{ "article": { "LEGIARTI000006698446": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "28", "TYPE": "ENTIEREMENT_MODIF", "DATE_FIN": "2999-01-01", "DATE_DEBUT": "2999-01-01" } }, "META_COMMUN": { "ID": "LEGIARTI000006698446", "URL": "article/LEGI/ARTI/00/00/06/69/84/LEGIARTI000006698446.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SPFBEXXXXXX028AAXXXXXXAA" } }, "LIENS": { "LIEN": [ { "@id": "LEGIARTI000006690154", "@num": "L5136-1", "#text": "Code de la santé publique - art. L5136-1 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "ABROGATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006690155", "@num": "L5136-2", "#text": "Code de la santé publique - art. L5136-2 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "ABROGATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006690156", "@num": "L5136-3", "#text": "Code de la santé publique - art. L5136-3 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "ABROGATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006690157", "@num": "L5136-4", "#text": "Code de la santé publique - art. L5136-4 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "ABROGATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006690158", "@num": "L5136-5", "#text": "Code de la santé publique - art. L5136-5 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "ABROGATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006690159", "@num": "L5136-6", "#text": "Code de la santé publique - art. L5136-6 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "ABROGATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006103664", "@fin": "2999-01-01", "#text": "Chapitre V : Insecticides et acaricides.", "@debut": "2007-04-28" } ] }, "@cid": "JORFTEXT000000646989", "@nor": "SANX0700046R", "@num": "2007-613", "@nature": "ORDONNANCE", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Ordonnance n° 2007-613 du 26 avril 2007 portant diverses dispositions d'adaptation au droit communautaire dans le domaine du médicament", "@debut": "2999-01-01", "@id_txt": "JORFTEXT000000646989", "@c_titre_court": "Ordonnance n° 2007-613 du 26 avril 2007" }, { "@fin": "2999-01-01", "#text": "Ordonnance n° 2007-613 du 26 avril 2007 portant diverses dispositions d'adaptation au droit communautaire dans le domaine du médicament", "@debut": "2008-04-17", "@id_txt": "LEGITEXT000018652169", "@c_titre_court": "Ordonnance n° 2007-613 du 26 avril 2007" }, { "@fin": "2008-04-17", "#text": "Ordonnance n° 2007-613 du 26 avril 2007 portant diverses dispositions d'adaptation au droit communautaire dans le domaine du médicament", "@debut": "2007-04-28", "@id_txt": "LEGITEXT000006056023", "@c_titre_court": "Ordonnance n° 2007-613 du 26 avril 2007" } ], "@ministere": "MINISTERE DE LA SANTE ET DES SOLIDARITES", "@date_publi": "2007-04-27", "@date_signature": "2007-04-26", "@num_parution_jo": "0099" } }, "VERSIONS": { "VERSION": [ { "LIEN_ART": { "@id": "LEGIARTI000006698446", "@fin": "2999-01-01", "@num": "28", "@debut": "2999-01-01", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "a modifié les dispositions suivantes
\n
" } }, "LEGIARTI000006690154": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "L5136-1", "ETAT": "ABROGE", "TYPE": "AUTONOME", "DATE_FIN": "2007-04-27", "DATE_DEBUT": "2000-06-22" } }, "META_COMMUN": { "ID": "LEGIARTI000006690154", "URL": "article/LEGI/ARTI/00/00/06/69/01/LEGIARTI000006690154.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SPANXXXXXXX1X5136L01XXAA" } }, "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": "LEGIARTI000006232079", "@num": "1", "#text": "Décret n°2004-651 du 2 juillet 2004 - art. 1 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000436350", "@nortexte": "SANG0421846D", "@numtexte": "2004-651", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2004-07-02" }, { "@id": "LEGIARTI000006698446", "@num": "28", "#text": "Ordonnance n°2007-613 du 26 avril 2007 - art. 28 () JORF 27 avril 2007", "@sens": "source", "@cidtexte": "JORFTEXT000000646989", "@nortexte": "SANX0700046R", "@numtexte": "2007-613", "@typelien": "ABROGATION", "@naturetexte": "ORDONNANCE", "@datesignatexte": "2007-04-26" }, { "@id": "LEGIARTI000006914709", "@num": "D5121-64", "#text": "Code de la santé publique - art. D5121-64 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006689912", "@num": "L5121-16", "#text": "Code de la santé publique - art. L5121-16 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006690155", "@num": "L5136-2", "#text": "Code de la santé publique - art. L5136-2 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006690156", "@num": "L5136-3", "#text": "Code de la santé publique - art. L5136-3 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006690157", "@num": "L5136-4", "#text": "Code de la santé publique - art. L5136-4 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006690158", "@num": "L5136-5", "#text": "Code de la santé publique - art. L5136-5 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006690159", "@num": "L5136-6", "#text": "Code de la santé publique - art. L5136-6 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006690532", "@num": "L5436-1", "#text": "Code