{ "article": { "LEGIARTI000006800060": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R5118", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "1988-05-08", "DATE_DEBUT": "1956-11-28" } }, "META_COMMUN": { "ID": "LEGIARTI000006800060", "URL": "article/LEGI/ARTI/00/00/06/80/00/LEGIARTI000006800060.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SXXXXXXXXXX5118R0000XXAA" } }, "LIENS": { "LIEN": [ { "@id": "JORFTEXT000000503843", "#text": "Décret 53-1001 1953-10-05 (Décret de codification)", "@sens": "source", "@cidtexte": "JORFTEXT000000503843", "@numtexte": "53-1001", "@typelien": "CODIFICATION", "@naturetexte": "DECRET", "@datesignatexte": "1953-10-05" }, { "@id": "JORFTEXT000000518702", "#text": "Décret 72-1062 1972-11-21 ART. 1 JORF 30 novembre 1972", "@sens": "source", "@cidtexte": "JORFTEXT000000518702", "@numtexte": "72-1062", "@typelien": "MODIFICATION", "@naturetexte": "DECRET", "@datesignatexte": "1972-11-21" }, { "@id": "JORFTEXT000000337674", "#text": "Décret 79-256 1979-03-21 art. 1 JORF 31 mars 1979", "@sens": "source", "@cidtexte": "JORFTEXT000000337674", "@numtexte": "79-256", "@typelien": "MODIFICATION", "@naturetexte": "DECRET", "@datesignatexte": "1979-03-21" }, { "@id": "LEGIARTI000006718724", "@num": "1", "#text": "Arrêté du 5 septembre 1989 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000840430", "@nortexte": "SPSM8901858A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "1989-09-05" }, { "@id": "LEGIARTI000006732698", "@num": "ANNEXE", "#text": "Arrêté du 9 décembre 1996 - art. ANNEXE (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000747887", "@nortexte": "TASP9624370A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "1996-12-09" }, { "@id": "LEGIARTI000006800059", "@num": "R5117", "#text": "Code de la santé publique - art. R5117 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006914727", "@num": "R5121-11", "#text": "Code de la santé publique - art. R5121-11 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006800097", "@num": "R5124", "#text": "Code de la santé publique - art. R5124 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006800105", "@num": "R5125", "#text": "Code de la santé publique - art. R5125 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006800147", "@num": "R5133", "#text": "Code de la santé publique - art. R5133 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "#text": "Décret 60-326 1960-04-05 ART. 10 JORF 7 avril 1960", "@sens": "source", "@typelien": "MODIFICATION" }, { "#text": "Loi 58-356 1958-04-03 (Loi de validation)", "@sens": "source", "@typelien": "CODIFICATION" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006187146", "@fin": "1994-01-09", "#text": "Paragraphe 1 : Expérimentation des médicaments.", "@debut": "1956-11-28" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006174539", "@fin": "1994-01-09", "#text": "Section 2 : Spécialités pharmaceutiques", "@debut": "1953-10-07" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006157765", "@fin": "1998-02-13", "#text": "Chapitre 2 : Préparation et vente en gros des produits pharmaceutiques", "@debut": "1953-10-07" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006142899", "@fin": "2999-01-01", "#text": "Titre 2 : Dispositions particulières aux divers modes d'exercice de la pharmacie", "@debut": "1953-10-07" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006128471", "@fin": "2999-01-01", "#text": "Livre 5 : Pharmacie", "@debut": "1953-10-07" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006107982", "@fin": "2999-01-01", "#text": "Partie réglementaire ancienne", "@debut": "1953-10-07" } ] }, "@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": "LEGIARTI000006800060", "@fin": "1988-05-08", "@num": "R5118", "@etat": "MODIFIE", "@debut": "1956-11-28", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006800061", "@fin": "1990-09-29", "@num": "R5118", "@etat": "MODIFIE", "@debut": "1988-05-08", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006800062", "@fin": "1993-08-07", "@num": "R5118", "@etat": "MODIFIE", "@debut": "1990-09-29", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006800063", "@fin": "1994-01-09", "@num": "R5118", "@etat": "MODIFIE", "@debut": "1993-08-07", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006800064", "@fin": "1998-02-13", "@num": "R5118", "@etat": "MODIFIE", "@debut": "1994-01-09", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006800065", "@fin": "1999-03-05", "@num": "R5118", "@etat": "MODIFIE", "@debut": "1998-02-13", "@origine": "LEGI" } }, { "@etat": "ABROGE", "LIEN_ART": { "@id": "LEGIARTI000006800066", "@fin": "2004-08-08", "@num": "R5118", "@etat": "ABROGE", "@debut": "1999-03-05", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
Le ministre chargé de la santé [*autorité compétente*] fixe par arrêté les protocoles déterminant les normes et méthodes applicables à l'expérimentation des médicaments.
