{ "article": { "LEGIARTI000006696681": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "31", "TYPE": "ENTIEREMENT_MODIF", "DATE_FIN": "2999-01-01", "DATE_DEBUT": "2999-01-01" } }, "META_COMMUN": { "ID": "LEGIARTI000006696681", "URL": "article/LEGI/ARTI/00/00/06/69/66/LEGIARTI000006696681.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SPEBVXXXXXX031AAXXXXXXAA" } }, "LIENS": { "LIEN": [ { "@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": "MODIFICATION", "@naturetexte": "LOI", "@datesignatexte": "1992-12-31" }, { "@id": "LEGIARTI000006693533", "@num": "L552", "#text": "Code de la santé publique - art. L552 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693565", "@num": "L564", "#text": "Code de la santé publique - art. L564 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693579", "@num": "L567-2", "#text": "Code de la santé publique - art. L567-2 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693584", "@num": "L567-4", "#text": "Code de la santé publique - art. L567-4 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693589", "@num": "L567-7", "#text": "Code de la santé publique - art. L567-7 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693694", "@num": "L598", "#text": "Code de la santé publique - art. L598 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693704", "@num": "L601", "#text": "Code de la santé publique - art. L601 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006125451", "@fin": "2999-01-01", "#text": "Chapitre IV : Agence du médicament.", "@debut": "1994-01-19" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006103513", "@fin": "2999-01-01", "#text": "Titre Ier : Dispositions relatives à la santé publique", "@debut": "1994-01-01" } ] }, "@cid": "JORFTEXT000000728979", "@nor": "SPSX9300136L", "@num": "94-43", "@nature": "LOI", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "LOI no 94-43 du 18 janvier 1994 relative à la santé publique et à la protection sociale (1)", "@debut": "2999-01-01", "@id_txt": "JORFTEXT000000728979", "@c_titre_court": "Loi n°94-43 du 18 janvier 1994" }, { "@fin": "2999-01-01", "#text": "Loi n° 94-43 du 18 janvier 1994 relative à la santé publique et à la protection sociale (1)", "@debut": "1994-01-19", "@id_txt": "LEGITEXT000005615126", "@c_titre_court": "Loi n° 94-43 du 18 janvier 1994" } ], "@date_publi": "1994-01-19", "@date_signature": "1994-01-18" } }, "VERSIONS": { "VERSION": [ { "LIEN_ART": { "@id": "LEGIARTI000006696681", "@fin": "2999-01-01", "@num": "31", "@debut": "2999-01-01", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "a modifié les dispositions suivantes
\n
" } }, "LEGIARTI000006616196": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "17", "ETAT": "ABROGE", "TYPE": "AUTONOME", "DATE_FIN": "2000-06-22", "DATE_DEBUT": "1994-01-19" } }, "META_COMMUN": { "ID": "LEGIARTI000006616196", "URL": "article/LEGI/ARTI/00/00/06/61/61/LEGIARTI000006616196.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "RDEABXXXXXX017AAXXXXXXAB" } }, "LIENS": { "LIEN": [ { "@id": "LEGIARTI000006696661", "@num": "13", "#text": "Loi n°94-43 du 18 janvier 1994 - art. 13 () JORF 19 janvier 1994", "@sens": "source", "@cidtexte": "JORFTEXT000000728979", "@nortexte": "SPSX9300136L", "@numtexte": "94-43", "@typelien": "MODIFICATION", "@naturetexte": "LOI", "@datesignatexte": "1994-01-18" }, { "@id": "LEGIARTI000006696681", "@num": "31", "#text": "Loi n°94-43 du 18 janvier 1994 - art. 31 () JORF 19 janvier 1994", "@sens": "source", "@cidtexte": "JORFTEXT000000728979", "@nortexte": "SPSX9300136L", "@numtexte": "94-43", "@typelien": "MODIFICATION", "@naturetexte": "LOI", "@datesignatexte": "1994-01-18" }, { "@id": "JORFTEXT000000217229", "#text": "Ordonnance 2000-548 2000-06-15 art. 4 II JORF 22 juin 2000", "@sens": "source", "@cidtexte": "JORFTEXT000000217229", "@nortexte": "MESX0000036P", "@typelien": "ABROGATION", "@naturetexte": "RAPPORT", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000050420759", "@num": "R163-2", "#text": "Code de la sécurité sociale. - art. R163-2 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006073189", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693411", "@num": "L511", "#text": "Code de la santé publique - art. L511 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693701", "@num": "L601", "#text": "Code de la santé publique - art. L601 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGITEXT000006072665", "#text": "Code de la santé publique L511, L601, L601-3 et L601-4", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006099287", "@fin": "2000-06-22", "#text": "Titre III : Dispositions relatives à l'exportation et à l'importation de médicaments, substances ou préparations classées comme stupéfiants ou comme psychotropes et à l'importation de certaines catégories de médicaments à usage humain.", "@debut": "1993-01-05" } ] }, "@cid": "JORFTEXT000000542776", "@nor": "EURX9200209L", "@num": "92-1477", "@nature": "LOI", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "LOI n° 92-1477 du 31 décembre 1992 relative aux produits soumis à certaines restrictions de circulation et à la complémentarité entre les services de police, de gendarmerie et de douane (1)", "@debut": "2999-01-01", "@id_txt": "JORFTEXT000000542776", "@c_titre_court": "Loi n°92-1477 du 31 décembre 1992" }, { "@fin": "2999-01-01", "#text": "Loi n° 92-1477 du 31 décembre 1992 relative aux produits soumis à certaines restrictions de circulation et à la complémentarité entre les services de police, de gendarmerie et de douane", "@debut": "1993-01-05", "@id_txt": "LEGITEXT000006080748", "@c_titre_court": "Loi n° 92-1477 du 31 décembre 1992" } ], "@date_publi": "1993-01-04", "@date_signature": "1992-12-31", "@num_parution_jo": "3" } }, "VERSIONS": { "VERSION": [ { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006616195", "@fin": "1994-01-19", "@num": "17", "@etat": "MODIFIE", "@debut": "1993-01-05", "@origine": "LEGI" } }, { "@etat": "ABROGE", "LIEN_ART": { "@id": "LEGIARTI000006616196", "@fin": "2000-06-22", "@num": "17", "@etat": "ABROGE", "@debut": "1994-01-19", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
L'importation dans le territoire douanier des médicaments à usage humain mentionnés à l'article L. 511 du code de la santé publique est soumise à une autorisation préalable délivrée par l'Agence du médicament dans les conditions fixées par décret en Conseil d'Etat.
