{ "article": { "LEGIARTI000026595976": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R5313-2-1", "ETAT": "ABROGE", "TYPE": "AUTONOME", "DATE_FIN": "2017-01-12", "DATE_DEBUT": "2012-11-10" } }, "META_COMMUN": { "ID": "LEGIARTI000026595976", "URL": "article/LEGI/ARTI/00/00/26/59/59/LEGIARTI000026595976.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "LIENS": { "LIEN": [ { "@id": "LEGIARTI000026593792", "@num": "6", "#text": "Décret n°2012-1244\n du 8 novembre 2012 - art. 6", "@sens": "cible", "@cidtexte": "JORFTEXT000026592596", "@nortexte": "AFSP1232131D", "@numtexte": "2012-1244", "@typelien": "CREE", "@naturetexte": "DECRET", "@datesignatexte": "2012-11-08" }, { "@id": "LEGIARTI000033851321", "@num": "1", "#text": "Décret n°2017-20 du 9 janvier 2017 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000033850698", "@nortexte": "AFSP1622630D", "@numtexte": "2017-20", "@typelien": "ABROGE", "@naturetexte": "DECRET", "@datesignatexte": "2017-01-09" }, { "@id": "LEGIARTI000006689881", "@num": "L5121-5", "#text": "Code de la santé publique - art. L5121-5", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006914938", "@num": "R5121-179", "#text": "Code de la santé publique - art. R5121-179", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006190768", "@fin": "2999-01-01", "#text": "Section 1 : Dispositions générales", "@debut": "2004-08-08" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006178672", "@fin": "2999-01-01", "#text": "Chapitre III : Inspection", "@debut": "2004-08-08" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006161018", "@fin": "2999-01-01", "#text": "Titre Ier : Missions et prérogatives", "@debut": "2004-08-08" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006145491", "@fin": "2012-05-01", "#text": "Livre III : Agence française de sécurité sanitaire des produits de santé", "@debut": "2004-08-08" }, { "@id": "LEGISCTA000025788966", "@fin": "2999-01-01", "#text": "Livre III : Agence nationale de sécurité du médicament et des produits de santé", "@debut": "2012-05-01" } ] }, "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": "ABROGE", "LIEN_ART": { "@id": "LEGIARTI000026595976", "@fin": "2017-01-12", "@num": "R5313-2-1", "@etat": "ABROGE", "@debut": "2012-11-10", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "

Les inspections menées au présent titre sont réalisées conformément à la réglementation en vigueur et aux bonnes pratiques dont les principes sont définis aux articles L. 5121-5 et R. 5121-179.