\n
" } }, "LEGIARTI000006800067": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R5119", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "1988-05-04", "DATE_DEBUT": "1956-11-28" } }, "META_COMMUN": { "ID": "LEGIARTI000006800067", "URL": "article/LEGI/ARTI/00/00/06/80/00/LEGIARTI000006800067.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SXXXXXXXXXX5119R0000XXAA" } }, "LIENS": { "LIEN": [ { "@id": "JORFTEXT000000503843", "#text": "Décret 53-1001 1953-10-05 (Décret de codification)", "@sens": "source", "@cidtexte": "JORFTEXT000000503843", "@numtexte": "53-1001", "@typelien": "CODIFICATION", "@naturetexte": "DECRET", "@datesignatexte": "1953-10-05" }, { "@id": "JORFTEXT000000518702", "#text": "Décret 72-1062 1972-11-21 ART. 1 JORF 30 novembre 1972", "@sens": "source", "@cidtexte": "JORFTEXT000000518702", "@numtexte": "72-1062", "@typelien": "MODIFICATION", "@naturetexte": "DECRET", "@datesignatexte": "1972-11-21" }, { "@id": "JORFTEXT000000307595", "#text": "Décret 78-988 1978-09-20 ART. 1 JORF 6 octobre 1978", "@sens": "source", "@cidtexte": "JORFTEXT000000307595", "@numtexte": "78-988", "@typelien": "MODIFICATION", "@naturetexte": "DECRET", "@datesignatexte": "1978-09-20" }, { "@id": "JORFTEXT000000337674", "#text": "Décret 79-256 1979-03-21 ART. 1 JORF 31 mars 1979", "@sens": "source", "@cidtexte": "JORFTEXT000000337674", "@numtexte": "79-256", "@typelien": "MODIFICATION", "@naturetexte": "DECRET", "@datesignatexte": "1979-03-21" }, { "@id": "LEGIARTI000006693742", "@num": "L605", "#text": "Code de la santé publique - art. L605 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006800059", "@num": "R5117", "#text": "Code de la santé publique - art. R5117 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006800075", "@num": "R5119-1", "#text": "Code de la santé publique - art. R5119-1 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006914760", "@num": "R5121-33", "#text": "Code de la santé publique - art. R5121-33 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006800209", "@num": "R5140", "#text": "Code de la santé publique - art. R5140 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "#text": "Décret 60-326 1960-04-05 ART. 10 JORF 7 avril 1960", "@sens": "source", "@typelien": "MODIFICATION" }, { "#text": "Loi 58-356 1958-04-03 (Loi de validation)", "@sens": "source", "@typelien": "CODIFICATION" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006187146", "@fin": "1994-01-09", "#text": "Paragraphe 1 : Expérimentation des médicaments.", "@debut": "1956-11-28" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006174539", "@fin": "1994-01-09", "#text": "Section 2 : Spécialités pharmaceutiques", "@debut": "1953-10-07" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006157765", "@fin": "1998-02-13", "#text": "Chapitre 2 : Préparation et vente en gros des produits pharmaceutiques", "@debut": "1953-10-07" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006142899", "@fin": "2999-01-01", "#text": "Titre 2 : Dispositions particulières aux divers modes d'exercice de la pharmacie", "@debut": "1953-10-07" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006128471", "@fin": "2999-01-01", "#text": "Livre 5 : Pharmacie", "@debut": "1953-10-07" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006107982", "@fin": "2999-01-01", "#text": "Partie réglementaire ancienne", "@debut": "1953-10-07" } ] }, "@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": "LEGIARTI000006800067", "@fin": "1988-05-04", "@num": "R5119", "@etat": "MODIFIE", "@debut": "1956-11-28", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006800068", "@fin": "1994-01-09", "@num": "R5119", "@etat": "MODIFIE", "@debut": "1988-05-04", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006800069", "@fin": "1998-02-13", "@num": "R5119", "@etat": "MODIFIE", "@debut": "1994-01-09", "@origine": "LEGI" } }, { "@etat": "ABROGE", "LIEN_ART": { "@id": "LEGIARTI000006800070", "@fin": "2004-08-08", "@num": "R5119", "@etat": "ABROGE", "@debut": "1998-02-13", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
Les candidats aux fonctions d'expert doivent présenter les garanties nécessaires d'honorabilité, posséder les qualifications techniques et professionnelles et disposer des moyens propres à l'accomplissement des travaux d'expertise.