de la santé publique - art. L5436-1 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006690534", "@num": "L5436-2", "#text": "Code de la santé publique - art. L5436-2 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006690536", "@num": "L5436-3", "#text": "Code de la santé publique - art. L5436-3 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006694011", "@num": "L658-11", "#text": "Code de la santé publique - art. L658-11 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006694008", "@num": "L658-11", "#text": "Code de la santé publique - art. L658-11 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006908399", "@num": "R1123-29", "#text": "Code de la santé publique - art. R1123-29 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006910602", "@num": "R1341-10", "#text": "Code de la santé publique - art. R1341-10 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000043335118", "@num": "R1342-20", "#text": "Code de la santé publique - art. R1342-20 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006914902", "@num": "R5121-150", "#text": "Code de la santé publique - art. R5121-150 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006914904", "@num": "R5121-152", "#text": "Code de la santé publique - art. R5121-152 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006915078", "@num": "R5124-2", "#text": "Code de la santé publique - art. R5124-2 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006915080", "@num": "R5124-3", "#text": "Code de la santé publique - art. R5124-3 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006915144", "@num": "R5124-47", "#text": "Code de la santé publique - art. R5124-47 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006915049", "@num": "R5124-49", "#text": "Code de la santé publique - art. R5124-49 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006915059", "@num": "R5124-53", "#text": "Code de la santé publique - art. R5124-53 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006915061", "@num": "R5124-54", "#text": "Code de la santé publique - art. R5124-54 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006915063", "@num": "R5124-55", "#text": "Code de la santé publique - art. R5124-55 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006915149", "@num": "R5124-60", "#text": "Code de la santé publique - art. R5124-60 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006915768", "@num": "R5136-1", "#text": "Code de la santé publique - art. R5136-1 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006915781", "@num": "R5136-14", "#text": "Code de la santé publique - art. R5136-14 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006915784", "@num": "R5136-17", "#text": "Code de la santé publique - art. R5136-17 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006915785", "@num": "R5136-18", "#text": "Code de la santé publique - art. R5136-18 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006915770", "@num": "R5136-3", "#text": "Code de la santé publique - art. R5136-3 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006171380", "@fin": "2007-04-27", "#text": "Chapitre VI : Insecticides et acaricides.", "@debut": "2000-06-22" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006155086", "@fin": "2999-01-01", "#text": "Titre III : Autres produits et substances pharmaceutiques réglementés", "@debut": "2000-06-22" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006140630", "@fin": "2999-01-01", "#text": "Livre Ier : Produits pharmaceutiques", "@debut": "2000-06-22" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006125349", "@fin": "2999-01-01", "#text": "Cinquième partie : Produits de 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": "LEGIARTI000006690154", "@fin": "2007-04-27", "@num": "L5136-1", "@etat": "ABROGE", "@debut": "2000-06-22", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
Les insecticides et les acaricides destinés à être appliqués sur l'homme doivent, avant leur mise sur le marché à titre onéreux ou à titre gratuit, faire l'objet d'une autorisation par l'Agence française de sécurité sanitaire des produits de santé.
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Cette autorisation peut être assortie de conditions adéquates ; elle n'est accordée que lorsque le fabricant justifie :
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1° Qu'il a fait procéder à la vérification de l'innocuité du produit dans des conditions normales d'emploi ainsi qu'à son analyse qualitative et quantitative ;
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2° Qu'il dispose effectivement d'une méthode de fabrication et de procédés de contrôle de nature à garantir la qualité du produit au stade de la fabrication en série.
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Cette autorisation est délivrée pour une durée de cinq ans ; elle est ensuite renouvelable par période quinquennale.
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Elle peut être suspendue ou supprimée par l'Agence française de sécurité sanitaire des produits de santé.
