{ "article": { "LEGIARTI000006690015": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "L5125-1", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2008-04-17", "DATE_DEBUT": "2000-06-22" } }, "META_COMMUN": { "ID": "LEGIARTI000006690015", "URL": "article/LEGI/ARTI/00/00/06/69/00/LEGIARTI000006690015.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SPANXXXXXXX1X5125L01XXAA" } }, "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": "LEGITEXT000021192676", "#text": "Décret n°2009-1283 du 22 octobre 2009 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000021190563", "@nortexte": "SASP0917871D", "@numtexte": "2009-1283", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2009-10-22" }, { "@id": "LEGIARTI000025541502", "@num": "4", "#text": "Arrêté du 9 mars 2012 - 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On entend par officine l'établissement affecté à la dispensation au détail des médicaments, produits et objets mentionnés à l'article L. 4211-1 ainsi qu'à l'exécution des préparations magistrales ou officinales.
\n
" } }, "LEGIARTI000006693602": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "L568", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "1992-12-11", "DATE_DEBUT": "1953-10-07" } }, "META_COMMUN": { "ID": "LEGIARTI000006693602", "URL": "article/LEGI/ARTI/00/00/06/69/36/LEGIARTI000006693602.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SPAOXXXXXXX1X568L00AXXAA" } }, "NOTA": { "CONTENU": "
[*Nota : Ordonnance 92-1070 du 1er octobre 1992 art. 46 : le présent article du code de la santé publique, en vigueur au 7 avril 1992, s'applique à la collectivité territoriale de Mayotte.*]
\n
" }, "LIENS": { "LIEN": [ { "@id": "JORFTEXT000000503843", "#text": "Décret 53-1001 1953-10-05 (décret de codification)", "@sens": "source", "@cidtexte": "JORFTEXT000000503843", "@numtexte": "53-1001", "@typelien": "CODIFICATION", "@naturetexte": "DECRET", "@datesignatexte": "1953-10-05" }, { "@id": "LEGIARTI000006723807", "@num": "1", "#text": "Décret n°99-740 du 25 août 1999 - art. 1 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000761890", "@nortexte": "MESP9922275D", "@numtexte": "99-740", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1999-08-25" }, { "@id": "LEGIARTI000006693411", "@num": "L511", "#text": "Code de la santé publique - art. L511 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006690015", "@num": "L5125-1", "#text": "Code de la santé publique - art. L5125-1 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006799044", "@num": "R5001", "#text": "Code de la santé publique - art. R5001 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006799071", "@num": "R5005", "#text": "Code de la santé publique - art. R5005 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006799093", "@num": "R5009", "#text": "Code de la santé publique - art. R5009 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006799485", "@num": "R5056", "#text": "Code de la santé publique - art. R5056 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006801233", "@num": "R5189", "#text": "Code de la santé publique - art. R5189 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGITEXT000006072665", "#text": "Code de la santé publique R5001 : PHARMACOPEE", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "TXT_ASSOCIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "#text": "Loi 41-3890 1941-09-11 art. 19", "@sens": "source", "@typelien": "CONCORDANCE" }, { "#text": "Loi 58-356 1958-04-03 (loi de validation)", "@sens": "source", "@typelien": "CODIFICATION" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006171754", "@fin": "2000-06-22", "#text": "Section 1 : Des officines de pharmacie", "@debut": "1953-10-07" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006155247", "@fin": "2000-06-22", "#text": "Chapitre 1 : Conditions de l'exercice de la pharmacie d'officine", "@debut": "1953-10-07" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006140721", "@fin": "2000-06-22", "#text": "Titre 2 : Dispositions particulières aux divers modes d'exercice de la pharmacie", "@debut": "1953-10-07" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006125380", "@fin": "2004-08-08", "#text": "Livre 5 : Pharmacie", "@debut": "1953-10-07" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006103420", "@fin": "2999-01-01", "#text": "Partie législative ancienne", "@debut": "1953-10-07" } ] }, "@cid": "LEGITEXT000006072665", "@nature": "CODE", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Code de la santé publique", "@debut": "1953-10-07", "@id_txt": "LEGITEXT000006072665", "@c_titre_court": "Code de la santé publique" } ], "@date_publi": "2999-01-01", "@date_signature": "2999-01-01" } }, "VERSIONS": { "VERSION": [ { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006693602", "@fin": "1992-12-11", "@num": "L568", "@etat": "MODIFIE", "@debut": "1953-10-07", "@origine": "LEGI" } }, { "@etat": "ABROGE", "LIEN_ART": { "@id": "LEGIARTI000006693603", "@fin": "2000-06-22", "@num": "L568", "@etat": "ABROGE", "@debut": "1992-12-11", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
On entend par officine [*définition*] l'établissement affecté à l'exécution des ordonnances magistrales, à la préparation des médicaments inscrits au codex [*pharmacopée*] et à la vente au détail des produits visés à l'article L. 511.
\n
" } }, "LEGIARTI000006693603": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "L568", "ETAT": "ABROGE", "TYPE": "AUTONOME", "DATE_FIN": "2000-06-22", "DATE_DEBUT": "1992-12-11" } }, "META_COMMUN": { "ID": "LEGIARTI000006693603", "URL": "article/LEGI/ARTI/00/00/06/69/36/LEGIARTI000006693603.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SPAOXXXXXXX1X568L00AXXAB" } }, "NOTA": { "CONTENU": "
[*Nota : Ordonnance 92-1070 du 1er octobre 1992 art. 46 : le présent article du code de la santé publique, en vigueur au 7 avril 1992, s'applique à la collectivité territoriale de Mayotte.*]
\n
" }, "LIENS": { "LIEN": [ { "@id": "JORFTEXT000000503843", "#text": "Décret 53-1001 1953-10-05 (décret de codification)", "@sens": "source", "@cidtexte": "JORFTEXT000000503843", "@numtexte": "53-1001", "@typelien": "CODIFICATION", "@naturetexte": "DECRET", "@datesignatexte": "1953-10-05" }, { "@id": "LEGIARTI000006696589", "@num": "5", "#text": "Loi n°92-1279 du 8 décembre 1992 - art. 5 () JORF 11 décembre 1992", "@sens": "source", "@cidtexte": "JORFTEXT000000178408", "@nortexte": "SANX9100161L", "@numtexte": "92-1279", "@typelien": "MODIFICATION", "@naturetexte": "LOI", "@datesignatexte": "1992-12-08" }, { "@id": "LEGIARTI000006723807", "@num": "1", "#text": "Décret n°99-740 du 25 août 1999 - art. 1 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000761890", "@nortexte": "MESP9922275D", "@numtexte": "99-740", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1999-08-25" }, { "@id": "JORFTEXT000000217229", "#text": "Ordonnance 2000-548 2000-06-15 art. 4 I JORF 22 juin 2000", "@sens": "source", "@cidtexte": "JORFTEXT000000217229", "@nortexte": "MESX0000036P", "@typelien": "ABROGATION", "@naturetexte": "RAPPORT", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693421", "@num": "L512", "#text": "Code de la santé publique - art. L512 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006690015", "@num": "L5125-1", "#text": "Code de la santé publique - art. L5125-1 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006690015", "@num": "L5125-1", "#text": "Code de la santé publique - art. L5125-1 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006799044", "@num": "R5001", "#text": "Code de la santé publique - art. R5001 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006799071", "@num": "R5005", "#text": "Code de la santé publique - art. R5005 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006799093", "@num": "R5009", "#text": "Code de la santé publique - art. R5009 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006799485", "@num": "R5056", "#text": "Code de la santé publique - art. R5056 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006801233", "@num": "R5189", "#text": "Code de la santé publique - art. R5189 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "#text": "Code de la santé publique l518 : dispositions pénales", "@sens": "source", "@typelien": "TXT_ASSOCIE" }, { "#text": "Code de la santé publique r5001 : pharmacopee", "@sens": "source", "@typelien": "TXT_ASSOCIE" }, { "#text": "Loi 58-356 1958-04-03 (loi de validation)", "@sens": "source", "@typelien": "CODIFICATION" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006171754", "@fin": "2000-06-22", "#text": "Section 1 : Des officines de pharmacie", "@debut": "1953-10-07" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006155247", "@fin": "2000-06-22", "#text": "Chapitre 1 : Conditions de l'exercice de la pharmacie d'officine", "@debut": "1953-10-07" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006140721", "@fin": "2000-06-22", "#text": "Titre 2 : Dispositions particulières aux divers modes d'exercice de la pharmacie", "@debut": "1953-10-07" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006125380", "@fin": "2004-08-08", "#text": "Livre 5 : Pharmacie", "@debut": "1953-10-07" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006103420", "@fin": "2999-01-01", "#text": "Partie législative ancienne", "@debut": "1953-10-07" } ] }, "@cid": "LEGITEXT000006072665", "@nature": "CODE", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Code de la santé publique", "@debut": "1953-10-07", "@id_txt": "LEGITEXT000006072665", "@c_titre_court": "Code de la santé publique" } ], "@date_publi": "2999-01-01", "@date_signature": "2999-01-01" } }, "VERSIONS": { "VERSION": [ { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006693602", "@fin": "1992-12-11", "@num": "L568", "@etat": "MODIFIE", "@debut": "1953-10-07", "@origine": "LEGI" } }, { "@etat": "ABROGE", "LIEN_ART": { "@id": "LEGIARTI000006693603", "@fin": "2000-06-22", "@num": "L568", "@etat": "ABROGE", "@debut": "1992-12-11", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
On entend par officine l'établissement affecté à la dispensation au détail des médicaments, produits et objets mentionnés à l'article L. 512 ainsi qu'à l'exécution des préparations magistrales ou officinales.
