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Le fait d'ouvrir ou de faire fonctionner un établissement défini à l'article L. 5142-1, sans l'autorisation exigée en application des articles 88 et 99 du règlement (UE) 2019/6 du 11 décembre 2018 ou sans que celle-ci ait été renouvelée en cas de modification des éléments figurant dans l'autorisation initiale, est puni de deux ans d'emprisonnement et de 150 000 euros d'amende.

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" } }, "LEGIARTI000006690231": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "L5142-1", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2022-03-25", "DATE_DEBUT": "2000-06-22" } }, "META_COMMUN": { "ID": "LEGIARTI000006690231", "URL": "article/LEGI/ARTI/00/00/06/69/02/LEGIARTI000006690231.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SPANXXXXXXX1X5142L01XXAA" } }, "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": "LEGIARTI000006734074", "@num": "ANNEXE", "#text": "Arrêté du 21 avril 2005 - art. 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La fabrication, l'importation, l'exportation et la distribution en gros de médicaments vétérinaires, la fabrication, l'importation et la distribution de médicaments soumis à des essais cliniques, ainsi que l'exploitation de médicaments vétérinaires, ne peuvent être effectuées que dans des établissements régis par le présent chapitre.
\n
Toute entreprise qui comporte au moins un établissement visé au premier alinéa doit être la propriété d'un pharmacien, d'un vétérinaire ou d'une société à la gérance ou à la direction générale de laquelle participe un pharmacien ou un vétérinaire. Elle peut être, en tout ou partie, concédée en location-gérance à une société. Cette société doit être la propriété d'un pharmacien ou d'un vétérinaire ou comporter la participation d'un pharmacien ou d'un vétérinaire à sa direction générale ou sa gérance.
\n
Les pharmaciens ou vétérinaires mentionnés à l'alinéa précédent sont dénommés : \" pharmaciens ou vétérinaires responsables \". Ils sont personnellement responsables du respect des dispositions du livre II de la partie IV et du présent livre, ayant trait à leur activité, sans préjudice, le cas échéant, de la responsabilité solidaire de la société.
\n
Dans chaque établissement pharmaceutique de l'entreprise, un pharmacien ou un vétérinaire délégué veille au respect des dispositions du présent livre sous l'autorité du pharmacien ou du vétérinaire responsable de l'entreprise. Lorsque le pharmacien ou le vétérinaire responsable exerce ses fonctions dans l'un des établissements pharmaceutiques d'une entreprise, la désignation d'un pharmacien délégué ou d'un vétérinaire délégué n'est pas obligatoire dans cet établissement.
\n
Les pharmaciens ou vétérinaires responsables et les pharmaciens ou vétérinaires délégués doivent justifier d'une expérience pratique appropriée.
\n
Toutefois, les établissements assurant la fabrication ou la distribution d'aliments médicamenteux ne sont pas tenus aux obligations prévues aux deuxième à cinquième alinéas ci-dessus ; dans le cas où ils n'y souscrivent pas, le contrôle de la fabrication et de la délivrance est cependant assuré, dans des conditions fixées par décret, par un pharmacien ou un vétérinaire ; ce pharmacien ou ce vétérinaire est personnellement responsable de l'application des dispositions législatives et réglementaires concernant les aliments médicamenteux, sans préjudice, le cas échéant, de la responsabilité solidaire de la société.
