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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
" } } }, "article_lien": [ { "article_id": "LEGIARTI000006689884", "cible": false, "cidtexte": "JORFTEXT000000613381", "id": "LEGIARTI000006697009", "typelien": "MODIFICATION" } ], "follow": [ "LIENS.LIEN[@sens=cible,@typelien=CREATION].@id" ], "id": "LEGIARTI000006697009", "liens_entrants": true }

Article 5 ENTIEREMENT_MODIF (LOI n° 2007-248 du 26 février 2007 portant diverses dispositions d'adaptation au droit communautaire dans le domaine du médicament (1))