{ "article": { "LEGIARTI000006800553": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R5144-4", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "1993-08-07", "DATE_DEBUT": "1984-05-30" } }, "META_COMMUN": { "ID": "LEGIARTI000006800553", "URL": "article/LEGI/ARTI/00/00/06/80/05/LEGIARTI000006800553.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SXXXXXXXXXX5144R0040XXAA" } }, "LIENS": { "LIEN": [ { "@id": "JORFTEXT000000882402", "#text": "Décret 84-402 1984-05-24 ART. 1 JORF 30 MAI 1984", "@sens": "source", "@cidtexte": "JORFTEXT000000882402", "@numtexte": "84-402", "@typelien": "CREATION", "@naturetexte": "DECRET", "@datesignatexte": "1984-05-24" }, { "@id": "LEGIARTI000006799360", "@num": "R5047-5", "#text": "Code de la santé publique - art. R5047-5 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006914905", "@num": "R5121-153", "#text": "Code de la santé publique - art. R5121-153 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006800525", "@num": "R5142-15-15", "#text": "Code de la santé publique - art. R5142-15-15 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006801294", "@num": "R5204", "#text": "Code de la santé publique - art. R5204 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006801330", "@num": "R5218-1", "#text": "Code de la santé publique - art. R5218-1 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006174543", "@fin": "1995-03-14", "#text": "Section 1 : Organisation de la pharmacovigilance.", "@debut": "1984-05-30" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006157772", "@fin": "2004-08-08", "#text": "Chapitre 2 bis : Pharmacovigilance", "@debut": "1984-05-30" } ] }, "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": "LEGIARTI000006800553", "@fin": "1993-08-07", "@num": "R5144-4", "@etat": "MODIFIE", "@debut": "1984-05-30", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006800554", "@fin": "1995-03-14", "@num": "R5144-4", "@etat": "MODIFIE", "@debut": "1993-08-07", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006800555", "@fin": "1999-04-01", "@num": "R5144-4", "@etat": "MODIFIE", "@debut": "1995-03-14", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006800556", "@fin": "2004-01-31", "@num": "R5144-4", "@etat": "MODIFIE", "@debut": "1999-04-01", "@origine": "LEGI" } }, { "@etat": "ABROGE", "LIEN_ART": { "@id": "LEGIARTI000006800557", "@fin": "2004-08-08", "@num": "R5144-4", "@etat": "ABROGE", "@debut": "2004-01-31", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
Le secrétariat de la Commission nationale et celui du comité technique sont assurés par la direction de la pharmacie et du médicament.
\n
" } }, "LEGIARTI000006799360": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R5047-5", "ETAT": "ABROGE", "TYPE": "AUTONOME", "DATE_FIN": "2004-08-08", "DATE_DEBUT": "1999-04-01" } }, "META_COMMUN": { "ID": "LEGIARTI000006799360", "URL": "article/LEGI/ARTI/00/00/06/79/93/LEGIARTI000006799360.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SXXXXXXXXXX5047R0050XXAC" } }, "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": "LEGIARTI000006723346", "@num": "1", "#text": "Décret n°99-249 du 31 mars 1999 - art. 1 () JORF 1er avril 1999", "@sens": "source", "@cidtexte": "JORFTEXT000000393106", "@nortexte": "MESP9921061D", "@numtexte": "99-249", "@typelien": "MODIFICATION", "@naturetexte": "DECRET", "@datesignatexte": "1999-03-31" }, { "@id": "JORFTEXT000000787339", "#text": "Décret 2004-802 2004-07-29 art. 4 JORF 8 août 2004", "@sens": "source", "@cidtexte": "JORFTEXT000000787339", "@nortexte": "SANP0422530D", "@numtexte": "2004-802", "@typelien": "ABROGATION", "@naturetexte": "DECRET", "@datesignatexte": "2004-07-29" }, { "@id": "LEGIARTI000006799381", "@num": "R5050", "#text": "Code de la santé publique - art. R5050 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006799384", "@num": "R5051", "#text": "Code de la santé publique - art. R5051 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006799409", "@num": "R5051-4", "#text": "Code de la santé publique - art. R5051-4 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006799422", "@num": "R5052-3", "#text": "Code de la santé publique - art. R5052-3 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006799426", "@num": "R5054", "#text": "Code de la santé publique - art. R5054 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006799451", "@num": "R5054-4", "#text": "Code de la santé publique - art. R5054-4 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006914994", "@num": "R5122-13", "#text": "Code de la santé publique - art. R5122-13 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006914994", "@num": "R5122-13", "#text": "Code de la santé publique - art. R5122-13 