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L'accomplissement des formalités prévues au présent article n'a pas pour effet d'exonérer le fabricant de la responsabilité qu'il peut encourir dans les conditions du droit commun en raison de la fabrication ou de la mise sur le marché du produit.
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Toute demande d'autorisation doit être accompagnée du versement du droit fixe prévu à l'article L. 5121-16.
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Des décrets en Conseil d'Etat précisent les conditions d'application du présent article ainsi que les règles applicables à la pharmacovigilance exercée sur ces produits postérieurement à la délivrance de l'autorisation administrative précitée ; ces règles fixent notamment les obligations de signalement incombant aux membres des professions de santé et aux entreprises exploitant ces produits.
" } }, "LEGIARTI000006690155": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "L5136-2", "ETAT": "ABROGE", "TYPE": "AUTONOME", "DATE_FIN": "2007-04-27", "DATE_DEBUT": "2000-06-22" } }, "META_COMMUN": { "ID": "LEGIARTI000006690155", "URL": "article/LEGI/ARTI/00/00/06/69/01/LEGIARTI000006690155.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SPANXXXXXXX1X5136L02XXAA" } }, "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": "LEGIARTI000006698446", "@num": "28", "#text": "Ordonnance n°2007-613 du 26 avril 2007 - art. 28 () JORF 27 avril 2007", "@sens": "source", "@cidtexte": "JORFTEXT000000646989", "@nortexte": "SANX0700046R", "@numtexte": "2007-613", "@typelien": "ABROGATION", "@naturetexte": "ORDONNANCE", "@datesignatexte": "2007-04-26" }, { "@id": "LEGIARTI000006690154", "@num": "L5136-1", "#text": "Code de la santé publique - art. L5136-1 (Ab)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693689", "@num": "L596", "#text": "Code de la santé publique - art. L596 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGITEXT000006072665", "#text": "Code de la santé publique L596 alinéa 1", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000041397411", "@num": "L138-1", "#text": "Code de la sécurité sociale. - art. L138-1 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006073189", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000044627476", "@num": "L245-1", "#text": "Code de la sécurité sociale. - art. L245-1 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006073189", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006171380", "@fin": "2007-04-27", "#text": "Chapitre VI : Insecticides et acaricides.", "@debut": "2000-06-22" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006155086", "@fin": "2999-01-01", "#text": "Titre III : Autres produits et substances pharmaceutiques réglementés", "@debut": "2000-06-22" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006140630", "@fin": "2999-01-01", "#text": "Livre Ier : Produits pharmaceutiques", "@debut": "2000-06-22" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006125349", "@fin": "2999-01-01", "#text": "Cinquième partie : Produits de 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": "LEGIARTI000006690155", "@fin": "2007-04-27", "@num": "L5136-2", "@etat": "ABROGE", "@debut": "2000-06-22", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
L'exploitation de produits mentionnés à l'article L. 5136-1 ne peut être effectuée que dans des établissements pharmaceutiques régis par le chapitre IV du titre II du présent livre.
\n
" } }, "LEGIARTI000006690156": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "L5136-3", "ETAT": "ABROGE", "TYPE": "AUTONOME", "DATE_FIN": "2007-04-27", "DATE_DEBUT": "2000-06-22" } }, "META_COMMUN": { "ID": "LEGIARTI000006690156", "URL": "article/LEGI/ARTI/00/00/06/69/01/LEGIARTI000006690156.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SPANXXXXXXX1X5136L03XXAA" } }, "LIENS": { "LIEN": [ { "@id": "JORFTEXT000000217229", "#text": "Ordonnance 2000-548 2000-06-15", "@sens": "source", "@cidtexte": "JORFTEXT000000217229", "@nortexte": "MESX0000036R", "@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": "LEGIARTI000006698446", "@num": "28", "#text": "Ordonnance n°2007-613 du 26 avril 2007 - art. 28 () JORF 27 avril 2007", "@sens": "source", "@cidtexte": "JORFTEXT000000646989", "@nortexte": "SANX0700046R", "@numtexte": "2007-613", "@typelien": "ABROGATION", "@naturetexte": "ORDONNANCE", "@datesignatexte": "2007-04-26" }, { "@id": "LEGIARTI000006693417", "@num": "L511-2", "#text": "Code de la santé publique - art. L511-2 (Ab)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693417", "@num": "L511-2", "#text": "Code de la santé publique - art. L511-2 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006690154", "@num": "L5136-1", "#text": "Code de la santé publique - art. L5136-1 (Ab)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006690532", "@num": "L5436-1", "#text": "Code de la santé