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L'autorisation de mise sur le marché prévue à l'article L. 601 du code de la santé publique ou l'enregistrement prévu aux articles L. 601-3 et L. 601-4 du même code valent autorisation au sens de l'alinéa précédent.
" } }, "LEGIARTI000006693533": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "L552", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "1998-07-02", "DATE_DEBUT": "1994-01-19" } }, "META_COMMUN": { "ID": "LEGIARTI000006693533", "URL": "article/LEGI/ARTI/00/00/06/69/35/LEGIARTI000006693533.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SPAOXXXXXXX1X552L00AXXAE" } }, "NOTA": { "CONTENU": "
[*Nota : Ordonnance 92-1070 du 1er octobre 1992 art. 42 : le présent article du code de la santé publique s'applique à la collectivité territoriale de Mayotte.*]
\n
[*Nota - Code de la santé publique L. 518 : dispositions pénales.*]
" }, "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": "LEGIARTI000006696681", "@num": "31", "#text": "Loi n°94-43 du 18 janvier 1994 - art. 31 () JORF 19 janvier 1994", "@sens": "source", "@cidtexte": "JORFTEXT000000728979", "@nortexte": "SPSX9300136L", "@numtexte": "94-43", "@typelien": "MODIFICATION", "@naturetexte": "LOI", "@datesignatexte": "1994-01-18" }, { "@id": "LEGIARTI000006689952", "@num": "L5122-15", "#text": "Code de la santé publique - art. L5122-15 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006689954", "@num": "L5122-16", "#text": "Code de la santé publique - art. L5122-16 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693445", "@num": "L518", "#text": "Code de la santé publique - art. L518 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "TXT_ASSOCIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006690441", "@num": "L5422-12", "#text": "Code de la santé publique - art. L5422-12 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693539", "@num": "L556", "#text": "Code de la santé publique - art. L556 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693539", "@num": "L556", "#text": "Code de la santé publique - art. L556 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "TXT_ASSOCIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693566", "@num": "L564", "#text": "Code de la santé publique - art. L564 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006799337", "@num": "R5045", "#text": "Code de la santé publique - art. R5045 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006799343", "@num": "R5045-2", "#text": "Code de la santé publique - art. R5045-2 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006799460", "@num": "R5055", "#text": "Code de la santé publique - art. R5055 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006799480", "@num": "R5055-6", "#text": "Code de la santé publique - art. R5055-6 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "#text": "LOI 58-356 1958-04-03 (loi de validation)", "@sens": "source", "@typelien": "CODIFICATION" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006155241", "@fin": "2000-06-22", "#text": "CHAPITRE 4 : REGLEMENTATION DE LA PUBLICITE.", "@debut": "1953-10-07" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006140715", "@fin": "2002-01-01", "#text": "Titre 1 : Dispositions générales", "@debut": "1953-10-07" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006125380", "@fin": "2004-08-08", "#text": "Livre 5 : Pharmacie", "@debut": "1953-10-07" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006103420", "@fin": "2999-01-01", "#text": "Partie législative 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": "LEGIARTI000006693529", "@fin": "1987-01-28", "@num": "L552", "@etat": "MODIFIE", "@debut": "1972-01-05", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006693530", "@fin": "1991-01-20", "@num": "L552", "@etat": "MODIFIE", "@debut": "1987-01-28", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006693531", "@fin": "1993-01-05", "@num": "L552", "@etat": "MODIFIE", "@debut": "1991-01-20", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006693532", "@fin": "1994-01-19", "@num": "L552", "@etat": "MODIFIE", "@debut": "1993-01-05", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006693533", "@fin": "1998-07-02", "@num": "L552", "@etat": "MODIFIE", "@debut": "1994-01-19", "@origine": "LEGI" } }, { "@etat": "ABROGE", "LIEN_ART": { "@id": "LEGIARTI000006693534", "@fin": "2000-06-22", "@num": "L552", "@etat": "ABROGE", "@debut": "1998-07-02", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
La publicité ou la propagande, sous quelque forme que ce soit, relative aux objets, appareils et méthodes, présentés comme favorisant le diagnostic, la prévention ou le traitement des maladies, des affections relevant de la pathologie chirurgicale et des dérèglements physiologiques, le diagnostic ou la modification de l'état physique ou physiologique, la restauration, la correction ou la modification des fonctions organiques, peut être interdite par le ministère chargé de la santé lorsqu'il n'est pas établi que lesdits objets, appareils et méthodes possèdent les propriétés annoncées. Le ministre chargé de la santé peut aussi, après avis de la commission prévue à l'alinéa 2 du présent article, soumettre cette publicité ou propagande à l'obligation de mentionner les avertissements et précautions d'emplois nécessaires à l'information du consommateur [*condition*].
\n
L'interdiction est prononcée après avis d'une commission et après que le fabricant, importateur ou distributeur desdits objets et appareils ou le promoteur desdites méthodes aura été appelé à présenter ses observations. Elle prend effet trois semaines après sa publication au Journal officiel [*date, délai*]. Elle est alors opposable au fabricant, importateur, distributeur ou promoteur, ainsi qu'aux personnes qui sollicitent ou font solliciter la publicité ou la propagande interdite et aux agents de publicité ou de diffusion.
\n
Un décret en Conseil d'Etat déterminera les conditions d'application du présent article et notamment la composition et les modalités de fonctionnement de la commission prévue à l'alinéa précédent.
