. 5125-1 et L. 5126-1. Ces essais sont interdits sur une personne qui n'est pas affiliée à un régime de sécurité sociale ou bénéficiaire d'un tel régime.

Leur sont également applicables les dispositions du 1° de l'article 76 de la loi n° 78-17 du 6 janvier 1978 modifiée relative à l'informatique et aux libertés.

\n
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Les personnes privées de liberté par une décision judiciaire ou administrative, les personnes faisant l'objet de soins psychiatriques en vertu des articles L. 3212-1 et L. 3213-1 qui ne relèvent pas des dispositions de l'article 60 du règlement (UE) 2017/746 du Parlement européen et du Conseil du 5 avril 2017 et les personnes admises dans un établissement sanitaire ou social à d'autres fins que celle de l'étude des performances peuvent être sollicitées pour se prêter à des études des performances qui ne comportent aucun risque ni contrainte et dans lesquelles tous les actes sont réalisés et les produits utilisés de manière habituelle.
\n
\n Elles ne peuvent être sollicitées pour se prêter aux autres études des performances que dans les conditions suivantes :
\n
\n-soit l'importance du bénéfice escompté pour ces personnes est de nature à justifier le risque prévisible encouru ;
\n
\n-soit ces études des performances se justifient au regard du bénéfice escompté pour d'autres personnes se trouvant dans la même situation juridique ou administrative à la condition que des études des performances d'une efficacité comparable ne puissent être effectuées sur une autre catégorie de la population. Dans ce cas, les risques prévisibles et les contraintes que comporte l'étude des performances doivent présenter un caractère minimal.

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Son article 1er prévoit que les dispositions annexées à la présente ordonnance constituent désormais la partie Législative du code de la santé publique. L'article 2 prévoit la mise à jour des dispositions que le projet de code reprend en tant que code suiveur d'autres codes ou d'autres lois, dans le cas où ces dispositions seraient codifiées. L'article 3 prescrit le remplacement des références aux dispositions abrogées par l'article 4 par les références correspondantes du code de la santé publique. L'article 4 (I) abroge les dispositions du code actuel, sous réserve des dispositions de l'article 5 ; il abroge également le code des débits de boissons et de lutte contre l'alcoolisme ainsi que les lois, ordonnances et décrets ou articles de lois, d'ordonnances ou de décrets qui sont désormais codifiés dans le code de la santé publique (II). L'article 5 reporte l'abrogation d'un certain nombre d'articles du code actuel à l'entrée en vigueur des dispositions réglementaires correspondantes. Quant aux articles relatifs aux statuts du personnel hospitalier qui n'ont pas vocation à figurer dans le code, ils devraient faire prochainement l'objet de projets de décrets. L'article 6 étend les dispositions de l'ordonnance aux territoires d'outre-mer, à la Nouvelle-Calédonie et à la collectivité territoriale de Mayotte. Le second alinéa permet aux dispositions applicables en Nouvelle-Calédonie et en Polynésie française, édictées par l’État à l'époque où il était compétent en matière de santé publique, de continuer à y trouver effet, nonobstant la compétence locale. Il appartient désormais aux institutions locales et non à l’État d'abroger, de modifier ou de remplacer ces dispositions. L'article 7 est l'article d'exécution." }, "ABRO": { "CONTENU": "RECTIFICATIFS A LA PAGINATION SPECIALE PUBLIES AUX JO DU 29 JUILLET 2000, p.11741, ET DU 6 SEPTEMBRE 2000, p.13895." }, "META": { "META_SPEC": { "META_TEXTE_VERSION": { "LIENS": { "LIEN": [ { "@id": "JORFTEXT000000503843", "#text": "Décret n° 53-1001 du 5 octobre 1953", "@sens": "source", "@cidtexte": "JORFTEXT000000503843", "@numtexte": "53-1001", "@typelien": "ABROGE", "@naturetexte": "DECRET", "@datesignatexte": "1953-10-05" }, { "@id": "LEGIARTI000006564395", "@num": "1", "#text": "Décret n°57-404 du 28 mars 1957 - art. 1 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000868477", "@numtexte": "57-404", "@typelien": "ABROGATION", "@naturetexte": "DECRET", "@datesignatexte": "1957-03-28" }, { "@id": "LEGIARTI000006564406", "@num": "2", "#text": "Décret n°57-404 du 28 mars 1957 - art. 2 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000868477", "@numtexte": "57-404", "@typelien": "ABROGATION", "@naturetexte": "DECRET", "@datesignatexte": "1957-03-28" }, { "@id": "JORFTEXT000000879150", "#text": "Décret n°58-1340 du 20 décembre 1958", "@sens": "source", "@cidtexte": "JORFTEXT000000879150", "@numtexte": "58-1340", "@typelien": "ABROGE", "@naturetexte": "DECRET", "@datesignatexte": "1958-12-20" }, { "@id": "LEGIARTI000006697898", "@num": "1", "#text": "Ordonnance n°58-1373 du 30 décembre 1958 - 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art. 3 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000299091", "@numtexte": "59-805", "@typelien": "ABROGATION", "@naturetexte": "DECRET", "@datesignatexte": "1959-07-04" }, { "@id": "JORFTEXT000000299091", "#text": "Décret n°59-805 du 4 juillet 1959", "@sens": "source", "@cidtexte": "JORFTEXT000000299091", "@numtexte": "59-805", "@typelien": "ABROGE", "@naturetexte": "DECRET", "@datesignatexte": "1959-07-04" }, { "@id": "JORFTEXT000000517669", "#text": "Ordonnance n° 60-372 du 15 avril 1960", "@sens": "source", "@cidtexte": "JORFTEXT000000517669", "@numtexte": "60-372", "@typelien": "ABROGE", "@naturetexte": "ORDONNANCE", "@datesignatexte": "1960-04-15" }, { "@id": "JORFTEXT000000330269", "#text": "Décret n°60-665 du 4 juillet 1960", "@sens": "source", "@cidtexte": "JORFTEXT000000330269", "@numtexte": "60-665", "@typelien": "ABROGE", "@naturetexte": "DECRET", "@datesignatexte": "1960-07-04" }, { "@id": "JORFTEXT000000874911", "#text": "Loi n°60-732 du 28 juillet 1960", "@sens": "source", "@cidtexte": "JORFTEXT000000874911", "@numtexte": "60-732", "@typelien": "ABROGE", "@naturetexte": "LOI", "@datesignatexte": "1960-07-28" }, { "@id": "JORFTEXT000000875392", "#text": "Loi n°63-1241 du 19 décembre 1963", "@sens": "source", "@cidtexte": "JORFTEXT000000875392", "@numtexte": "63-1241", "@typelien": "ABROGE", "@naturetexte": "LOI", "@datesignatexte": "1963-12-19" }, { "@id": "LEGIARTI000006846631", "@num": "18", "#text": "Loi n°64-1245 du 16 décembre 1964 - art. 18 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000509753", "@numtexte": "64-1245", "@typelien": "ABROGATION", "@naturetexte": "LOI", "@datesignatexte": "1964-12-16" }, { "@id": "JORFTEXT000000509753", "#text": "Loi n° 64-1245 du 16 décembre 1964", "@sens": "source", "@cidtexte": "JORFTEXT000000509753", "@numtexte": "64-1245", "@typelien": "ABROGE", "@naturetexte": "LOI", "@datesignatexte": "1964-12-16" }, { "@id": "JORFTEXT000000880196", "#text": "Loi n°65-497 du 29 juin 1965", "@sens": "source", "@cidtexte": "JORFTEXT000000880196", "@numtexte": "65-497", "@typelien": "ABROGE", "@naturetexte": "LOI", "@datesignatexte": "1965-06-29" }, { "@id": "JORFTEXT000000320878", "#text": "Loi n° 67-1114 du 21 décembre 1967", "@sens": "source", "@cidtexte": "JORFTEXT000000320878", "@numtexte": "67-1114", "@typelien": "ABROGE", "@naturetexte": "LOI", "@datesignatexte": "1967-12-21" }, { "@id": "LEGIARTI000006696241", "@num": "2", "#text": "Loi n°67-1176 du 28 décembre 1967 - art. 2 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000880754", "@numtexte": "67-1176", "@typelien": "ABROGATION", "@naturetexte": "LOI", "@datesignatexte": "1967-12-28" }, { "@id": "LEGIARTI000006696246", "@num": "3", "#text": "Loi n°67-1176 du 28 décembre 1967 - art. 3 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000880754", "@numtexte": "67-1176", "@typelien": "ABROGATION", "@naturetexte": "LOI", "@datesignatexte": "1967-12-28" }, { "@id": "LEGIARTI000006696257", "@num": "5", "#text": "Loi n°67-1176 du 28 décembre 1967 - art. 5 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000880754", "@numtexte": "67-1176", "@typelien": "ABROGATION", "@naturetexte": "LOI", "@datesignatexte": "1967-12-28" }, { "@id": "LEGIARTI000006696263", "@num": "6 bis", "#text": "Loi n°67-1176 du 28 décembre 1967 - art. 6 bis (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000880754", "@numtexte": "67-1176", "@typelien": "ABROGATION", "@naturetexte": "LOI", "@datesignatexte": "1967-12-28" }, { "@id": "LEGIARTI000006696265", "@num": "7", "#text": "Loi n°67-1176 du 28 décembre 1967 - art. 7 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000880754", "@numtexte": "67-1176", "@typelien": "ABROGATION", "@naturetexte": "LOI", "@datesignatexte": "1967-12-28" }, { "@id": "LEGIARTI000006696266", "@num": "8", "#text": "Loi n°67-1176 du 28 décembre 1967 - art. 8 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000880754", "@numtexte": "67-1176", "@typelien": "ABROGATION", "@naturetexte": "LOI", "@datesignatexte": "1967-12-28" }, { "@id": "JORFTEXT000000880754", "#text": "LOI n° 67-1176 du 28 décembre 1967", "@sens": "source", "@cidtexte": "JORFTEXT000000880754", "@numtexte": "67-1176", "@typelien": "ABROGE", "@naturetexte": "LOI", "@datesignatexte": "1967-12-28" }, { "@id": "JORFTEXT000000321402", "#text": "Loi n°70-1320 du 31 décembre 1970", "@sens": "source", "@cidtexte": "JORFTEXT000000321402", "@numtexte": "70-1320", "@typelien": "ABROGE", "@naturetexte": "LOI", "@datesignatexte": "1970-12-31" }, { "@id": "JORFTEXT000000321858", "#text": "Loi n°71-536 du 7 juillet 1971", "@sens": "source", "@cidtexte": "JORFTEXT000000321858", "@numtexte": "71-536", "@typelien": "ABROGE", "@naturetexte": "LOI", "@datesignatexte": "1971-07-07" }, { "@id": "LEGIARTI000006697521", "@num": "2", "#text": "Loi n°71-1112 du 31 décembre 1971 - art. 2 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000321844", "@numtexte": "71-1112", "@typelien": "ABROGATION", "@naturetexte": "LOI", "@datesignatexte": "1971-12-31" }, { "@id": "LEGIARTI000006289613", "@num": "2", "#text": "Loi n°72-652 du 11 juillet 1972 - art. 2 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000684300", "@numtexte": "72-652", "@typelien": "MODIFICATION", "@naturetexte": "LOI", "@datesignatexte": "1972-07-11" }, { "@id": "JORFTEXT000000518345", "#text": "Loi n°73-639 du 11 juillet 1973", "@sens": "source", "@cidtexte": "JORFTEXT000000518345", "@numtexte": "73-639", "@typelien": "ABROGE", "@naturetexte": "LOI", "@datesignatexte": "1973-07-11" }, { "@id": "LEGIARTI000006695556", "@num": "1", "#text": "Loi n°75-17 du 17 janvier 1975 - art. 1 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000700230", "@numtexte": "75-17", "@typelien": "ABROGATION", "@naturetexte": "LOI", "@datesignatexte": "1975-01-17" }, { "@id": "LEGIARTI000006695571", "@num": "13", "#text": "Loi n°75-17 du 17 janvier 1975 - art. 13 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000700230", "@numtexte": "75-17", "@typelien": "ABROGATION", "@naturetexte": "LOI", "@datesignatexte": "1975-01-17" }, { "@id": "LEGIARTI000006695572", "@num": "14", "#text": "Loi n°75-17 du 17 janvier 1975 - art. 14 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000700230", "@numtexte": "75-17", "@typelien": "ABROGATION", "@naturetexte": "LOI", "@datesignatexte": "1975-01-17" }, { "@id": "LEGIARTI000006695574", "@num": "16", "#text": "Loi