" } }, "LEGIARTI000006689881": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "L5121-5", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2004-08-07", "DATE_DEBUT": "2000-06-22" } }, "META_COMMUN": { "ID": "LEGIARTI000006689881", "URL": "article/LEGI/ARTI/00/00/06/68/98/LEGIARTI000006689881.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SPANXXXXXXX1X5121L05XXAA" } }, "LIENS": { "LIEN": [ { "@id": "JORFTEXT000000217229", "#text": "Ordonnance 2000-548 2000-06-15", "@sens": "source", "@cidtexte": "JORFTEXT000000217229", "@nortexte": "MESX0000036P", "@typelien": "CODIFICATION", "@naturetexte": "RAPPORT", "@datesignatexte": "2999-01-01" }, { "@id": "JORFTEXT000000227015", "#text": "Loi 2002-303 2002-03-04 art. 92 JORF 5 mars 2002", "@sens": "source", "@cidtexte": "JORFTEXT000000227015", "@nortexte": "MESX0100092L", "@numtexte": "2002-303", "@typelien": "CODIFICATION", "@naturetexte": "LOI", "@datesignatexte": "2002-03-04" }, { "@id": "LEGIARTI000020320259", "@num": "3", "#text": "Arrêté du 24 mai 2006 - art. 3 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000457818", "@nortexte": "SANP0622223A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-05-24" }, { "@id": "LEGIARTI000006734457", "@num": "ANNEXE", "#text": "Arrêté du 24 mai 2006 - art. ANNEXE (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000455897", "@nortexte": "SANP0622221A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-05-24" }, { "@id": "LEGIARTI000022933815", "@num": "6", "#text": "Arrêté du 29 septembre 2010 - art. 6 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000022932466", "@nortexte": "SASP1025728A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2010-09-29" }, { "@id": "LEGIARTI000027594512", "#text": "Arrêté du 20 juin 2013 - art. 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La préparation, l'importation et la distribution des médicaments doivent être réalisées en conformité avec des bonnes pratiques dont les principes sont définis par arrêtés du ministre chargé de la santé.
\n
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La préparation, l'importation et la distribution des médicaments doivent être réalisées en conformité avec des bonnes pratiques dont les principes sont définis par arrêtés du ministre chargé de la santé.
\n
Pour les préparations de thérapie génique et les préparations de thérapie cellulaire xénogénique mentionnées au 12° et au 13° de l'article L. 5121-1, outre les activités mentionnées au premier alinéa, ces bonnes pratiques portent sur les activités de conservation, de cession et d'exportation. Elles sont fixées par arrêté du ministre chargé de la santé, sur proposition du directeur général de l'Agence française de sécurité sanitaire des produits de santé, après avis du directeur général de l'Agence de la biomédecine lorsqu'elles concernent les préparations de thérapie cellulaire xénogénique.
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La préparation, l'importation et la distribution des médicaments doivent être réalisées en conformité avec des bonnes pratiques dont les principes sont définis par décision de l'Agence française de sécurité sanitaire des produits de santé.
\n
Pour les préparations de thérapie génique et les préparations de thérapie cellulaire xénogénique mentionnées au 12° et au 13° de l'article L. 5121-1, outre les activités mentionnées au premier alinéa, ces bonnes pratiques portent sur les activités de conservation, de cession et d'exportation. Elles sont fixées par décision de l'Agence française de sécurité sanitaire des produits de santé, après avis du directeur général de l'Agence de la biomédecine lorsqu'elles concernent les préparations de thérapie cellulaire xénogénique.
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La préparation, l'importation, l'exportation et la distribution en gros des médicaments doivent être réalisées en conformité avec des bonnes pratiques dont les principes sont définis par décision de l'Agence nationale de sécurité du médicament et des produits de santé.

Pour les préparations de thérapie génique et les préparations de thérapie cellulaire xénogénique mentionnées au 12° et au 13° de l'article L. 5121-1, outre les activités mentionnées au premier alinéa, ces bonnes pratiques portent sur les activités de conservation, de cession et d'exportation. Elles sont fixées par décision de l'Agence nationale de sécurité du médicament et des produits de santé, après avis du directeur général de l'Agence de la biomédecine lorsqu'elles concernent les préparations de thérapie cellulaire xénogénique.

La dispensation des médicaments doit être réalisée en conformité avec des bonnes pratiques dont les principes sont définis par arrêté du ministre chargé de la santé.

Ces bonnes pratiques prévoient notamment les modalités de suivi permettant d'assurer, à l'occasion de chacune des opérations susmentionnées, la traçabilité des médicaments.

\n
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Un arrêté du ministre chargé de la santé pris sur proposition du directeur général de l'Agence française de sécurité sanitaire des produits de santé définit les principes des bonnes pratiques de pharmacovigilance auxquels sont soumis les intervenants du système national de pharmacovigilance mentionnés à l'article R. 5121-154. Cet arrêté fixe en outre les modalités de recueil, de vérification et d'évaluation des informations mentionnées à l'article R. 5121-151.
\n
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Loi n° 2011-302 du 22 mars 2011 article 8 II : Les dispositions du présent article relatives aux médicaments de thérapie innovante tels que définis au 17° de l'article L. 5121-1 du code de la santé publique entrent en vigueur six mois à compter de la date de publication du décret mentionné au 18° de l'article L. 5121-20 du même code.

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La préparation, l'importation, l'exportation, la distribution en gros et l'activité de courtage de médicaments doivent être réalisées en conformité avec des bonnes pratiques dont les principes sont définis par décision de l'Agence nationale de sécurité du médicament et des produits de santé.

La préparation, la conservation, la distribution et la cession des médicaments de thérapie innovante mentionnés au 17° de l'article L. 5121-1 doivent être réalisées en conformité avec les bonnes pratiques mentionnées au premier alinéa du présent article ou avec des bonnes pratiques dont les principes sont définis par décision de l'Agence nationale de sécurité du médicament et des produits de santé, après avis du directeur général de l'Agence de la biomédecine, lorsque ces bonnes pratiques concernent des médicaments de thérapie cellulaire somatique, des produits issus de l'ingénierie tissulaire ou des médicaments combinés de thérapie innovante.