" } }, "LEGIARTI000006693565": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "L564", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "1996-05-29", "DATE_DEBUT": "1994-01-19" } }, "META_COMMUN": { "ID": "LEGIARTI000006693565", "URL": "article/LEGI/ARTI/00/00/06/69/35/LEGIARTI000006693565.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SPAOXXXXXXX1X564L00AXXAD" } }, "NOTA": { "CONTENU": "
[*Nota : Code de la santé publique L567-11 : les dispositions de l'article L564, 3ème et 4ème alinéa, sont applicables à l'exercice des fonctions des inspecteurs de l'agence.*]
\n
" }, "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" }, { "#text": "Loi 58-356 1958-04-03 (loi de validation)", "@sens": "source", "@typelien": "CODIFICATION" }, { "@id": "LEGIARTI000006696681", "@num": "31", "#text": "Loi n°94-43 du 18 janvier 1994 - art. 31 () JORF 19 janvier 1994", "@sens": "source", "@cidtexte": "JORFTEXT000000728979", "@nortexte": "SPSX9300136L", "@numtexte": "94-43", "@typelien": "MODIFICATION", "@naturetexte": "LOI", "@datesignatexte": "1994-01-18" }, { "@id": "LEGIARTI000006693511", "@num": "L551-1", "#text": "Code de la santé publique - art. 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L564-1 (T)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006694006", "@num": "L658-9", "#text": "Code de la santé publique - art. L658-9 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006695248", "@num": "L793-10", "#text": "Code de la santé publique - art. L793-10 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006799469", "@num": "R5055-2", "#text": "Code de la santé publique - art. R5055-2 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006799488", "@num": "R5057", "#text": "Code de la santé publique - art. R5057 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006799502", "@num": "R5062", "#text": "Code de la santé publique - art. R5062 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGITEXT000006072665", "#text": "Code de la santé publique L518 : DISPOSITIONS PENALES", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "TXT_ASSOCIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006155242", "@fin": "2000-06-22", "#text": "Chapitre 5 : De l'inspection de la pharmacie", "@debut": "1953-10-07" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006140715", "@fin": "2002-01-01", "#text": "Titre 1 : Dispositions générales", "@debut": "1953-10-07" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006125380", "@fin": "2004-08-08", "#text": "Livre 5 : Pharmacie", "@debut": "1953-10-07" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006103420", "@fin": "2999-01-01", "#text": "Partie législative 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": "LEGIARTI000006693562", "@fin": "1988-12-22", "@num": "L564", "@etat": "MODIFIE", "@debut": "1972-01-05", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006693563", "@fin": "1993-01-05", "@num": "L564", "@etat": "MODIFIE", "@debut": "1988-12-22", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006693564", "@fin": "1994-01-19", "@num": "L564", "@etat": "MODIFIE", "@debut": "1993-01-05", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006693565", "@fin": "1996-05-29", "@num": "L564", "@etat": "MODIFIE", "@debut": "1994-01-19", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006693566", "@fin": "1998-07-02", "@num": "L564", "@etat": "MODIFIE", "@debut": "1996-05-29", "@origine": "LEGI" } }, { "@etat": "ABROGE", "LIEN_ART": { "@id": "LEGIARTI000006693567", "@fin": "2000-06-22", "@num": "L564", "@etat": "ABROGE", "@debut": "1998-07-02", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
Dans tous les établissements mentionnés à l'article L. 562 et dans tous les lieux publics, les pharmaciens inspecteurs de la santé ont qualité pour [*attributions*] rechercher et constater les infractions aux dispositions du présent livre, aux lois sur la répression des fraudes et aux lois et règlements qui concernent l'exercice de la pharmacie. Même en dehors des établissements précités, les pharmaciens inspecteurs ont qualité pour rechercher et constater les infractions aux dispositions des articles L. 551-1 à L. 551-10.
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Outre les officiers et agents de police judiciaire agissant conformément aux dispositions du code de procédure pénale, les inspecteurs de la pharmacie peuvent rechercher et constater par procès-verbal les infractions aux dispositions législatives et réglementaires dont ils contrôlent l'application conformément à l'article L. 562.
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Les inspecteurs peuvent accéder aux locaux, terrains ou moyens de transport à usage professionnel utilisés par les personnels et les établissements qu'ils sont chargés d'inspecter. Ils peuvent demander la communication de tous documents professionnels et en prendre copie, prélever des échantillons, recueillir, sur convocation ou sur place, les renseignements ou justifications. Les inspecteurs ne peuvent accéder à ces locaux que pendant leurs heures d'ouverture, lorsqu'ils sont ouverts au public et, dans les autres cas, qu'entre 8 heures et 20 heures. Ils ne peuvent accéder aux locaux qui servent pour partie de domicile aux intéressés.
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Le procureur de la République est préalablement informé des opérations envisagées en vue de la recherche des infractions par les inspecteurs. Il peut s'opposer à ces opérations. Les procès-verbaux lui sont transmis dans les cinq jours suivant leur établissement. Une copie en est également remise à l'intéressé.