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006914995", "@num": "R5122-14", "#text": "Code de la santé publique - art. R5122-14 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006914995", "@num": "R5122-14", "#text": "Code de la santé publique - art. R5122-14 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006914996", "@num": "R5122-15", "#text": "Code de la santé publique - art. R5122-15 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006914996", "@num": "R5122-15", "#text": "Code de la santé publique - art. R5122-15 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006914999", "@num": "R5122-16", "#text": "Code de la santé publique - art. R5122-16 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006914999", "@num": "R5122-16", "#text": "Code de la santé publique - art. R5122-16 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006800553", "@num": "R5144-4", "#text": "Code de la santé publique - art. R5144-4 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006801334", "@num": "R5219-1", "#text": "Code de la santé publique - art. R5219-1 (M)", "@sens": "source", "@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": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006187105", "@fin": "2004-08-08", "#text": "Sous-section 3 : Publicité pour les médicaments auprès des professionnels de santé habilités à les prescrire, à les dispenser ou à les utiliser dans l'exercice de leur art.", "@debut": "1996-06-16" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006174501", "@fin": "2004-08-08", "#text": "Section 1 : Dispositions relatives à la publicité pour les médicaments", "@debut": "1996-06-16" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006157745", "@fin": "2004-08-08", "#text": "Chapitre 4 : Réglementation de la publicité", "@debut": "1956-11-28" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006142895", "@fin": "2004-08-08", "#text": "Titre 1 : Dispositions générales", "@debut": "1956-11-28" } ] }, "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": "LEGIARTI000006799358", "@fin": "1999-03-05", "@num": "R5047-5", "@etat": "MODIFIE", "@debut": "1996-06-16", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006799359", "@fin": "1999-04-01", "@num": "R5047-5", "@etat": "MODIFIE", "@debut": "1999-03-05", "@origine": "LEGI" } }, { "@etat": "ABROGE", "LIEN_ART": { "@id": "LEGIARTI000006799360", "@fin": "2004-08-08", "@num": "R5047-5", "@etat": "ABROGE", "@debut": "1999-04-01", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
I. - Le directeur général de l'Agence française de sécurité sanitaire des produits de santé peut mettre en demeure l'entreprise exploitant le médicament de modifier le contenu de la publicité dans un délai déterminé.
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En cas de non-respect de cette mise en demeure à l'issue de ce délai, et après avis de la commission mentionnée à l'article R. 5054, le directeur général peut interdire la poursuite et la diffusion ultérieure de cette publicité.
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II. - Le directeur général de l'Agence peut, après avis de la commission prévue à l'article R. 5054 :
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a) Interdire la publicité, sous quelque forme que ce soit, ou la poursuite de la campagne publicitaire ;
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b) Interdire la publicité, ou la poursuite de la campagne publicitaire et exiger soit la diffusion, par les mêmes moyens ou des moyens équivalents, d'un rectificatif approuvé par la commission, soit l'envoi de lettres rectificatives aux destinataires de la publicité et ce aux frais de l'entreprise.
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Ces mesures d'interdiction ne peuvent être prises qu'après que l'intéressé a été avisé et, s'il le désire, entendu par la commission. Elles sont publiées au Journal officiel de la République française.
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III. - En cas d'urgence, le directeur général de l'Agence peut suspendre, sans consultation préalable de la commission et pour une durée de trois mois au plus, la diffusion d'une publicité manifestement contraire aux dispositions applicables. La commission prévue à l'article R. 5054 doit être immédiatement saisie ensuite par le directeur général de l'Agence.
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IV. - Pour des raisons tenant à la protection de la santé publique, les mesures prévues au présent article peuvent être prises en cas de mésusage, tel qu'il est défini à l'article R. 5144-4, ou de pharmacodépendance ou d'abus, tels qu'ils sont définis à l'article R. 5219-1, du médicament faisant l'objet de la publicité.