La dispensation, y compris par voie électronique, des médicaments doit être réalisée en conformité avec des bonnes pratiques dont les principes sont définis par arrêté du ministre chargé de la santé.

Ces bonnes pratiques prévoient notamment les modalités de suivi permettant d'assurer, à l'occasion de chacune des opérations susmentionnées, la traçabilité des médicaments.

" } }, "LEGIARTI000025787815": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R5121-179", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2012-11-10", "DATE_DEBUT": "2012-05-01" } }, "META_COMMUN": { "ID": "LEGIARTI000025787815", "URL": "article/LEGI/ARTI/00/00/25/78/78/LEGIARTI000025787815.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": "LEGITEXT000024154142", "#text": "Décret n°2011-655\n du 10 juin 2011 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000024153599", "@nortexte": "ETSP1024824D", "@numtexte": "2011-655", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2011-06-10" }, { "@id": "LEGIARTI000025765496", "@num": "5", "#text": "Décret n°2012-597\n du 27 avril 2012 - art. 5", "@sens": "cible", "@cidtexte": "JORFTEXT000025757625", "@nortexte": "ETSP1206945D", "@numtexte": "2012-597", "@typelien": "MODIFIE", "@naturetexte": "DECRET", "@datesignatexte": "2012-04-27" }, { "@id": "LEGIARTI000006914903", "@num": "R5121-151", "#text": "Code de la santé publique - art. 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R5313-2-1 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006196562", "@fin": "2012-11-10", "#text": "Sous-section 4 : Autres obligations de pharmacovigilance.", "@debut": "2004-08-08" }, { "@id": "LEGISCTA000026596771", "@fin": "2999-01-01", "#text": "Sous-section 4 : Bonnes pratiques de pharmacovigilance", "@debut": "2012-11-10" } ] }, "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": "LEGIARTI000006914938", "@fin": "2012-05-01", "@num": "R5121-179", "@etat": "MODIFIE", "@debut": "2004-08-08", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000025787815", "@fin": "2012-11-10", "@num": "R5121-179", "@etat": "MODIFIE", "@debut": "2012-05-01", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000026596766", "@fin": "2017-01-12", "@num": "R5121-179", "@etat": "MODIFIE", "@debut": "2012-11-10", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000033857169", "@fin": "2021-01-01", "@num": "R5121-179", "@etat": "MODIFIE", "@debut": "2017-01-12", "@origine": "LEGI" } }, { "@etat": "VIGUEUR", "LIEN_ART": { "@id": "LEGIARTI000039659062", "@fin": "2999-01-01", "@num": "R5121-179", "@etat": "VIGUEUR", "@debut": "2021-01-01", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "

Un arrêté du ministre chargé de la santé pris sur proposition du directeur général de l'Agence nationale de sécurité du médicament et des produits de santé définit les principes des bonnes pratiques de pharmacovigilance auxquels sont soumis les intervenants du système national de pharmacovigilance mentionnés à l'article R. 5121-154. Cet arrêté fixe en outre les modalités de recueil, de vérification et d'évaluation des informations mentionnées à l'article R. 5121-151.

" } }, "LEGIARTI000026593792": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "6", "TYPE": "ENTIEREMENT_MODIF", "DATE_FIN": "2999-01-01", "DATE_DEBUT": "2999-01-01" } }, "META_COMMUN": { "ID": "LEGIARTI000026593792", "URL": "article/LEGI/ARTI/00/00/26/59/37/LEGIARTI000026593792.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "LIENS": { "LIEN": [ { "@id": "LEGIARTI000026595976", "@num": "R5313-2-1", "#text": "Code de la santé publique - art. R5313-2-1 (Ab)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CREE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "@cid": "JORFTEXT000026592596", "@nor": "AFSP1232131D", "@num": "2012-1244", "@nature": "DECRET", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Décret n° 2012-1244 du 8 novembre 2012 relatif au renforcement des dispositions en matière de sécurité des médicaments à usage humain soumis à autorisation de mise sur le marché et à la pharmacovigilance", "@debut": "2999-01-01", "@id_txt": "JORFTEXT000026592596", "@c_titre_court": "Décret n°2012-1244 du 8 novembre 2012" }, { "@fin": "2999-01-01", "#text": "Décret n° 2012-1244 du 8 novembre 2012 relatif au renforcement des dispositions en matière de sécurité des médicaments à usage humain soumis à autorisation de mise sur le marché et à la pharmacovigilance", "@debut": "2012-11-10", "@id_txt": "LEGITEXT000026593781", "@c_titre_court": "Décret n°2012-1244 du 8 novembre 2012" } ], "@ministere": "Ministère des affaires sociales et de la santé", "@date_publi": "2012-11-09", "@date_signature": "2012-11-08" } }, "VERSIONS": { "VERSION": [ { "LIEN_ART": { "@id": "LEGIARTI000026593792", "@fin": "2999-01-01", "@num": "6", "@debut": "2999-01-01", "@origine": "LEGI" } }, { "LIEN_ART": { "@id": "JORFARTI000026592685", "@fin": "2999-01-01", "@num": "6", "@debut": "2999-01-01", "@origine": "JORF" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
A modifié les dispositions suivantes :