" } }, "LEGIARTI000006693579": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "L567-2", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "1995-02-05", "DATE_DEBUT": "1994-01-19" } }, "META_COMMUN": { "ID": "LEGIARTI000006693579", "URL": "article/LEGI/ARTI/00/00/06/69/35/LEGIARTI000006693579.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SPAOXXXXXXX1X567L02AXXAB" } }, "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": "JORFTEXT000000880754", "#text": "Loi 67-1176 1967-12-28", "@sens": "source", "@cidtexte": "JORFTEXT000000880754", "@numtexte": "67-1176", "@typelien": "CITATION", "@naturetexte": "LOI", "@datesignatexte": "1967-12-28" }, { "@id": "LEGIARTI000006696681", "@num": "31", "#text": "Loi n°94-43 du 18 janvier 1994 - art. 31 () JORF 19 janvier 1994", "@sens": "source", "@cidtexte": "JORFTEXT000000728979", "@nortexte": "SPSX9300136L", "@numtexte": "94-43", "@typelien": "MODIFICATION", "@naturetexte": "LOI", "@datesignatexte": "1994-01-18" }, { "@id": "LEGIARTI000006696682", "@num": "32", "#text": "Loi n°94-43 du 18 janvier 1994 - art. 32 () JORF 19 janvier 1994", "@sens": "source", "@cidtexte": "JORFTEXT000000728979", "@nortexte": "SPSX9300136L", "@numtexte": "94-43", "@typelien": "MODIFICATION", "@naturetexte": "LOI", "@datesignatexte": "1994-01-18" }, { "@id": "LEGIARTI000006729393", "@num": "2", "#text": "Arrêté du 28 avril 1994 - art. 2 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000346589", "@nortexte": "SANM9401325A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "1994-04-28" }, { "@id": "LEGIARTI000006729394", "@num": "3", "#text": "Arrêté du 28 avril 1994 - art. 3 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000346589", "@nortexte": "SANM9401325A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "1994-04-28" }, { "@id": "LEGIARTI000006506986", "@num": "3", "#text": "Décret n°98-385 du 18 mai 1998 - art. 3 (M)", "@sens": "cible", "@cidtexte": "JORFTEXT000000571865", "@nortexte": "MESG9820693D", "@numtexte": "98-385", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1998-05-18" }, { "@id": "LEGIARTI000006693421", "@num": "L512", "#text": "Code de la santé publique - art. L512 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693507", "@num": "L551", "#text": "Code de la santé publique - art. L551 (M)", "@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": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693594", "@num": "L567-9", "#text": "Code de la santé publique - art. L567-9 (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": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006799606", "@num": "R5089-2", "#text": "Code de la santé publique - art. R5089-2 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "#text": "Loi 58-356 1958-04-03 (loi de validation)", "@sens": "source", "@typelien": "CODIFICATION" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006155243", "@fin": "1998-07-02", "#text": "Chapitre 1er : Dispositions générales", "@debut": "1993-01-05" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006140720", "@fin": "1998-07-02", "#text": "Titre 1 bis : Agence du médicament", "@debut": "1993-01-05" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006125380", "@fin": "2004-08-08", "#text": "Livre 5 : Pharmacie", "@debut": "1953-10-07" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006103420", "@fin": "2999-01-01", "#text": "Partie législative 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": "LEGIARTI000006693578", "@fin": "1994-01-19", "@num": "L567-2", "@etat": "MODIFIE", "@debut": "1993-01-05", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006693579", "@fin": "1995-02-05", "@num": "L567-2", "@etat": "MODIFIE", "@debut": "1994-01-19", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006693580", "@fin": "1996-05-29", "@num": "L567-2", "@etat": "MODIFIE", "@debut": "1995-02-05", "@origine": "LEGI" } }, { "@etat": "ABROGE", "LIEN_ART": { "@id": "LEGIARTI000006693581", "@fin": "1998-07-02", "@num": "L567-2", "@etat": "ABROGE", "@debut": "1996-05-29", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
L'agence [*du médicament*] est chargée [*attributions*] :
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1° De participer à l'application des lois et règlements relatifs :
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a) Aux essais, à la fabrication, à l'importation, à l'exportation, à la mise sur le marché des médicaments à usage humain, des produits mentionnés à l'article L. 658-11 ainsi que des produits et objets contraceptifs mentionnés par la loi n° 67-1176 du 28 décembre 1967 relative à la régulation des naissances ;
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b) Aux substances stupéfiantes, psychotropes, aux autres substances vénéneuses utilisées en médecine, aux réactifs de laboratoire destinés aux analyses de biologie médicale et aux réactifs mentionnés au 2° de l'article L. 512 ;
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2° Du fonctionnement de la commission de la transparence ;
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3° De recueillir et d'évaluer les informations sur les effets inattendus ou toxiques des médicaments et produits mentionnés au 1° ainsi que sur les usages abusifs et les dépendances susceptibles d'être entraînées par des substances psycho-actives et de prendre en la matière toute mesure utile pour préserver la santé publique ;
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4° De proposer toute mesure contribuant au développement de la recherche et des activités industrielles dans le domaine du médicament ;
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5° D'appliquer les dispositions des articles L. 551 à L. 551-9;
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6° De préparer la pharmacopée ;
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7° De procéder à toutes expertises et contrôles techniques relatifs à la qualité :
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a) Des produits et objets mentionnés au présent article, des substances entrant dans leur composition et des produits utilisés pour la désinfection des locaux ;
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b) Des méthodes et moyens de fabrication, de conditionnement ou de contrôle correspondants ;
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7° bis D'exécuter le contrôle de qualité des analyses de biologie médicale et de procéder, à la demande des services concernés, aux expertises techniques de qualité des analyses ;
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8° De proposer aux ministres chargés de la santé et de la sécurité sociale toute mesure intéressant les domaines relevant de leur compétence ;
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9° De participer, à la demande du ministre chargé de la santé, à l'élaboration et à la mise en oeuvre des règles communautaires et des accords internationaux et à la représentation de la France dans les organisations internationales compétentes ;
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10° De recueillir les données, notamment en terme d'évaluation scientifique et technique, nécessaires à la préparation des décisions relatives à la politique du médicament et de participer à l'application des décisions prises en la matière ;
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11° De mener toutes études, recherches, actions de formation ou d'information dans les domaines relevant de sa compétence.
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L'agence peut, en outre, à la demande des services concernés, procéder à tous contrôles ou expertises techniques relatifs à la qualité des eaux minérales ou de sources, de leurs conditions de captage, de transport et de conditionnement.