\n
L'agrément prévu à l'article L. 605 (2°) est donné par le ministre chargé de la santé, après consultation éventuelle de la commission prévue à l'article R. 5140.
\n
L'agrément est valable pendant cinq ans [*durée*] ; il peut être retiré par le ministre chargé de la santé après que l'expert a été mis à même de présenter ses observations écrites.
\n
Le ministre chargé de la santé répartit les experts entre différentes sections en fonction de leurs disciplines respectives.
\n
Les experts ne peuvent effectuer d'expertise qu'au titre de la ou des disciplines afférentes aux sections auxquelles ils sont rattachés.
\n
Ils ne doivent avoir aucun intérêt financier direct ou indirect, même par personne interposée, dans la commercialisation des médicaments faisant l'objet de leurs expertises.
\n
" } } }, "article_lien": [ { "article_id": "LEGIARTI000006800067", "cible": false, "cidtexte": "JORFTEXT000000337674", "id": "JORFTEXT000000337674", "typelien": "MODIFICATION" }, { "article_id": "LEGIARTI000006800060", "cible": false, "cidtexte": "JORFTEXT000000337674", "id": "JORFTEXT000000337674", "typelien": "MODIFICATION" } ], "texte_version": { "JORFTEXT000000337674": { "SM": { "CONTENU": "ART: R5118 : LE MINISTRE CHARGE DE LA SANTE FIXE PAR ARRETE LES PROTOCOLES DETERMINANT LES NORMES ET METHODES APPLICABLES A L'EXPERIMENTATION DES MEDICAMENTS (SUPPRESSION DE LA COMMISSION CHARGEE DE PROPOSER LES EXPERTS).
ART. R5119 : QUALIFICATIONS TECHNIQUES ET PROFESSIONNELLES DES CANDIDATS AUX FONCTIONS D'EXPERTS (EXPERTS PHARMACEUTIQUES,EXPERTS TOXICOLOGUES,EXPERTS PHARMACOLOGUES,EXPERTS CLINICIENS).
MODALITES D'ATTRIBUTION DE L'AGREMENT PREVU A L'ART. L605 (2EMEMENT) DU CODE PRECITE." }, "META": { "META_SPEC": { "META_TEXTE_VERSION": { "LIENS": { "LIEN": [ { "@id": "JORFTEXT000000705819", "#text": "Directive 86/609/CEE du Conseil du 24 novembre 1986", "@sens": "source", "@cidtexte": "JORFTEXT000000705819", "@nortexte": "386L0609", "@numtexte": "86-609", "@typelien": "APPLICATION", "@naturetexte": "DIRECTIVE_EURO", "@datesignatexte": "1986-11-24" }, { "@id": "LEGIARTI000006800060", "@num": "R5118", "#text": "Code de la santé publique - art. R5118 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006800067", "@num": "R5119", "#text": "Code de la santé publique - art. R5119 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "TITRE": "Décret n°79-256 du 21 mars 1979", "MCS_TXT": { "MC": [ "SANTE PUBLIQUE", "CODE DE LA SANTE PUBLIQUE", "INDUSTRIE PHARMACEUTIQUE", "PRODUIT PHARMACEUTIQUE", "MEDICAMENT", "EXPERIMENTATION", "EXPERT", "NORME", "LABORATOIRE", "EXPERTISE", "AGREMENT", "COMPETENCE", "ESSAI PHARMACEUTIQUE", "ESSAI TOXICOLOGIQUE", "TRANSPOSITION DE DIRECTIVE CE" ] }, "TITREFULL": "Décret n°79-256 du 21 mars 1979 REMPLACANT LES ART. R5118 ET R5119 DU CODE DE LA SANTE PUBLIQUE" }, "META_TEXTE_CHRONICLE": { "CID": "JORFTEXT000000337674", "NUM": "79-256", "DATE_PUBLI": "1979-03-31", "DATE_TEXTE": "1979-03-21", "ORIGINE_PUBLI": "JORF