\n
" } }, "LEGIARTI000006799094": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R5009", "ETAT": "ABROGE", "TYPE": "AUTONOME", "DATE_FIN": "2004-08-08", "DATE_DEBUT": "2004-05-28" } }, "META_COMMUN": { "ID": "LEGIARTI000006799094", "URL": "article/LEGI/ARTI/00/00/06/79/90/LEGIARTI000006799094.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SXXXXXXXXXX5009R0000XXAD" } }, "LIENS": { "LIEN": [ { "@id": "JORFTEXT000000503843", "#text": "Décret 53-1001 1953-10-05 (Décret de codification)", "@sens": "source", "@cidtexte": "JORFTEXT000000503843", "@numtexte": "53-1001", "@typelien": "CODIFICATION", "@naturetexte": "DECRET", "@datesignatexte": "1953-10-05" }, { "@id": "LEGIARTI000006230931", "@num": "5", "#text": "Décret n°2004-451 du 21 mai 2004 - art. 5 () JORF 28 mai 2004", "@sens": "source", "@cidtexte": "JORFTEXT000000251548", "@nortexte": "SANH0420956D", "@numtexte": "2004-451", "@typelien": "MODIFICATION", "@naturetexte": "DECRET", "@datesignatexte": "2004-05-21" }, { "@id": "LEGIARTI000006230933", "@num": "7", "#text": "Décret n°2004-451 du 21 mai 2004 - art. 7 () JORF 28 mai 2004", "@sens": "source", "@cidtexte": "JORFTEXT000000251548", "@nortexte": "SANH0420956D", "@numtexte": "2004-451", "@typelien": "MODIFICATION", "@naturetexte": "DECRET", "@datesignatexte": "2004-05-21" }, { "@id": "JORFTEXT000000787339", "#text": "Décret 2004-802 2004-07-29 art. 4 JORF 8 août 2004", "@sens": "source", "@cidtexte": "JORFTEXT000000787339", "@nortexte": "SANP0422530D", "@numtexte": "2004-802", "@typelien": "ABROGATION", "@naturetexte": "DECRET", "@datesignatexte": "2004-07-29" }, { "@id": "LEGIARTI000006690015", "@num": "L5125-1", "#text": "Code de la santé publique - art. L5125-1 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006690017", "@num": "L5125-2", "#text": "Code de la santé publique - art. L5125-2 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006690054", "@num": "L5125-25", "#text": "Code de la santé publique - art. L5125-25 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006690093", "@num": "L5126-11", "#text": "Code de la santé publique - art. L5126-11 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006690095", "@num": "L5126-12", "#text": "Code de la santé publique - art. L5126-12 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006690078", "@num": "L5126-5", "#text": "Code de la santé publique - art. L5126-5 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006799942", "@num": "R5106", "#text": "Code de la santé publique - art. R5106 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006799999", "@num": "R5114-2", "#text": "Code de la santé publique - art. R5114-2 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006915214", "@num": "R5125-35", "#text": "Code de la santé publique - art. R5125-35 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006915214", "@num": "R5125-35", "#text": "Code de la santé publique - art. R5125-35 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006800681", "@num": "R5145-32", "#text": "Code de la santé publique - art. R5145-32 (Ab)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "#text": "Loi 58-356 1958-04-03 (Loi de validation)", "@sens": "source", "@typelien": "CODIFICATION" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006174806", "@fin": "2004-08-08", "#text": "Section 3 : Pharmaciens adjoints", "@debut": "2002-03-05" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006157741", "@fin": "2004-08-08", "#text": "Chapitre 1 : Conditions générales d'exercice de la profession de pharmacien", "@debut": "1956-11-28" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006142895", "@fin": "2004-08-08", "#text": "Titre 1 : Dispositions générales", "@debut": "1956-11-28" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006128471", "@fin": "2999-01-01", "#text": "Livre 5 : Pharmacie", "@debut": "1953-10-07" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006107982", "@fin": "2999-01-01", "#text": "Partie réglementaire ancienne", "@debut": "1953-10-07" } ] }, "@cid": "LEGITEXT000006072665", "@nature": "CODE", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Code de la santé publique", "@debut": "1953-10-07", "@id_txt": "LEGITEXT000006072665", "@c_titre_court": "Code de la santé publique" } ], "@date_publi": "2999-01-01", "@date_signature": "2999-01-01" } }, "VERSIONS": { "VERSION": [ { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006799091", "@fin": "1998-02-13", "@num": "R5009", "@etat": "MODIFIE", "@debut": "1956-11-28", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006799092", "@fin": "2003-03-22", "@num": "R5009", "@etat": "MODIFIE", "@debut": "1998-02-13", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006799093", "@fin": "2004-05-28", "@num": "R5009", "@etat": "MODIFIE", "@debut": "2003-03-22", "@origine": "LEGI" } }, { "@etat": "ABROGE", "LIEN_ART": { "@id": "LEGIARTI000006799094", "@fin": "2004-08-08", "@num": "R5009", "@etat": "ABROGE", "@debut": "2004-05-28", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
Les activités des pharmaciens adjoints comprennent :
\n
a) Dans les officines et les pharmacies mutualistes ou des sociétés de secours minières, les activités mentionnées aux articles L. 5125-1, L. 5125-2 et L. 5125-25 ;
\n
b) Dans les pharmacies à usage intérieur, les activités mentionnées aux articles L. 5126-5, L. 5126-11 et L. 5126-12 ;
\n
c) Dans les établissements pharmaceutiques, les activités mentionnées aux articles R. 5106 et R. 5114-2 ;
\n
d) Dans les établissements pharmaceutiques vétérinaires, les activités ou opérations mentionnées aux 1° à 10° de l'article R. 5l45-2 et à l'article R. 5145-32.
" } }, "LEGIARTI000006913770": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R4241-9", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2009-08-03", "DATE_DEBUT": "2004-08-08" } }, "META_COMMUN": { "ID": "LEGIARTI000006913770", "URL": "article/LEGI/ARTI/00/00/06/91/37/LEGIARTI000006913770.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "YXXXXXXXXXX4241R0090XX0A" } }, "LIENS": { "LIEN": [ { "@id": "JORFTEXT000000761890", "#text": "Décret 99-740 1999-08-25 art. 1, I", "@sens": "source", "@cidtexte": "JORFTEXT000000761890", "@nortexte": "MESP9922275D", "@numtexte": "99-740", "@typelien": "CONCORDANCE", "@naturetexte": "DECRET", "@datesignatexte": "1999-08-25" }, { "@id": "LEGIARTI000006723807", "@num": "1", "#text": "Décret n°99-740 du 25 août 1999 - art. 1 (Ab)", "@sens": "source", "@cidtexte": "JORFTEXT000000761890", "@nortexte": "MESP9922275D", "@numtexte": "99-740", "@typelien": "CONCORDANCE", "@naturetexte": "DECRET", "@datesignatexte": "1999-08-25" }, { "@id": "LEGIARTI000006723807", "@num": "1", "#text": "Décret n°99-740 du 25 août 1999 - art. 1 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000761890", "@nortexte": "MESP9922275D", "@numtexte": "99-740", "@typelien": "CONCORDE", "@naturetexte": "DECRET", "@datesignatexte": "1999-08-25" }, { "@id": "JORFTEXT000000787339", "#text": "Décret 2004-802 2004-07-29", "@sens": "source", "@cidtexte": "JORFTEXT000000787339", "@nortexte": "SANP0422530D", "@numtexte": "2004-802", "@typelien": "CODIFICATION", "@naturetexte": "DECRET", "@datesignatexte": "2004-07-29" }, { "@id": "LEGIARTI000047678319", "@num": "1", "#text": "Arrêté du 8 décembre 2017 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000036171783", "@nortexte": "SSAH1734749A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2017-12-08" }, { "@id": "LEGIARTI000006913760", "@num": "D4241-3", "#text": "Code de la santé publique - art. D4241-3 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006689186", "@num": "L4241-7", "#text": "Code de la santé publique - art. L4241-7 (T)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006690015", "@num": "L5125-1", "#text": "Code de la santé publique - art. L5125-1 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006690078", "@num": "L5126-5", "#text": "Code de la santé publique - art. L5126-5 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006913771", "@num": "R4241-10", "#text": "Code de la santé publique - art. R4241-10 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006196462", "@fin": "2009-08-03", "#text": "Sous-section 2 : Ressortissants d'un Etat membre de la Communauté européenne ou partie à l'accord sur l'Espace économique européen.", "@debut": "2004-08-08" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006190605", "@fin": "2009-08-03", "#text": "Section 1 : Personnes autorisées à exercer la profession", "@debut": "2004-08-08" }, { "@id": "LEGISCTA000020953395", "@fin": "2999-01-01", "#text": "Section 1 : Personnes autorisées à exercer la profession de préparateur en pharmacie", "@debut": "2009-08-03" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006178627", "@fin": "2009-08-03", "#text": "Chapitre Ier : Exercice de la profession", "@debut": "2004-08-08" }, { "@id": "LEGISCTA000020953397", "@fin": "2999-01-01", "#text": "Chapitre Ier : Exercice des professions de préparateur en pharmacie et de préparateur en pharmacie hospitalière", "@debut": "2009-08-03" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006161000", "@fin": "2009-08-03", "#text": "Titre IV : Profession de préparateur en pharmacie", "@debut": "2004-08-08" }, { "@id": "LEGISCTA000020953399", "@fin": "2999-01-01", "#text": "Titre IV : Profession de préparateur en pharmacie et de préparateur en pharmacie hospitalière", "@debut": "2009-08-03" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006145487", "@fin": "2017-11-04", "#text": "Livre II : Professions de la pharmacie", "@debut": "2004-08-08" }, { "@id": "LEGISCTA000035971135", "@fin": "2999-01-01", "#text": "Livre II : Professions de la pharmacie et de la physique médicale", "@debut": "2017-11-04" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006132386", "@fin": "2999-01-01", "#text": "Quatrième partie : Professions de santé", "@debut": "2004-08-08" } ] }, "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": "LEGIARTI000006913770", "@fin": "2009-08-03", "@num": "R4241-9", "@etat": "MODIFIE", "@debut": "2004-08-08", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000020953361", "@fin": "2010-03-29", "@num": "R4241-9", "@etat": "MODIFIE", "@debut": "2009-08-03", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000022035486", "@fin": "2017-11-04", "@num": "R4241-9", "@etat": "MODIFIE", "@debut": "2010-03-29", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000035970733", "@fin": "2020-07-31", "@num": "R4241-9", "@etat": "MODIFIE", "@debut": "2017-11-04", "@origine": "LEGI" } }, { "@etat": "VIGUEUR", "LIEN_ART": { "@id": "LEGIARTI000042179778", "@fin": "2999-01-01", "@num": "R4241-9", "@etat": "VIGUEUR", "@debut": "2020-07-31", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