" } }, "LEGIARTI000006693584": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "L567-4", "ETAT": "ABROGE", "TYPE": "AUTONOME", "DATE_FIN": "1998-07-02", "DATE_DEBUT": "1994-01-19" } }, "META_COMMUN": { "ID": "LEGIARTI000006693584", "URL": "article/LEGI/ARTI/00/00/06/69/35/LEGIARTI000006693584.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SPAOXXXXXXX1X567L04AXXAB" } }, "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" }, { "#text": "Loi 58-356 1958-04-03 (loi de validation)", "@sens": "source", "@typelien": "CODIFICATION" }, { "@id": "JORFTEXT000000880754", "#text": "Loi 67-1176 1967-12-28", "@sens": "source", "@cidtexte": "JORFTEXT000000880754", "@numtexte": "67-1176", "@typelien": "CITATION", "@naturetexte": "LOI", "@datesignatexte": "1967-12-28" }, { "@id": "JORFTEXT000000542776", "#text": "Loi 92-1477 1992-12-31 art. 17", "@sens": "source", "@cidtexte": "JORFTEXT000000542776", "@nortexte": "EURX9200209L", "@numtexte": "92-1477", "@typelien": "CITATION", "@naturetexte": "LOI", "@datesignatexte": "1992-12-31" }, { "@id": "LEGIARTI000006696635", "@num": "17", "#text": "Loi n°93-5 du 4 janvier 1993 - art. 17 (M)", "@sens": "cible", "@cidtexte": "JORFTEXT000000178299", "@nortexte": "SPSX9200032L", "@numtexte": "93-5", "@typelien": "CITATION", "@naturetexte": "LOI", "@datesignatexte": "1993-01-04" }, { "@id": "LEGIARTI000006712863", "@num": "8", "#text": "Décret n°93-295 du 8 mars 1993 - art. 8 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000179546", "@nortexte": "SANC9300746D", "@numtexte": "93-295", "@typelien": "TXT_ASSOCIE", "@naturetexte": "DECRET", "@datesignatexte": "1993-03-08" }, { "@id": "LEGIARTI000006712863", "@num": "8", "#text": "Décret n°93-295 du 8 mars 1993 - art. 8 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000179546", "@nortexte": "SANC9300746D", "@numtexte": "93-295", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1993-03-08" }, { "@id": "LEGIARTI000006696681", "@num": "31", "#text": "Loi n°94-43 du 18 janvier 1994 - art. 31 () JORF 19 janvier 1994", "@sens": "source", "@cidtexte": "JORFTEXT000000728979", "@nortexte": "SPSX9300136L", "@numtexte": "94-43", "@typelien": "MODIFICATION", "@naturetexte": "LOI", "@datesignatexte": "1994-01-18" }, { "@id": "LEGIARTI000006696338", "@num": "8", "#text": "Loi n°98-535 du 1 juillet 1998 - art. 8 () JORF 2 juillet 1998", "@sens": "source", "@cidtexte": "JORFTEXT000000573437", "@nortexte": "MESX9702267L", "@numtexte": "98-535", "@typelien": "ABROGATION", "@naturetexte": "LOI", "@datesignatexte": "1998-07-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006155244", "@fin": "1998-07-02", "#text": "Chapitre 2 : Conseil d'administration, direction générale et personnel", "@debut": "1993-01-05" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006140720", "@fin": "1998-07-02", "#text": "Titre 1 bis : Agence du médicament", "@debut": "1993-01-05" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006125380", "@fin": "2004-08-08", "#text": "Livre 5 : Pharmacie", "@debut": "1953-10-07" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006103420", "@fin": "2999-01-01", "#text": "Partie législative 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": "LEGIARTI000006693583", "@fin": "1994-01-19", "@num": "L567-4", "@etat": "MODIFIE", "@debut": "1993-01-05", "@origine": "LEGI" } }, { "@etat": "ABROGE", "LIEN_ART": { "@id": "LEGIARTI000006693584", "@fin": "1998-07-02", "@num": "L567-4", "@etat": "ABROGE", "@debut": "1994-01-19", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
Le directeur général de l'Agence du médicament prend au nom de l'Etat les décisions qui relèvent de la compétence de l'agence en vertu des dispositions des titres Ier, II et III du présent livre, de celles de la loi n° 67-1176 du 28 décembre 1967 relative à la régulation des naissances, de l'article 17 de la loi n° 92-1477 du 31 décembre 1992 relative aux produits soumis à certaines restrictions de circulation et à la complémentarité entre les services de police, de gendarmerie et de douane, ainsi que des mesures réglementaires prises pour l'application de ces dispositions.
\n
Les décisions prises par le directeur général en application du présent article ne sont susceptibles d'aucun recours hiérarchique. Toutefois, en cas de menace grave pour la santé publique, le ministre chargé de la santé peut s'opposer, par arrêté motivé, à la décision du directeur général et lui demander de procéder, dans le délai de trente jours, à un nouvel examen du dossier ayant servi de fondement à ladite décision. Cette opposition est suspensive de l'application de cette décision.