" } }, "LEGIARTI000006690232": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "L5142-2", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2007-04-27", "DATE_DEBUT": "2000-06-22" } }, "META_COMMUN": { "ID": "LEGIARTI000006690232", "URL": "article/LEGI/ARTI/00/00/06/69/02/LEGIARTI000006690232.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SPANXXXXXXX1X5142L02XXAA" } }, "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": "LEGIARTI000006232360", "@num": "1", "#text": "Arrêté du 29 juin 2004 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000441440", "@nortexte": "SANP0422287A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2004-06-29" }, { "@id": "LEGIARTI000006734074", "@num": "ANNEXE", "#text": "Arrêté du 21 avril 2005 - art. 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L234-2 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006071367", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006171387", "@fin": "2999-01-01", "#text": "Chapitre II : Préparation industrielle et vente en gros.", "@debut": "2000-06-22" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006155087", "@fin": "2999-01-01", "#text": "Titre IV : Médicaments vétérinaires", "@debut": "2000-06-22" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006140630", "@fin": "2999-01-01", "#text": "Livre Ier : Produits pharmaceutiques", "@debut": "2000-06-22" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006125349", "@fin": "2999-01-01", "#text": "Cinquième partie : Produits de santé", "@debut": "2000-06-22" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006103419", "@fin": "2999-01-01", "#text": "Partie législative", "@debut": "2000-06-22" } ] }, "@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": "LEGIARTI000006690232", "@fin": "2007-04-27", "@num": "L5142-2", "@etat": "MODIFIE", "@debut": "2000-06-22", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006690233", "@fin": "2010-07-01", "@num": "L5142-2", "@etat": "MODIFIE", "@debut": "2007-04-27", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000021666189", "@fin": "2022-03-25", "@num": "L5142-2", "@etat": "MODIFIE", "@debut": "2010-07-01", "@origine": "LEGI" } }, { "@etat": "VIGUEUR", "LIEN_ART": { "@id": "LEGIARTI000045405173", "@fin": "2999-01-01", "@num": "L5142-2", "@etat": "VIGUEUR", "@debut": "2022-03-25", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
L'ouverture d'un établissement visé à l'article L. 5142-1 est subordonnée à une autorisation délivrée par l'agence française de sécurité sanitaire des aliments. Celle-ci peut être, après mise en demeure, suspendue ou retirée en cas d'infraction aux dispositions du livre II de la partie IV et du présent livre.
\n
Toute modification des éléments figurant dans l'autorisation initiale doit faire l'objet d'une autorisation préalable.
" } }, "LEGIARTI000006690233": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "L5142-2", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2010-07-01", "DATE_DEBUT": "2007-04-27" } }, "META_COMMUN": { "ID": "LEGIARTI000006690233", "URL": "article/LEGI/ARTI/00/00/06/69/02/LEGIARTI000006690233.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SPANXXXXXXX1X5142L02XXAB" } }, "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": "LEGIARTI000006232360", "@num": "1", "#text": "Arrêté du 29 juin 2004 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000441440", "@nortexte": "SANP0422287A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2004-06-29" }, { "@id": "LEGIARTI000006734074", "@num": "ANNEXE", "#text": "Arrêté du 21 avril 2005 - art. ANNEXE (VT)", "@sens": "cible", "@cidtexte": "JORFTEXT000000627974", "@nortexte": "SANP0521551A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2005-04-21" }, { "@id": "LEGIARTI000006733880", "@num": "1", "#text": "Arrêté du 19 mai 2005 - art. 1 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000810854", "@nortexte": "SANP0521868A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2005-05-19" }, { "@id": "LEGIARTI000006698459", "@num": "40", "#text": "Ordonnance n°2007-613 du 26 avril 2007 - art. 40 () JORF 27 avril 2007", "@sens": "source", "@cidtexte": "JORFTEXT000000646989", "@nortexte": "SANX0700046R", "@numtexte": "2007-613", "@typelien": "MODIFICATION", "@naturetexte": "ORDONNANCE", "@datesignatexte": "2007-04-26" }, { "@id": "LEGIARTI000025882819", "#text": "Arrêté du 1er septembre 2009 - art. (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000021021310", "@nortexte": "SASP0920309A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2009-09-01" }, { "@id": "LEGIARTI000025797173", "@num": "1", "#text": "Arrêté du 20 avril 2012 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000025794925", "@nortexte": "ETSP1221356A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2012-04-20" }, { "@id": "LEGIARTI000039012758", "@num": "4", "#text": "Décret n°2019-917 du 30 août 2019 - art. 4 (VD)", "@sens": "cible", "@cidtexte": "JORFTEXT000039003634", "@nortexte": "ECOI1914037D", "@numtexte": "2019-917", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2019-08-30" }, { "@id": "LEGITEXT000039325764", "#text": "Arrêté du 14 octobre 2019 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000039322983", "@nortexte": "ECOI1922087A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2019-10-14" }, { "@id": "LEGIARTI000046211966", "@num": "10-1", "#text": "Arrêté du 14 octobre 2019 - art. 10-1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000039322983", "@nortexte": "ECOI1922087A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2019-10-14" }, { "@id": "LEGIARTI000044157349", "@num": "2", "#text": "Décret n°2021-1287 du 1er octobre 2021 - art. 