n°75-17 du 17 janvier 1975 - art. 16 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000700230", "@numtexte": "75-17", "@typelien": "ABROGATION", "@naturetexte": "LOI", "@datesignatexte": "1975-01-17" }, { "@id": "JORFTEXT000000700230", "#text": "LOI n° 75-17 du 17 janvier 1975", "@sens": "source", "@cidtexte": "JORFTEXT000000700230", "@numtexte": "75-17", "@typelien": "ABROGE", "@naturetexte": "LOI", "@datesignatexte": "1975-01-17" }, { "@id": "JORFTEXT000000333976", "#text": "Loi n°75-534 du 30 juin 1975", "@sens": "source", "@cidtexte": "JORFTEXT000000333976", "@numtexte": "75-534", "@typelien": "ABROGE", "@naturetexte": "LOI", "@datesignatexte": "1975-06-30" }, { "@id": "LEGIARTI000006695539", "@num": "2", "#text": "Loi n°75-626 du 11 juillet 1975 - art. 2 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000522105", "@numtexte": "75-626", "@typelien": "MODIFICATION", "@naturetexte": "LOI", "@datesignatexte": "1975-07-11" }, { "@id": "LEGIARTI000006273008", "@num": "3", "#text": "Loi n°75-626 du 11 juillet 1975 - art. 3 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000522105", "@numtexte": "75-626", "@typelien": "ABROGATION", "@naturetexte": "LOI", "@datesignatexte": "1975-07-11" }, { "@id": "JORFTEXT000000522105", "#text": "Loi n° 75-626 du 11 juillet 1975", "@sens": "source", "@cidtexte": "JORFTEXT000000522105", "@numtexte": "75-626", "@typelien": "ABROGE", "@naturetexte": "LOI", "@datesignatexte": "1975-07-11" }, { "@id": "JORFTEXT000000700095", "#text": "Décret n°77-470 du 3 mai 1977", "@sens": "source", "@cidtexte": "JORFTEXT000000700095", "@numtexte": "77-470", "@typelien": "ABROGE", "@naturetexte": "DECRET", "@datesignatexte": "1977-05-03" }, { "@id": "LEGIARTI000006682481", "@num": "20", "#text": "Ordonnance n°77-1102 du 26 septembre 1977 - art. 20 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000699946", "@numtexte": "77-1102", "@typelien": "ABROGATION", "@naturetexte": "ORDONNANCE", "@datesignatexte": "1977-09-26" }, { "@id": "LEGIARTI000006682484", "@num": "21", "#text": "Ordonnance n°77-1102 du 26 septembre 1977 - art. 21 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000699946", "@numtexte": "77-1102", "@typelien": "MODIFICATION", "@naturetexte": "ORDONNANCE", "@datesignatexte": "1977-09-26" }, { "@id": "LEGIARTI000006682485", "@num": "22", "#text": "Ordonnance n°77-1102 du 26 septembre 1977 - art. 22 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000699946", "@numtexte": "77-1102", "@typelien": "ABROGATION", "@naturetexte": "ORDONNANCE", "@datesignatexte": "1977-09-26" }, { "@id": "LEGIARTI000006682486", "@num": "23", "#text": "Ordonnance n°77-1102 du 26 septembre 1977 - art. 23 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000699946", "@numtexte": "77-1102", "@typelien": "ABROGATION", "@naturetexte": "ORDONNANCE", "@datesignatexte": "1977-09-26" }, { "@id": "LEGIARTI000006682487", "@num": "24", "#text": "Ordonnance n°77-1102 du 26 septembre 1977 - art. 24 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000699946", "@numtexte": "77-1102", "@typelien": "ABROGATION", "@naturetexte": "ORDONNANCE", "@datesignatexte": "1977-09-26" }, { "@id": "LEGIARTI000006682492", "@num": "27", "#text": "Ordonnance n°77-1102 du 26 septembre 1977 - art. 27 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000699946", "@numtexte": "77-1102", "@typelien": "ABROGATION", "@naturetexte": "ORDONNANCE", "@datesignatexte": "1977-09-26" }, { "@id": "LEGIARTI000006682493", "@num": "28", "#text": "Ordonnance n°77-1102 du 26 septembre 1977 - art. 28 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000699946", "@numtexte": "77-1102", "@typelien": "ABROGATION", "@naturetexte": "ORDONNANCE", "@datesignatexte": "1977-09-26" }, { "@id": "JORFTEXT000000699946", "#text": "Ordonnance n° 77-1102 du 26 septembre 1977", "@sens": "source", "@cidtexte": "JORFTEXT000000699946", "@numtexte": "77-1102", "@typelien": "ABROGE", "@naturetexte": "ORDONNANCE", "@datesignatexte": "1977-09-26" }, { "@id": "LEGIARTI000006273200", "@num": "109", "#text": "Loi n°78-1239 du 29 décembre 1978 - art. 109 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000886458", "@numtexte": "78-1239", "@typelien": "ABROGATION", "@naturetexte": "LOI", "@datesignatexte": "1978-12-29" }, { "@id": "JORFTEXT000000886458", "#text": "LOI n° 78-1239 du 29 décembre 1978", "@sens": "source", "@cidtexte": "JORFTEXT000000886458", "@numtexte": "78-1239", "@typelien": "ABROGE", "@naturetexte": "LOI", "@datesignatexte": "1978-12-29" }, { "@id": "LEGITEXT000006068670", "#text": "Loi n°79-520 du 2 juillet 1979", "@sens": "cible", "@cidtexte": "JORFTEXT000000684778", "@numtexte": "79-520", "@typelien": "ABROGATION", "@naturetexte": "LOI", "@datesignatexte": "1979-07-02" }, { "@id": "LEGIARTI000006696322", "@num": "1", "#text": "Loi n°79-520 du 2 juillet 1979 - art. 1 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000684778", "@numtexte": "79-520", "@typelien": "ABROGATION", "@naturetexte": "LOI", "@datesignatexte": "1979-07-02" }, { "@id": "JORFTEXT000000684778", "#text": "Loi n°79-520 du 2 juillet 1979", "@sens": "source", "@cidtexte": "JORFTEXT000000684778", "@numtexte": "79-520", "@typelien": "ABROGE", "@naturetexte": "LOI", "@datesignatexte": "1979-07-02" }, { "@id": "LEGIARTI000006695485", "@num": "10", "#text": "Loi n°79-1140 du 29 décembre 1979 - art. 10 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000705042", "@numtexte": "79-1140", "@typelien": "ABROGATION", "@naturetexte": "LOI", "@datesignatexte": "1979-12-29" }, { "@id": "JORFTEXT000000705042", "#text": "Loi n°79-1140 du 29 décembre 1979", "@sens": "source", "@cidtexte": "JORFTEXT000000705042", "@numtexte": "79-1140", "@typelien": "ABROGE", "@naturetexte": "LOI", "@datesignatexte": "1979-12-29" }, { "@id": "LEGIARTI000006695587", "@num": "13", "#text": "Loi n°79-1204 du 31 décembre 1979 - art. 13 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000705056", "@numtexte": "79-1204", "@typelien": "ABROGATION", "@naturetexte": "LOI", "@datesignatexte": "1979-12-31" }, { "@id": "JORFTEXT000000705056", "#text": "Loi n°79-1204 du 31 décembre 1979", "@sens": "source", "@cidtexte": "JORFTEXT000000705056", "@numtexte": "79-1204", "@typelien": "ABROGE", "@naturetexte": "LOI", "@datesignatexte": "1979-12-31" }, { "@id": "LEGIARTI000006274343", "@num": "1", "#text": "Loi n°84-391 du 25 mai 1984 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000501101", "@numtexte": "84-391", "@typelien": "MODIFICATION", "@naturetexte": "LOI", "@datesignatexte": "1984-05-25" }, { "@id": "LEGIARTI000006756890", "@num": "12", "#text": "Loi n°85-772 du 25 juillet 1985 - art. 12 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000317523", "@numtexte": "85-772", "@typelien": "ABROGATION", "@naturetexte": "LOI", "@datesignatexte": "1985-07-25" }, { "@id": "LEGIARTI000006756895", "@num": "17", "#text": "Loi n°85-772 du 25 juillet 1985 - art. 17 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000317523", "@numtexte": "85-772", "@typelien": "ABROGATION", "@naturetexte": "LOI", "@datesignatexte": "1985-07-25" }, { "@id": "JORFTEXT000000317523", "#text": "Loi n°85-772 du 25 juillet 1985", "@sens": "source", "@cidtexte": "JORFTEXT000000317523", "@numtexte": "85-772", "@typelien": "ABROGE", "@naturetexte": "LOI", "@datesignatexte": "1985-07-25" }, { "@id": "LEGIARTI000006695615", "@num": "5", "#text": "Loi n°85-1468 du 31 décembre 1985 - art. 5 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000878232", "@numtexte": "85-1468", "@typelien": "ABROGATION", "@naturetexte": "LOI", "@datesignatexte": "1985-12-31" }, { "@id": "LEGIARTI000006695616", "@num": "6", "#text": "Loi n°85-1468 du 31 décembre 1985 - art. 6 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000878232", "@numtexte": "85-1468", "@typelien": "ABROGATION", "@naturetexte": "LOI", "@datesignatexte": "1985-12-31" }, { "@id": "JORFTEXT000000878232", "#text": "Loi n°85-1468 du 31 décembre 1985", "@sens": "source", "@cidtexte": "JORFTEXT000000878232", "@numtexte": "85-1468", "@typelien": "ABROGE", "@naturetexte": "LOI", "@datesignatexte": "1985-12-31" }, { "@id": "LEGIARTI000006847694", "@num": "17", "#text": "Loi n°86-2 du 3 janvier 1986 - art. 17 (M)", "@sens": "cible", "@cidtexte": "JORFTEXT000000317531", "@numtexte": "86-2", "@typelien": "MODIFICATION", "@naturetexte": "LOI", "@datesignatexte": "1986-01-03" }, { "@id": "LEGIARTI000006695596", "@num": "1", "#text": "Loi n°86-11 du 6 janvier 1986 - art. 1 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000512206", "@numtexte": "86-11", "@typelien": "ABROGATION", "@naturetexte": "LOI", "@datesignatexte": "1986-01-06" }, { "@id": "LEGIARTI000006695597", "@num": "2", "#text": "Loi n°86-11 du 6 janvier 1986 - art. 2 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000512206", "@numtexte": "86-11", "@typelien": "ABROGATION", "@naturetexte": "LOI", "@datesignatexte": "1986-01-06" }, { "@id": "JORFTEXT000000512206", "#text": "Loi n°86-11 du 6 janvier 1986", "@sens": "source", "@cidtexte": "JORFTEXT000000512206", "@numtexte": "86-11", "@typelien": "ABROGE", "@naturetexte": "LOI", "@datesignatexte": "1986-01-06" }, { "@id": "LEGIARTI000006275233", "@num": "1", "#text": "Loi n°87-1157 du 31 décembre 1987 - art. 1 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000512241", "@nortexte": "JUSX8700015L", "@numtexte": "87-1157", "@typelien": "ABROGATION", "@naturetexte": "LOI", "@datesignatexte": "1987-12-31" }, { "@id": "JORFTEXT000000512241", "#text": "Loi n° 87-1157 du 31 décembre 1987", "@sens": "source", "@cidtexte": "JORFTEXT000000512241", "@nortexte": "JUSX8700015L", "@numtexte": "87-1157", "@typelien": "ABROGE", "@naturetexte": "LOI", "@datesignatexte": "1987-12-31" }, { "@id": "LEGIARTI000006275437", "@num": "6", "#text": "Loi n°88-1138 du 20 décembre 1988 - art. 6 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000508831", "@nortexte": "SPSX8810045L", "@numtexte": "88-1138", "@typelien": "MODIFICATION", "@naturetexte": "LOI", "@datesignatexte": "1988-12-20" }, { "@id": "LEGIARTI000006756528", "@num": "40", "#text": "Loi n°89-18 du 13 janvier 1989 - art. 40 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000321867", "@nortexte": "SPSX8800135L", "@numtexte": "89-18", "@typelien": "ABROGATION", "@naturetexte": "LOI", "@datesignatexte": "1989-01-13" }, { "@id": "LEGIARTI000006756529", "@num": "41", "#text": "Loi n°89-18 du 13 janvier 1989 - art. 41 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000321867", "@nortexte": "SPSX8800135L", "@numtexte": "89-18", "@typelien": "ABROGATION", "@naturetexte": "LOI", "@datesignatexte": "1989-01-13" }, { "@id": "LEGIARTI000006756530", "@num": "42", "#text": "Loi n°89-18 du 13 janvier 1989 - art. 42 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000321867", "@nortexte": "SPSX8800135L", "@numtexte": "89-18", "@typelien": "ABROGATION", "@naturetexte": "LOI", "@datesignatexte": "1989-01-13" }, { "@id": "LEGIARTI000006756532", "@num": "43", "#text": "Loi n°89-18 du 13 janvier 1989 - art. 43 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000321867", "@nortexte": "SPSX8800135L", "@numtexte": "89-18", "@typelien": "MODIFICATION", "@naturetexte": "LOI", "@datesignatexte": "1989-01-13" }, { "@id": "JORFTEXT000000321867", "#text": "LOI