" } }, "LEGIARTI000006693589": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "L567-7", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "1995-02-05", "DATE_DEBUT": "1994-01-19" } }, "META_COMMUN": { "ID": "LEGIARTI000006693589", "URL": "article/LEGI/ARTI/00/00/06/69/35/LEGIARTI000006693589.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SPAOXXXXXXX1X567L07AXXAB" } }, "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" }, { "#text": "Loi 58-356 1958-04-03 (loi de validation)", "@sens": "source", "@typelien": "CODIFICATION" }, { "@id": "LEGIARTI000006530080", "@num": "5", "#text": "Ordonnance n°59-2 du 2 janvier 1959 - art. 5 (Ab)", "@sens": "source", "@cidtexte": "JORFTEXT000000339591", "@numtexte": "59-2", "@typelien": "CITATION", "@naturetexte": "ORDONNANCE", "@datesignatexte": "1959-01-02" }, { "@id": "JORFARTI000001867616", "@num": "33", "#text": "Loi n°67-1114 du 21 décembre 1967 - art. 33, v. init.", "@sens": "source", "@cidtexte": "JORFTEXT000000320878", "@numtexte": "67-1114", "@typelien": "CITATION", "@naturetexte": "LOI", "@datesignatexte": "1967-12-21" }, { "@id": "JORFARTI000001867678", "@num": "70", "#text": "Loi n°71-1061 du 29 décembre 1971 - art. 70, v. init.", "@sens": "source", "@cidtexte": "JORFTEXT000000687436", "@numtexte": "71-1061", "@typelien": "CITATION", "@naturetexte": "LOI", "@datesignatexte": "1971-12-29" }, { "@id": "JORFARTI000001691487", "@num": "109", "#text": "Loi n°78-1239 du 29 décembre 1978 - art. 109, v. init.", "@sens": "source", "@cidtexte": "JORFTEXT000000886458", "@numtexte": "78-1239", "@typelien": "CITATION", "@naturetexte": "LOI", "@datesignatexte": "1978-12-29" }, { "@id": "JORFTEXT000000178299", "#text": "Loi 93-5 1993-01-04 art. 21, art. 23", "@sens": "source", "@cidtexte": "JORFTEXT000000178299", "@nortexte": "SPSX9200032L", "@numtexte": "93-5", "@typelien": "CITATION", "@naturetexte": "LOI", "@datesignatexte": "1993-01-04" }, { "@id": "LEGIARTI000006696681", "@num": "31", "#text": "Loi n°94-43 du 18 janvier 1994 - art. 31 () JORF 19 janvier 1994", "@sens": "source", "@cidtexte": "JORFTEXT000000728979", "@nortexte": "SPSX9300136L", "@numtexte": "94-43", "@typelien": "MODIFICATION", "@naturetexte": "LOI", "@datesignatexte": "1994-01-18" }, { "@id": "LEGIARTI000006693710", "@num": "L602", "#text": "Code de la santé publique - art. L602 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693715", "@num": "L602-1", "#text": "Code de la santé publique - art. L602-1 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006799645", "@num": "R5089-24-1", "#text": "Code de la santé publique - art. R5089-24-1 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006799647", "@num": "R5089-24-3", "#text": "Code de la santé publique - art. R5089-24-3 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006155245", "@fin": "1998-07-02", "#text": "Chapitre 3 : Régime financier", "@debut": "1993-01-05" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006140720", "@fin": "1998-07-02", "#text": "Titre 1 bis : Agence du médicament", "@debut": "1993-01-05" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006125380", "@fin": "2004-08-08", "#text": "Livre 5 : Pharmacie", "@debut": "1953-10-07" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006103420", "@fin": "2999-01-01", "#text": "Partie législative 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": "LEGIARTI000006693588", "@fin": "1994-01-19", "@num": "L567-7", "@etat": "MODIFIE", "@debut": "1993-01-05", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006693589", "@fin": "1995-02-05", "@num": "L567-7", "@etat": "MODIFIE", "@debut": "1994-01-19", "@origine": "LEGI" } }, { "@etat": "ABROGE", "LIEN_ART": { "@id": "LEGIARTI000006693590", "@fin": "1998-07-02", "@num": "L567-7", "@etat": "ABROGE", "@debut": "1995-02-05", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
Les ressources [*financières*] de l'agence sont constituées :
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1° Par les subventions des collectivités publiques et de leurs établissements publics ;
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2° Par les redevances et taxes perçues en application des articles L. 602 et L. 602-1 du présent code, de l'article 33 de la loi de finances pour 1968 (n° 67-1114 du 21 décembre 1967), du II de l'article 70 de la loi de finances pour 1972 (n° 71-1061 du 29 décembre 1971), de l'article 109 de la loi de finances pour 1979 (n° 78-1239 du 29 décembre 1978) et des articles 19 et 21 de la loi n° 93-5 du 4 janvier 1993 relative à la sécurité en matière de transfusion sanguine et de médicament ;
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3° Par les redevances pour services rendus établies par décret en Conseil d'Etat ;
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4° Par des produits divers, dons et legs ;
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5° Par des emprunts.
" } }, "LEGIARTI000006693694": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "L598", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "1995-02-05", "DATE_DEBUT": "1994-01-19" } }, "META_COMMUN": { "ID": "LEGIARTI000006693694", "URL": "article/LEGI/ARTI/00/00/06/69/36/LEGIARTI000006693694.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SPAOXXXXXXX1X598L00AXXAC" } }, "NOTA": { "CONTENU": "

\n
" }, "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": "LEGIARTI000006706312", "@num": "1", "#text": "Décret n°69-104 du 3 février 1969 - art. 1 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000868130", "@numtexte": "69-104", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1969-02-03" }, { "@id": "LEGIARTI000006706315", "@num": "2", "#text": "Décret n°69-104 du 3 février 1969 - art. 2 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000868130", "@numtexte": "69-104", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1969-02-03" }, { "@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": "CITATION", "@naturetexte": "LOI", "@datesignatexte": "1992-12-08" }, { "@id": "LEGIARTI000006696681", "@num": "31", "#text": "Loi n°94-43 du 18 janvier 1994 - art. 31 () JORF 19 janvier 1994", "@sens": "source", "@cidtexte": "JORFTEXT000000728979", "@nortexte": "SPSX9300136L", "@numtexte": "94-43", "@typelien": "MODIFICATION", "@naturetexte": "LOI", "@datesignatexte": "1994-01-18" }, { "@id": "LEGIARTI000006698729", "@num": "1", "#text": "Décret n°94-193 du 7 mars 1994 - art. 1 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000364005", "@nortexte": "SPSP9400453D", "@numtexte": "94-193", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1994-03-07" }, { "@id": "LEGIARTI000006699386", "@num": "6", "#text": "Décret n°95-106 du 31 janvier 1995 - art. 6 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000734714", "@nortexte": "INDD9401321D", "@numtexte": "95-106", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1995-01-31" }, { "@id": "LEGIARTI000006732387", "@num": "3", "#text": "Arrêté du 18 novembre 1996 - art. 3 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000380455", "@nortexte": "TASP9624051A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "1996-11-18" }, { "@id": "LEGIARTI000006700646", "@num": "7", "#text": "Décret n°96-1061 du 5 décembre 1996 - art. 7 (VT)", "@sens": "cible", "@cidtexte": "JORFTEXT000000380658", "@nortexte": "INDD9600699D", "@numtexte": "96-1061", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1996-12-05" }, { "@id": "LEGIARTI000006732677", "@num": "2", "#text": "Arrêté du 10 décembre 1996 - art. 2 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000380513", "@nortexte": "INDD9600817A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "1996-12-10" }, { "@id": "LEGIARTI000006701001", "@num": "1", "#text": "Décret n°97-529 du 26 mai 1997 - art. 1 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000749652", "@nortexte": "TASP9721378D", "@numtexte": "97-529", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1997-05-26" }, { "@id": "LEGIARTI000006701004", "@num": "3", "#text": "Décret n°97-529 du 26 mai 1997 - art. 3 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000749652", "@nortexte": "TASP9721378D", "@numtexte": "97-529", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1997-05-26" }, { "@id": "LEGIARTI000006701006", "@num": "4", "#text": "Décret n°97-529 du 26 mai 1997 - art. 4 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000749652", "@nortexte": "TASP9721378D", "@numtexte": "97-529", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1997-05-26" }, { "@id": "LEGIARTI000006701010", "@num": "8", "#text": "Décret n°97-529 du 26 mai 1997 - art. 8 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000749652", "@nortexte": "TASP9721378D", "@numtexte": "97-529", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1997-05-26" }, { "@id": "LEGIARTI000006722897", "@num": "11", "#text": "Décret n°98-79 du 11 février 1998 - art. 11 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000372654", "@nortexte": "MESP9820016D", "@numtexte": "98-79", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1998-02-11" }, { "@id": "LEGIARTI000006693421", "@num": "L512", "#text": "Code de la santé publique - art. L512 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006690011", "@num": "L5124-18", "#text": "Code de la santé publique - art. L5124-18 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006690011", "@num": "L5124-18", "#text": "Code de la santé publique - art. L5124-18 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006689977", "@num": "L5124-3", "#text": "Code de la santé publique - art. L5124-3 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006689978", "@num": "L5124-3", "#text": "Code de la santé publique - art. L5124-3 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006690457", "@num": "L5423-3", "#text": "Code de la santé publique - art. L5423-3 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693699", "@num": "L600", "#text": "Code de la santé publique - art. L600 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693737", "@num": "L603", "#text": "Code de la santé publique - art. L603 (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": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006799485", "@num": "R5056", "#text": "Code de la santé publique - art. R5056 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006799956", "@num": "R5108", "#text": "Code de la santé publique - art. R5108 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006799966", "@num": "R5110", "#text": "Code de la santé publique - art. R5110 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006800477", "@num": "R5111-2", "#text": "Code de la santé publique - art. R5111-2 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006799979", "@num": "R5112-3", "#text": "Code de la santé publique - art. R5112-3 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006800325", "@num": "R5142-16", "#text": "Code de la santé publique - art. R5142-16 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006801217", "@num": "R5184", "#text": "Code de la santé publique - art. R5184 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006801421", "@num": "R5234", "#text": "Code de la santé publique - art. R5234 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006801422", "@num": "R5234-1", "#text": "Code de la santé publique - art. R5234-1 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006802004", "@num": "R672-13", "#text": "Code de la santé publique - art. R672-13 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGITEXT000006072665", "#text": "Code de la santé publique L518 : dispositions pénales", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "TXT_ASSOCIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "#text": "Loi 58-356 1958-04-03 (loi de validation)", "@sens": "source", "@typelien": "CODIFICATION" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006171766", "@fin": "2000-06-22", "#text": "Section 1 : Des établissements pharmaceutiques", "@debut": "1992-12-11" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006155250", "@fin": "2000-06-22", "#text": "Chapitre 2 : Fabrication, importation, exportation et distribution en gros des produits pharmaceutiques et exploitation des spécialités ou autres médicaments", "@debut": "1992-12-11" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006140721", "@fin": "2000-06-22", "#text": "Titre 2 : Dispositions particulières aux divers modes d'exercice de la pharmacie", "@debut": "1953-10-07" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006125380", "@fin": "2004-08-08", "#text": "Livre 5 : Pharmacie", "@debut": "1953-10-07" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006103420", "@fin": "2999-01-01", "#text": "Partie législative 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": "LEGIARTI000006693692", "@fin": "1992-12-11", "@num": "L598", "@etat": "MODIFIE", "@debut": "1953-10-07", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006693693", "@fin": "1994-01-19", "@num": "L598", "@etat": "MODIFIE", "@debut": "1992-12-11", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006693694", "@fin": "1995-02-05", "@num": "L598", "@etat": "MODIFIE", "@debut": "1994-01-19", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006693695", "@fin": "1998-07-02", "@num": "L598", "@etat": "MODIFIE", "@debut": "1995-02-05", "@origine": "LEGI" } }, { "@etat": "ABROGE", "LIEN_ART": { "@id": "LEGIARTI000006693696", "@fin": "2000-06-22", "@num": "L598", "@etat": "ABROGE", "@debut": "1998-07-02", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
L'ouverture d'un établissement pharmaceutique est subordonnée à une autorisation délivrée par l'Agence du médicament lorsqu'il s'agit d'un établissement pharmaceutique se livrant à la fabrication, l'exploitation, l'exportation ou à l'importation des médicaments, des générateurs, trousses ou précurseurs mentionnés au 3° de l'article L. 512 et des produits mentionnés à l'article L. 658-11, et par le ministre chargé de la santé pour les autres établissements pharmaceutiques. Lorsqu'un établissement pharmaceutique se livre exclusivement à l'exportation de ces médicaments, générateurs, trousses, précurseurs ou produits, cette autorisation est délivrée par le ministre chargé de la santé. Cette autorisation peut, après mise en demeure, être suspendue ou retirée en cas d'infraction aux dispositions du présent livre. Les modalités d'octroi, de suspension ou de retrait de cette autorisation sont définies par décret en Conseil d'Etat.