2", "@sens": "cible", "@cidtexte": "JORFTEXT000044155805", "@nortexte": "ECOI2101035D", "@numtexte": "2021-1287", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2021-10-01" }, { "@id": "LEGIARTI000046211409", "@num": "5", "#text": "Arrêté du 10 août 2022 - art. 5", "@sens": "cible", "@cidtexte": "JORFTEXT000046210756", "@nortexte": "ECOI2219267A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2022-08-10" }, { "@id": "LEGIARTI000021941908", "@num": "L5141-8", "#text": "Code de la santé publique - art. L5141-8 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006690231", "@num": "L5142-1", "#text": "Code de la santé publique - art. L5142-1 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000021666170", "@num": "L5142-8", "#text": "Code de la santé publique - art. L5142-8 (VD)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000045405453", "@num": "L5441-5", "#text": "Code de la santé publique - art. L5441-5 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000045405480", "@num": "L5442-11", "#text": "Code de la santé publique - art. L5442-11 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000029581907", "@num": "L5442-14", "#text": "Code de la santé publique - art. L5442-14 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693802", "@num": "L616", "#text": "Code de la santé publique - art. L616 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693800", "@num": "L616", "#text": "Code de la santé publique - art. L616 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000044365291", "@num": "R5132-89", "#text": "Code de la santé publique - art. R5132-89 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006916018", "@num": "R5141-123-17", "#text": "Code de la santé publique - art. R5141-123-17 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000025787346", "@num": "R5141-123-3", "#text": "Code de la santé publique - art. R5141-123-3 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000023860523", "@num": "R5141-127", "#text": "Code de la santé publique - art. R5141-127 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000023860519", "@num": "R5141-128", "#text": "Code de la santé publique - art. R5141-128 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006915811", "@num": "R5141-14", "#text": "Code de la santé publique - art. R5141-14 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006915875", "@num": "R5141-64", "#text": "Code de la santé publique - art. R5141-64 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000025787330", "@num": "R5142-15", "#text": "Code de la santé publique - art. R5142-15 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000027859950", "@num": "R5142-9", "#text": "Code de la santé publique - art. R5142-9 (VD)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006800660", "@num": "R5145-12", "#text": "Code de la santé publique - art. R5145-12 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006800655", "@num": "R5145-8", "#text": "Code de la santé publique - art. R5145-8 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006800932", "@num": "R5146-39-9", "#text": "Code de la santé publique - art. R5146-39-9 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006801051", "@num": "R5146-55-5", "#text": "Code de la santé publique - art. R5146-55-5 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006801052", "@num": "R5146-55-6", "#text": "Code de la santé publique - art. R5146-55-6 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000045405624", "@num": "L234-2", "#text": "Code rural et de la pêche maritime - art. L234-2 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006071367", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006171387", "@fin": "2999-01-01", "#text": "Chapitre II : Préparation industrielle et vente en gros.", "@debut": "2000-06-22" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006155087", "@fin": "2999-01-01", "#text": "Titre IV : Médicaments vétérinaires", "@debut": "2000-06-22" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006140630", "@fin": "2999-01-01", "#text": "Livre Ier : Produits pharmaceutiques", "@debut": "2000-06-22" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006125349", "@fin": "2999-01-01", "#text": "Cinquième partie : Produits de santé", "@debut": "2000-06-22" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006103419", "@fin": "2999-01-01", "#text": "Partie législative", "@debut": "2000-06-22" } ] }, "@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": "LEGIARTI000006690232", "@fin": "2007-04-27", "@num": "L5142-2", "@etat": "MODIFIE", "@debut": "2000-06-22", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006690233", "@fin": "2010-07-01", "@num": "L5142-2", "@etat": "MODIFIE", "@debut": "2007-04-27", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000021666189", "@fin": "2022-03-25", "@num": "L5142-2", "@etat": "MODIFIE", "@debut": "2010-07-01", "@origine": "LEGI" } }, { "@etat": "VIGUEUR", "LIEN_ART": { "@id": "LEGIARTI000045405173", "@fin": "2999-01-01", "@num": "L5142-2", "@etat": "VIGUEUR", "@debut": "2022-03-25", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
L'ouverture d'un établissement visé à l'article L. 5142-1 est subordonnée à une autorisation délivrée par l'agence française de sécurité sanitaire des aliments. Celle-ci peut être, après mise en demeure, suspendue ou retirée en cas d'infraction aux dispositions du livre II de la partie IV et du présent livre.
\n
Toute modification substantielle des éléments de l'autorisation initiale est subordonnée à une autorisation préalable. Un décret en Conseil d'Etat fixe les cas de modification substantielle de l'autorisation initiale. Les autres modifications font l'objet d'une déclaration.