Les cycles d'études mentionnés à l'article L. 4241-7 qui préparent aux diplômes, certificats ou autres titres conduisant à l'exercice de la profession de préparateur en pharmacie et qui ont été obtenus dans un Etat mentionné au même article répondent aux conditions suivantes pour permettre à ceux qui les ont suivis avec succès d'obtenir l'autorisation d'exercer en France cette profession :
\n
1° Dans le cas prévu au 1° de l'article L. 4241-7 :
\n
a) Avoir été accomplis après un cycle d'études secondaires d'enseignement général, technique ou professionnel, sous la forme d'un cycle dispensé dans un établissement d'enseignement, ou dans une entreprise ou un établissement se livrant à la préparation et à la dispensation de produits pharmaceutiques au sens des articles L. 5125-1 et L. 5126-5, ou en alternance dans une telle entreprise ou un tel établissement et dans un établissement d'enseignement ;
\n
b) Avoir comporté une période de pratique professionnelle ;
\n
c) S'être déroulés selon une durée au moins équivalente à la durée de formation conduisant à l'obtention du brevet professionnel de préparateur en pharmacie telle que fixée par l'article D. 4241-3 ;
\n
2° Dans les cas prévus aux 2° et 3° de l'article L. 4241-7 :
\n
a) Avoir été accomplis après un cycle d'études secondaires d'enseignement général, technique ou professionnel, sous la forme d'un cycle dispensé dans un établissement d'enseignement ou dans une entreprise ou établissement se livrant à la préparation et à la dispensation de produits pharmaceutiques au sens des articles L. 5125-1 et L. 5126-5, ou en alternance dans une telle entreprise ou établissement et dans un établissement d'enseignement ;
\n
b) Ou avoir pris la forme d'un stage ou d'une période de pratique professionnelle intégrée au cycle d'études secondaires et ayant préparé l'intéressé à l'exercice de la profession.
" } }, "LEGIARTI000006914692": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R5112-3", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2005-07-26", "DATE_DEBUT": "2004-08-08" } }, "META_COMMUN": { "ID": "LEGIARTI000006914692", "URL": "article/LEGI/ARTI/00/00/06/91/46/LEGIARTI000006914692.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "YXXXXXXXXXX5112R0030XX0A" } }, "LIENS": { "LIEN": [ { "@id": "JORFTEXT000000787339", "#text": "Décret 2004-802 2004-07-29", "@sens": "source", "@cidtexte": "JORFTEXT000000787339", "@nortexte": "SANP0422530D", "@numtexte": "2004-802", "@typelien": "CODIFICATION", "@naturetexte": "DECRET", "@datesignatexte": "2004-07-29" }, { "@id": "LEGIARTI000006689009", "@num": "L4211-3", "#text": "Code de la santé publique - art. L4211-3 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006689013", "@num": "L4211-6", "#text": "Code de la santé publique - art. L4211-6 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006689973", "@num": "L5124-1", "#text": "Code de la santé publique - art. L5124-1 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006690015", "@num": "L5125-1", "#text": "Code de la santé publique - art. L5125-1 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006690045", "@num": "L5125-19", "#text": "Code de la santé publique - art. L5125-19 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006799070", "@num": "R5005", "#text": "Code de la santé publique - art. R5005 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGITEXT000006072665", "#text": "Code de la santé publique L5125-1, L5125-19, L4211-3, L5124-1, L4211-6, R5112-2", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006190658", "@fin": "2999-01-01", "#text": "Section 1 : Dispositions générales.", "@debut": "2004-08-08" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006178648", "@fin": "2999-01-01", "#text": "Chapitre II : Pharmacopée", "@debut": "2004-08-08" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006161011", "@fin": "2999-01-01", "#text": "Titre Ier : Dispositions générales relatives aux médicaments", "@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": "LEGIARTI000006914692", "@fin": "2005-07-26", "@num": "R5112-3", "@etat": "MODIFIE", "@debut": "2004-08-08", "@origine": "LEGI" } }, { "@etat": "ABROGE", "LIEN_ART": { "@id": "LEGIARTI000006914693", "@fin": "2017-01-12", "@num": "R5112-3", "@etat": "ABROGE", "@debut": "2005-07-26", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
Le pharmacien, propriétaire ou gérant d'une officine définie à l'article L. 5125-1 ou d'une pharmacie mentionnée à l'article L. 5125-19, le médecin bénéficiaire de l'autorisation prévue par l'article L. 4211-3, l'établissement mentionné à l'article L. 5124-1 et, le cas échéant, chacune de ses succursales, ainsi que la personne physique autorisée à préparer des produits mentionnés à l'article L. 4211-6, est tenu de posséder au moins un exemplaire de la pharmacopée et de ses suppléments dès la date fixée par l'arrêté ministériel prévu à l'article R. 5112-2.
\n
" } }, "LEGIARTI000006914693": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R5112-3", "ETAT": "ABROGE", "TYPE": "AUTONOME", "DATE_FIN": "2017-01-12", "DATE_DEBUT": "2005-07-26" } }, "META_COMMUN": { "ID": "LEGIARTI000006914693", "URL": "article/LEGI/ARTI/00/00/06/91/46/LEGIARTI000006914693.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "YXXXXXXXXXX5112R0030XX0B" } }, "LIENS": { "LIEN": [ { "@id": "JORFTEXT000000787339", "#text": "Décret 2004-802 2004-07-29", "@sens": "source", "@cidtexte": "JORFTEXT000000787339", "@nortexte": "SANP0422530D", "@numtexte": "2004-802", "@typelien": "CODIFICATION", "@naturetexte": "DECRET", "@datesignatexte": "2004-07-29" }, { "@id": "JORFTEXT000000814956", "#text": "Décret 2005-840 2005-07-20 art. 12 1° JORF 26 juillet 2005", "@sens": "source", "@cidtexte": "JORFTEXT000000814956", "@nortexte": "SANP0522707D", "@numtexte": "2005-840", "@typelien": "MODIFICATION", "@naturetexte": "DECRET", "@datesignatexte": "2005-07-20" }, { "@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": "ABROGE", "@naturetexte": "DECRET", "@datesignatexte": "2017-01-09" }, { "@id": "LEGIARTI000006689009", "@num": "L4211-3", "#text": "Code de la santé publique - art. L4211-3", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006689013", "@num": "L4211-6", "#text": "Code de la santé publique - art. L4211-6", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006689973", "@num": "L5124-1", "#text": "Code de la santé publique - art. L5124-1", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006690015", "@num": "L5125-1", "#text": "Code de la santé publique - art. L5125-1", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006690064", "@num": "L5126-1", "#text": "Code de la santé publique - art. L5126-1", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006799070", "@num": "R5005", "#text": "Code de la santé publique - art. R5005 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006914691", "@num": "R5112-2", "#text": "Code de la santé publique - art. R5112-2", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006190658", "@fin": "2999-01-01", "#text": "Section 1 : Dispositions générales.", "@debut": "2004-08-08" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006178648", "@fin": "2999-01-01", "#text": "Chapitre II : Pharmacopée", "@debut": "2004-08-08" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006161011", "@fin": "2999-01-01", "#text": "Titre Ier : Dispositions générales relatives aux médicaments", "@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": "LEGIARTI000006914692", "@fin": "2005-07-26", "@num": "R5112-3", "@etat": "MODIFIE", "@debut": "2004-08-08", "@origine": "LEGI" } }, { "@etat": "ABROGE", "LIEN_ART": { "@id": "LEGIARTI000006914693", "@fin": "2017-01-12", "@num": "R5112-3", "@etat": "ABROGE", "@debut": "2005-07-26", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
Le pharmacien, propriétaire ou gérant d'une officine définie à l'article L. 5125-1 ou d'une pharmacie mentionnée à l'article L. 5126-1, le médecin bénéficiaire de l'autorisation prévue par l'article L. 4211-3, l'établissement mentionné à l'article L. 5124-1 et, le cas échéant, chacune de ses succursales, ainsi que la personne physique autorisée à préparer des produits mentionnés à l'article L. 4211-6, est tenu de posséder au moins un exemplaire de la pharmacopée et de ses suppléments dès la date fixée par l'arrêté ministériel prévu à l'article R. 5112-2.
\n