n° 89-18 du 13 janvier 1989", "@sens": "source", "@cidtexte": "JORFTEXT000000321867", "@nortexte": "SPSX8800135L", "@numtexte": "89-18", "@typelien": "ABROGE", "@naturetexte": "LOI", "@datesignatexte": "1989-01-13" }, { "@id": "LEGIARTI000006696197", "@num": "18", "#text": "Loi n°89-432 du 28 juin 1989 - art. 18 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000321874", "@nortexte": "SPOX8800141L", "@numtexte": "89-432", "@typelien": "ABROGATION", "@naturetexte": "LOI", "@datesignatexte": "1989-06-28" }, { "@id": "JORFTEXT000000321874", "#text": "Loi n°89-432 du 28 juin 1989", "@sens": "source", "@cidtexte": "JORFTEXT000000321874", "@nortexte": "SPOX8800141L", "@numtexte": "89-432", "@typelien": "ABROGE", "@naturetexte": "LOI", "@datesignatexte": "1989-06-28" }, { "@id": "LEGIARTI000006697908", "@num": "1", "#text": "Ordonnance no 90-570 du 25 juin 1990 portant exten - art. 1 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000533238", "@nortexte": "DOMX9000086R", "@numtexte": "90-570", "@typelien": "ABROGATION", "@naturetexte": "ORDONNANCE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006697918", "@num": "10", "#text": "Ordonnance no 90-570 du 25 juin 1990 portant exten - art. 10 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000533238", "@nortexte": "DOMX9000086R", "@numtexte": "90-570", "@typelien": "ABROGATION", "@naturetexte": "ORDONNANCE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006697919", "@num": "11", "#text": "Ordonnance no 90-570 du 25 juin 1990 portant exten - art. 11 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000533238", "@nortexte": "DOMX9000086R", "@numtexte": "90-570", "@typelien": "ABROGATION", "@naturetexte": "ORDONNANCE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006697909", "@num": "2", "#text": "Ordonnance no 90-570 du 25 juin 1990 portant exten - art. 2 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000533238", "@nortexte": "DOMX9000086R", "@numtexte": "90-570", "@typelien": "ABROGATION", "@naturetexte": "ORDONNANCE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006697911", "@num": "3", "#text": "Ordonnance no 90-570 du 25 juin 1990 portant exten - art. 3 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000533238", "@nortexte": "DOMX9000086R", "@numtexte": "90-570", "@typelien": "ABROGATION", "@naturetexte": "ORDONNANCE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006697912", "@num": "4", "#text": "Ordonnance no 90-570 du 25 juin 1990 portant exten - art. 4 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000533238", "@nortexte": "DOMX9000086R", "@numtexte": "90-570", "@typelien": "ABROGATION", "@naturetexte": "ORDONNANCE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006697913", "@num": "5", "#text": "Ordonnance no 90-570 du 25 juin 1990 portant exten - art. 5 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000533238", "@nortexte": "DOMX9000086R", "@numtexte": "90-570", "@typelien": "ABROGATION", "@naturetexte": "ORDONNANCE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006697914", "@num": "6", "#text": "Ordonnance no 90-570 du 25 juin 1990 portant exten - art. 6 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000533238", "@nortexte": "DOMX9000086R", "@numtexte": "90-570", "@typelien": "ABROGATION", "@naturetexte": "ORDONNANCE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006697915", "@num": "7", "#text": "Ordonnance no 90-570 du 25 juin 1990 portant exten - art. 7 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000533238", "@nortexte": "DOMX9000086R", "@numtexte": "90-570", "@typelien": "ABROGATION", "@naturetexte": "ORDONNANCE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006697916", "@num": "8", "#text": "Ordonnance no 90-570 du 25 juin 1990 portant exten - art. 8 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000533238", "@nortexte": "DOMX9000086R", "@numtexte": "90-570", "@typelien": "ABROGATION", "@naturetexte": "ORDONNANCE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006697917", "@num": "9", "#text": "Ordonnance no 90-570 du 25 juin 1990 portant exten - art. 9 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000533238", "@nortexte": "DOMX9000086R", "@numtexte": "90-570", "@typelien": "ABROGATION", "@naturetexte": "ORDONNANCE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGITEXT000006076133", "#text": "Ordonnance n°90-570 du 25 juin 1990", "@sens": "cible", "@cidtexte": "JORFTEXT000000533238", "@nortexte": "DOMX9000086R", "@numtexte": "90-570", "@typelien": "ABROGATION", "@naturetexte": "ORDONNANCE", "@datesignatexte": "2999-01-01" }, { "@id": "JORFTEXT000000533238", "#text": "Ordonnance no 90-570 du 25 juin 1990 portant extension et adaptation à la collectivité territoriale de Mayotte de diverses dispositions législatives relatives à la santé publique", "@sens": "source", "@cidtexte": "JORFTEXT000000533238", "@nortexte": "DOMX9000086R", "@numtexte": "90-570", "@typelien": "ABROGE", "@naturetexte": "ORDONNANCE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006696446", "@num": "13", "#text": "Loi n°90-1010 du 14 novembre 1990 - art. 13 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000160354", "@nortexte": "JUSX9000076L", "@numtexte": "90-1010", "@typelien": "MODIFICATION", "@naturetexte": "LOI", "@datesignatexte": "1990-11-14" }, { "@id": "LEGIARTI000006503303", "@num": "7", "#text": "Loi n°91-32 du 10 janvier 1991 - art. 7 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000344577", "@nortexte": "SPSX9000097L", "@numtexte": "91-32", "@typelien": "ABROGATION", "@naturetexte": "LOI", "@datesignatexte": "1991-01-10" }, { "@id": "JORFTEXT000000173995", "#text": "Loi n° 92-3 du 3 janvier 1992", "@sens": "source", "@cidtexte": "JORFTEXT000000173995", "@nortexte": "ENVX9100061L", "@numtexte": "92-3", "@typelien": "ABROGE", "@naturetexte": "LOI", "@datesignatexte": "1992-01-03" }, { "@id": "LEGIARTI000006757520", "@num": "47", "#text": "Loi n°91-1406 du 31 décembre 1991 - art. 47 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000721455", "@nortexte": "SPSX9100176L", "@numtexte": "91-1406", "@typelien": "ABROGATION", "@naturetexte": "LOI", "@datesignatexte": "1991-12-31" }, { "@id": "LEGIARTI000006848102", "@num": "13", "#text": "Loi n°92-3 du 3 janvier 1992 - art. 13 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000173995", "@nortexte": "ENVX9100061L", "@numtexte": "92-3", "@typelien": "MODIFICATION", "@naturetexte": "LOI", "@datesignatexte": "1992-01-03" }, { "@id": "LEGIARTI000006848136", "@num": "37", "#text": "Loi n°92-3 du 3 janvier 1992 - art. 37 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000173995", "@nortexte": "ENVX9100061L", "@numtexte": "92-3", "@typelien": "MODIFICATION", "@naturetexte": "LOI", "@datesignatexte": "1992-01-03" }, { "@id": "LEGIARTI000006848139", "@num": "40", "#text": "Loi n°92-3 du 3 janvier 1992 - art. 40 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000173995", "@nortexte": "ENVX9100061L", "@numtexte": "92-3", "@typelien": "ABROGATION", "@naturetexte": "LOI", "@datesignatexte": "1992-01-03" }, { "@id": "JORFTEXT000000721455", "#text": "Loi n° 91-1406 du 31 décembre 1991", "@sens": "source", "@cidtexte": "JORFTEXT000000721455", "@nortexte": "SPSX9100176L", "@numtexte": "91-1406", "@typelien": "ABROGE", "@naturetexte": "LOI", "@datesignatexte": "1991-12-31" }, { "@id": "LEGIARTI000006696550", "@num": "1", "#text": "Loi n°92-614 du 6 juillet 1992 - art. 1 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000723282", "@nortexte": "JUSX9100125L", "@numtexte": "92-614", "@typelien": "ABROGATION", "@naturetexte": "LOI", "@datesignatexte": "1992-07-06" }, { "@id": "LEGIARTI000006696561", "@num": "11", "#text": "Loi n°92-614 du 6 juillet 1992 - art. 11 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000723282", "@nortexte": "JUSX9100125L", "@numtexte": "92-614", "@typelien": "ABROGATION", "@naturetexte": "LOI", "@datesignatexte": "1992-07-06" }, { "@id": "LEGIARTI000006696552", "@num": "2", "#text": "Loi n°92-614 du 6 juillet 1992 - art. 2 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000723282", "@nortexte": "JUSX9100125L", "@numtexte": "92-614", "@typelien": "ABROGATION", "@naturetexte": "LOI", "@datesignatexte": "1992-07-06" }, { "@id": "LEGIARTI000006696553", "@num": "3", "#text": "Loi n°92-614 du 6 juillet 1992 - art. 3 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000723282", "@nortexte": "JUSX9100125L", "@numtexte": "92-614", "@typelien": "ABROGATION", "@naturetexte": "LOI", "@datesignatexte": "1992-07-06" }, { "@id": "LEGIARTI000006696554", "@num": "4", "#text": "Loi n°92-614 du 6 juillet 1992 - art. 4 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000723282", "@nortexte": "JUSX9100125L", "@numtexte": "92-614", "@typelien": "ABROGATION", "@naturetexte": "LOI", "@datesignatexte": "1992-07-06" }, { "@id": "LEGIARTI000006696555", "@num": "5", "#text": "Loi n°92-614 du 6 juillet 1992 - art. 5 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000723282", "@nortexte": "JUSX9100125L", "@numtexte": "92-614", "@typelien": "ABROGATION", "@naturetexte": "LOI", "@datesignatexte": "1992-07-06" }, { "@id": "LEGIARTI000006696556", "@num": "6", "#text": "Loi n°92-614 du 6 juillet 1992 - art. 6 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000723282", "@nortexte": "JUSX9100125L", "@numtexte": "92-614", "@typelien": "ABROGATION", "@naturetexte": "LOI", "@datesignatexte": "1992-07-06" }, { "@id": "LEGIARTI000006696557", "@num": "7", "#text": "Loi n°92-614 du 6 juillet 1992 - art. 7 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000723282", "@nortexte": "JUSX9100125L", "@numtexte": "92-614", "@typelien": "ABROGATION", "@naturetexte": "LOI", "@datesignatexte": "1992-07-06" }, { "@id": "LEGIARTI000006696558", "@num": "8", "#text": "Loi n°92-614 du 6 juillet 1992 - art. 8 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000723282", "@nortexte": "JUSX9100125L", "@numtexte": "92-614", "@typelien": "ABROGATION", "@naturetexte": "LOI", "@datesignatexte": "1992-07-06" }, { "@id": "LEGIARTI000006696559", "@num": "9", "#text": "Loi n°92-614 du 6 juillet 1992 - art. 9 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000723282", "@nortexte": "JUSX9100125L", "@numtexte": "92-614", "@typelien": "ABROGATION", "@naturetexte": "LOI", "@datesignatexte": "1992-07-06" }, { "@id": "JORFTEXT000000723282", "#text": "Loi n° 92-614 du 6 juillet 1992", "@sens": "source", "@cidtexte": "JORFTEXT000000723282", "@nortexte": "JUSX9100125L", "@numtexte": "92-614", "@typelien": "ABROGE", "@naturetexte": "LOI", "@datesignatexte": "1992-07-06" }, { "@id": "LEGIARTI000006697921", "@num": "1", "#text": "Ordonnance no 92-1070 du 1er octobre 1992 portant - art. 1 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000542223", "@nortexte": "DOMX9200105R", "@numtexte": "92-1070", "@typelien": "ABROGATION", "@naturetexte": "ORDONNANCE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006697930", "@num": "10", "#text": "Ordonnance no 92-1070 du 1er octobre 1992 portant - art. 10 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000542223", "@nortexte": "DOMX9200105R", "@numtexte": "92-1070", "@typelien": "ABROGATION", "@naturetexte": "ORDONNANCE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006697931", "@num": "11", "#text": "Ordonnance