" } }, "LEGIARTI000021666189": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "L5142-2", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2022-03-25", "DATE_DEBUT": "2010-07-01" } }, "META_COMMUN": { "ID": "LEGIARTI000021666189", "URL": "article/LEGI/ARTI/00/00/21/66/61/LEGIARTI000021666189.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "NOTA": { "CONTENU": "
" }, "LIENS": { "LIEN": [ { "@id": "LEGIARTI000006232360", "@num": "1", "#text": "Arrêté du 29 juin 2004 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000441440", "@nortexte": "SANP0422287A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2004-06-29" }, { "@id": "LEGIARTI000006734074", "@num": "ANNEXE", "#text": "Arrêté du 21 avril 2005 - art. ANNEXE (VT)", "@sens": "cible", "@cidtexte": "JORFTEXT000000627974", "@nortexte": "SANP0521551A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2005-04-21" }, { "@id": "LEGIARTI000006733880", "@num": "1", "#text": "Arrêté du 19 mai 2005 - art. 1 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000810854", "@nortexte": "SANP0521868A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2005-05-19" }, { "@id": "LEGIARTI000025882819", "#text": "Arrêté du 1er septembre 2009 - art. (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000021021310", "@nortexte": "SASP0920309A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2009-09-01" }, { "@id": "LEGIARTI000021661274", "@num": "3", "#text": "Ordonnance n°2010-18\n du 7 janvier 2010 - art. 3", "@sens": "cible", "@cidtexte": "JORFTEXT000021637409", "@nortexte": "SASX0928345R", "@numtexte": "2010-18", "@typelien": "MODIFIE", "@naturetexte": "ORDONNANCE", "@datesignatexte": "2010-01-07" }, { "@id": "LEGIARTI000025797173", "@num": "1", "#text": "Arrêté du 20 avril 2012 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000025794925", "@nortexte": "ETSP1221356A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2012-04-20" }, { "@id": "LEGIARTI000039012758", "@num": "4", "#text": "Décret n°2019-917 du 30 août 2019 - art. 4 (VD)", "@sens": "cible", "@cidtexte": "JORFTEXT000039003634", "@nortexte": "ECOI1914037D", "@numtexte": "2019-917", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2019-08-30" }, { "@id": "LEGITEXT000039325764", "#text": "Arrêté du 14 octobre 2019 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000039322983", "@nortexte": "ECOI1922087A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2019-10-14" }, { "@id": "LEGIARTI000046211966", "@num": "10-1", "#text": "Arrêté du 14 octobre 2019 - art. 10-1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000039322983", "@nortexte": "ECOI1922087A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2019-10-14" }, { "@id": "LEGIARTI000044157349", "@num": "2", "#text": "Décret n°2021-1287 du 1er octobre 2021 - art. 2", "@sens": "cible", "@cidtexte": "JORFTEXT000044155805", "@nortexte": "ECOI2101035D", "@numtexte": "2021-1287", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2021-10-01" }, { "@id": "LEGIARTI000046211409", "@num": "5", "#text": "Arrêté du 10 août 2022 - art. 5", "@sens": "cible", "@cidtexte": "JORFTEXT000046210756", "@nortexte": "ECOI2219267A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2022-08-10" }, { "@id": "LEGIARTI000021941908", "@num": "L5141-8", "#text": "Code de la santé publique - art. L5141-8 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006690231", "@num": "L5142-1", "#text": "Code de la santé publique - art. L5142-1", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000021666170", "@num": "L5142-8", "#text": "Code de la santé publique - art. L5142-8 (VD)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000045405453", "@num": "L5441-5", "#text": "Code de la santé publique - art. L5441-5 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000045405480", "@num": "L5442-11", "#text": "Code de la santé publique - art. L5442-11 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000029581907", "@num": "L5442-14", "#text": "Code de la santé publique - art. L5442-14 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693802", "@num": "L616", "#text": "Code de la santé publique - art. L616 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693800", "@num": "L616", "#text": "Code de la santé publique - art. L616 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000044365291", "@num": "R5132-89", "#text": "Code de la santé publique - art. R5132-89 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006916018", "@num": "R5141-123-17", "#text": "Code de la santé publique - art. R5141-123-17 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000025787346", "@num": "R5141-123-3", "#text": "Code de la santé publique - art. R5141-123-3 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000023860523", "@num": "R5141-127", "#text": "Code de la santé publique - art. R5141-127 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000023860519", "@num": "R5141-128", "#text": "Code