{ "article": { "LEGIARTI000026806468": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "3", "TYPE": "ENTIEREMENT_MODIF", "DATE_FIN": "2999-01-01", "DATE_DEBUT": "2999-01-01" } }, "META_COMMUN": { "ID": "LEGIARTI000026806468", "URL": "article/LEGI/ARTI/00/00/26/80/64/LEGIARTI000026806468.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "LIENS": { "LIEN": [ { "@id": "LEGIARTI000026809018", "@num": "L5121-5", "#text": "Code de la santé publique - art. L5121-5 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "ABROGE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000026809018", "@num": "L5121-5", "#text": "Code de la santé publique - art. L5121-5 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "@cid": "JORFTEXT000026805101", "@nor": "AFSX1240311R", "@num": "2012-1427", "@nature": "ORDONNANCE", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Ordonnance n° 2012-1427 du 19 décembre 2012 relative au renforcement de la sécurité de la chaîne d'approvisionnement des médicaments, à l'encadrement de la vente de médicaments sur internet et à la lutte contre la falsification de médicaments", "@debut": "2999-01-01", "@id_txt": "JORFTEXT000026805101", "@c_titre_court": "Ordonnance n° 2012-1427 du 19 décembre 2012" }, { "@fin": "2999-01-01", "#text": "Ordonnance n° 2012-1427 du 19 décembre 2012 relative au renforcement de la sécurité de la chaîne d'approvisionnement des médicaments, à l'encadrement de la vente de médicaments sur internet et à la lutte contre la falsification de médicaments", "@debut": "2012-12-22", "@id_txt": "LEGITEXT000026806459", "@c_titre_court": "Ordonnance n°2012-1427 du 19 décembre 2012" } ], "@ministere": "Ministère des affaires sociales et de la santé", "@date_publi": "2012-12-21", "@date_signature": "2012-12-19" } }, "VERSIONS": { "VERSION": [ { "LIEN_ART": { "@id": "LEGIARTI000026806468", "@fin": "2999-01-01", "@num": "3", "@debut": "2999-01-01", "@origine": "LEGI" } }, { "LIEN_ART": { "@id": "JORFARTI000026805114", "@fin": "2999-01-01", "@num": "3", "@debut": "2999-01-01", "@origine": "JORF" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
A modifié les dispositions suivantes :

- Code de la santé publique
\n Art. L5121-5\n
\n

\n
" } }, "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. 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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.

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 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, 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.

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Article 3 ENTIEREMENT_MODIF (Ordonnance n° 2012-1427 du 19 décembre 2012 relative au renforcement de la sécurité de la chaîne d'approvisionnement des médicaments, à l'encadrement de la vente de médicaments sur internet et à la lutte contre la falsification de médicaments)