- Code de la santé publique
Art. R5313-2-1
\n

\n
" } }, "LEGIARTI000026596766": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R5121-179", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2017-01-12", "DATE_DEBUT": "2012-11-10" } }, "META_COMMUN": { "ID": "LEGIARTI000026596766", "URL": "article/LEGI/ARTI/00/00/26/59/67/LEGIARTI000026596766.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": "LEGITEXT000024154142", "#text": "Décret n°2011-655\n du 10 juin 2011 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000024153599", "@nortexte": "ETSP1024824D", "@numtexte": "2011-655", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2011-06-10" }, { "@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": "LEGIARTI000006914903", "@num": "R5121-151", "#text": "Code de la santé publique - art. R5121-151", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006914905", "@num": "R5121-153", "#text": "Code de la santé publique - art. R5121-153", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000025787842", "@num": "R5121-171", "#text": "Code de la santé publique - art. R5121-171 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006914945", "@num": "R5121-182", "#text": "Code de la santé publique - art. R5121-182 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000032926258", "@num": "R5124-47", "#text": "Code de la santé publique - art. R5124-47 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006800605", "@num": "R5144-18", "#text": "Code de la santé publique - art. R5144-18 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006800603", "@num": "R5144-18", "#text": "Code de la santé publique - art. R5144-18 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000026595976", "@num": "R5313-2-1", "#text": "Code de la santé publique - art. R5313-2-1 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006196562", "@fin": "2012-11-10", "#text": "Sous-section 4 : Autres obligations de pharmacovigilance.", "@debut": "2004-08-08" }, { "@id": "LEGISCTA000026596771", "@fin": "2999-01-01", "#text": "Sous-section 4 : Bonnes pratiques de pharmacovigilance", "@debut": "2012-11-10" } ] }, "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": "LEGIARTI000006914938", "@fin": "2012-05-01", "@num": "R5121-179", "@etat": "MODIFIE", "@debut": "2004-08-08", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000025787815", "@fin": "2012-11-10", "@num": "R5121-179", "@etat": "MODIFIE", "@debut": "2012-05-01", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000026596766", "@fin": "2017-01-12", "@num": "R5121-179", "@etat": "MODIFIE", "@debut": "2012-11-10", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000033857169", "@fin": "2021-01-01", "@num": "R5121-179", "@etat": "MODIFIE", "@debut": "2017-01-12", "@origine": "LEGI" } }, { "@etat": "VIGUEUR", "LIEN_ART": { "@id": "LEGIARTI000039659062", "@fin": "2999-01-01", "@num": "R5121-179", "@etat": "VIGUEUR", "@debut": "2021-01-01", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "

Un arrêté du ministre chargé de la santé pris sur proposition du directeur général de l'Agence nationale de sécurité du médicament et des produits de santé définit les principes des bonnes pratiques de pharmacovigilance auxquels sont soumis les intervenants du système national de pharmacovigilance mentionnés à l'article R. 5121-153. Cet arrêté fixe en outre les modalités de recueil, de vérification et d'évaluation des informations mentionnées à l'article R. 5121-151.