no 92-1070 du 1er octobre 1992 portant - art. 11 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000542223", "@nortexte": "DOMX9200105R", "@numtexte": "92-1070", "@typelien": "ABROGATION", "@naturetexte": "ORDONNANCE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006697932", "@num": "12", "#text": "Ordonnance no 92-1070 du 1er octobre 1992 portant - art. 12 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000542223", "@nortexte": "DOMX9200105R", "@numtexte": "92-1070", "@typelien": "ABROGATION", "@naturetexte": "ORDONNANCE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006697934", "@num": "14", "#text": "Ordonnance no 92-1070 du 1er octobre 1992 portant - art. 14 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000542223", "@nortexte": "DOMX9200105R", "@numtexte": "92-1070", "@typelien": "ABROGATION", "@naturetexte": "ORDONNANCE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006697935", "@num": "15", "#text": "Ordonnance no 92-1070 du 1er octobre 1992 portant - art. 15 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000542223", "@nortexte": "DOMX9200105R", "@numtexte": "92-1070", "@typelien": "ABROGATION", "@naturetexte": "ORDONNANCE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006697936", "@num": "16", "#text": "Ordonnance no 92-1070 du 1er octobre 1992 portant - art. 16 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000542223", "@nortexte": "DOMX9200105R", "@numtexte": "92-1070", "@typelien": "ABROGATION", "@naturetexte": "ORDONNANCE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006697937", "@num": "17", "#text": "Ordonnance no 92-1070 du 1er octobre 1992 portant - art. 17 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000542223", "@nortexte": "DOMX9200105R", "@numtexte": "92-1070", "@typelien": "ABROGATION", "@naturetexte": "ORDONNANCE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006697938", "@num": "18", "#text": "Ordonnance no 92-1070 du 1er octobre 1992 portant - art. 18 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000542223", "@nortexte": "DOMX9200105R", "@numtexte": "92-1070", "@typelien": "ABROGATION", "@naturetexte": "ORDONNANCE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006697939", "@num": "19", "#text": "Ordonnance no 92-1070 du 1er octobre 1992 portant - art. 19 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000542223", "@nortexte": "DOMX9200105R", "@numtexte": "92-1070", "@typelien": "ABROGATION", "@naturetexte": "ORDONNANCE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006697922", "@num": "2", "#text": "Ordonnance no 92-1070 du 1er octobre 1992 portant - art. 2 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000542223", "@nortexte": "DOMX9200105R", "@numtexte": "92-1070", "@typelien": "ABROGATION", "@naturetexte": "ORDONNANCE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006697940", "@num": "20", "#text": "Ordonnance no 92-1070 du 1er octobre 1992 portant - art. 20 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000542223", "@nortexte": "DOMX9200105R", "@numtexte": "92-1070", "@typelien": "ABROGATION", "@naturetexte": "ORDONNANCE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006697941", "@num": "21", "#text": "Ordonnance no 92-1070 du 1er octobre 1992 portant - art. 21 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000542223", "@nortexte": "DOMX9200105R", "@numtexte": "92-1070", "@typelien": "ABROGATION", "@naturetexte": "ORDONNANCE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006697943", "@num": "22", "#text": "Ordonnance no 92-1070 du 1er octobre 1992 portant - art. 22 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000542223", "@nortexte": "DOMX9200105R", "@numtexte": "92-1070", "@typelien": "ABROGATION", "@naturetexte": "ORDONNANCE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006697944", "@num": "23", "#text": "Ordonnance no 92-1070 du 1er octobre 1992 portant - art. 23 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000542223", "@nortexte": "DOMX9200105R", "@numtexte": "92-1070", "@typelien": "ABROGATION", "@naturetexte": "ORDONNANCE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006697945", "@num": "24", "#text": "Ordonnance no 92-1070 du 1er octobre 1992 portant - art. 24 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000542223", "@nortexte": "DOMX9200105R", "@numtexte": "92-1070", "@typelien": "ABROGATION", "@naturetexte": "ORDONNANCE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006697946", "@num": "25", "#text": "Ordonnance no 92-1070 du 1er octobre 1992 portant - art. 25 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000542223", "@nortexte": "DOMX9200105R", "@numtexte": "92-1070", "@typelien": "ABROGATION", "@naturetexte": "ORDONNANCE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006697947", "@num": "26", "#text": "Ordonnance no 92-1070 du 1er octobre 1992 portant - art. 26 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000542223", "@nortexte": "DOMX9200105R", "@numtexte": "92-1070", "@typelien": "ABROGATION", "@naturetexte": "ORDONNANCE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006697948", "@num": "27", "#text": "Ordonnance no 92-1070 du 1er octobre 1992 portant - art. 27 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000542223", "@nortexte": "DOMX9200105R", "@numtexte": "92-1070", "@typelien": "ABROGATION", "@naturetexte": "ORDONNANCE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006697949", "@num": "28", "#text": "Ordonnance no 92-1070 du 1er octobre 1992 portant - art. 28 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000542223", "@nortexte": "DOMX9200105R", "@numtexte": "92-1070", "@typelien": "ABROGATION", "@naturetexte": "ORDONNANCE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006697950", "@num": "29", "#text": "Ordonnance no 92-1070 du 1er octobre 1992 portant - art. 29 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000542223", "@nortexte": "DOMX9200105R", "@numtexte": "92-1070", "@typelien": "ABROGATION", "@naturetexte": "ORDONNANCE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006697923", "@num": "3", "#text": "Ordonnance no 92-1070 du 1er octobre 1992 portant - art. 3 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000542223", "@nortexte": "DOMX9200105R", "@numtexte": "92-1070", "@typelien": "ABROGATION", "@naturetexte": "ORDONNANCE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006697951", "@num": "30", "#text": "Ordonnance no 92-1070 du 1er octobre 1992 portant - art. 30 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000542223", "@nortexte": "DOMX9200105R", "@numtexte": "92-1070", "@typelien": "ABROGATION", "@naturetexte": "ORDONNANCE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006697956", "@num": "35", "#text": "Ordonnance no 92-1070 du 1er octobre 1992 portant - art. 35 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000542223", "@nortexte": "DOMX9200105R", "@numtexte": "92-1070", "@typelien": "ABROGATION", "@naturetexte": "ORDONNANCE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006697957", "@num": "36", "#text": "Ordonnance no 92-1070 du 1er octobre 1992 portant - art. 36 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000542223", "@nortexte": "DOMX9200105R", "@numtexte": "92-1070", "@typelien": "ABROGATION", "@naturetexte": "ORDONNANCE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006697958", "@num": "37", "#text": "Ordonnance no 92-1070 du 1er octobre 1992 portant - art. 37 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000542223", "@nortexte": "DOMX9200105R", "@numtexte": "92-1070", "@typelien": "ABROGATION", "@naturetexte": "ORDONNANCE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006697959", "@num": "38", "#text": "Ordonnance no 92-1070 du 1er octobre 1992 portant - art. 38 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000542223", "@nortexte": "DOMX9200105R", "@numtexte": "92-1070", "@typelien": "ABROGATION", "@naturetexte": "ORDONNANCE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006697960", "@num": "39", "#text": "Ordonnance no 92-1070 du 1er octobre 1992 portant - art. 39 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000542223", "@nortexte": "DOMX9200105R", "@numtexte": "92-1070", "@typelien": "ABROGATION", "@naturetexte": "ORDONNANCE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006697924", "@num": "4", "#text": "Ordonnance no 92-1070 du 1er octobre 1992 portant - art. 4 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000542223", "@nortexte": "DOMX9200105R", "@numtexte": "92-1070", "@typelien": "ABROGATION", "@naturetexte": "ORDONNANCE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006697961", "@num": "40", "#text": "Ordonnance no 92-1070 du 1er octobre 1992 portant - art. 40 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000542223", "@nortexte": "DOMX9200105R", "@numtexte": "92-1070", "@typelien": "ABROGATION", "@naturetexte": "ORDONNANCE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006697962", "@num": "41", "#text": "Ordonnance no 92-1070 du 1er octobre 1992 portant - art. 41 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000542223", "@nortexte": "DOMX9200105R", "@numtexte": "92-1070", "@typelien": "ABROGATION", "@naturetexte": "ORDONNANCE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006697963", "@num": "42", "#text": "Ordonnance no 92-1070 du 1er octobre 1992 portant - art. 42 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000542223", "@nortexte": "DOMX9200105R", "@numtexte": "92-1070", "@typelien": "ABROGATION", "@naturetexte": "ORDONNANCE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006697964", "@num": "43", "#text": "Ordonnance no 92-1070 du 1er octobre 1992 portant - art. 43 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000542223", "@nortexte": "DOMX9200105R", "@numtexte": "92-1070", "@typelien": "ABROGATION", "@naturetexte": "ORDONNANCE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006697965", "@num": "44", "#text": "Ordonnance no 92-1070 du 1er octobre 1992 portant - art. 44 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000542223", "@nortexte": "DOMX9200105R", "@numtexte": "92-1070", "@typelien": "ABROGATION", "@naturetexte": "ORDONNANCE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006697966", "@num": "45", "#text": "Ordonnance no 92-1070 du 1er octobre 1992 portant - art. 45 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000542223", "@nortexte": "DOMX9200105R", "@numtexte": "92-1070", "@typelien": "ABROGATION", "@naturetexte": "ORDONNANCE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006697967", "@num": "46", "#text": "Ordonnance no 92-1070 du 1er octobre 1992 portant - art. 46 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000542223", "@nortexte": "DOMX9200105R", "@numtexte": "92-1070", "@typelien": "ABROGATION", "@naturetexte": "ORDONNANCE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006697968", "@num": "47", "#text": "Ordonnance no 92-1070 du 1er octobre 1992 portant - art. 47 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000542223", "@nortexte": "DOMX9200105R", "@numtexte": "92-1070", "@typelien": "ABROGATION", "@naturetexte": "ORDONNANCE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006697969", "@num": "48", "#text": "Ordonnance