" } }, "LEGIARTI000006915214": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R5125-35", "ETAT": "VIGUEUR", "TYPE": "AUTONOME", "DATE_FIN": "2999-01-01", "DATE_DEBUT": "2004-08-08" } }, "META_COMMUN": { "ID": "LEGIARTI000006915214", "URL": "article/LEGI/ARTI/00/00/06/91/52/LEGIARTI000006915214.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "YXXXXXXXXXX5125R0350XX0A" } }, "LIENS": { "LIEN": [ { "@id": "JORFTEXT000000787339", "#text": "Décret 2004-802 2004-07-29", "@sens": "source", "@cidtexte": "JORFTEXT000000787339", "@nortexte": "SANP0422530D", "@numtexte": "2004-802", "@typelien": "CODIFICATION", "@naturetexte": "DECRET", "@datesignatexte": "2004-07-29" }, { "@id": "LEGIARTI000006690015", "@num": "L5125-1", "#text": "Code de la santé publique - art. L5125-1 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006690017", "@num": "L5125-2", "#text": "Code de la santé publique - art. L5125-2 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006690054", "@num": "L5125-25", "#text": "Code de la santé publique - art. L5125-25 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006690093", "@num": "L5126-11", "#text": "Code de la santé publique - art. L5126-11 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006690095", "@num": "L5126-12", "#text": "Code de la santé publique - art. L5126-12 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006690078", "@num": "L5126-5", "#text": "Code de la santé publique - art. L5126-5 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006799094", "@num": "R5009", "#text": "Code de la santé publique - art. R5009 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006799091", "@num": "R5009", "#text": "Code de la santé publique - art. R5009 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006915076", "@num": "R5124-2", "#text": "Code de la santé publique - art. R5124-2 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006915132", "@num": "R5124-40", "#text": "Code de la santé publique - art. R5124-40 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006916126", "@num": "R5142-40", "#text": "Code de la santé publique - art. R5142-40 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGITEXT000006072665", "#text": "Code de la santé publique L5125-1, L5125-2, L5125-25, L5126-5, L5126-11, L5126-12, R5124-2, R5124-40, R5142-1, R5142-40", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006196578", "@fin": "2999-01-01", "#text": "Sous-section 1 : Pharmaciens adjoints.", "@debut": "2004-08-08" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006190691", "@fin": "2999-01-01", "#text": "Section 2 : Exercice de la profession de pharmacien", "@debut": "2004-08-08" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006178653", "@fin": "2999-01-01", "#text": "Chapitre V : Distribution au détail", "@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": "VIGUEUR", "LIEN_ART": { "@id": "LEGIARTI000006915214", "@fin": "2999-01-01", "@num": "R5125-35", "@etat": "VIGUEUR", "@debut": "2004-08-08", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
Les activités des pharmaciens adjoints comprennent :
\n
1° Dans les officines et les pharmacies mutualistes ou des sociétés de secours minières, les activités mentionnées aux articles L. 5125-1, L. 5125-2 et L. 5125-25 ;
\n
2° Dans les pharmacies à usage intérieur, les activités mentionnées aux articles L. 5126-5, L. 5126-11 et L. 5126-12 ;
\n
3° Dans les établissements pharmaceutiques, les activités mentionnées aux articles R. 5124-2 et R. 5124-40 ;
\n
4° Dans les établissements pharmaceutiques vétérinaires, les activités ou opérations mentionnées aux 1° à 10° de l'article R. 5142-1 et à l'article R. 5142-40.
" } }, "LEGIARTI000006915468": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R5127-1", "ETAT": "VIGUEUR", "TYPE": "AUTONOME", "DATE_FIN": "2999-01-01", "DATE_DEBUT": "2004-08-08" } }, "META_COMMUN": { "ID": "LEGIARTI000006915468", "URL": "article/LEGI/ARTI/00/00/06/91/54/LEGIARTI000006915468.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "YXXXXXXXXXX5127R0010XX0A" } }, "LIENS": { "LIEN": [ { "@id": "JORFTEXT000000787339", "#text": "Décret 2004-802 2004-07-29", "@sens": "source", "@cidtexte": "JORFTEXT000000787339", "@nortexte": "SANP0422530D", "@numtexte": "2004-802", "@typelien": "CODIFICATION", "@naturetexte": "DECRET", "@datesignatexte": "2004-07-29" }, { "@id": "LEGIARTI000006689009", "@num": "L4211-3", "#text": "Code de la santé publique - art. L4211-3 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006689014", "@num": "L4211-7", "#text": "Code de la santé publique - art. L4211-7 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006690015", "@num": "L5125-1", "#text": "Code de la santé publique - art. L5125-1 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006690045", "@num": "L5125-19", "#text": "Code de la santé publique - art. L5125-19 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006690064", "@num": "L5126-1", "#text": "Code de la santé publique - art. L5126-1 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006690097", "@num": "L5126-13", "#text": "Code de la santé publique - art. L5126-13 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006690087", "@num": "L5126-8", "#text": "Code de la santé publique - art. L5126-8 (Ab)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006690088", "@num": "L5126-9", "#text": "Code de la santé publique - art. L5126-9 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006799485", "@num": "R5056", "#text": "Code de la santé publique - art. R5056 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006799481", "@num": "R5056", "#text": "Code de la santé publique - art. R5056 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006915076", "@num": "R5124-2", "#text": "Code de la santé publique - art. R5124-2 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006915139", "@num": "R5124-45", "#text": "Code de la santé publique - art. R5124-45 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGITEXT000006072665", "#text": "Code de la santé publique R5056, II", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006190702", "@fin": "2999-01-01", "#text": "Section 1 : Dispositions générales.", "@debut": "2004-08-08" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006178655", "@fin": "2999-01-01", "#text": "Chapitre VII : Inspection de la pharmacie", "@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": "VIGUEUR", "LIEN_ART": { "@id": "LEGIARTI000006915468", "@fin": "2999-01-01", "@num": "R5127-1", "@etat": "VIGUEUR", "@debut": "2004-08-08", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
Les pharmaciens inspecteurs de santé publique procèdent, selon une périodicité fixée par le ministre chargé de la santé, à l'inspection des officines et pharmacies mentionnées aux articles L. 5125-1, L. 5125-19, L. 5126-1, L. 5126-8, L. 5126-9 et L. 5126-13, des lieux de détention de médicaments par les médecins mentionnés à l'article L. 4211-3 et par les personnes physiques et morales mentionnées aux articles R. 5124-2 et R. 5124-45, ainsi que des herboristeries mentionnées à l'article L. 4211-7.
\n
" } }, "LEGIARTI000017842140": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "L5521-2", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2008-12-20", "DATE_DEBUT": "2007-12-22" } }, "META_COMMUN": { "ID": "LEGIARTI000017842140", "URL": "article/LEGI/ARTI/00/00/17/84/21/LEGIARTI000017842140.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "LIENS": { "LIEN": [ { "@id": "LEGIARTI000017730797", "@num": "59", "#text": "LOI n°2007-1786 du 19 décembre 2007 - art. 59 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000017726554", "@nortexte": "BCFX0766311L", "@numtexte": "2007-1786", "@typelien": "MODIFIE", "@naturetexte": "LOI", "@datesignatexte": "2007-12-19" }, { "@id": "LEGIARTI000006690015", "@num": "L5125-1", "#text": "Code de la santé publique - art. 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L5125-21", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006690049", "@num": "L5125-23", "#text": "Code de la santé publique - art. L5125-23", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006690019", "@num": "L5125-4", "#text": "Code de la santé publique - art. L5125-4", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000025104451", "@num": "L5521-1-1", "#text": "Code de la santé publique - art. L5521-1-1 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006690655", "@num": "L5521-3", "#text": "Code de la santé publique - art. L5521-3", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006690657", "@num": "L5521-4", "#text": "Code de la santé publique - art. L5521-4", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006171437", "@fin": "2999-01-01", "#text": "Chapitre Ier : Produits pharmaceutiques.", "@debut": "2000-06-22" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006155103", "@fin": "2999-01-01", "#text": "Titre II : Îles Wallis et Futuna", "@debut": "2000-06-22" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006140635", "@fin": "2999-01-01", "#text": "Livre V : Mayotte, îles Wallis et Futuna et Terres australes et antarctiques françaises, Nouvelle-Calédonie et Polynésie française", "@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": "LEGIARTI000006690651", "@fin": "2001-12-26", "@num": "L5521-2", "@etat": "MODIFIE", "@debut": "2000-06-22", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006690652", "@fin": "2005-08-27", "@num": "L5521-2", "@etat": "MODIFIE", "@debut": "2001-12-26", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006690653", "@fin": "2007-12-22", "@num": "L5521-2", "@etat": "MODIFIE", "@debut": "2005-08-27", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000017842140", "@fin": "2008-12-20", "@num": "L5521-2", "@etat": "MODIFIE", "@debut": "2007-12-22", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000019960237", "@fin": "2018-01-05", "@num": "L5521-2", "@etat": "MODIFIE", "@debut": "2008-12-20", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000036408597", "@fin": "2019-07-27", "@num": "L5521-2", "@etat": "MODIFIE", "@debut": "2018-01-05", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000038886657", "@fin": "2020-12-09", "@num": "L5521-2", "@etat": "MODIFIE", "@debut": "2019-07-27", "@origine": "LEGI" } }, { "@etat": "VIGUEUR", "LIEN_ART": { "@id": "LEGIARTI000042655940", "@fin": "2999-01-01", "@num": "L5521-2", "@etat": "VIGUEUR", "@debut": "2020-12-09", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
Les articles L. 5125-1 à L. 5125-3, L. 5125-4 premier alinéa, L. 5125-16, L. 5125-17, L. 5125-20, L. 5125-21, L. 5125-23 premier et deuxième alinéas, L. 5125-24 à L. 5125-31 et L. 5125-32 3° à 5° sont applicables dans le territoire des îles Wallis et Futuna sous réserve des adaptations prévues aux articles L. 5521-3 et L. 5521-4.
\n
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L512-3 (Ab)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693428", "@num": "L512-3", "#text": "Code de la santé publique - art. L512-3 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006690015", "@num": "L5125-1", "#text": "Code de la santé publique - art. L5125-1", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006690016", "@num": "L5125-1-1", "#text": "Code de la santé publique - art. L5125-1-1", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006690035", "@num": "L5125-14", "#text": "Code de la santé publique - art. 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Sont fixées par décret en Conseil d'Etat :