du 31 mars 1979", "PAGE_DEB_PUBLI": 711 } }, "META_COMMUN": { "ID": "JORFTEXT000000337674", "URL": "texte/version/JORF/TEXT/00/00/00/33/76/JORFTEXT000000337674.xml", "NATURE": "DECRET", "ORIGINE": "JORF", "ANCIEN_ID": "1DX979256" } } }, "JORFTEXT000000705819": { "SM": { "CONTENU": "Abrogation de la présente directive CEE à compter du 01-01-2013, à l'exception de son article 13, à compter du 10-05-2013." }, "META": { "META_SPEC": { "META_TEXTE_VERSION": { "LIENS": { "LIEN": [ { "@id": "JORFTEXT000000337674", "#text": "Décret n°79-256 du 21 mars 1979", "@sens": "cible", "@cidtexte": "JORFTEXT000000337674", "@numtexte": "79-256", "@typelien": "APPLICATION", "@naturetexte": "DECRET", "@datesignatexte": "1979-03-21" }, { "@id": "JORFTEXT000000522762", "#text": "Décret n°87-848 du 19 octobre 1987", "@sens": "cible", "@cidtexte": "JORFTEXT000000522762", "@nortexte": "AGRG8701834D", "@numtexte": "87-848", "@typelien": "APPLICATION", "@naturetexte": "DECRET", "@datesignatexte": "1987-10-19" }, { "@id": "JORFTEXT000000478478", "#text": "Arrêté du 19 avril 1988", "@sens": "cible", "@cidtexte": "JORFTEXT000000478478", "@nortexte": "AGRG8800565A", "@typelien": "APPLICATION", "@naturetexte": "ARRETE", "@datesignatexte": "1988-04-19" }, { "@id": "JORFTEXT000000663551", "#text": "Arrêté du 19 avril 1988", "@sens": "cible", "@cidtexte": "JORFTEXT000000663551", "@nortexte": "AGRG8800566A", "@typelien": "APPLICATION", "@naturetexte": "ARRETE", "@datesignatexte": "1988-04-19" }, { "@id": "JORFTEXT000000312908", "#text": "Décret n°88-661 du 6 mai 1988", "@sens": "cible", "@cidtexte": "JORFTEXT000000312908", "@nortexte": "ASEM8800585D", "@numtexte": "88-661", "@typelien": "APPLICATION", "@naturetexte": "DECRET", "@datesignatexte": "1988-05-06" }, { "@id": "JORFTEXT000000479984", "#text": "Arrêté du 23 juin 1989", "@sens": "cible", "@cidtexte": "JORFTEXT000000479984", "@nortexte": "RESY8900148A", "@typelien": "APPLICATION", "@naturetexte": "ARRETE", "@datesignatexte": "1989-06-23" }, { "@id": "JORFTEXT000000339052", "#text": "Directive Européenne n°91-414 du 15 juillet 1991", "@sens": "cible", "@cidtexte": "JORFTEXT000000339052", "@nortexte": "31991L0414", "@numtexte": "91-414", "@typelien": "APPLICATION", "@naturetexte": "DIRECTIVE_EURO", "@datesignatexte": "1991-07-15" }, { "@id": "JORFTEXT000000887725", "#text": "Directive Européenne n°92-18 du 20 mars 1992", "@sens": "cible", "@cidtexte": "JORFTEXT000000887725", "@nortexte": "392L0018", "@numtexte": "92-18", "@typelien": "APPLICATION", "@naturetexte": "DIRECTIVE_EURO", "@datesignatexte": "1992-03-20" }, { "@id": "JORFTEXT000000521669", "#text": "Directive Européenne n°92-32 du 30 avril 1992", "@sens": "cible", "@cidtexte": "JORFTEXT000000521669", "@nortexte": "392L0032", "@numtexte": "92-32", "@typelien": 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