no 92-1070 du 1er octobre 1992 portant - art. 48 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000542223", "@nortexte": "DOMX9200105R", "@numtexte": "92-1070", "@typelien": "ABROGATION", "@naturetexte": "ORDONNANCE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006697970", "@num": "49", "#text": "Ordonnance no 92-1070 du 1er octobre 1992 portant - art. 49 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000542223", "@nortexte": "DOMX9200105R", "@numtexte": "92-1070", "@typelien": "ABROGATION", "@naturetexte": "ORDONNANCE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006697925", "@num": "5", "#text": "Ordonnance no 92-1070 du 1er octobre 1992 portant - art. 5 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000542223", "@nortexte": "DOMX9200105R", "@numtexte": "92-1070", "@typelien": "ABROGATION", "@naturetexte": "ORDONNANCE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006697971", "@num": "50", "#text": "Ordonnance no 92-1070 du 1er octobre 1992 portant - art. 50 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000542223", "@nortexte": "DOMX9200105R", "@numtexte": "92-1070", "@typelien": "ABROGATION", "@naturetexte": "ORDONNANCE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006697972", "@num": "51", "#text": "Ordonnance no 92-1070 du 1er octobre 1992 portant - art. 51 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000542223", "@nortexte": "DOMX9200105R", "@numtexte": "92-1070", "@typelien": "ABROGATION", "@naturetexte": "ORDONNANCE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006697973", "@num": "52", "#text": "Ordonnance no 92-1070 du 1er octobre 1992 portant - art. 52 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000542223", "@nortexte": "DOMX9200105R", "@numtexte": "92-1070", "@typelien": "ABROGATION", "@naturetexte": "ORDONNANCE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006697974", "@num": "53", "#text": "Ordonnance no 92-1070 du 1er octobre 1992 portant - art. 53 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000542223", "@nortexte": "DOMX9200105R", "@numtexte": "92-1070", "@typelien": "ABROGATION", "@naturetexte": "ORDONNANCE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006697975", "@num": "54", "#text": "Ordonnance no 92-1070 du 1er octobre 1992 portant - art. 54 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000542223", "@nortexte": "DOMX9200105R", "@numtexte": "92-1070", "@typelien": "ABROGATION", "@naturetexte": "ORDONNANCE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006697976", "@num": "55", "#text": "Ordonnance no 92-1070 du 1er octobre 1992 portant - art. 55 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000542223", "@nortexte": "DOMX9200105R", "@numtexte": "92-1070", "@typelien": "ABROGATION", "@naturetexte": "ORDONNANCE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006697977", "@num": "56", "#text": "Ordonnance no 92-1070 du 1er octobre 1992 portant - art. 56 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000542223", "@nortexte": "DOMX9200105R", "@numtexte": "92-1070", "@typelien": "ABROGATION", "@naturetexte": "ORDONNANCE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006697978", "@num": "57", "#text": "Ordonnance no 92-1070 du 1er octobre 1992 portant - art. 57 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000542223", "@nortexte": "DOMX9200105R", "@numtexte": "92-1070", "@typelien": "ABROGATION", "@naturetexte": "ORDONNANCE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006697979", "@num": "58", "#text": "Ordonnance no 92-1070 du 1er octobre 1992 portant - art. 58 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000542223", "@nortexte": "DOMX9200105R", "@numtexte": "92-1070", "@typelien": "ABROGATION", "@naturetexte": "ORDONNANCE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006697980", "@num": "59", "#text": "Ordonnance no 92-1070 du 1er octobre 1992 portant - art. 59 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000542223", "@nortexte": "DOMX9200105R", "@numtexte": "92-1070", "@typelien": "ABROGATION", "@naturetexte": "ORDONNANCE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006697926", "@num": "6", "#text": "Ordonnance no 92-1070 du 1er octobre 1992 portant - art. 6 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000542223", "@nortexte": "DOMX9200105R", "@numtexte": "92-1070", "@typelien": "ABROGATION", "@naturetexte": "ORDONNANCE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006697981", "@num": "60", "#text": "Ordonnance no 92-1070 du 1er octobre 1992 portant - art. 60 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000542223", "@nortexte": "DOMX9200105R", "@numtexte": "92-1070", "@typelien": "ABROGATION", "@naturetexte": "ORDONNANCE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006697927", "@num": "7", "#text": "Ordonnance no 92-1070 du 1er octobre 1992 portant - art. 7 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000542223", "@nortexte": "DOMX9200105R", "@numtexte": "92-1070", "@typelien": "ABROGATION", "@naturetexte": "ORDONNANCE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006697928", "@num": "8", "#text": "Ordonnance no 92-1070 du 1er octobre 1992 portant - art. 8 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000542223", "@nortexte": "DOMX9200105R", "@numtexte": "92-1070", "@typelien": "ABROGATION", "@naturetexte": "ORDONNANCE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006697929", "@num": "9", "#text": "Ordonnance no 92-1070 du 1er octobre 1992 portant - art. 9 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000542223", "@nortexte": "DOMX9200105R", "@numtexte": "92-1070", "@typelien": "ABROGATION", "@naturetexte": "ORDONNANCE", "@datesignatexte": "2999-01-01" }, { "@id": "JORFTEXT000000542223", "#text": "Ordonnance no 92-1070 du 1er octobre 1992 portant extension et adaptation à la collectivité territoriale de Mayotte de diverses dispositions législatives relatives à la santé publique", "@sens": "source", "@cidtexte": "JORFTEXT000000542223", "@nortexte": "DOMX9200105R", "@numtexte": "92-1070", "@typelien": "ABROGE", "@naturetexte": "ORDONNANCE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006524483", "@num": "1", "#text": "Ordonnance no 92-1079 du 1er octobre 1992 relative - art. 1 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000359398", "@nortexte": "DOMX9200180R", "@numtexte": "92-1079", "@typelien": "ABROGATION", "@naturetexte": "ORDONNANCE", "@datesignatexte": "1992-10-01" }, { "@id": "LEGIARTI000006524495", "@num": "2", "#text": "Ordonnance no 92-1079 du 1er octobre 1992 relative - art. 2 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000359398", "@nortexte": "DOMX9200180R", "@numtexte": "92-1079", "@typelien": "ABROGATION", "@naturetexte": "ORDONNANCE", "@datesignatexte": "1992-10-01" }, { "@id": "LEGITEXT000006080124", "#text": "Ordonnance n°92-1079 du 1 octobre 1992", "@sens": "cible", "@cidtexte": "JORFTEXT000000359398", "@nortexte": "DOMX9200180R", "@numtexte": "92-1079", "@typelien": "ABROGATION", "@naturetexte": "ORDONNANCE", "@datesignatexte": "1992-10-01" }, { "@id": "JORFTEXT000000359398", "#text": "Ordonnance no 92-1079 du 1er octobre 1992 relative au code de la consommation des boissons et des mesures contre l'alcoolisme applicable dans la collectivité territoriale de Mayotte", "@sens": "source", "@cidtexte": "JORFTEXT000000359398", "@nortexte": "DOMX9200180R", "@numtexte": "92-1079", "@typelien": "ABROGE", "@naturetexte": "ORDONNANCE", "@datesignatexte": "1992-10-01" }, { "@id": "JORFTEXT000000178408", "#text": "Loi n°92-1279 du 8 décembre 1992", "@sens": "source", "@cidtexte": "JORFTEXT000000178408", "@nortexte": "SANX9100161L", "@numtexte": "92-1279", "@typelien": "ABROGE", "@naturetexte": "LOI", "@datesignatexte": "1992-12-08" }, { "@id": "LEGIARTI000006696612", "@num": "26", "#text": "Loi n°92-1279 du 8 décembre 1992 - art. 26 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000178408", "@nortexte": "SANX9100161L", "@numtexte": "92-1279", "@typelien": "ABROGATION", "@naturetexte": "LOI", "@datesignatexte": "1992-12-08" }, { "@id": "JORFTEXT000000178299", "#text": "Loi n°93-5 du 4 janvier 1993", "@sens": "source", "@cidtexte": "JORFTEXT000000178299", "@nortexte": "SPSX9200032L", "@numtexte": "93-5", "@typelien": "ABROGE", "@naturetexte": "LOI", "@datesignatexte": "1993-01-04" }, { "@id": "LEGIARTI000006616194", "@num": "16", "#text": "Loi n°92-1477 du 31 décembre 1992 - art. 16 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000542776", "@nortexte": "EURX9200209L", "@numtexte": "92-1477", "@typelien": "ABROGATION", "@naturetexte": "LOI", "@datesignatexte": "1992-12-31" }, { "@id": "LEGIARTI000006616196", "@num": "17", "#text": "Loi n°92-1477 du 31 décembre 1992 - art. 17 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000542776", "@nortexte": "EURX9200209L", "@numtexte": "92-1477", "@typelien": "ABROGATION", "@naturetexte": "LOI", "@datesignatexte": "1992-12-31" }, { "@id": "LEGIARTI000006616200", "@num": "18", "#text": "Loi n°92-1477 du 31 décembre 1992 - art. 18 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000542776", "@nortexte": "EURX9200209L", "@numtexte": "92-1477", "@typelien": "ABROGATION", "@naturetexte": "LOI", "@datesignatexte": "1992-12-31" }, { "@id": "LEGIARTI000006696632", "@num": "15", "#text": "Loi n°93-5 du 4 janvier 1993 - art. 15 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000178299", "@nortexte": "SPSX9200032L", "@numtexte": "93-5", "@typelien": "ABROGATION", "@naturetexte": "LOI", "@datesignatexte": "1993-01-04" }, { "@id": "LEGIARTI000006696640", "@num": "19", "#text": "Loi n°93-5 du 4 janvier 1993 - art. 19 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000178299", "@nortexte": "SPSX9200032L", "@numtexte": "93-5", "@typelien": "ABROGATION", "@naturetexte": "LOI", "@datesignatexte": "1993-01-04" }, { "@id": "LEGIARTI000006757682", "@num": "10", "#text": "Loi n°93-8 du 4 janvier 1993 - art. 10 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000727115", "@nortexte": "SPSX9200085L", "@numtexte": "93-8", "@typelien": "ABROGATION", "@naturetexte": "LOI", "@datesignatexte": "1993-01-04" }, { "@id": "LEGIARTI000006757673", "@num": "5", "#text": "Loi n°93-8 du 4 janvier 1993 - art. 5 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000727115", "@nortexte": "SPSX9200085L", "@numtexte": "93-8", "@typelien": "ABROGATION", "@naturetexte": "LOI", "@datesignatexte": "1993-01-04" }, { "@id": "LEGIARTI000006757674", "@num": "6", "#text": "Loi n°93-8 du 4 janvier 1993 - art. 6 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000727115", "@nortexte": "SPSX9200085L", "@numtexte": "93-8", "@typelien": "ABROGATION", "@naturetexte": "LOI", "@datesignatexte": "1993-01-04" }, { "@id": "LEGIARTI000006757675", "@num": "7", "#text": "Loi n°93-8 du 4 janvier 1993 - art. 7 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000727115", "@nortexte": "SPSX9200085L", "@numtexte": "93-8", "@typelien": "ABROGATION", "@naturetexte": "LOI", "@datesignatexte": "1993-01-04" }, { "@id": "LEGIARTI000006757679", "@num": "8", "#text": "Loi n°93-8 du 4 janvier 1993 - art. 8 