" } }, "LEGIARTI000006800525": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R5142-15-15", "ETAT": "ABROGE", "TYPE": "AUTONOME", "DATE_FIN": "2004-08-08", "DATE_DEBUT": "2004-01-27" } }, "META_COMMUN": { "ID": "LEGIARTI000006800525", "URL": "article/LEGI/ARTI/00/00/06/80/05/LEGIARTI000006800525.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SXXXXXXXXXX5142R0151XX5A" } }, "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": "LEGIARTI000006228175", "@num": "6", "#text": "Décret n°2004-83 du 23 janvier 2004 - art. 6 () JORF 27 janvier 2004", "@sens": "source", "@cidtexte": "JORFTEXT000000246661", "@nortexte": "SANP0324239D", "@numtexte": "2004-83", "@typelien": "CREATION", "@naturetexte": "DECRET", "@datesignatexte": "2004-01-23" }, { "@id": "JORFTEXT000000787339", "#text": "Décret 2004-802 2004-07-29 art. 4 JORF 8 août 2004", "@sens": "source", "@cidtexte": "JORFTEXT000000787339", "@nortexte": "SANP0422530D", "@numtexte": "2004-802", "@typelien": "ABROGATION", "@naturetexte": "DECRET", "@datesignatexte": "2004-07-29" }, { "@id": "LEGIARTI000006914881", "@num": "R5121-131", "#text": "Code de la santé publique - art. R5121-131 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006914881", "@num": "R5121-131", "#text": "Code de la santé publique - art. R5121-131 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006800523", "@num": "R5142-15-13", "#text": "Code de la santé publique - art. R5142-15-13 (Ab)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006800512", "@num": "R5142-15-4", "#text": "Code de la santé publique - art. R5142-15-4 (Ab)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006800553", "@num": "R5144-4", "#text": "Code de la santé publique - art. R5144-4 (M)", "@sens": "source", "@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": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006194981", "@fin": "2004-08-08", "#text": "Importation", "@debut": "1998-02-13" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006187165", "@fin": "2004-08-08", "#text": "Paragraphe 2 bis : Importation et exportation des médicaments", "@debut": "1998-02-13" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006174542", "@fin": "2004-08-08", "#text": "Section 2 : Médicaments et produits soumis à autorisation", "@debut": "1998-02-13" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006157770", "@fin": "2004-08-08", "#text": "Chapitre 2 : Fabrication, exploitation, importation, distribution en gros, exportation des médicaments et autres produits pharmaceutiques à usage humain", "@debut": "1998-02-13" } ] }, "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": "ABROGE", "LIEN_ART": { "@id": "LEGIARTI000006800525", "@fin": "2004-08-08", "@num": "R5142-15-15", "@etat": "ABROGE", "@debut": "2004-01-27", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
Dès qu'il en a connaissance, le titulaire d'une autorisation d'importation parallèle informe immédiatement le titulaire de l'autorisation de mise sur le marché dans l'Etat de provenance ainsi que le titulaire de l'autorisation de mise sur le marché de la spécialité ayant obtenu l'autorisation de mise sur le marché en France de tout effet indésirable grave, au sens de l'article R. 5144-4, concernant la spécialité importée.
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Il informe également l'Agence française de sécurité sanitaire des produits de santé de toute modification dont il a connaissance portant sur l'autorisation de mise sur le marché dont bénéficie la spécialité dans l'Etat de provenance. Le cas échéant, il prend les mesures nécessaires pour que la spécialité bénéficiant de l'autorisation d'importation parallèle respecte les dispositions des articles R. 5142-15-4 et R. 5142-15-13.