de la santé publique - art. R5141-128 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006915811", "@num": "R5141-14", "#text": "Code de la santé publique - art. R5141-14 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006915875", "@num": "R5141-64", "#text": "Code de la santé publique - art. R5141-64 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000025787330", "@num": "R5142-15", "#text": "Code de la santé publique - art. R5142-15 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000027859950", "@num": "R5142-9", "#text": "Code de la santé publique - art. R5142-9 (VD)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006800660", "@num": "R5145-12", "#text": "Code de la santé publique - art. R5145-12 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006800655", "@num": "R5145-8", "#text": "Code de la santé publique - art. R5145-8 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006800932", "@num": "R5146-39-9", "#text": "Code de la santé publique - art. R5146-39-9 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006801051", "@num": "R5146-55-5", "#text": "Code de la santé publique - art. R5146-55-5 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006801052", "@num": "R5146-55-6", "#text": "Code de la santé publique - art. R5146-55-6 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000045405624", "@num": "L234-2", "#text": "Code rural et de la pêche maritime - art. L234-2 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006071367", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006171387", "@fin": "2999-01-01", "#text": "Chapitre II : Préparation industrielle et vente en gros.", "@debut": "2000-06-22" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006155087", "@fin": "2999-01-01", "#text": "Titre IV : Médicaments vétérinaires", "@debut": "2000-06-22" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006140630", "@fin": "2999-01-01", "#text": "Livre Ier : Produits pharmaceutiques", "@debut": "2000-06-22" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006125349", "@fin": "2999-01-01", "#text": "Cinquième partie : Produits de santé", "@debut": "2000-06-22" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006103419", "@fin": "2999-01-01", "#text": "Partie législative", "@debut": "2000-06-22" } ] }, "@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": "LEGIARTI000006690232", "@fin": "2007-04-27", "@num": "L5142-2", "@etat": "MODIFIE", "@debut": "2000-06-22", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006690233", "@fin": "2010-07-01", "@num": "L5142-2", "@etat": "MODIFIE", "@debut": "2007-04-27", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000021666189", "@fin": "2022-03-25", "@num": "L5142-2", "@etat": "MODIFIE", "@debut": "2010-07-01", "@origine": "LEGI" } }, { "@etat": "VIGUEUR", "LIEN_ART": { "@id": "LEGIARTI000045405173", "@fin": "2999-01-01", "@num": "L5142-2", "@etat": "VIGUEUR", "@debut": "2022-03-25", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "

Toute modification substantielle des éléments de l'autorisation initiale est subordonnée à une autorisation préalable. Un décret en Conseil d'Etat fixe les cas de modification substantielle de l'autorisation initiale. Les autres modifications font l'objet d'une déclaration.

" } }, "LEGIARTI000045398889": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "10", "TYPE": "ENTIEREMENT_MODIF", "DATE_FIN": "2999-01-01", "DATE_DEBUT": "2999-01-01" } }, "META_COMMUN": { "ID": "LEGIARTI000045398889", "URL": "article/LEGI/ARTI/00/00/45/39/88/LEGIARTI000045398889.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "LIENS": { "LIEN": [ { "@id": "LEGIARTI000045405412", "@num": "L5441-14", "#text": "Code de la santé publique - art. L5441-14 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000045405410", "@num": "L5441-15", "#text": "Code de la santé publique - art. L5441-15 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000045405404", "@num": "L5441-4", "#text": "Code de la santé publique - art. L5441-4 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000045405453", "@num": "L5441-5", "#text": "Code de la santé publique - art. L5441-5 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000045405438", "@num": "L5441-6", "#text": "Code de la santé publique - art. L5441-6 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000045405421", "@num": "L5441-8", "#text": "Code de la santé publique - art. L5441-8 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000045401437", "@num": "L5441-8-1", "#text": "Code de la santé publique - art. L5441-8-1 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CREE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000045405415", "@num": "L5441-9", "#text": "Code de la santé publique - art. L5441-9 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "@cid": "JORFTEXT000045398547", "@nor": "AGRG2202804R", "@num": "2022-414", "@nature": "ORDONNANCE", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Ordonnance