1° Les modalités de présentation et d'instruction des demandes de création, transfert et regroupement des officines de pharmacie, les règles relatives à l'appréciation du droit de priorité et du droit d'antériorité, et les conditions minimales d'installation auxquelles doivent satisfaire les officines ;

2° (Paragraphe supprimé) ;

3° Les conditions dans lesquelles le remplacement du titulaire d'une officine prévu à l'article L. 5125-21 doit être assuré par des pharmaciens ou par des étudiants en pharmacie justifiant d'un minimum de scolarité ;

4° Les modalités d'application des articles L. 5125-23 et L. 5125-25 ;

5° Les conditions dans lesquelles peut être faite la publicité en faveur des officines de pharmacie ;

6° Les modalités d'application des deuxième et troisième alinéas de l'article L. 5125-1, notamment les catégories de préparations concernées, et les modalités d'application de l'article L. 5125-1-1.

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(M)", "@sens": "cible", "@cidtexte": "JORFTEXT000029676018", "@nortexte": "AFSX1419039D", "@numtexte": "2014-1287", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2014-10-23" }, { "@id": "LEGIARTI000042293117", "#text": "DÉCRET n°2014-1288 du 23 octobre 2014 - art. (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000029676038", "@nortexte": "AFSX1419044D", "@numtexte": "2014-1288", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2014-10-23" }, { "@id": "LEGIARTI000030189762", "@num": "8", "#text": "ARRÊTÉ du 28 novembre 2014 - art. 8 (VD)", "@sens": "cible", "@cidtexte": "JORFTEXT000030189026", "@nortexte": "EINC1415451A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2014-11-28" }, { "@id": "LEGIARTI000030189876", "@num": "1", "#text": "ARRÊTÉ du 3 février 2015 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000030188934", "@nortexte": "AFSP1503244A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2015-02-03" }, { "@id": "LEGIARTI000032291698", "@num": "1", "#text": "Décret n°2016-349 du 24 mars 2016 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000032291186", "@nortexte": "AFSH1532721D", "@numtexte": "2016-349", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2016-03-24" }, { "@id": "LEGIARTI000032730970", "@num": "3", "#text": "Décret n°2016-817 du 20 juin 2016 - art. 3", "@sens": "cible", "@cidtexte": "JORFTEXT000032729458", "@nortexte": "AFSS1610671D", "@numtexte": "2016-817", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2016-06-20" }, { "@id": "LEGIARTI000034392999", "@num": "1", "#text": "Décret n°2017-500 du 6 avril 2017 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000034390458", "@nortexte": "AFSH1702718D", "@numtexte": "2017-500", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2017-04-06" }, { "@id": "LEGIARTI000038879548", "@num": "1", "#text": "Décret n°2019-818 du 1er août 2019 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000038873188", "@nortexte": "SSAS1911214D", "@numtexte": "2019-818", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2019-08-01" }, { "@id": "LEGIARTI000042267406", "@num": "1", "#text": "Décret n°2020-1090 du 25 août 2020 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000042266405", "@nortexte": "SSAS2006857D", "@numtexte": "2020-1090", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2020-08-25" }, { "@id": "LEGIARTI000044941358", "@num": "6", "#text": "Décret n°2021-1905 du 30 décembre 2021 - art. 6", "@sens": "cible", "@cidtexte": "JORFTEXT000044638030", "@nortexte": "TREP2130559D", "@numtexte": "2021-1905", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2021-12-30" }, { "@id": "LEGIARTI000045632789", "@num": "1", "#text": "Décret n°2022-597 du 21 avril 2022 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000045632039", "@nortexte": "SSAH2205181D", "@numtexte": "2022-597", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2022-04-21" }, { "@id": "LEGITEXT000049536357", "#text": "Décret n°2024-435 du 14 mai 2024 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000049535648", "@nortexte": "TSSS2408227D", "@numtexte": "2024-435", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2024-05-14" }, { "@id": "LEGITEXT000049850758", "#text": "Décret n°2024-626 du 27 juin 2024 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000049832038", "@nortexte": "TSSP2408968D", "@numtexte": "2024-626", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2024-06-27" }, { "@id": "LEGITEXT000049922585", "#text": "Arrêté du 5 juillet 2024 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000049892254", "@nortexte": "TSSS2418508A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2024-07-05" }, { "@id": "LEGITEXT000050737433", "#text": "Décret n°2024-1135 du 4 décembre 2024 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000050731183", "@nortexte": "MSAH2429400D", "@numtexte": "2024-1135", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2024-12-04" }, { "@id": "LEGIARTI000006279394", "@num": "L611-2", "#text": "Code de la propriété intellectuelle - art. 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On entend par :

1° Préparation magistrale, tout médicament préparé selon une prescription médicale destinée à un malade déterminé, soit extemporanément en pharmacie, soit dans les conditions prévues à l'article L. 5125-1 ;

3° Préparation officinale, tout médicament préparé en pharmacie, inscrit à la pharmacopée ou au formulaire national et destiné à être dispensé directement aux patients approvisionnés par cette pharmacie ;

4° Produit officinal divisé, toute drogue simple, tout produit chimique ou toute préparation stable décrite par la pharmacopée, préparés à l'avance par un établissement pharmaceutique et divisés soit par lui, soit par la pharmacie d'officine qui le met en vente, soit par une pharmacie à usage intérieur, telle que définie au chapitre VI du présent titre ;

5° a) Sans préjudice des articles L. 611-2 et suivants du code de la propriété intellectuelle, spécialité générique d'une spécialité de référence, celle qui a la même composition qualitative et quantitative en principes actifs, la même forme pharmaceutique et dont la bioéquivalence avec la spécialité de référence est démontrée par des études de biodisponibilité appropriées. Une spécialité ne peut être qualifiée de spécialité de référence que si son autorisation de mise sur le marché a été délivrée au vu d'un dossier comportant, dans des conditions fixées par voie réglementaire, l'ensemble des données nécessaires et suffisantes à elles seules pour son évaluation. Pour l'application du présent alinéa, les différentes formes pharmaceutiques orales à libération immédiate sont considérées comme une même forme pharmaceutique. De même, les différents sels, esters, éthers, isomères, mélanges d'isomères, complexes ou dérivés d'un principe actif sont regardés comme ayant la même composition qualitative en principe actif, sauf s'ils présentent des propriétés sensiblement différentes au regard de la sécurité ou de l'efficacité. Dans ce cas, des informations supplémentaires fournissant la preuve de la sécurité et de l'efficacité des différents sels, esters ou dérivés d'une substance active autorisée doivent être données par le demandeur de l'autorisation de mise sur le marché ;

6° Médicament immunologique, tout médicament consistant en :

a) Allergène, défini comme tout produit destiné à identifier ou provoquer une modification spécifique et acquise de la réponse immunologique à un agent allergisant ;

b) Vaccin, toxine ou sérum, définis comme tous agents utilisés en vue de provoquer une immunité active ou passive ou en vue de diagnostiquer l'état d'immunité ;

7° Médicament radiopharmaceutique, tout médicament qui, lorsqu'il est prêt à l'emploi, contient un ou plusieurs isotopes radioactifs, dénommés radionucléides, incorporés à des fins médicales ;

8° Générateur, tout système contenant un radionucléide parent déterminé servant à la production d'un radionucléide de filiation obtenu par élution ou par toute autre méthode et utilisé dans un médicament radiopharmaceutique ;

9° Trousse, toute préparation qui doit être reconstituée ou combinée avec des radionucléides dans le produit radiopharmaceutique final ;

10° Précurseur, tout autre radionucléide produit pour le marquage radioactif d'une autre substance avant administration ;

11° Médicament homéopathique, tout médicament obtenu à partir de substances appelées souches homéopathiques, selon un procédé de fabrication homéopathique décrit par la pharmacopée européenne, la pharmacopée française ou, à défaut, par les pharmacopées utilisées de façon officielle dans un autre Etat membre de la Communauté européenne. Un médicament homéopathique peut aussi contenir plusieurs principes ;

12° Préparation de thérapie génique, tout médicament autre que les spécialités pharmaceutiques et les médicaments fabriqués industriellement mentionnés à l'article L. 5121-8, servant à transférer du matériel génétique et ne consistant pas en des cellules d'origine humaine ou animale. Ces préparations sont préparées à l'avance et dispensées sur prescription médicale à un ou plusieurs patients. Elles font l'objet d'une autorisation de l'Agence française de sécurité sanitaire des produits de santé pour une indication thérapeutique donnée. Cette autorisation peut être assortie de conditions particulières ou de restrictions d'utilisation. Elle peut être modifiée, suspendue ou retirée ;

13° Préparation de thérapie cellulaire xénogénique, tout médicament autre que les spécialités pharmaceutiques et les médicaments fabriqués industriellement mentionnés à l'article L. 5121-8, consistant en des cellules d'origine animale et leurs dérivés utilisés à des fins thérapeutiques, y compris les cellules servant à transférer du matériel génétique, quel que soit leur niveau de transformation. Ces préparations sont préparées à l'avance et dispensées sur prescription médicale à un ou plusieurs patients. Elles font l'objet d'une autorisation de l'Agence française de sécurité sanitaire des produits de santé pour une indication thérapeutique donnée. Cette autorisation peut être assortie de conditions particulières ou de restrictions d'utilisation. Elle peut être modifiée, suspendue ou retirée. L'Agence de la biomédecine est informée des décisions relatives à ces préparations prises en application du présent alinéa ;

14° Médicament biologique, tout médicament dont la substance active est produite à partir d'une source biologique ou en est extraite et dont la caractérisation et la détermination de la qualité nécessitent une combinaison d'essais physiques, chimiques et biologiques ainsi que la connaissance de son procédé de fabrication et de son contrôle ;

15° Sans préjudice des articles L. 611-2 et suivants du code de la propriété intellectuelle, médicament biologique similaire, tout médicament biologique de même composition qualitative et quantitative en substance active et de même forme pharmaceutique qu'un médicament biologique de référence mais qui ne remplit pas les conditions prévues au a du 5° du présent article pour être regardé comme une spécialité générique en raison de différences liées notamment à la variabilité de la matière première ou aux procédés de fabrication et nécessitant que soient produites des données précliniques et cliniques supplémentaires dans des conditions déterminées par voie réglementaire ;

16° Médicament à base de plantes, tout médicament dont les substances actives sont exclusivement une ou plusieurs substances végétales ou préparations à base de plantes ou une association de plusieurs substances végétales ou préparations à base de plantes.