" } }, "LEGIARTI000006801294": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R5204", "ETAT": "ABROGE", "TYPE": "AUTONOME", "DATE_FIN": "2000-06-22", "DATE_DEBUT": "1999-04-01" } }, "META_COMMUN": { "ID": "LEGIARTI000006801294", "URL": "article/LEGI/ARTI/00/00/06/80/12/LEGIARTI000006801294.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SXXXXXXXXXX5204R0000XXAE" } }, "NOTA": { "CONTENU": "
[*Nota : Décret 94-1030 du 2 décembre 1994 art. 9 : date d'application.*]
\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": "LEGIARTI000006714046", "@num": "2", "#text": "Arrêté du 21 décembre 1990 - art. 2 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000351973", "@nortexte": "DEFD9101003A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "1990-12-21" }, { "@id": "LEGIARTI000006723350", "@num": "5", "#text": "Décret n°99-249 du 31 mars 1999 - art. 5 () JORF 1er avril 1999", "@sens": "source", "@cidtexte": "JORFTEXT000000393106", "@nortexte": "MESP9921061D", "@numtexte": "99-249", "@typelien": "MODIFICATION", "@naturetexte": "DECRET", "@datesignatexte": "1999-03-31" }, { "@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": "LEGITEXT000025882865", "#text": "Arrêté du 24 avril 2012 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000025837104", "@nortexte": "ETSP1221693A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2012-04-24" }, { "@id": "LEGITEXT000026293964", "#text": "Arrêté du 8 août 2012 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000026292918", "@nortexte": "AFSP1232079A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2012-08-08" }, { "@id": "LEGITEXT000036947672", "#text": "Arrêté du 5 mai 2018 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000036944375", "@nortexte": "AGRG1813166A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2018-05-05" }, { "@id": "LEGIARTI000006690133", "@num": "L5132-6", "#text": "Code de la santé publique - art. L5132-6 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006690134", "@num": "L5132-6", "#text": "Code de la santé publique - art. L5132-6 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006799706", "@num": "R5093", "#text": "Code de la santé publique - art. R5093 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006800090", "@num": "R5123", "#text": "Code de la santé publique - art. R5123 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006800166", "@num": "R5135", "#text": "Code de la santé publique - art. R5135 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006800553", "@num": "R5144-4", "#text": "Code de la santé publique - art. R5144-4 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006801070", "@num": "R5149", "#text": "Code de la santé publique - art. R5149 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006801146", "@num": "R5170", "#text": "Code de la santé publique - art. R5170 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006801243", "@num": "R5190", "#text": "Code de la santé publique - art. R5190 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006801252", "@num": "R5193", "#text": "Code de la santé publique - art. R5193 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006801334", "@num": "R5219-1", "#text": "Code de la santé publique - art. R5219-1 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGITEXT000006072665", "#text": "Code de la santé publique R5190 : champ d'application de la présente section", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "SPEC_APPLI", "@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": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006187208", "@fin": "2004-08-08", "#text": "2) Régime particulier des listes 1 et 2.", "@debut": "1988-12-31" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006174570", "@fin": "2004-08-08", "#text": "Section 3 : Médicaments, produits insecticides et acaricides destinés à être appliqués sur l'homme, produits destinés à l'entretien ou à l'application des lentilles oculaires de contact", "@debut": "1988-12-31" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006157778", "@fin": "2004-08-08", "#text": "CHAPITRE 1 : SUBSTANCES VENENEUSES", "@debut": "1956-11-28" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006142908", "@fin": "2004-08-08", "#text": "TITRE 3 : RESTRICTION AU COMMERCE DE CERTAINES SUBSTANCES ET DE CERTAINS OBJETS", "@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": "LEGIARTI000006801290", "@fin": "1988-05-08", "@num": "R5204", "@etat": "MODIFIE", "@debut": "1956-11-28", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006801291", "@fin": "1988-12-31", "@num": "R5204", "@etat": "MODIFIE", "@debut": "1988-05-08", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006801292", "@fin": "1994-12-03", "@num": "R5204", "@etat": "MODIFIE", "@debut": "1988-12-31", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006801293", "@fin": "1999-04-01", "@num": "R5204", "@etat": "MODIFIE", "@debut": "1994-12-03", "@origine": "LEGI" } }, { "@etat": "ABROGE", "LIEN_ART": { "@id": "LEGIARTI000006801294", "@fin": "2000-06-22", "@num": "R5204", "@etat": "ABROGE", "@debut": "1999-04-01", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
Les listes I et II mentionnées à l'article R. 5149 comprennent [*composition*]:
\n
1° Les substances ou préparations vénéneuses présentant pour la santé des risques directs ou indirects ;
\n
2° Les médicaments et produits vénéneux mentionnés à l'article R. 5190 présentant pour la santé des risques directs ou indirects ;
\n
3° Les médicaments à usage humain susceptibles de présenter directement ou indirectement un danger pour la santé en cas de mésusage tel qu'il est défini à l'article R. 5144-4, ou de pharmacodépendance ou d'abus tels qu'ils sont définis à l'article R. 5219-1 ;
\n
4° Les médicaments à usage humain contenant des substances dont l'activité ou les effets indésirables nécessitent une surveillance médicale.
\n
La liste I comprend les substances ou préparations et les médicaments et produits présentant les risques les plus élevés pour la santé.