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000727115", "@nortexte": "SPSX9200085L", "@numtexte": "93-8", "@typelien": "ABROGATION", "@naturetexte": "LOI", "@datesignatexte": "1993-01-04" }, { "@id": "LEGIARTI000006757681", "@num": "9", "#text": "Loi n°93-8 du 4 janvier 1993 - art. 9 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000727115", "@nortexte": "SPSX9200085L", "@numtexte": "93-8", "@typelien": "ABROGATION", "@naturetexte": "LOI", "@datesignatexte": "1993-01-04" }, { "@id": "JORFTEXT000000727115", "#text": "Loi n°93-8 du 4 janvier 1993", "@sens": "source", "@cidtexte": "JORFTEXT000000727115", "@nortexte": "SPSX9200085L", "@numtexte": "93-8", "@typelien": "ABROGE", "@naturetexte": "LOI", "@datesignatexte": "1993-01-04" }, { "@id": "LEGIARTI000006757775", "@num": "71", "#text": "Loi n°93-121 du 27 janvier 1993 - art. 71 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000711603", "@nortexte": "SPSX9200178L", "@numtexte": "93-121", "@typelien": "ABROGATION", "@naturetexte": "LOI", "@datesignatexte": "1993-01-27" }, { "@id": "JORFTEXT000000711603", "#text": "LOI n° 93-121 du 27 janvier 1993", "@sens": "source", "@cidtexte": "JORFTEXT000000711603", "@nortexte": "SPSX9200178L", "@numtexte": "93-121", "@typelien": "ABROGE", "@naturetexte": "LOI", "@datesignatexte": "1993-01-27" }, { "@id": "LEGIARTI000006696659", "@num": "11", "#text": "Loi n°94-43 du 18 janvier 1994 - art. 11 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000728979", "@nortexte": "SPSX9300136L", "@numtexte": "94-43", "@typelien": "ABROGATION", "@naturetexte": "LOI", "@datesignatexte": "1994-01-18" }, { "@id": "JORFTEXT000000728979", "#text": "Loi n°94-43 du 18 janvier 1994", "@sens": "source", "@cidtexte": "JORFTEXT000000728979", "@nortexte": "SPSX9300136L", "@numtexte": "94-43", "@typelien": "ABROGE", "@naturetexte": "LOI", "@datesignatexte": "1994-01-18" }, { "@id": "LEGIARTI000006696796", "@num": "23", "#text": "Loi n°94-654 du 29 juillet 1994 - art. 23 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000549618", "@nortexte": "SPSX9400032L", "@numtexte": "94-654", "@typelien": "ABROGATION", "@naturetexte": "LOI", "@datesignatexte": "1994-07-29" }, { "@id": "JORFTEXT000000549618", "#text": "Loi n°94-654 du 29 juillet 1994", "@sens": "source", "@cidtexte": "JORFTEXT000000549618", "@nortexte": "SPSX9400032L", "@numtexte": "94-654", "@typelien": "ABROGE", "@naturetexte": "LOI", "@datesignatexte": "1994-07-29" }, { "@id": "LEGIARTI000006698050", "@num": "61", "#text": "Rapport - art. 61 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000742206", "@nortexte": "TASX9600043R", "@numtexte": "96-346", "@typelien": "ABROGATION", "@naturetexte": "ORDONNANCE", "@datesignatexte": "1996-04-24" }, { "@id": "JORFTEXT000000742032", "#text": "Rapport", "@sens": "source", "@cidtexte": "JORFTEXT000000742032", "@nortexte": "TASX9600043R", "@typelien": "ABROGE", "@naturetexte": "RAPPORT", "@datesignatexte": "2999-01-01" }, { "@id": "JORFTEXT000000192901", "#text": "Loi n°96-452 du 28 mai 1996", "@sens": "source", "@cidtexte": "JORFTEXT000000192901", "@nortexte": "TASX9500161L", "@numtexte": "96-452", "@typelien": "ABROGE", "@naturetexte": "LOI", "@datesignatexte": "1996-05-28" }, { "@id": "LEGIARTI000006696948", "@num": "19", "#text": "Loi n°96-452 du 28 mai 1996 - art. 19 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000192901", "@nortexte": "TASX9500161L", "@numtexte": "96-452", "@typelien": "MODIFICATION", "@naturetexte": "LOI", "@datesignatexte": "1996-05-28" }, { "@id": "LEGIARTI000006696933", "@num": "5", "#text": "Loi n°96-452 du 28 mai 1996 - art. 5 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000192901", "@nortexte": "TASX9500161L", "@numtexte": "96-452", "@typelien": "ABROGATION", "@naturetexte": "LOI", "@datesignatexte": "1996-05-28" }, { "@id": "LEGIARTI000006302510", "@num": "58", "#text": "Loi n°96-609 du 5 juillet 1996 - art. 58 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000377215", "@nortexte": "DOMX9400139L", "@numtexte": "96-609", "@typelien": "ABROGATION", "@naturetexte": "LOI", "@datesignatexte": "1996-07-05" }, { "@id": "JORFTEXT000000377215", "#text": "Loi n° 96-609 du 5 juillet 1996", "@sens": "source", "@cidtexte": "JORFTEXT000000377215", "@nortexte": "DOMX9400139L", "@numtexte": "96-609", "@typelien": "ABROGE", "@naturetexte": "LOI", "@datesignatexte": "1996-07-05" }, { "@id": "LEGIARTI000006698071", "@num": "14", "#text": "Ordonnance n°96-1122 du 20 décembre 1996 - art. 14 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000368749", "@nortexte": "DOMX9600135R", "@numtexte": "96-1122", "@typelien": "ABROGATION", "@naturetexte": "ORDONNANCE", "@datesignatexte": "1996-12-20" }, { "@id": "LEGIARTI000006698073", "@num": "15", "#text": "Ordonnance n°96-1122 du 20 décembre 1996 - art. 15 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000368749", "@nortexte": "DOMX9600135R", "@numtexte": "96-1122", "@typelien": "ABROGATION", "@naturetexte": "ORDONNANCE", "@datesignatexte": "1996-12-20" }, { "@id": "LEGIARTI000006698075", "@num": "16", "#text": "Ordonnance n°96-1122 du 20 décembre 1996 - art. 16 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000368749", "@nortexte": "DOMX9600135R", "@numtexte": "96-1122", "@typelien": "ABROGATION", "@naturetexte": "ORDONNANCE", "@datesignatexte": "1996-12-20" }, { "@id": "LEGIARTI000006698077", "@num": "17", "#text": "Ordonnance n°96-1122 du 20 décembre 1996 - art. 17 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000368749", "@nortexte": "DOMX9600135R", "@numtexte": "96-1122", "@typelien": "ABROGATION", "@naturetexte": "ORDONNANCE", "@datesignatexte": "1996-12-20" }, { "@id": "LEGIARTI000006698079", "@num": "18", "#text": "Ordonnance n°96-1122 du 20 décembre 1996 - art. 18 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000368749", "@nortexte": "DOMX9600135R", "@numtexte": "96-1122", "@typelien": "ABROGATION", "@naturetexte": "ORDONNANCE", "@datesignatexte": "1996-12-20" }, { "@id": "LEGIARTI000006696327", "@num": "4", "#text": "Loi n°98-144 du 6 mars 1998 - art. 4 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000374977", "@nortexte": "INTX9700017L", "@numtexte": "98-144", "@typelien": "ABROGATION", "@naturetexte": "LOI", "@datesignatexte": "1998-03-06" }, { "@id": "JORFTEXT000000374977", "#text": "Loi n°98-144 du 6 mars 1998", "@sens": "source", "@cidtexte": "JORFTEXT000000374977", "@nortexte": "INTX9700017L", "@numtexte": "98-144", "@typelien": "ABROGE", "@naturetexte": "LOI", "@datesignatexte": "1998-03-06" }, { "@id": "LEGIARTI000006492940", "@num": "51", "#text": "Loi n°98-468 du 17 juin 1998 - art. 51 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000556901", "@nortexte": "JUSX9700090L", "@numtexte": "98-468", "@typelien": "ABROGATION", "@naturetexte": "LOI", "@datesignatexte": "1998-06-17" }, { "@id": "JORFTEXT000000556901", "#text": "LOI n° 98-468 du 17 juin 1998", "@sens": "source", "@cidtexte": "JORFTEXT000000556901", "@nortexte": "JUSX9700090L", "@numtexte": "98-468", "@typelien": "ABROGE", "@naturetexte": "LOI", "@datesignatexte": "1998-06-17" }, { "@id": "LEGIARTI000006657963", "@num": "67", "#text": "Loi n°98-657 du 29 juillet 1998 - art. 67 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000206894", "@nortexte": "MESX9800027L", "@numtexte": "98-657", "@typelien": "ABROGATION", "@naturetexte": "LOI", "@datesignatexte": "1998-07-29" }, { "@id": "LEGIARTI000006657967", "@num": "71", "#text": "Loi n°98-657 du 29 juillet 1998 - art. 71 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000206894", "@nortexte": "MESX9800027L", "@numtexte": "98-657", "@typelien": "ABROGATION", "@naturetexte": "LOI", "@datesignatexte": "1998-07-29" }, { "@id": "LEGIARTI000006696375", "@num": "1", "#text": "Loi n°99-223 du 23 mars 1999 - art. 1 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000758636", "@nortexte": "MJSX9800040L", "@numtexte": "99-223", "@typelien": "ABROGATION", "@naturetexte": "LOI", "@datesignatexte": "1999-03-23" }, { "@id": "LEGIARTI000006696384", "@num": "10", "#text": "Loi n°99-223 du 23 mars 1999 - art. 10 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000758636", "@nortexte": "MJSX9800040L", "@numtexte": "99-223", "@typelien": "ABROGATION", "@naturetexte": "LOI", "@datesignatexte": "1999-03-23" }, { "@id": "LEGIARTI000006696385", "@num": "11", "#text": "Loi n°99-223 du 23 mars 1999 - art. 11 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000758636", "@nortexte": "MJSX9800040L", "@numtexte": "99-223", "@typelien": "ABROGATION", "@naturetexte": "LOI", "@datesignatexte": "1999-03-23" }, { "@id": "LEGIARTI000006696386", "@num": "12", "#text": "Loi n°99-223 du 23 mars 1999 - art. 12 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000758636", "@nortexte": "MJSX9800040L", "@numtexte": "99-223", "@typelien": "ABROGATION", "@naturetexte": "LOI", "@datesignatexte": "1999-03-23" }, { "@id": "LEGIARTI000006696387", "@num": "13", "#text": "Loi n°99-223 du 23 mars 1999 - art. 13 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000758636", "@nortexte": "MJSX9800040L", "@numtexte": "99-223", "@typelien": "ABROGATION", "@naturetexte": "LOI", "@datesignatexte": "1999-03-23" }, { "@id": "LEGIARTI000006696388", "@num": "14", "#text": "Loi n°99-223 du 23 mars 1999 - art. 14 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000758636", "@nortexte": "MJSX9800040L", "@numtexte": "99-223", "@typelien": "ABROGATION", "@naturetexte": "LOI", "@datesignatexte": "1999-03-23" }, { "@id": "LEGIARTI000006696390", "@num": "15", "#text": "Loi n°99-223 du 23 mars 1999 - art. 15 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000758636", "@nortexte": "MJSX9800040L", "@numtexte": "99-223", "@typelien": "ABROGATION", "@naturetexte": "LOI", "@datesignatexte": "1999-03-23" }, { "@id": "LEGIARTI000006696391", "@num": "16", "#text": "Loi n°99-223 du 23 mars 1999 - art. 16 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000758636", "@nortexte": "MJSX9800040L", "@numtexte": "99-223", "@typelien": "ABROGATION", "@naturetexte": "LOI", "@datesignatexte": "1999-03-23" }, { "@id": "LEGIARTI000006696392", "@num": "17", "#text": "Loi n°99-223 du 23 mars 1999 - art. 17 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000758636", "@nortexte": "MJSX9800040L", "@numtexte": "99-223", "@typelien": "ABROGATION", "@naturetexte": "LOI", "@datesignatexte": "1999-03-23" }, { "@id": "LEGIARTI000006696393", "@num": "18", "#text": "Loi n°99-223 du 23 mars 1999 - art. 18 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000758636", "@nortexte": "MJSX9800040L", "@numtexte": "99-223", "@typelien": "ABROGATION", "@naturetexte": "LOI", "@datesignatexte": "1999-03-23" }, { "@id": "LEGIARTI000006696394", "@num": "19", "#text": "Loi n°99-223 du 23 mars 1999 - art. 19 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000758636", "@nortexte": "MJSX9800040L", "@numtexte": "99-223", "@typelien": "ABROGATION", "@naturetexte": "LOI", "@datesignatexte": "1999-03-23" }, { "@id": "LEGIARTI000006696376", "@num": "2", "#text": "Loi n°99-223 du 23 mars 1999 - art. 2 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000758636", "@nortexte": "MJSX9800040L", "@numtexte": "99-223", "@typelien": "ABROGATION", "@naturetexte": "LOI", "@datesignatexte": "1999-03-23" }, { "@id": "LEGIARTI000006696395", "@num": "20", "#text": "Loi n°99-223 du 23 mars 1999 - art. 20 