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Annexe (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000195660", "@nortexte": "ENVP9640024D", "@numtexte": "96-850", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1996-09-20" }, { "@id": "LEGIARTI000006725129", "@num": "71", "#text": "Décret n°2001-1065 du 15 novembre 2001 - art. 71 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000403855", "@nortexte": "INTM0100035D", "@numtexte": "2001-1065", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2001-11-15" }, { "@id": "LEGIARTI000006758846", "@num": "12", "#text": "Loi n°2003-1199 du 18 décembre 2003 - art. 12 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000249276", "@nortexte": "SANX0300139L", "@numtexte": "2003-1199", "@typelien": "CITATION", "@naturetexte": "LOI", "@datesignatexte": "2003-12-18" }, { "@id": "LEGIARTI000006697606", "@num": "35", "#text": "Loi n°2004-800 du 6 août 2004 - art. 35 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000441469", "@nortexte": "SANX0100053L", "@numtexte": "2004-800", "@typelien": "CITATION", "@naturetexte": "LOI", "@datesignatexte": "2004-08-06" }, { "@id": "LEGIARTI000047109474", "@num": "14", "#text": "Décret n°2004-942 du 3 septembre 2004 - art. 14 (M)", "@sens": "cible", "@cidtexte": "JORFTEXT000000253592", "@nortexte": "SANS0422327D", "@numtexte": "2004-942", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2004-09-03" }, { "@id": "LEGIARTI000032182077", "@num": "41", "#text": "Loi n°2005-1579 du 19 décembre 2005 - art. 41 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000815414", "@nortexte": "SANX0500246L", "@numtexte": "2005-1579", "@typelien": "CITATION", "@naturetexte": "LOI", "@datesignatexte": "2005-12-19" }, { "@id": "LEGIARTI000020140266", "@num": "8", "#text": "Arrêté du 24 mai 2006 - art. 8 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000457818", "@nortexte": "SANP0622223A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-05-24" }, { "@id": "LEGIARTI000043762395", "@num": "21", "#text": "Décret n° 2007-359 du 19 mars 2007 - art. 21 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000645145", "@nortexte": "AGRG0700643D", "@numtexte": "2007-359", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2007-03-19" }, { "@id": "LEGIARTI000019945438", "@num": "49", "#text": "LOI n°2008-1330\n du 17 décembre 2008 - art. 49", "@sens": "cible", "@cidtexte": "JORFTEXT000019942966", "@nortexte": "BCFX0823210L", "@numtexte": "2008-1330", "@typelien": "MODIFIE", "@naturetexte": "LOI", "@datesignatexte": "2008-12-17" }, { "@id": "LEGIARTI000022933811", "@num": "3", "#text": "Arrêté du 29 septembre 2010 - art. 3 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000022932466", "@nortexte": "SASP1025728A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2010-09-29" }, { "@id": "LEGIARTI000023501118", "@num": "4", "#text": "Arrêté du 21 janvier 2011 - art. 4 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000023491451", "@nortexte": "ETSP1101997A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2011-01-21" }, { "@id": "LEGIARTI000023824330", "@num": "1", "#text": "Arrêté du 29 mars 2011 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000023823216", "@nortexte": "ETSP1108796A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2011-03-29" }, { "@id": "LEGIARTI000046423270", "@num": "13", "#text": "Arrêté du 6 avril 2011 - art. 13 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000023865866", "@nortexte": "ETSH1109848A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2011-04-06" }, { "@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": "LEGIARTI000026041157", "@num": "2", "#text": "Arrêté du 8 juin 2012 - art. 2 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000026040448", "@nortexte": "AFSP1225501A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2012-06-08" }, { "@id": "LEGITEXT000026558683", "#text": "Décret n°2012-1201\n du 29 octobre 2012 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000026557838", "@nortexte": "AFSP1232892D", "@numtexte": "2012-1201", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2012-10-29" }, { "@id": "LEGIARTI000026589554", "@num": "2", "#text": "Décret n°2012-1236\n du 6 novembre 2012 - art. 2 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000026588856", "@nortexte": "AFSP1226229D", "@numtexte": "2012-1236", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2012-11-06" }, { "@id": "LEGIARTI000035971424", "#text": "DÉCRET n°2014-1287 du 23 octobre 2014 - art. (M)", "@sens": "cible", "@cidtexte": "JORFTEXT000029676018", "@nortexte": "AFSX1419039D", "@numtexte": "2014-1287", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2014-10-23" }, { "@id": "LEGIARTI000042293117", "#text": "DÉCRET n°2014-1288 du 23 octobre 2014 - art. (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000029676038", "@nortexte": "AFSX1419044D", "@numtexte": "2014-1288", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2014-10-23" }, { "@id": "LEGIARTI000030189762", "@num": "8", "#text": "ARRÊTÉ du 28 novembre 2014 - art. 8 (VD)", "@sens": "cible", "@cidtexte": "JORFTEXT000030189026", "@nortexte": "EINC1415451A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2014-11-28" }, { "@id": "LEGIARTI000030189876", "@num": "1", "#text": "ARRÊTÉ du 3 février 2015 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000030188934", "@nortexte": "AFSP1503244A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2015-02-03" }, { "@id": "LEGIARTI000032291698", "@num": "1", "#text": "Décret n°2016-349 du 24 mars 2016 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000032291186", "@nortexte": "AFSH1532721D", "@numtexte": "2016-349", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2016-03-24" }, { "@id": "LEGIARTI000032730970", "@num": "3", "#text": "Décret n°2016-817 du 20 juin 2016 - art. 3", "@sens": "cible", "@cidtexte": "JORFTEXT000032729458", "@nortexte": "AFSS1610671D", "@numtexte": "2016-817", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2016-06-20" }, { "@id": "LEGIARTI000034392999", "@num": "1", "#text": "Décret n°2017-500 du 6 avril 2017 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000034390458", "@nortexte": "AFSH1702718D", "@numtexte": "2017-500", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2017-04-06" }, { "@id": "LEGIARTI000038879548", "@num": "1", "#text": "Décret n°2019-818 du 1er août 2019 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000038873188", "@nortexte": "SSAS1911214D", "@numtexte": "2019-818", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2019-08-01" }, { "@id": "LEGIARTI000042267406", "@num": "1", "#text": "Décret n°2020-1090 du 25 août 2020 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000042266405", "@nortexte": "SSAS2006857D", "@numtexte": "2020-1090", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2020-08-25" }, { "@id": "LEGIARTI000044941358", "@num": "6", "#text": "Décret n°2021-1905 du 30 décembre 2021 - art. 6", "@sens": "cible", "@cidtexte": "JORFTEXT000044638030", "@nortexte": "TREP2130559D", "@numtexte": "2021-1905", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2021-12-30" }, { "@id": "LEGIARTI000045632789", "@num": "1", "#text": "Décret n°2022-597 du 21 avril 2022 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000045632039", "@nortexte": "SSAH2205181D", "@numtexte": "2022-597", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2022-04-21" }, { "@id": "LEGITEXT000049536357", "#text": "Décret n°2024-435 du 14 mai 2024 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000049535648", "@nortexte": "TSSS2408227D", "@numtexte": "2024-435", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2024-05-14" }, { "@id": "LEGITEXT000049850758", "#text": "Décret n°2024-626 du 27 juin 2024 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000049832038", "@nortexte": "TSSP2408968D", "@numtexte": "2024-626", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2024-06-27" }, { "@id": "LEGITEXT000049922585", "#text": "Arrêté du 5 juillet 2024 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000049892254", "@nortexte": "TSSS2418508A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2024-07-05" }, { "@id": "LEGITEXT000050737433", "#text": "Décret n°2024-1135 du 4 décembre 2024 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000050731183", "@nortexte": "MSAH2429400D", "@numtexte": "2024-1135", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2024-12-04" }, { "@id": "LEGIARTI000006279394", "@num": "L611-2", "#text": "Code de la propriété intellectuelle - art. 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On entend par :

b) Groupe générique, le regroupement d'une spécialité de référence et des spécialités qui en sont génériques. Toutefois, une spécialité remplissant les conditions pour être une spécialité de référence, qui présente la même composition qualitative en substance active, la même composition quantitative en substance active ou, à défaut, une fraction thérapeutique active identique dans les limites prévues à l'annexe I de la directive 2001/83/CE du Parlement européen et du Conseil du 6 novembre 2001 instituant un code communautaire relatif aux médicaments à usage humain, et la même forme pharmaceutique qu'une spécialité de référence d'un groupe générique déjà existant, et dont la bioéquivalence avec cette spécialité est démontrée par des études de biodisponibilité appropriées, peut aussi figurer dans ce groupe générique, à condition que ces deux spécialités soient considérées comme relevant d'une même autorisation de mise sur le marché globale, définie par voie réglementaire et qu'elles ne présentent pas de propriétés sensiblement différentes au regard de la sécurité ou de l'efficacité. En l'absence de spécialité de référence, un groupe générique peut être constitué de spécialités ayant la même composition qualitative et quantitative en principes actifs, la même forme pharmaceutique et dont les caractéristiques en termes de sécurité et d'efficacité sont équivalentes. Pour l'application du présent b, sont inscrites au répertoire des groupes génériques les spécialités qui se présentent sous une forme pharmaceutique orale à libération modifiée différente de celle de la spécialité de référence, à condition que ces spécialités et la spécialité de référence appartiennent à la même catégorie de forme pharmaceutique à libération modifiée et qu'elles ne présentent pas de propriétés sensiblement différentes au regard de la sécurité ou de l'efficacité ;

6° Médicament immunologique, tout médicament consistant en :

a) Allergène, défini comme tout produit destiné à identifier ou provoquer une modification spécifique et acquise de la réponse immunologique à un agent allergisant ;

b) Vaccin, toxine ou sérum, définis comme tous agents utilisés en vue de provoquer une immunité active ou passive ou en vue de diagnostiquer l'état d'immunité ;