" } }, "LEGIARTI000006801330": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R5218-1", "ETAT": "ABROGE", "TYPE": "AUTONOME", "DATE_FIN": "2004-08-08", "DATE_DEBUT": "1999-04-01" } }, "META_COMMUN": { "ID": "LEGIARTI000006801330", "URL": "article/LEGI/ARTI/00/00/06/80/13/LEGIARTI000006801330.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SXXXXXXXXXX5218R0010XXAD" } }, "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": "LEGIARTI000006723350", "@num": "5", "#text": "Décret n°99-249 du 31 mars 1999 - art. 5 () JORF 1er avril 1999", "@sens": "source", "@cidtexte": "JORFTEXT000000393106", "@nortexte": "MESP9921061D", "@numtexte": "99-249", "@typelien": "MODIFICATION", "@naturetexte": "DECRET", "@datesignatexte": "1999-03-31" }, { "@id": "JORFTEXT000000787339", "#text": "Décret 2004-802 2004-07-29 art. 4 JORF 8 août 2004", "@sens": "source", "@cidtexte": "JORFTEXT000000787339", "@nortexte": "SANP0422530D", "@numtexte": "2004-802", "@typelien": "ABROGATION", "@naturetexte": "DECRET", "@datesignatexte": "2004-07-29" }, { "@id": "LEGIARTI000006915598", "@num": "R5132-39", "#text": "Code de la santé publique - art. R5132-39 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006915599", "@num": "R5132-39", "#text": "Code de la santé publique - art. R5132-39 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006800166", "@num": "R5135", "#text": "Code de la santé publique - art. R5135 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006800553", "@num": "R5144-4", "#text": "Code de la santé publique - art. R5144-4 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006801334", "@num": "R5219-1", "#text": "Code de la santé publique - art. R5219-1 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGITEXT000006072665", "#text": "Code de la santé publique R5190 : champ d'application de la présente section", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "SPEC_APPLI", "@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": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006187209", "@fin": "2004-08-08", "#text": "3) Régime particulier des stupéfiants.", "@debut": "1988-12-31" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006174570", "@fin": "2004-08-08", "#text": "Section 3 : Médicaments, produits insecticides et acaricides destinés à être appliqués sur l'homme, produits destinés à l'entretien ou à l'application des lentilles oculaires de contact", "@debut": "1988-12-31" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006157778", "@fin": "2004-08-08", "#text": "CHAPITRE 1 : SUBSTANCES VENENEUSES", "@debut": "1956-11-28" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006142908", "@fin": "2004-08-08", "#text": "TITRE 3 : RESTRICTION AU COMMERCE DE CERTAINES SUBSTANCES ET DE CERTAINS OBJETS", "@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": "LEGIARTI000006801327", "@fin": "1993-08-07", "@num": "R5218-1", "@etat": "MODIFIE", "@debut": "1992-09-10", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006801328", "@fin": "1999-03-05", "@num": "R5218-1", "@etat": "MODIFIE", "@debut": "1993-08-07", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006801329", "@fin": "1999-04-01", "@num": "R5218-1", "@etat": "MODIFIE", "@debut": "1999-03-05", "@origine": "LEGI" } }, { "@etat": "ABROGE", "LIEN_ART": { "@id": "LEGIARTI000006801330", "@fin": "2004-08-08", "@num": "R5218-1", "@etat": "ABROGE", "@debut": "1999-04-01", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
Les dispositions du présent paragraphe peuvent, pour des motifs de santé publique, être appliquées, en totalité ou en partie, à des médicaments ou produits contenant des substances ou des préparations qui, bien que n'étant pas classées comme stupéfiants, sont fabriquées à partir de stupéfiants ou donnent lieu à la formation de stupéfiants au cours de leur fabrication. Il en est de même pour les médicaments ou produits qui, en cas de mésusage tel que défini à l'article R. 5144-4 ou en cas de pharmacodépendance ou d'abus tels qu'ils sont définis à l'article R. 5219-1, peuvent nécessiter un contrôle à certains stades de leur commercialisation ainsi que de leur prescription.
\n
Le ministre chargé de la santé sur proposition du directeur général de l'Agence française de sécurité sanitaire des produits de santé fixe par arrêté, pour les médicaments ou produits contenant ces substances ou préparations, les dispositions du présent paragraphe qui leur sont applicables.