" } }, "LEGIARTI000026809018": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "L5121-5", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2016-07-17", "DATE_DEBUT": "2012-12-22" } }, "META_COMMUN": { "ID": "LEGIARTI000026809018", "URL": "article/LEGI/ARTI/00/00/26/80/90/LEGIARTI000026809018.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "LIENS": { "LIEN": [ { "@id": "JORFTEXT000000217229", "#text": "Rapport relatif à l'ordonnance n° 2000-548 du 15 juin 2000", "@sens": "source", "@cidtexte": "JORFTEXT000000217229", "@nortexte": "MESX0000036P", "@typelien": "CODIFICATION", "@naturetexte": "RAPPORT", "@datesignatexte": "2999-01-01" }, { "@id": "JORFTEXT000000227015", "#text": "Loi n°2002-303 du 4 mars 2002", "@sens": "source", "@cidtexte": "JORFTEXT000000227015", "@nortexte": "MESX0100092L", "@numtexte": "2002-303", "@typelien": "CODIFICATION", "@naturetexte": "LOI", "@datesignatexte": "2002-03-04" }, { "@id": "LEGIARTI000020320259", "@num": "3", "#text": "Arrêté du 24 mai 2006 - art. 3 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000457818", "@nortexte": "SANP0622223A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-05-24" }, { "@id": "LEGIARTI000006734457", "@num": "ANNEXE", "#text": "Arrêté du 24 mai 2006 - art. ANNEXE (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000455897", "@nortexte": "SANP0622221A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-05-24" }, { "@id": "LEGIARTI000022933815", "@num": "6", "#text": "Arrêté du 29 septembre 2010 - art. 6 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000022932466", "@nortexte": "SASP1025728A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2010-09-29" }, { "@id": "LEGIARTI000026806468", "@num": "3", "#text": "Ordonnance n°2012-1427\n du 19 décembre 2012 - art. 3", "@sens": "cible", "@cidtexte": "JORFTEXT000026805101", "@nortexte": "AFSX1240311R", "@numtexte": "2012-1427", "@typelien": "ABROGE", "@naturetexte": "ORDONNANCE", "@datesignatexte": "2012-12-19" }, { "@id": "LEGIARTI000026806468", "@num": "3", "#text": "Ordonnance n°2012-1427\n du 19 décembre 2012 - art. 3", "@sens": "cible", "@cidtexte": "JORFTEXT000026805101", "@nortexte": "AFSX1240311R", "@numtexte": "2012-1427", "@typelien": "MODIFIE", "@naturetexte": "ORDONNANCE", "@datesignatexte": "2012-12-19" }, { "@id": "LEGIARTI000027594512", "#text": "Arrêté du 20 juin 2013 - art. (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000027592947", "@nortexte": "AFSP1313848A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2013-06-20" }, { "@id": "LEGIARTI000027594508", "@num": "1", "#text": "Arrêté du 20 juin 2013 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000027592947", "@nortexte": "AFSP1313848A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2013-06-20" }, { "@id": "LEGIARTI000036782201", "@num": "1", "#text": "Arrêté du 28 novembre 2016 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000033507633", "@nortexte": "AFSP1633476A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2016-11-28" }, { "@id": "LEGIARTI000043196022", "@num": "Annexe", "#text": "Arrêté du 28 novembre 2016 - art. 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La préparation, la conservation, la distribution et la cession des médicaments de thérapie innovante mentionnés au 17° de l'article L. 5121-1 doivent être réalisées en conformité avec les bonnes pratiques mentionnées au premier alinéa du présent article ou avec des bonnes pratiques dont les principes sont définis par décision de l'Agence française de sécurité sanitaire des produits de santé, après avis du directeur général de l'Agence de la biomédecine, lorsque ces bonnes pratiques concernent des médicaments de thérapie cellulaire somatique, des produits issus de l'ingénierie tissulaire ou des médicaments combinés de thérapie innovante.

Ces bonnes pratiques prévoient notamment les modalités de suivi permettant d'assurer, à l'occasion de chacune des opérations susmentionnées, la traçabilité des médicaments.

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La préparation, la conservation, la distribution et la cession des médicaments de thérapie innovante mentionnés au 17° de l'article L. 5121-1 doivent être réalisées en conformité avec les bonnes pratiques mentionnées au premier alinéa du présent article ou avec des bonnes pratiques dont les principes sont définis par décision de l'Agence française de sécurité sanitaire des produits de santé, après avis du directeur général de l'Agence de la biomédecine, lorsque ces bonnes pratiques concernent des médicaments de thérapie cellulaire somatique, des produits issus de l'ingénierie tissulaire ou des médicaments combinés de thérapie innovante.

La dispensation des médicaments doit être réalisée en conformité avec des bonnes pratiques dont les principes sont définis par arrêté du ministre chargé de la santé.