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000758636", "@nortexte": "MJSX9800040L", "@numtexte": "99-223", "@typelien": "ABROGATION", "@naturetexte": "LOI", "@datesignatexte": "1999-03-23" }, { "@id": "LEGIARTI000006696396", "@num": "21", "#text": "Loi n°99-223 du 23 mars 1999 - art. 21 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000758636", "@nortexte": "MJSX9800040L", "@numtexte": "99-223", "@typelien": "ABROGATION", "@naturetexte": "LOI", "@datesignatexte": "1999-03-23" }, { "@id": "LEGIARTI000006696397", "@num": "22", "#text": "Loi n°99-223 du 23 mars 1999 - art. 22 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000758636", "@nortexte": "MJSX9800040L", "@numtexte": "99-223", "@typelien": "ABROGATION", "@naturetexte": "LOI", "@datesignatexte": "1999-03-23" }, { "@id": "LEGIARTI000006696398", "@num": "23", "#text": "Loi n°99-223 du 23 mars 1999 - art. 23 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000758636", "@nortexte": "MJSX9800040L", "@numtexte": "99-223", "@typelien": "ABROGATION", "@naturetexte": "LOI", "@datesignatexte": "1999-03-23" }, { "@id": "LEGIARTI000006696399", "@num": "24", "#text": "Loi n°99-223 du 23 mars 1999 - art. 24 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000758636", "@nortexte": "MJSX9800040L", "@numtexte": "99-223", "@typelien": "ABROGATION", "@naturetexte": "LOI", "@datesignatexte": "1999-03-23" }, { "@id": "LEGIARTI000006696400", "@num": "25", "#text": "Loi n°99-223 du 23 mars 1999 - art. 25 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000758636", "@nortexte": "MJSX9800040L", "@numtexte": "99-223", "@typelien": "ABROGATION", "@naturetexte": "LOI", "@datesignatexte": "1999-03-23" }, { "@id": "LEGIARTI000006696402", "@num": "26", "#text": "Loi n°99-223 du 23 mars 1999 - art. 26 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000758636", "@nortexte": "MJSX9800040L", "@numtexte": "99-223", "@typelien": "ABROGATION", "@naturetexte": "LOI", "@datesignatexte": "1999-03-23" }, { "@id": "LEGIARTI000006696403", "@num": "27", "#text": "Loi n°99-223 du 23 mars 1999 - art. 27 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000758636", "@nortexte": "MJSX9800040L", "@numtexte": "99-223", "@typelien": "ABROGATION", "@naturetexte": "LOI", "@datesignatexte": "1999-03-23" }, { "@id": "LEGIARTI000006696404", "@num": "28", "#text": "Loi n°99-223 du 23 mars 1999 - art. 28 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000758636", "@nortexte": "MJSX9800040L", "@numtexte": "99-223", "@typelien": "ABROGATION", "@naturetexte": "LOI", "@datesignatexte": "1999-03-23" }, { "@id": "LEGIARTI000006696406", "@num": "29", "#text": "Loi n°99-223 du 23 mars 1999 - art. 29 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000758636", "@nortexte": "MJSX9800040L", "@numtexte": "99-223", "@typelien": "MODIFICATION", "@naturetexte": "LOI", "@datesignatexte": "1999-03-23" }, { "@id": "LEGIARTI000006696377", "@num": "3", "#text": "Loi n°99-223 du 23 mars 1999 - art. 3 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000758636", "@nortexte": "MJSX9800040L", "@numtexte": "99-223", "@typelien": "ABROGATION", "@naturetexte": "LOI", "@datesignatexte": "1999-03-23" }, { "@id": "LEGIARTI000006696378", "@num": "4", "#text": "Loi n°99-223 du 23 mars 1999 - art. 4 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000758636", "@nortexte": "MJSX9800040L", "@numtexte": "99-223", "@typelien": "ABROGATION", "@naturetexte": "LOI", "@datesignatexte": "1999-03-23" }, { "@id": "LEGIARTI000006696379", "@num": "5", "#text": "Loi n°99-223 du 23 mars 1999 - art. 5 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000758636", "@nortexte": "MJSX9800040L", "@numtexte": "99-223", "@typelien": "ABROGATION", "@naturetexte": "LOI", "@datesignatexte": "1999-03-23" }, { "@id": "LEGIARTI000006696380", "@num": "6", "#text": "Loi n°99-223 du 23 mars 1999 - art. 6 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000758636", "@nortexte": "MJSX9800040L", "@numtexte": "99-223", "@typelien": "ABROGATION", "@naturetexte": "LOI", "@datesignatexte": "1999-03-23" }, { "@id": "LEGIARTI000006696381", "@num": "7", "#text": "Loi n°99-223 du 23 mars 1999 - art. 7 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000758636", "@nortexte": "MJSX9800040L", "@numtexte": "99-223", "@typelien": "ABROGATION", "@naturetexte": "LOI", "@datesignatexte": "1999-03-23" }, { "@id": "LEGIARTI000006696382", "@num": "8", "#text": "Loi n°99-223 du 23 mars 1999 - art. 8 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000758636", "@nortexte": "MJSX9800040L", "@numtexte": "99-223", "@typelien": "ABROGATION", "@naturetexte": "LOI", "@datesignatexte": "1999-03-23" }, { "@id": "LEGIARTI000006696383", "@num": "9", "#text": "Loi n°99-223 du 23 mars 1999 - art. 9 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000758636", "@nortexte": "MJSX9800040L", "@numtexte": "99-223", "@typelien": "ABROGATION", "@naturetexte": "LOI", "@datesignatexte": "1999-03-23" }, { "@id": "JORFTEXT000000758636", "#text": "Loi n°99-223 du 23 mars 1999", "@sens": "source", "@cidtexte": "JORFTEXT000000758636", "@nortexte": "MJSX9800040L", "@numtexte": "99-223", "@typelien": "ABROGE", "@naturetexte": "LOI", "@datesignatexte": "1999-03-23" }, { "@id": "JORFTEXT000000212121", "#text": "Loi n°99-477 du 9 juin 1999", "@sens": "source", "@cidtexte": "JORFTEXT000000212121", "@nortexte": "MESX9903552L", "@numtexte": "99-477", "@typelien": "ABROGE", "@naturetexte": "LOI", "@datesignatexte": "1999-06-09" }, { "@id": "LEGIARTI000006696371", "@num": "10", "#text": "Loi n°99-477 du 9 juin 1999 - art. 10 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000212121", "@nortexte": "MESX9903552L", "@numtexte": "99-477", "@typelien": "ABROGATION", "@naturetexte": "LOI", "@datesignatexte": "1999-06-09" }, { "@id": "LEGIARTI000006696374", "@num": "13", "#text": "Loi n°99-477 du 9 juin 1999 - art. 13 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000212121", "@nortexte": "MESX9903552L", "@numtexte": "99-477", "@typelien": "ABROGATION", "@naturetexte": "LOI", "@datesignatexte": "1999-06-09" }, { "@id": "JORFTEXT000000198392", "#text": "Loi n° 99-641 du 27 juillet 1999", "@sens": "source", "@cidtexte": "JORFTEXT000000198392", "@nortexte": "MESX9900011L", "@numtexte": "99-641", "@typelien": "ABROGE", "@naturetexte": "LOI", "@datesignatexte": "1999-07-27" }, { "@id": "LEGIARTI000006758139", "@num": "38", "#text": "Loi n°99-641 du 27 juillet 1999 - art. 38 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000198392", "@nortexte": "MESX9900011L", "@numtexte": "99-641", "@typelien": "ABROGATION", "@naturetexte": "LOI", "@datesignatexte": "1999-07-27" }, { "@id": "LEGIARTI000006758164", "@num": "60", "#text": "Loi n°99-641 du 27 juillet 1999 - art. 60 (M)", "@sens": "cible", "@cidtexte": "JORFTEXT000000198392", "@nortexte": "MESX9900011L", "@numtexte": "99-641", "@typelien": "MODIFICATION", "@naturetexte": "LOI", "@datesignatexte": "1999-07-27" }, { "@id": "LEGIARTI000006758168", "@num": "61", "#text": "Loi n°99-641 du 27 juillet 1999 - art. 61 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000198392", "@nortexte": "MESX9900011L", "@numtexte": "99-641", "@typelien": "MODIFICATION", "@naturetexte": "LOI", "@datesignatexte": "1999-07-27" }, { "@id": "LEGIARTI000006758173", "@num": "65", "#text": "Loi n°99-641 du 27 juillet 1999 - art. 65 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000198392", "@nortexte": "MESX9900011L", "@numtexte": "99-641", "@typelien": "MODIFICATION", "@naturetexte": "LOI", "@datesignatexte": "1999-07-27" }, { "@id": "LEGIARTI000006698233", "@num": "4", "#text": "Rapport - art. 4 (M)", "@sens": "cible", "@cidtexte": "JORFTEXT000000400219", "@nortexte": "MESX0000036R", "@numtexte": "2000-548", "@typelien": "CITATION", "@naturetexte": "ORDONNANCE", "@datesignatexte": "2000-06-15" }, { "@id": "LEGIARTI000006698235", "@num": "5", "#text": "Rapport - art. 5 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000400219", "@nortexte": "MESX0000036R", "@numtexte": "2000-548", "@typelien": "CITATION", "@naturetexte": "ORDONNANCE", "@datesignatexte": "2000-06-15" }, { "@id": "LEGIARTI000006698236", "@num": "6", "#text": "Rapport - art. 6 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000400219", "@nortexte": "MESX0000036R", "@numtexte": "2000-548", "@typelien": "CITATION", "@naturetexte": "ORDONNANCE", "@datesignatexte": "2000-06-15" }, { "@id": "LEGIARTI000006697482", "@num": "92", "#text": "Loi n°2002-303 du 4 mars 2002 - art. 92 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000227015", "@nortexte": "MESX0100092L", "@numtexte": "2002-303", "@typelien": "CITATION", "@naturetexte": "LOI", "@datesignatexte": "2002-03-04" }, { "@id": "LEGIARTI000006229469", "@num": "3", "#text": "Loi n°2004-237 du 18 mars 2004 - art. 3 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000800837", "@nortexte": "MAEX0300214L", "@numtexte": "2004-237", "@typelien": "CITATION", "@naturetexte": "LOI", "@datesignatexte": "2004-03-18" }, { "@id": "JORFARTI000019215033", "#text": "Rapport du - art., v. init.", "@sens": "cible", "@cidtexte": "JORFTEXT000019215032", "@nortexte": "SJSX0814719P", "@typelien": "CITATION", "@naturetexte": "RAPPORT", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006844323", "@num": "L351-2", "#text": "Code de l'aviation civile - art. L351-2 (VT)", "@sens": "cible", "@cidtexte": "LEGITEXT000006074234", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006292238", "@num": "L213-5", "#text": "Code de la consommation - art. L213-5 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006069565", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000022234570", "@num": "L213-5", "#text": "Code de la consommation - art. L213-5 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006069565", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006286867", "@num": "L1", "#text": "Code de la consommation des boissons et des mesure - art. L1 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006069472", "@typelien": "ABROGATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006286876", "@num": "L10", "#text": "Code de la consommation des boissons et des mesure - art. L10 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006069472", "@typelien": "ABROGATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006286877", "@num": "L11", "#text": "Code de la consommation des boissons et des mesure - art. L11 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006069472", "@typelien": "ABROGATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006286878", "@num": "L12", "#text": "Code de la consommation des boissons et des mesure - art. L12 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006069472", "@typelien": "ABROGATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006286879", "@num": "L13", "#text": "Code de la consommation des boissons et des mesure - art. L13 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006069472", "@typelien": "ABROGATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006286880", "@num": "L14", "#text": "Code de la consommation des boissons et des mesure - art. L14 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006069472", "@typelien": "ABROGATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006286882", "@num": "L15", "#text": "Code