n° 2022-414 du 23 mars 2022 portant adaptation des dispositions du code de la santé publique et du code rural et de la pêche maritime au droit de l'Union européenne dans le domaine des médicaments vétérinaires et aliments médicamenteux", "@debut": "2999-01-01", "@id_txt": "JORFTEXT000045398547", "@c_titre_court": "Ordonnance n°2022-414 du 23 mars 2022" }, { "@fin": "2999-01-01", "#text": "Ordonnance n° 2022-414 du 23 mars 2022 portant adaptation des dispositions du code de la santé publique et du code rural et de la pêche maritime au droit de l'Union européenne dans le domaine des médicaments vétérinaires et aliments médicamenteux", "@debut": "2022-03-25", "@id_txt": "LEGITEXT000045398868", "@c_titre_court": "Ordonnance n°2022-414 du 23 mars 2022" } ], "@ministere": "Ministère de l'agriculture et de l'alimentation", "@date_publi": "2022-03-24", "@date_signature": "2022-03-23", "@num_parution_jo": "0070" } }, "VERSIONS": { "VERSION": [ { "LIEN_ART": { "@id": "LEGIARTI000045398889", "@fin": "2999-01-01", "@num": "10", "@debut": "2999-01-01", "@origine": "LEGI" } }, { "LIEN_ART": { "@id": "JORFARTI000045398557", "@fin": "2999-01-01", "@num": "10", "@debut": "2999-01-01", "@origine": "JORF" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
A modifié les dispositions suivantes :

- Code de la santé publique
\n Art. L5441-5, Art. L5441-6, Art. L5441-8, Art. L5441-9, Art. L5441-14, Art. L5441-15, Art. L5441-4\n
\n

\n
\n
A créé les dispositions suivantes :

- Code de la santé publique
\n Art. L5441-8-1\n
\n

\n
" } }, "LEGIARTI000045405173": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "L5142-2", "ETAT": "VIGUEUR", "TYPE": "AUTONOME", "DATE_FIN": "2999-01-01", "DATE_DEBUT": "2022-03-25" } }, "META_COMMUN": { "ID": "LEGIARTI000045405173", "URL": "article/LEGI/ARTI/00/00/45/40/51/LEGIARTI000045405173.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "NOTA": { "CONTENU": "
" }, "LIENS": { "LIEN": [ { "@id": "LEGIARTI000006232360", "@num": "1", "#text": "Arrêté du 29 juin 2004 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000441440", "@nortexte": "SANP0422287A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2004-06-29" }, { "@id": "LEGIARTI000006734074", "@num": "ANNEXE", "#text": "Arrêté du 21 avril 2005 - art. ANNEXE (VT)", "@sens": "cible", "@cidtexte": "JORFTEXT000000627974", "@nortexte": "SANP0521551A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2005-04-21" }, { "@id": "LEGIARTI000006733880", "@num": "1", "#text": "Arrêté du 19 mai 2005 - art. 1 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000810854", "@nortexte": "SANP0521868A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2005-05-19" }, { "@id": "LEGIARTI000025882819", "#text": "Arrêté du 1er septembre 2009 - art. 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L'ouverture d'un établissement visé à l'article L. 5142-1 est subordonnée à une autorisation délivrée par l'Agence nationale chargée de la sécurité sanitaire de l'alimentation, de l'environnement et du travail. Celle-ci peut être, après mise en demeure, modifiée, suspendue ou retirée en cas de manquement ou d'infraction au règlement (UE) 2019/6 du 11 décembre 2018 ou aux dispositions du livre II de la quatrième partie et du présent livre.
\n
\n Toute modification des éléments de l'autorisation initiale est subordonnée à une autorisation préalable.

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I.-La fabrication, l'importation, l'exportation et la distribution en gros de médicaments vétérinaires, la fabrication, l'importation et la distribution de médicaments soumis à des essais cliniques, sont effectuées par des établissements régis par le règlement (UE) 2019/6 du 11 décembre 2018 et par le présent chapitre.
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\n II.-Dans chaque établissement autorisé au titre de l'article 88 du règlement (UE) 2019/6 du 11 décembre 2018, une personne qualifiée est notamment responsable de l'exécution des missions spécifiées à l'article 97 du même règlement.
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\n III.-Dans chaque établissement de distribution en gros de médicaments vétérinaires autorisé au titre de l'article 99 du règlement (UE) 2019/6 du 11 décembre 2018, une personne est responsable de l'exécution des missions spécifiées à l'article 101 du même règlement.
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\n IV.-Les personnes mentionnées aux II et III sont personnellement responsables respectivement du respect des dispositions des points 6 à 8 de l'article 97 et des dispositions de l'article 101 du règlement (UE) 2019/6 du 11 décembre 2018 et du présent livre ayant trait à leur activité, sans préjudice, le cas échéant, de la responsabilité solidaire de l'entreprise.

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Article L5441-5 AUTONOME VIGUEUR, en vigueur depuis le 25/03/2022 (Code de la santé publique)