" } }, "LEGIARTI000006914905": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R5121-153", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2012-11-10", "DATE_DEBUT": "2004-08-08" } }, "META_COMMUN": { "ID": "LEGIARTI000006914905", "URL": "article/LEGI/ARTI/00/00/06/91/49/LEGIARTI000006914905.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "YXXXXXXXXXX5121R1530XX0A" } }, "LIENS": { "LIEN": [ { "@id": "JORFTEXT000000787339", "#text": "Décret 2004-802 2004-07-29", "@sens": "source", "@cidtexte": "JORFTEXT000000787339", "@nortexte": "SANP0422530D", "@numtexte": "2004-802", "@typelien": "CODIFICATION", "@naturetexte": "DECRET", "@datesignatexte": "2004-07-29" }, { "@id": "LEGIARTI000006254821", "@num": "3", "#text": "Arrêté du 24 août 2006 - art. 3 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000267770", "@nortexte": "SANP0623519A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-24" }, { "@id": "LEGITEXT000018604403", "#text": "Arrêté du 1er avril 2008 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000018598614", "@nortexte": "SJSP0808150A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2008-04-01" }, { "@id": "LEGIARTI000018604409", "@num": "2", "#text": "Arrêté du 1er avril 2008 - art. 2 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000018598614", "@nortexte": "SJSP0808150A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2008-04-01" }, { "@id": "LEGIARTI000043196022", "@num": "Annexe", "#text": "Arrêté du 28 novembre 2016 - art. Annexe (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000033507633", "@nortexte": "AFSP1633476A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2016-11-28" }, { "@id": "LEGIARTI000043194559", "#text": "Arrêté du 26 février 2021 - art.", "@sens": "cible", "@cidtexte": "JORFTEXT000043189686", "@nortexte": "SSAP2105925A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2021-02-26" }, { "@id": "LEGIARTI000025787915", "@num": "R5121-131", "#text": "Code de la santé publique - art. R5121-131 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000033857169", "@num": "R5121-179", "#text": "Code de la santé publique - art. R5121-179 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006914744", "@num": "R5121-21", "#text": "Code de la santé publique - art. R5121-21 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000025853192", "@num": "R5122-16", "#text": "Code de la santé publique - art. R5122-16 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000045117845", "@num": "R5132-39", "#text": "Code de la santé publique - art. R5132-39 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006800557", "@num": "R5144-4", "#text": "Code de la santé publique - art. R5144-4 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006800553", "@num": "R5144-4", "#text": "Code de la santé publique - art. R5144-4 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006196559", "@fin": "2999-01-01", "#text": "Sous-section 1 : Dispositions générales.", "@debut": "2004-08-08" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006190672", "@fin": "2999-01-01", "#text": "Section 13 : Pharmacovigilance", "@debut": "2004-08-08" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006178649", "@fin": "2999-01-01", "#text": "Chapitre Ier : Dispositions générales", "@debut": "2004-08-08" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006161012", "@fin": "2999-01-01", "#text": "Titre II : Médicaments à usage humain", "@debut": "2004-08-08" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006145489", "@fin": "2999-01-01", "#text": "Livre Ier : Produits pharmaceutiques", "@debut": "2004-07-29" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006132399", "@fin": "2999-01-01", "#text": "Cinquième partie : Produits de santé", "@debut": "2004-07-29" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006112927", "@fin": "2999-01-01", "#text": "Partie réglementaire", "@debut": "2000-12-23" } ] }, "@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": "LEGIARTI000006914905", "@fin": "2012-11-10", "@num": "R5121-153", "@etat": "MODIFIE", "@debut": "2004-08-08", "@origine": "LEGI" } }, { "@etat": "ABROGE", "LIEN_ART": { "@id": "LEGIARTI000026596733", "@fin": "2021-01-01", "@num": "R5121-153", "@etat": "ABROGE", "@debut": "2012-11-10", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
Pour l'application du présent chapitre, on entend par :
\n
1° \"Effet indésirable\" : une réaction nocive et non voulue, se produisant aux posologies normalement utilisées chez l'homme pour la prophylaxie, le diagnostic ou le traitement d'une maladie ou pour la restauration, la correction ou la modification d'une fonction physiologique, ou résultant d'un mésusage du médicament ou produit ;
\n
2° \"Effet indésirable grave\" : un effet indésirable létal, ou susceptible de mettre la vie en danger, ou entraînant une invalidité ou une incapacité importantes ou durables, ou provoquant ou prolongeant une hospitalisation, ou se manifestant par une anomalie ou une malformation congénitale ;
\n
3° \"Effet indésirable inattendu\" : un effet indésirable dont la nature, la sévérité ou l'évolution ne correspondent pas aux informations contenues dans le résumé des caractéristiques du produit mentionné à l'article R. 5121-21 ;
\n
4° \"Mésusage\" : une utilisation non conforme aux recommandations du résumé des caractéristiques du produit mentionné à l'article R. 5121-21 ;
\n
5° \"Abus\" : un usage excessif intentionnel, persistant ou sporadique, de médicaments, accompagné de réactions physiques ou psychologiques nocives ;
\n
6° \"Etudes de sécurité après autorisation de mise sur le marché\" :
\n une étude pharmaco-épidémiologique ou un essai clinique effectués conformément aux dispositions de l'autorisation de mise sur le marché, dans le but d'identifier ou de quantifier un risque relatif à la sécurité d'emploi d'un médicament autorisé.