de la consommation des boissons et des mesure - art. L15 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006069472", "@typelien": "ABROGATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006286883", "@num": "L16", "#text": "Code de la consommation des boissons et des mesure - art. L16 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006069472", "@typelien": "ABROGATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006286884", "@num": "L17", "#text": "Code de la consommation des boissons et des mesure - art. L17 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006069472", "@typelien": "ABROGATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006286885", "@num": "L18", "#text": "Code de la consommation des boissons et des mesure - art. L18 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006069472", "@typelien": "ABROGATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006286886", "@num": "L19", "#text": "Code de la consommation des boissons et des mesure - art. L19 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006069472", "@typelien": "ABROGATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006286868", "@num": "L2", "#text": "Code de la consommation des boissons et des mesure - art. L2 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006069472", "@typelien": "ABROGATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006286888", "@num": "L20", "#text": "Code de la consommation des boissons et des mesure - art. L20 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006069472", "@typelien": "ABROGATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006286890", "@num": "L22", "#text": "Code de la consommation des boissons et des mesure - art. L22 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006069472", "@typelien": "ABROGATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006286893", "@num": "L23", "#text": "Code de la consommation des boissons et des mesure - art. L23 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006069472", "@typelien": "ABROGATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006286894", "@num": "L24", "#text": "Code de la consommation des boissons et des mesure - art. L24 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006069472", "@typelien": "ABROGATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006286895", "@num": "L25", "#text": "Code de la consommation des boissons et des mesure - art. L25 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006069472", "@typelien": "ABROGATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006286896", "@num": "L26", "#text": "Code de la consommation des boissons et des mesure - art. L26 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006069472", "@typelien": "ABROGATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006286897", "@num": "L27", "#text": "Code de la consommation des boissons et des mesure - art. L27 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006069472", "@typelien": "ABROGATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006286898", "@num": "L28", "#text": "Code de la consommation des boissons et des mesure - art. L28 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006069472", "@typelien": "ABROGATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006286899", "@num": "L29", "#text": "Code de la consommation des boissons et des mesure - art. L29 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006069472", "@typelien": "ABROGATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006286869", "@num": "L3", "#text": "Code de la consommation des boissons et des mesure - art. L3 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006069472", "@typelien": "ABROGATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006286900", "@num": "L30", "#text": "Code de la consommation des boissons et des mesure - art. L30 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006069472", "@typelien": "ABROGATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006286902", "@num": "L31", "#text": "Code de la consommation des boissons et des mesure - art. L31 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006069472", "@typelien": "ABROGATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006286903", "@num": "L32", "#text": "Code de la consommation des boissons et des mesure - art. L32 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006069472", "@typelien": "ABROGATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006286904", "@num": "L33", "#text": "Code de la consommation des boissons et des mesure - art. L33 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006069472", "@typelien": "ABROGATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006286905", "@num": "L34", "#text": "Code de la consommation des boissons et des mesure - art. L34 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006069472", "@typelien": "ABROGATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006286906", "@num": "L35", "#text": "Code de la consommation des boissons et des mesure - art. L35 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006069472", "@typelien": "ABROGATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006286907", "@num": "L36", "#text": "Code de la consommation des boissons et des mesure - art. L36 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006069472", "@typelien": "ABROGATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006286908", "@num": "L37", "#text": "Code de la consommation des boissons et des mesure - art. L37 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006069472", "@typelien": "ABROGATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006286910", "@num": "L38", "#text": "Code de la consommation des boissons et des mesure - art. L38 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006069472", "@typelien": "ABROGATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006286912", "@num": "L39", "#text": "Code de la consommation des boissons et des mesure - art. L39 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006069472", "@typelien": "ABROGATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006286870", "@num": "L4", "#text": "Code de la consommation des boissons et des mesure - art. L4 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006069472", "@typelien": "ABROGATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006286913", "@num": "L40", "#text": "Code de la consommation des boissons et des mesure - art. L40 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006069472", "@typelien": "ABROGATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006286914", "@num": "L41", "#text": "Code de la consommation des boissons et des mesure - art. L41 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006069472", "@typelien": "ABROGATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006286915", "@num": "L42", "#text": "Code de la consommation des boissons et des mesure - art. L42 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006069472", "@typelien": "ABROGATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006286916", "@num": "L43", "#text": "Code de la consommation des boissons et des mesure - art. L43 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006069472", "@typelien": "ABROGATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006286917", "@num": "L44", "#text": "Code de la consommation des boissons et des mesure - art. L44 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006069472", "@typelien": "ABROGATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006286918", "@num": "L45", "#text": "Code de la consommation des boissons et des mesure - art. L45 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006069472", "@typelien": "ABROGATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006286920", "@num": "L46", "#text": "Code de la consommation des boissons et des mesure - art. L46 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006069472", "@typelien": "ABROGATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006286921", "@num": "L47", "#text": "Code de la consommation des boissons et des mesure - art. L47 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006069472", "@typelien": "ABROGATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006286922", "@num": "L48", "#text": "Code de la consommation des boissons et des mesure - art. L48 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006069472", "@typelien": "ABROGATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006286923", "@num": "L49", "#text": "Code de la consommation des boissons et des mesure - art. L49 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006069472", "@typelien": "ABROGATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006286871", "@num": "L5", "#text": "Code de la consommation des boissons et des mesure - art. L5 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006069472", "@typelien": "ABROGATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006286924", "@num": "L50", "#text": "Code de la consommation des boissons et des mesure - art. L50 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006069472", "@typelien": "ABROGATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006286926", "@num": "L51", "#text": "Code de la consommation des boissons et des mesure - art. L51 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006069472", "@typelien": "ABROGATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006286927", "@num": "L52", "#text": "Code de la consommation des boissons et des mesure - art. L52 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006069472", "@typelien": "ABROGATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006286928", "@num": "L53", "#text": "Code de la consommation des boissons et des mesure - art. L53 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006069472", "@typelien": "ABROGATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006286929", "@num": "L54", "#text": "Code de la consommation des boissons et des mesure - art. 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L3212-1 (VD)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006687929", "@num": "L3212-10", "#text": "Code de la santé publique - art. L3212-10 (VT)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006687930", "@num": "L3212-11", "#text": "Code de la santé publique - art. L3212-11 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000024316523", "@num": "L3212-11", "#text": "Code de la santé publique - art. L3212-11 (VD)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000048447102", "@num": "L3212-11", "#text": "Code de la santé publique - art. L3212-11 (VD)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006687931", "@num": "L3212-12", "#text": "Code de la santé publique - art. L3212-12 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006687919", "@num": "L3212-2", "#text": "Code de la santé publique - art. L3212-2 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000024316581", "@num": "L3212-2", "#text": "Code de la santé publique - art. L3212-2 (VD)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-0

Article L1121-10 AUTONOME MODIFIE, en vigueur du 22/06/2000 au 11/08/2004 (Code de la santé publique)