Ces bonnes pratiques prévoient notamment les modalités de suivi permettant d'assurer, à l'occasion de chacune des opérations susmentionnées, la traçabilité des médicaments.

\n
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La préparation, l'importation, l'exportation, la distribution en gros et l'activité de courtage de médicaments ainsi que la pharmacovigilance, doivent être réalisées en conformité avec des bonnes pratiques dont les principes sont définis par décision de l'Agence nationale de sécurité du médicament et des produits de santé.

La préparation, la conservation, la distribution et la cession des médicaments de thérapie innovante mentionnés au 17° de l'article L. 5121-1 doivent être réalisées en conformité avec les bonnes pratiques mentionnées au premier alinéa du présent article ou avec des bonnes pratiques dont les principes sont définis par décision de l'Agence française de sécurité sanitaire des produits de santé, après avis du directeur général de l'Agence de la biomédecine, lorsque ces bonnes pratiques concernent des médicaments de thérapie cellulaire somatique, des produits issus de l'ingénierie tissulaire ou des médicaments combinés de thérapie innovante.

Ces bonnes pratiques prévoient notamment les modalités de suivi permettant d'assurer, à l'occasion de chacune des opérations susmentionnées, la traçabilité des médicaments.

" } }, "LEGIARTI000033851321": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "1", "TYPE": "ENTIEREMENT_MODIF", "DATE_FIN": "2999-01-01", "DATE_DEBUT": "2999-01-01" } }, "META_COMMUN": { "ID": "LEGIARTI000033851321", "URL": "article/LEGI/ARTI/00/00/33/85/13/LEGIARTI000033851321.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "LIENS": { "LIEN": [ { "@id": "LEGIARTI000029460533", "@num": "R1223-31", "#text": "Code de la santé publique - art. R1223-31 (Ab)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "ABROGE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000029460452", "@num": "R1223-7-1", "#text": "Code de la santé publique - art. R1223-7-1 (Ab)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "ABROGE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000033857061", "@num": "R1243-22", "#text": "Code de la santé publique - art. 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R5124-10 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000033856916", "@num": "R5124-10-1", "#text": "Code de la santé publique - art. R5124-10-1 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000033856911", "@num": "R5124-13", "#text": "Code de la santé publique - art. R5124-13 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000033856899", "@num": "R5124-14", "#text": "Code de la santé publique - art. R5124-14 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000033857013", "@num": "R5124-2", "#text": "Code de la santé publique - art. R5124-2 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006915111", "@num": "R5124-25", "#text": "Code de la santé publique - art. R5124-25 (Ab)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "ABROGE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000033857003", "@num": "R5124-3", "#text": "Code de la santé publique - art. R5124-3 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000033856986", "@num": "R5124-3-1", "#text": "Code de la santé publique - art. R5124-3-1 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000033856881", "@num": "R5124-34", "#text": "Code de la santé publique - art. R5124-34 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000033856873", "@num": "R5124-35", "#text": "Code de la santé publique - art. R5124-35 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000033856976", "@num": "R5124-4", "#text": "Code de la santé publique - art. R5124-4 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000033856858", "@num": "R5124-43", "#text": "Code de la santé publique - art. R5124-43 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000033856806", "@num": "R5124-45", "#text": "Code de la santé publique - art. R5124-45 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000033856800", "@num": "R5124-46", "#text": "Code de la santé publique - art. R5124-46 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000033856780", "@num": "R5124-47", "#text": "Code de la santé publique - art. R5124-47 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000033856959", "@num": "R5124-5", "#text": "Code de la santé publique - art. R5124-5 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000033856771", "@num": "R5124-53", "#text": "Code de la santé publique - art. R5124-53 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000033856695", "@num": "R5124-6", "#text": "Code de la santé publique - art. R5124-6 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000033856760", "@num": "R5124-61", "#text": "Code de la santé publique - art. R5124-61 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000033856952", "@num": "R5124-7", "#text": "Code de la santé publique - art. R5124-7 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000033856943", "@num": "R5124-8", "#text": "Code de la santé publique - art. R5124-8 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000033856936", "@num": "R5124-9", "#text": "Code de la santé publique - art. R5124-9 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000033851841", "@num": "R5124-9-1", "#text": "Code de la santé publique - art. R5124-9-1 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CREE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000033856753", "@num": "R5313-1", "#text": "Code de la santé publique - art. R5313-1 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000026595976", "@num": "R5313-2-1", "#text": "Code de la santé publique - art. R5313-2-1 (Ab)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "ABROGE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000033856747", "@num": "R5313-3", "#text": "Code de la santé publique - art. R5313-3 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000033851855", "@num": "R5313-3-1", "#text": "Code de la santé publique - art. R5313-3-1 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CREE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000033851857", "@num": "R5313-3-2", "#text": "Code de la santé publique - art. R5313-3-2 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CREE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000033856733", "@num": "R5313-4", "#text": "Code de la santé publique - art. R5313-4 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000033856706", "@num": "R5313-5", "#text": "Code de la santé publique - art. R5313-5 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000033851866", "@num": "R5313-5-1", "#text": "Code de la santé publique - art. R5313-5-1 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CREE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000033851879", "@num": "R5313-6-1", "#text": "Code de la santé publique - art. R5313-6-1 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CREE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000033851881", "@num": "R5313-6-2", "#text": "Code de la santé publique - art. R5313-6-2 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CREE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000033851884", "@num": "R5313-6-3", "#text": "Code de la santé publique - art. R5313-6-3 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CREE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "@cid": "JORFTEXT000033850698", "@nor": "AFSP1622630D", "@num": "2017-20", "@nature": "DECRET", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Décret n° 2017-20 du 9 janvier 2017 relatif aux établissements pharmaceutiques et à l'inspection par l'Agence nationale de sécurité du médicament et des produits de santé et portant simplification de procédures mises en œuvre par cette agence", "@debut": "2999-01-01", "@id_txt": "JORFTEXT000033850698", "@c_titre_court": "Décret n°2017-20 du 9 janvier 2017" }, { "@fin": "2999-01-01", "#text": "Décret n° 2017-20 du 9 janvier 2017 relatif aux établissements pharmaceutiques et à l'inspection par l'Agence nationale de sécurité du médicament et des produits de santé et portant simplification de procédures mises en œuvre par cette agence", "@debut": "2017-01-12", "@id_txt": "LEGITEXT000033851310", "@c_titre_court": "Décret n°2017-20 du 9 janvier 2017" } ], "@ministere": "Ministère des affaires sociales et de la santé", "@date_publi": "2017-01-11", "@date_signature": "2017-01-09", "@num_parution_jo": "0009" } }, "VERSIONS": { "VERSION": [ { "LIEN_ART": { "@id": "LEGIARTI000033851321", "@fin": "2999-01-01", "@num": "1", "@debut": "2999-01-01", "@origine": "LEGI" } }, { "LIEN_ART": { "@id": "JORFARTI000033850705", "@fin": "2999-01-01", "@num": "1", "@debut": "2999-01-01", "@origine": "JORF" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "

\n
A abrogé les dispositions suivantes :

-Code de la santé publique
\nArt. R1243-28, Art. R5124-25, Art. R5313-2-1, Art. R1223-7-1, Art. R1223-31 \n
\n

A créé les dispositions suivantes :

-Code de la santé publique
\nArt. R5124-9-1 \n
\n

A créé les dispositions suivantes :

-Code de la santé publique
\nArt. R5313-6-1, Art. R5313-6-2, Art. R5313-6-3 \n
\n

A créé les dispositions suivantes :

-Code de la santé publique
\nArt. R5313-3-1, Art. R5313-3-2 \n
\n

A créé les dispositions suivantes :

-Code de la santé publique
\nArt. R5313-5-1 \n
\n

A modifié les dispositions suivantes :

-Code de la santé publique
\nArt. R1243-22, Art. R1245-19, Art. R5124-2, Art. R5124-3, Art. R5124-3-1, Art. R5124-4, Art. R5124-5, Art. R5124-6, Art. R5124-7, Art. R5124-8, Art. R5124-9, Art. R5124-10, Art. R5124-10-1, Art. R5124-13, Art. R5124-14, Art. R5124-34, Art. R5124-35, Art. R5124-43, Art. R5124-45, Art. R5124-46, Art. R5124-47, Art. R5124-53, Art. R5124-61, Art. R5313-1, Art. R5313-3, Art. R5313-4, Art. R5313-5\n
\n