9° Trousse, toute préparation qui doit être reconstituée ou combinée avec des radionucléides dans le produit radiopharmaceutique final ;

10° Précurseur, tout autre radionucléide produit pour le marquage radioactif d'une autre substance avant administration ;

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L5121-16", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006689916", "@num": "L5121-17", "#text": "Code de la santé publique - art. L5121-17", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006690015", "@num": "L5125-1", "#text": "Code de la santé publique - art. L5125-1", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006690046", "@num": "L5125-20", "#text": "Code de la santé publique - art. L5125-20", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006690047", "@num": "L5125-21", "#text": "Code de la santé publique - art. L5125-21", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006690049", "@num": "L5125-23", "#text": "Code de la santé publique - art. L5125-23", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006690053", "@num": "L5125-24", "#text": "Code de la santé publique - art. L5125-24", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006690061", "@num": "L5125-32", "#text": "Code de la santé publique - art. L5125-32", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006690019", "@num": "L5125-4", "#text": "Code de la santé publique - art. L5125-4", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000025104451", "@num": "L5521-1-1", "#text": "Code de la santé publique - art. L5521-1-1 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006690655", "@num": "L5521-3", "#text": "Code de la santé publique - art. L5521-3", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006690657", "@num": "L5521-4", "#text": "Code de la santé publique - art. L5521-4", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006171437", "@fin": "2999-01-01", "#text": "Chapitre Ier : Produits pharmaceutiques.", "@debut": "2000-06-22" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006155103", "@fin": "2999-01-01", "#text": "Titre II : Îles Wallis et Futuna", "@debut": "2000-06-22" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006140635", "@fin": "2999-01-01", "#text": "Livre V : Mayotte, îles Wallis et Futuna et Terres australes et antarctiques françaises, Nouvelle-Calédonie et Polynésie française", "@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": "LEGIARTI000006690651", "@fin": "2001-12-26", "@num": "L5521-2", "@etat": "MODIFIE", "@debut": "2000-06-22", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006690652", "@fin": "2005-08-27", "@num": "L5521-2", "@etat": "MODIFIE", "@debut": "2001-12-26", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006690653", "@fin": "2007-12-22", "@num": "L5521-2", "@etat": "MODIFIE", "@debut": "2005-08-27", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000017842140", "@fin": "2008-12-20", "@num": "L5521-2", "@etat": "MODIFIE", "@debut": "2007-12-22", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000019960237", "@fin": "2018-01-05", "@num": "L5521-2", "@etat": "MODIFIE", "@debut": "2008-12-20", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000036408597", "@fin": "2019-07-27", "@num": "L5521-2", "@etat": "MODIFIE", "@debut": "2018-01-05", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000038886657", "@fin": "2020-12-09", "@num": "L5521-2", "@etat": "MODIFIE", "@debut": "2019-07-27", "@origine": "LEGI" } }, { "@etat": "VIGUEUR", "LIEN_ART": { "@id": "LEGIARTI000042655940", "@fin": "2999-01-01", "@num": "L5521-2", "@etat": "VIGUEUR", "@debut": "2020-12-09", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "

Les articles L. 5125-1 à L. 5125-3, L. 5125-4 premier alinéa, L. 5125-16, L. 5125-17, L. 5125-20, L. 5125-21, L. 5125-23 premier et deuxième alinéas, L. 5125-24 à L. 5125-31 et L. 5125-32 3° à 6° sont applicables dans le territoire des îles Wallis et Futuna sous réserve des adaptations prévues aux articles L. 5521-3 et L. 5521-4.

" } }, "LEGIARTI000020886469": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "L5121-1", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2010-02-26", "DATE_DEBUT": "2009-07-23" } }, "META_COMMUN": { "ID": "LEGIARTI000020886469", "URL": "article/LEGI/ARTI/00/00/20/88/64/LEGIARTI000020886469.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "LIENS": { "LIEN": [ { "@id": "LEGIARTI000049923273", "@num": "2", "#text": "Arrêté du 4 août 1987 - art. 2 (VD)", "@sens": "cible", "@cidtexte": "JORFTEXT000000843609", "@nortexte": "ECOX8798330A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "1987-08-04" }, { "@id": "LEGIARTI000023731730", "@num": "3", "#text": "Arrêté du 4 août 1987 - art. 3 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000843609", "@nortexte": "ECOX8798330A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "1987-08-04" }, { "@id": "LEGIARTI000034405848", "@num": "69", "#text": "Décret n°90-1215 du 20 décembre 1990 - art. 69 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000717193", "@nortexte": "SPSS9001980D", "@numtexte": "90-1215", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1990-12-20" }, { "@id": "LEGIARTI000006699999", "@num": "1", "#text": "Décret n°95-1172 du 6 novembre 1995 - art. 1 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000737358", "@nortexte": "SANP9502594D", "@numtexte": "95-1172", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1995-11-06" }, { "@id": "LEGIARTI000006700029", "@num": "10", "#text": "Décret n°95-1172 du 6 novembre 1995 - art. 10 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000737358", "@nortexte": "SANP9502594D", "@numtexte": "95-1172", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1995-11-06" }, { "@id": "LEGIARTI000006700040", "@num": "14", "#text": "Décret n°95-1172 du 6 novembre 1995 - art. 14 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000737358", "@nortexte": "SANP9502594D", "@numtexte": "95-1172", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1995-11-06" }, { "@id": "LEGIARTI000006700043", "@num": "15", "#text": "Décret n°95-1172 du 6 novembre 1995 - art. 15 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000737358", "@nortexte": "SANP9502594D", "@numtexte": "95-1172", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1995-11-06" }, { "@id": "LEGIARTI000006700045", "@num": "16", "#text": "Décret n°95-1172 du 6 novembre 1995 - art. 16 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000737358", "@nortexte": "SANP9502594D", "@numtexte": "95-1172", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1995-11-06" }, { "@id": "LEGIARTI000006700047", "@num": "17", "#text": "Décret n°95-1172 du 6 novembre 1995 - art. 17 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000737358", "@nortexte": "SANP9502594D", "@numtexte": "95-1172", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1995-11-06" }, { "@id": "LEGIARTI000006700002", "@num": "2", "#text": "Décret n°95-1172 du 6 novembre 1995 - art. 2 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000737358", "@nortexte": "SANP9502594D", "@numtexte": "95-1172", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1995-11-06" }, { "@id": "LEGIARTI000006700054", "@num": "20", "#text": "Décret n°95-1172 du 6 novembre 1995 - art. 20 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000737358", "@nortexte": "SANP9502594D", "@numtexte": "95-1172", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1995-11-06" }, { "@id": "LEGIARTI000006700005", "@num": "3", "#text": "Décret n°95-1172 du 6 novembre 1995 - art. 3 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000737358", "@nortexte": "SANP9502594D", "@numtexte": "95-1172", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1995-11-06" }, { "@id": "LEGIARTI000006700008", "@num": "4", "#text": "Décret n°95-1172 du 6 novembre 1995 - art. 4 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000737358", "@nortexte": "SANP9502594D", "@numtexte": "95-1172", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1995-11-06" }, { "@id": "LEGIARTI000006865783", "@num": "Annexe", "#text": "Décret n°96-850 du 20 septembre 1996 - art. Annexe (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000195660", "@nortexte": "ENVP9640024D", "@numtexte": "96-850", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1996-09-20" }, { "@id": "LEGIARTI000006725129", "@num": "71", "#text": "Décret n°2001-1065 du 15 novembre 2001 - art. 71 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000403855", "@nortexte": "INTM0100035D", "@numtexte": "2001-1065", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2001-11-15" }, { "@id": "LEGIARTI000006758846", "@num": "12", "#text": "Loi n°2003-1199 du 18 décembre 2003 - art. 12 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000249276", "@nortexte": "SANX0300139L", "@numtexte": "2003-1199", "@typelien": "CITATION", "@naturetexte": "LOI", "@datesignatexte": "2003-12-18" }, { "@id": "LEGIARTI000006697606", "@num": "35", "#text": "Loi n°2004-800 du 6 août 2004 - art. 35 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000441469", "@nortexte": "SANX0100053L", "@numtexte": "2004-800", "@typelien": "CITATION", "@naturetexte": "LOI", "@datesignatexte": "2004-08-06" }, { "@id": "LEGIARTI000047109474", "@num": "14", "#text": "Décret n°2004-942 du 3 septembre 2004 - art. 14 (M)", "@sens": "cible", "@cidtexte": "JORFTEXT000000253592", "@nortexte": "SANS0422327D", "@numtexte": "2004-942", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2004-09-03" }, { "@id": "LEGIARTI000032182077", "@num": "41", "#text": "Loi n°2005-1579 du 19 décembre 2005 - art. 41 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000815414", "@nortexte": "SANX0500246L", "@numtexte": "2005-1579", "@typelien": "CITATION", "@naturetexte": "LOI", "@datesignatexte": "2005-12-19" }, { "@id": "LEGIARTI000020140266", "@num": "8", "#text": "Arrêté du 24 mai 2006 - art. 8 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000457818", "@nortexte": "SANP0622223A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-05-24" }, { "@id": "LEGIARTI000043762395", "@num": "21", "#text": "Décret n° 2007-359 du 19 mars 2007 - art. 21 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000645145", "@nortexte": "AGRG0700643D", "@numtexte": "2007-359", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2007-03-19" }, { "@id": "LEGIARTI000020881220", "@num": "3", "#text": "LOI n°2009-879\n du 21 juillet 2009 - art. 3", "@sens": "cible", "@cidtexte": "JORFTEXT000020879475", "@nortexte": "SASX0822640L", "@numtexte": "2009-879", "@typelien": "MODIFIE", "@naturetexte": "LOI", "@datesignatexte": "2009-07-21" }, { "@id": "LEGIARTI000022933811", "@num": "3", "#text": "Arrêté du 29 septembre 2010 - art. 3 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000022932466", "@nortexte": "SASP1025728A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2010-09-29" }, { "@id": "LEGIARTI000023501118", "@num": "4", "#text": "Arrêté du 21 janvier 2011 - art. 4 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000023491451", "@nortexte": "ETSP1101997A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2011-01-21" }, { "@id": "LEGIARTI000023824330", "@num": "1", "#text": "Arrêté du 29 mars 2011 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000023823216", "@nortexte": "ETSP1108796A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2011-03-29" }, { "@id": "LEGIARTI000046423270", "@num": "13", "#text": "Arrêté du 6 avril 2011 - art. 13 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000023865866", "@nortexte": "ETSH1109848A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2011-04-06" }, { "@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": "LEGIARTI000026041157", "@num": "2", "#text": "Arrêté du 8 juin 2012 - art. 2 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000026040448", "@nortexte": "AFSP1225501A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2012-06-08" }, { "@id": "LEGITEXT000026558683", "#text": "Décret n°2012-1201\n du 29 octobre 2012 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000026557838", "@nortexte": "AFSP1232892D", "@numtexte": "2012-1201", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2012-10-29" }, { "@id": "LEGIARTI000026589554", "@num": "2", "#text": "Décret n°2012-1236\n du 6 novembre 2012 - art. 2 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000026588856", "@nortexte": "AFSP1226229D", "@numtexte": "2012-1236", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2012-11-06" }, { "@id": "LEGIARTI000035971424", "#text": "DÉCRET n°2014-1287 du 23 octobre 2014 - art. (M)", "@sens": "cible", "@cidtexte": "JORFTEXT000029676018", "@nortexte": "AFSX1419039D", "@numtexte": "2014-1287", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2014-10-23" }, { "@id": "LEGIARTI000042293117", "#text": "DÉCRET n°2014-1288 du 23 octobre 2014 - art. 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On entend par :