publique - art. L5436-1 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006694008", "@num": "L658-11", "#text": "Code de la santé publique - art. L658-11 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006915078", "@num": "R5124-2", "#text": "Code de la santé publique - art. R5124-2 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006915142", "@num": "R5124-46", "#text": "Code de la santé publique - art. R5124-46 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006915144", "@num": "R5124-47", "#text": "Code de la santé publique - art. R5124-47 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006915055", "@num": "R5124-52", "#text": "Code de la santé publique - art. R5124-52 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000018087934", "@num": "R5124-62", "#text": "Code de la santé publique - art. R5124-62 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006916408", "@num": "R5313-5", "#text": "Code de la santé publique - art. R5313-5 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006171380", "@fin": "2007-04-27", "#text": "Chapitre VI : Insecticides et acaricides.", "@debut": "2000-06-22" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006155086", "@fin": "2999-01-01", "#text": "Titre III : Autres produits et substances pharmaceutiques réglementés", "@debut": "2000-06-22" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006140630", "@fin": "2999-01-01", "#text": "Livre Ier : Produits pharmaceutiques", "@debut": "2000-06-22" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006125349", "@fin": "2999-01-01", "#text": "Cinquième partie : Produits de 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": "LEGIARTI000006690156", "@fin": "2007-04-27", "@num": "L5136-3", "@etat": "ABROGE", "@debut": "2000-06-22", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
La préparation, l'importation et la distribution des produits mentionnés à l'article L. 5136-1 doivent être réalisées en conformité avec des bonnes pratiques dont les principes sont définis par arrêtés du ministre chargé de la santé.
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" } }, "LEGIARTI000006690157": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "L5136-4", "ETAT": "ABROGE", "TYPE": "AUTONOME", "DATE_FIN": "2007-04-27", "DATE_DEBUT": "2000-06-22" } }, "META_COMMUN": { "ID": "LEGIARTI000006690157", "URL": "article/LEGI/ARTI/00/00/06/69/01/LEGIARTI000006690157.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SPANXXXXXXX1X5136L04XXAA" } }, "LIENS": { "LIEN": [ { "@id": "JORFTEXT000000217229", "#text": "Ordonnance 2000-548 2000-06-15", "@sens": "source", "@cidtexte": "JORFTEXT000000217229", "@nortexte": "MESX0000036R", "@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": "LEGIARTI000006698446", "@num": "28", "#text": "Ordonnance n°2007-613 du 26 avril 2007 - art. 28 () JORF 27 avril 2007", "@sens": "source", "@cidtexte": "JORFTEXT000000646989", "@nortexte": "SANX0700046R", "@numtexte": "2007-613", "@typelien": "ABROGATION", "@naturetexte": "ORDONNANCE", "@datesignatexte": "2007-04-26" }, { "@id": "LEGIARTI000006693432", "@num": "L513-1", "#text": "Code de la santé publique - art. L513-1 (Ab)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693432", "@num": "L513-1", "#text": "Code de la santé publique - art. L513-1 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006690154", "@num": "L5136-1", "#text": "Code de la santé publique - art. L5136-1 (Ab)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006690159", "@num": "L5136-6", "#text": "Code de la santé publique - art. L5136-6 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006690536", "@num": "L5436-3", "#text": "Code de la santé publique - art. L5436-3 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006694008", "@num": "L658-11", "#text": "Code de la santé publique - art. L658-11 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006171380", "@fin": "2007-04-27", "#text": "Chapitre VI : Insecticides et acaricides.", "@debut": "2000-06-22" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006155086", "@fin": "2999-01-01", "#text": "Titre III : Autres produits et substances pharmaceutiques réglementés", "@debut": "2000-06-22" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006140630", "@fin": "2999-01-01", "#text": "Livre Ier : Produits pharmaceutiques", "@debut": "2000-06-22" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006125349", "@fin": "2999-01-01", "#text": "Cinquième partie : Produits de 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": "LEGIARTI000006690157", "@fin": "2007-04-27", "@num": "L5136-4", "@etat": "ABROGE", "@debut": "2000-06-22", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
Les essais non cliniques destinés à évaluer les propriétés et l'innocuité des produits mentionnés à l'alinéa premier de l'article L. 5136-1 doivent être conformes aux bonnes pratiques de laboratoire.