\n
" } }, "LEGIARTI000033857169": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R5121-179", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2021-01-01", "DATE_DEBUT": "2017-01-12" } }, "META_COMMUN": { "ID": "LEGIARTI000033857169", "URL": "article/LEGI/ARTI/00/00/33/85/71/LEGIARTI000033857169.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": "LEGITEXT000024154142", "#text": "Décret n°2011-655\n du 10 juin 2011 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000024153599", "@nortexte": "ETSP1024824D", "@numtexte": "2011-655", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2011-06-10" }, { "@id": "LEGIARTI000033851323", "@num": "2", "#text": "Décret n°2017-20 du 9 janvier 2017 - art. 2", "@sens": "cible", "@cidtexte": "JORFTEXT000033850698", "@nortexte": "AFSP1622630D", "@numtexte": "2017-20", "@typelien": "MODIFIE", "@naturetexte": "DECRET", "@datesignatexte": "2017-01-09" }, { "@id": "LEGIARTI000006914903", "@num": "R5121-151", "#text": "Code de la santé publique - art. R5121-151", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006914905", "@num": "R5121-153", "#text": "Code de la santé publique - art. R5121-153", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000025787842", "@num": "R5121-171", "#text": "Code de la santé publique - art. R5121-171 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006914945", "@num": "R5121-182", "#text": "Code de la santé publique - art. R5121-182 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000033856780", "@num": "R5124-47", "#text": "Code de la santé publique - art. R5124-47 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006800605", "@num": "R5144-18", "#text": "Code de la santé publique - art. R5144-18 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006800603", "@num": "R5144-18", "#text": "Code de la santé publique - art. R5144-18 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000026595976", "@num": "R5313-2-1", "#text": "Code de la santé publique - art. R5313-2-1 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006196562", "@fin": "2012-11-10", "#text": "Sous-section 4 : Autres obligations de pharmacovigilance.", "@debut": "2004-08-08" }, { "@id": "LEGISCTA000026596771", "@fin": "2999-01-01", "#text": "Sous-section 4 : Bonnes pratiques de pharmacovigilance", "@debut": "2012-11-10" } ] }, "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": "LEGIARTI000006914938", "@fin": "2012-05-01", "@num": "R5121-179", "@etat": "MODIFIE", "@debut": "2004-08-08", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000025787815", "@fin": "2012-11-10", "@num": "R5121-179", "@etat": "MODIFIE", "@debut": "2012-05-01", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000026596766", "@fin": "2017-01-12", "@num": "R5121-179", "@etat": "MODIFIE", "@debut": "2012-11-10", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000033857169", "@fin": "2021-01-01", "@num": "R5121-179", "@etat": "MODIFIE", "@debut": "2017-01-12", "@origine": "LEGI" } }, { "@etat": "VIGUEUR", "LIEN_ART": { "@id": "LEGIARTI000039659062", "@fin": "2999-01-01", "@num": "R5121-179", "@etat": "VIGUEUR", "@debut": "2021-01-01", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "

Une décision du directeur général de l'Agence nationale de sécurité du médicament et des produits de santé définit les principes des bonnes pratiques de pharmacovigilance auxquels sont soumis les intervenants du système national de pharmacovigilance mentionnés à l'article R. 5121-153. Cette décision fixe en outre les modalités de recueil, de vérification et d'évaluation des informations mentionnées à l'article R. 5121-151. Elle est publiée sur le site internet de l'agence.

" } }, "LEGIARTI000039659062": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R5121-179", "ETAT": "VIGUEUR", "TYPE": "AUTONOME", "DATE_FIN": "2999-01-01", "DATE_DEBUT": "2021-01-01" } }, "META_COMMUN": { "ID": "LEGIARTI000039659062", "URL": "article/LEGI/ARTI/00/00/39/65/90/LEGIARTI000039659062.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "NOTA": { "CONTENU": "

Conformément à l'article 2 du décret n° 2019-1306 du 6 décembre 2019, ces dispositions entrent en vigueur à une date fixée par arrêté et au plus tard le 1er janvier 2021.

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Une décision du directeur général de l'Agence nationale de sécurité du médicament et des produits de santé définit les principes des bonnes pratiques de pharmacovigilance. Cette décision fixe en outre les modalités de recueil, de vérification et d'évaluation des informations mentionnées à l'article R. 5121-151. Elle est publiée sur le site internet de l'agence.

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Article R5313-2-1 AUTONOME ABROGE, en vigueur du 10/11/2012 au 12/01/2017 (Code de la santé publique)