\n
Toute modification des éléments figurant dans l'autorisation initiale doit faire l'objet d'une nouvelle autorisation préalable.
" } }, "LEGIARTI000006693704": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "L601", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "1996-05-29", "DATE_DEBUT": "1994-01-19" } }, "META_COMMUN": { "ID": "LEGIARTI000006693704", "URL": "article/LEGI/ARTI/00/00/06/69/37/LEGIARTI000006693704.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SPAOXXXXXXX1X601L00AXXAD" } }, "NOTA": { "CONTENU": "

\n

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R163-7 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006073189", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000021629545", "@num": "281 nonies", "#text": "Code général des impôts, CGI. - art. 281 nonies (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006069577", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "#text": "Loi 58-356 1958-04-03 (loi de validation)", "@sens": "source", "@typelien": "CODIFICATION" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006171767", "@fin": "2000-06-22", "#text": "Section 2 : Des médicaments et produits soumis à autorisation", "@debut": "1992-12-11" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006155250", "@fin": "2000-06-22", "#text": "Chapitre 2 : Fabrication, importation, exportation et distribution en gros des produits pharmaceutiques et exploitation des spécialités ou autres médicaments", "@debut": "1992-12-11" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006140721", "@fin": "2000-06-22", "#text": "Titre 2 : Dispositions particulières aux divers modes d'exercice de la pharmacie", "@debut": "1953-10-07" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006125380", "@fin": "2004-08-08", "#text": "Livre 5 : Pharmacie", "@debut": "1953-10-07" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006103420", "@fin": "2999-01-01", "#text": "Partie législative 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": "LEGIARTI000006693701", "@fin": "1992-12-11", "@num": "L601", "@etat": "MODIFIE", "@debut": "1953-10-07", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006693702", "@fin": "1993-01-05", "@num": "L601", "@etat": "MODIFIE", "@debut": "1992-12-11", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006693703", "@fin": "1994-01-19", "@num": "L601", "@etat": "MODIFIE", "@debut": "1993-01-05", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006693704", "@fin": "1996-05-29", "@num": "L601", "@etat": "MODIFIE", "@debut": "1994-01-19", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006693705", "@fin": "1998-07-02", "@num": "L601", "@etat": "MODIFIE", "@debut": "1996-05-29", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006693706", "@fin": "1999-12-30", "@num": "L601", "@etat": "MODIFIE", "@debut": "1998-07-02", "@origine": "LEGI" } }, { "@etat": "ABROGE", "LIEN_ART": { "@id": "LEGIARTI000006693707", "@fin": "2000-06-22", "@num": "L601", "@etat": "ABROGE", "@debut": "1999-12-30", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
Tout médicament ou produit pharmaceutique ou tout autre médicament fabriqué industriellement ainsi que tout générateur, trousse ou précurseur doit faire l'objet, avant sa commercialisation ou sa distribution à titre gratuit, en gros ou au détail, d'une autorisation de mise sur le marché délivrée par l'Agence du médicament.
\n
\n
Cette autorisation peut être assortie de conditions adéquates. Elle n'est accordée que lorsque le fabricant justifie :
\n
1° Qu'il a fait procéder à la vérification de l'innocuité du produit dans des conditions normales d'emploi et de son intérêt thérapeutique, ainsi qu'à son analyse qualitative et quantitative ;
\n
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.
\n
Cette autorisation est délivrée pour une durée de cinq ans ;
\n elle est ensuite renouvelable par période quinquennale.
\n
Elle peut être suspendue ou supprimée par l'Agence du médicament.
\n
L'accomplissement des formalités prévues au présent article n'a pas pour effet d'exonérer le fabricant ou, s'il est distinct, le titulaire de l'autorisation de mise sur le marché de la responsabilité que l'un ou l'autre peut encourir dans les conditions du droit commun en raison de la fabrication ou de la mise sur le marché d'un médicament ou produit.
" } } }, "article_lien": [ { "article_id": "LEGIARTI000006693533", "cible": false, "cidtexte": "JORFTEXT000000728979", "id": "LEGIARTI000006696681", "typelien": "MODIFICATION" }, { "article_id": "LEGIARTI000006693565", "cible": false, "cidtexte": "JORFTEXT000000728979", "id": "LEGIARTI000006696681", "typelien": "MODIFICATION" }, { "article_id": "LEGIARTI000006693579", "cible": false, "cidtexte": "JORFTEXT000000728979", "id": "LEGIARTI000006696681", "typelien": "MODIFICATION" }, { "article_id": "LEGIARTI000006693584", "cible": false, "cidtexte": "JORFTEXT000000728979", "id": "LEGIARTI000006696681", "typelien": "MODIFICATION" }, { "article_id": "LEGIARTI000006693704", "cible": false, "cidtexte": "JORFTEXT000000728979", "id": "LEGIARTI000006696681", "typelien": "MODIFICATION" }, { "article_id": "LEGIARTI000006693589", "cible": false, "cidtexte": "JORFTEXT000000728979", "id": "LEGIARTI000006696681", "typelien": "MODIFICATION" }, { "article_id": "LEGIARTI000006693694", "cible": false, "cidtexte": "JORFTEXT000000728979", "id": "LEGIARTI000006696681", "typelien": "MODIFICATION" }, { "article_id": "LEGIARTI000006616196", "cible": false, "cidtexte": "JORFTEXT000000728979", "id": "LEGIARTI000006696681", "typelien": "MODIFICATION" } ], "follow": [ "LIENS.LIEN[@sens=cible,@typelien=CREATION].@id" ], "id": "LEGIARTI000006696681", "liens_entrants": true }

Article 31 ENTIEREMENT_MODIF (LOI no 94-43 du 18 janvier 1994 relative à la santé publique et à la protection sociale (1))