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Les bonnes pratiques de laboratoire doivent garantir la qualité et l'intégrité des résultats des essais. Elles concernent l'organisation du laboratoire et les conditions dans lesquelles ces essais sont prévus, réalisés et rapportés.
" } }, "LEGIARTI000006690158": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "L5136-5", "ETAT": "ABROGE", "TYPE": "AUTONOME", "DATE_FIN": "2007-04-27", "DATE_DEBUT": "2000-06-22" } }, "META_COMMUN": { "ID": "LEGIARTI000006690158", "URL": "article/LEGI/ARTI/00/00/06/69/01/LEGIARTI000006690158.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SPANXXXXXXX1X5136L05XXAA" } }, "LIENS": { "LIEN": [ { "@id": "JORFTEXT000000217229", "#text": "Ordonnance 2000-548 2000-06-15", "@sens": "source", "@cidtexte": "JORFTEXT000000217229", "@nortexte": "MESX0000036R", "@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": "LEGIARTI000006698446", "@num": "28", "#text": "Ordonnance n°2007-613 du 26 avril 2007 - art. 28 () JORF 27 avril 2007", "@sens": "source", "@cidtexte": "JORFTEXT000000646989", "@nortexte": "SANX0700046R", "@numtexte": "2007-613", "@typelien": "ABROGATION", "@naturetexte": "ORDONNANCE", "@datesignatexte": "2007-04-26" }, { "@id": "LEGIARTI000006689930", "@num": "L5122-2", "#text": "Code de la santé publique - art. L5122-2 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006689933", "@num": "L5122-3", "#text": "Code de la santé publique - art. L5122-3 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006689939", "@num": "L5122-6", "#text": "Code de la santé publique - art. L5122-6 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006689942", "@num": "L5122-7", "#text": "Code de la santé publique - art. L5122-7 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006689943", "@num": "L5122-8", "#text": "Code de la santé publique - art. L5122-8 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006689944", "@num": "L5122-9", "#text": "Code de la santé publique - art. L5122-9 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006690154", "@num": "L5136-1", "#text": "Code de la santé publique - art. L5136-1 (Ab)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693522", "@num": "L551-9", "#text": "Code de la santé publique - art. L551-9 (Ab)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693522", "@num": "L551-9", "#text": "Code de la santé publique - art. L551-9 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006694008", "@num": "L658-11", "#text": "Code de la santé publique - art. L658-11 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006171380", "@fin": "2007-04-27", "#text": "Chapitre VI : Insecticides et acaricides.", "@debut": "2000-06-22" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006155086", "@fin": "2999-01-01", "#text": "Titre III : Autres produits et substances pharmaceutiques réglementés", "@debut": "2000-06-22" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006140630", "@fin": "2999-01-01", "#text": "Livre Ier : Produits pharmaceutiques", "@debut": "2000-06-22" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006125349", "@fin": "2999-01-01", "#text": "Cinquième partie : Produits de 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": "LEGIARTI000006690158", "@fin": "2007-04-27", "@num": "L5136-5", "@etat": "ABROGE", "@debut": "2000-06-22", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
Les dispositions des articles L. 5122-2, L. 5122-3, du premier alinéa de l'article L. 5122-6, des articles L. 5122-7, L. 5122-8, L. 5122-9, et L. 5122-11 sont applicables à la publicité pour les produits mentionnés à l'article L. 5136-1.
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Sont déterminées par décret en Conseil d'Etat :
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1° Les règles applicables à l'autorisation de mise sur le marché prévue à l'article L. 5136-1 ;
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2° Les règles applicables à la pharmacovigilance exercée sur les produits mentionnés à l'article L. 5136-1 postérieurement à la délivrance de l'autorisation administrative précitée ; ces règles fixent notamment les obligations de signalement incombant aux membres des professions de santé et aux entreprises exploitant ces produits ;
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3° Les conditions d'application de l'article L. 5136-4 relatif aux essais non cliniques.
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Article 28 ENTIEREMENT_MODIF (Ordonnance n° 2007-613 du 26 avril 2007 portant diverses dispositions d'adaptation au droit communautaire dans le domaine du médicament)