" } }, "LEGIARTI000026596733": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R5121-153", "ETAT": "ABROGE", "TYPE": "AUTONOME", "DATE_FIN": "2021-01-01", "DATE_DEBUT": "2012-11-10" } }, "META_COMMUN": { "ID": "LEGIARTI000026596733", "URL": "article/LEGI/ARTI/00/00/26/59/67/LEGIARTI000026596733.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "LIENS": { "LIEN": [ { "@id": "JORFTEXT000000787339", "#text": "Décret n°2004-802 du 29 juillet 2004", "@sens": "source", "@cidtexte": "JORFTEXT000000787339", "@nortexte": "SANP0422530D", "@numtexte": "2004-802", "@typelien": "CODIFICATION", "@naturetexte": "DECRET", "@datesignatexte": "2004-07-29" }, { "@id": "LEGIARTI000006254821", "@num": "3", "#text": "Arrêté du 24 août 2006 - art. 3 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000267770", "@nortexte": "SANP0623519A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-24" }, { "@id": "LEGITEXT000018604403", "#text": "Arrêté du 1er avril 2008 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000018598614", "@nortexte": "SJSP0808150A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2008-04-01" }, { "@id": "LEGIARTI000018604409", "@num": "2", "#text": "Arrêté du 1er avril 2008 - art. 2 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000018598614", "@nortexte": "SJSP0808150A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2008-04-01" }, { "@id": "LEGIARTI000026593806", "@num": "5", "#text": "Décret n°2012-1244\n du 8 novembre 2012 - art. 5", "@sens": "cible", "@cidtexte": "JORFTEXT000026592596", "@nortexte": "AFSP1232131D", "@numtexte": "2012-1244", "@typelien": "MODIFIE", "@naturetexte": "DECRET", "@datesignatexte": "2012-11-08" }, { "@id": "LEGIARTI000043196022", "@num": "Annexe", "#text": "Arrêté du 28 novembre 2016 - art. 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R5121-150", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006914911", "@num": "R5121-158", "#text": "Code de la santé publique - art. R5121-158", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006914914", "@num": "R5121-161", "#text": "Code de la santé publique - art. R5121-161", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000033857169", "@num": "R5121-179", "#text": "Code de la santé publique - art. R5121-179 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000025853192", "@num": "R5122-16", "#text": "Code de la santé publique - art. 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Les acteurs du système de pharmacovigilance tel que mentionné à l'article L. 5121-23 sont :
\n
1° L'Agence nationale de sécurité du médicament et des produits de santé ;
\n
2° Les centres régionaux de pharmacovigilance mentionnés à l'article R. 5121-158 ;
\n
3° Les professionnels de santé mentionnés à l'article R. 5121-161, les pharmacies à usage intérieur mentionnées à l'article L. 5126-1 ainsi que les titulaires de l'autorisation prévue à l'article L. 4211-6 ;
\n
4° Les entreprises ou les organismes exploitant un médicament ou un produit mentionné à l'article R. 5121-150 et tout tiers effectuant tout ou partie des opérations constitutives de la pharmacovigilance mentionnées au quatrième alinéa de l'article R. 5124-47 pour le compte des entreprises et organismes mentionnés ci-dessus ;
\n
5° Les établissements pharmaceutiques, y compris ceux gérés par les établissements pharmaceutiques des établissements publics de santé mentionnés aux articles R. 5124-68 à R. 5124-73 pour leur activité de réalisation de préparation hospitalière et de préparation magistrale.
\n
Les patients et les associations agréées de patients mentionnés à l'article R. 5121-161 concourent à ce système

" } } }, "article_lien": [ { "article_id": "LEGIARTI000006801330", "cible": false, "cidtexte": "LEGITEXT000006072665", "id": "LEGIARTI000006800553", "typelien": "CITATION" }, { "article_id": "LEGIARTI000006914905", "cible": false, "cidtexte": "LEGITEXT000006072665", "id": "LEGIARTI000006800553", "typelien": "CONCORDANCE" }, { "article_id": "LEGIARTI000026596733", "cible": false, "cidtexte": "LEGITEXT000006072665", "id": "LEGIARTI000006800553", "typelien": "CONCORDANCE" }, { "article_id": "LEGIARTI000006800525", "cible": false, "cidtexte": "LEGITEXT000006072665", "id": "LEGIARTI000006800553", "typelien": "CITATION" }, { "article_id": "LEGIARTI000006799360", "cible": false, "cidtexte": "LEGITEXT000006072665", "id": "LEGIARTI000006800553", "typelien": "CITATION" }, { "article_id": "LEGIARTI000006801294", "cible": false, "cidtexte": "LEGITEXT000006072665", "id": "LEGIARTI000006800553", "typelien": "CITATION" } ], "texte_version": { "JORFTEXT000000882402": { "SM": { "CONTENU": "IL EST INSTITUE AUPRES DU MINISTRE CHARGE DE LA SANTE UNE COMMISSION NATIONALE DE LA PHARMACOVIGILANCE: COMPOSITION ET MISSION.
LES TRAVAUX DE LA COMMISSION NATIONALE SONT PREPARES PAR UN COMITE TECHNIQUE.
CREATION ET ORGANISATION,ROLE DES CENTRES REGIONAUX DE PHARMACOVIGILANCE.
DECLARATIONS OBLIGATOIRES: TOUT MEDECIN,CHIRURGIEN-DENTISTE OU SAGE-FEMME,AYANT CONSTATE UN EFFET INATTENDU OU TOXIQUE SUSCEPTIBLE D'ETRE DU A UN MEDICAMENT QU'IL A PRESCRIT DOIT EN FAIRE LA DECLARATION IMMEDIATE AU CENTRE REGIONAL DE LA PHARMACOVIGILANCE.
LE TITRE II DU LIVRE V DU CODE DE LA SANTE PUBLIQUE (2EME PARTIE) EST COMPLETE PAR UN CHAPITRE II-BIS.
ABROGATION DU CHAPITRE I-BIS DU LIVRE V DU MEME CODE.
ABROGATION DU DECRET 82682 DU 30-07-1982.
APPLICATION DE LA LOI 80512 DU 07-07-1980." }, "META": { "META_SPEC": { "META_TEXTE_VERSION": { "LIENS": { "LIEN": [ { "@id": "JORFTEXT000000886862", "#text": "Loi n°80-512 du 7 juillet 1980", "@sens": "source", "@cidtexte": "JORFTEXT000000886862", "@numtexte": "80-512", "@typelien": "APPLICATION", "@naturetexte": "LOI", "@datesignatexte": "1980-07-07" }, { "@id": "JORFTEXT000000313499", "#text": "Décret n°82-682 du 30 juillet 1982", "@sens": "source", "@cidtexte": "JORFTEXT000000313499", "@numtexte": "82-682", "@typelien": "ABROGE", "@naturetexte": "DECRET", "@datesignatexte": "1982-07-30" }, { "@id": "LEGIARTI000006462378", "@num": "1", "#text": "Arrêté du 7 août 1991 - art. 1 (M)", "@sens": "cible", "@cidtexte": "JORFTEXT000000841554", "@nortexte": "SPSG9101812A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "1991-08-07" }, { "@id": "JORFTEXT000000608303", "#text": "Décret2004-99", "@sens": "cible", "@cidtexte": "JORFTEXT000000608303", "@nortexte": "SANP0325028D", "@numtexte": "2004-99", "@typelien": "MODIFIE", "@naturetexte": "DECRET", "@datesignatexte": "2004-01-29" }, { "@id": "JORFTEXT000000611541", "#text": "Décret2004-188", "@sens": "cible", "@cidtexte": "JORFTEXT000000611541", "@nortexte": "SANP0325030D", "@numtexte": "2004-188", "@typelien": "MODIFIE", "@naturetexte": "DECRET", "@datesignatexte": "2004-02-23" }, { "@id": "LEGIARTI000006800542", "@num": "R5144-1", "#text": "Code de la santé publique - art. 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Article R5144-4 AUTONOME MODIFIE, en vigueur du 30/05/1984 au 07/08/1993 (Code de la santé publique)