2° Préparation hospitalière, tout médicament, à l'exception des produits de thérapies génique ou cellulaire, préparé selon les indications de la pharmacopée et en conformité avec les bonnes pratiques mentionnées à l'article L. 5121-5, en raison de l'absence de spécialité pharmaceutique disponible ou adaptée par une pharmacie à usage intérieur d'un établissement de santé, ou par l'établissement pharmaceutique de cet établissement de santé autorisé en application de l'article L. 5124-9 ou dans les conditions prévues à l'article L. 5126-2. Les préparations hospitalières sont dispensées sur prescription médicale à un ou plusieurs patients par une pharmacie à usage intérieur dudit établissement. Elles font l'objet d'une déclaration auprès de l'Agence française de sécurité sanitaire des produits de santé, dans des conditions définies par arrêté du ministre chargé de la santé ;

6° Médicament immunologique, tout médicament consistant en :

a) Allergène, défini comme tout produit destiné à identifier ou provoquer une modification spécifique et acquise de la réponse immunologique à un agent allergisant ;

b) Vaccin, toxine ou sérum, définis comme tous agents utilisés en vue de provoquer une immunité active ou passive ou en vue de diagnostiquer l'état d'immunité ;

9° Trousse, toute préparation qui doit être reconstituée ou combinée avec des radionucléides dans le produit radiopharmaceutique final ;

10° Précurseur, tout autre radionucléide produit pour le marquage radioactif d'une autre substance avant administration ;

" } }, "LEGIARTI000021199789": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R5125-33-2", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2010-04-01", "DATE_DEBUT": "2009-10-25" } }, "META_COMMUN": { "ID": "LEGIARTI000021199789", "URL": "article/LEGI/ARTI/00/00/21/19/97/LEGIARTI000021199789.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "LIENS": { "LIEN": [ { "@id": "LEGIARTI000021192680", "@num": "1", "#text": "Décret n°2009-1283 du 22 octobre 2009 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000021190563", "@nortexte": "SASP0917871D", "@numtexte": "2009-1283", "@typelien": "CREE", "@naturetexte": "DECRET", "@datesignatexte": "2009-10-22" }, { "@id": "LEGIARTI000029764207", "@num": "4", "#text": "DÉCRET n°2014-1367 du 14 novembre 2014 - art. 4 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000029762609", "@nortexte": "AFSP1320938D", "@numtexte": "2014-1367", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2014-11-14" }, { "@id": "LEGIARTI000006690015", "@num": "L5125-1", "#text": "Code de la santé publique - art. L5125-1", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006690021", "@num": "L5125-5", "#text": "Code de la santé publique - art. L5125-5", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000021199541", "@num": "R5125-33-1", "#text": "Code de la santé publique - art. R5125-33-1", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000021199794", "@fin": "2014-11-17", "#text": "Sous-section 10 : Dispositions particulières à l'activité de sous-traitance de préparations", "@debut": "2009-10-25" }, { "@id": "LEGISCTA000029774347", "@fin": "2999-01-01", "#text": "Sous-section 10 : Dispositions relatives à l'activité de sous-traitance de l'exécution de préparations", "@debut": "2014-11-17" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006190690", "@fin": "2999-01-01", "#text": "Section 1 : Officines de pharmacie", "@debut": "2004-08-08" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006178653", "@fin": "2999-01-01", "#text": "Chapitre V : Distribution au détail", "@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": "LEGIARTI000021199789", "@fin": "2010-04-01", "@num": "R5125-33-2", "@etat": "MODIFIE", "@debut": "2009-10-25", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000022055163", "@fin": "2014-11-17", "@num": "R5125-33-2", "@etat": "MODIFIE", "@debut": "2010-04-01", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000029774339", "@fin": "2018-08-01", "@num": "R5125-33-2", "@etat": "MODIFIE", "@debut": "2014-11-17", "@origine": "LEGI" } }, { "@etat": "VIGUEUR", "LIEN_ART": { "@id": "LEGIARTI000037269772", "@fin": "2999-01-01", "@num": "R5125-33-2", "@etat": "VIGUEUR", "@debut": "2018-08-01", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "I.-Le contrat écrit de sous-traitance mentionné au deuxième alinéa de l'article L. 5125-1 est établi conformément aux bonnes pratiques de préparation mentionnées à l'article L. 5121-5.
\n
II.-Un relevé annuel des contrats de sous-traitance indiquant les coordonnées des donneurs d'ordre, les formes pharmaceutiques des préparations sous-traitées et les principes actifs qu'elles contiennent est transmis par le titulaire de l'autorisation d'exercer l'activité de sous-traitance au pharmacien inspecteur régional au plus tard le 31 mars de l'année suivante.
\n
A défaut de transmission, l'autorisation pourra être retirée dans les conditions prévues au V de l'article R. 5125-33-1." } }, "LEGIARTI000021199796": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R5125-33-1", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2010-04-01", "DATE_DEBUT": "2009-10-25" } }, "META_COMMUN": { "ID": "LEGIARTI000021199796", "URL": "article/LEGI/ARTI/00/00/21/19/97/LEGIARTI000021199796.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "LIENS": { "LIEN": [ { "@id": "LEGIARTI000021192680", "@num": "1", "#text": "Décret n°2009-1283 du 22 octobre 2009 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000021190563", "@nortexte": "SASP0917871D", "@numtexte": "2009-1283", "@typelien": "CREE", "@naturetexte": "DECRET", "@datesignatexte": "2009-10-22" }, { "@id": "LEGIARTI000029764207", "@num": "4", "#text": "DÉCRET n°2014-1367 du 14 novembre 2014 - art. 4 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000029762609", "@nortexte": "AFSP1320938D", "@numtexte": "2014-1367", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2014-11-14" }, { "@id": "LEGIARTI000006690015", "@num": "L5125-1", "#text": "Code de la santé publique - art. L5125-1", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006690016", "@num": "L5125-1-1", "#text": "Code de la santé publique - art. L5125-1-1", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006690127", "@num": "L5132-2", "#text": "Code de la santé publique - art. L5132-2", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006915188", "@num": "R5125-12", "#text": "Code de la santé publique - art. R5125-12", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000029774339", "@num": "R5125-33-2", "#text": "Code de la santé publique - art. R5125-33-2 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000022055160", "@num": "R5125-33-3", "#text": "Code de la santé publique - art. R5125-33-3 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000021199802", "@fin": "2014-11-17", "#text": "Sous-section 9 : Dispositions communes à la sous-traitance de préparations et à l'exécution de préparations stériles ou dangereuses.", "@debut": "2009-10-25" }, { "@id": "LEGISCTA000029774336", "@fin": "2999-01-01", "#text": "Sous-section 9 : Dispositions relatives à l'exécution de préparations pouvant présenter un risque pour la santé", "@debut": "2014-11-17" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006190690", "@fin": "2999-01-01", "#text": "Section 1 : Officines de pharmacie", "@debut": "2004-08-08" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006178653", "@fin": "2999-01-01", "#text": "Chapitre V : Distribution au détail", "@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": "LEGIARTI000021199796", "@fin": "2010-04-01", "@num": "R5125-33-1", "@etat": "MODIFIE", "@debut": "2009-10-25", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000022055139", "@fin": "2014-11-17", "@num": "R5125-33-1", "@etat": "MODIFIE", "@debut": "2010-04-01", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000029774329", "@fin": "2018-08-01", "@num": "R5125-33-1", "@etat": "MODIFIE", "@debut": "2014-11-17", "@origine": "LEGI" } }, { "@etat": "VIGUEUR", "LIEN_ART": { "@id": "LEGIARTI000037269786", "@fin": "2999-01-01", "@num": "R5125-33-1", "@etat": "VIGUEUR", "@debut": "2018-08-01", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "I.-L'autorisation d'exercice de l'activité de sous-traitance mentionnée au deuxième alinéa de l'article L. 5125-1 et l'autorisation d'exécution de préparations stériles ou dangereuses mentionnée au deuxième alinéa de l'article L. 5125-1-1 sont demandées au préfet du département où l'exécution de ces activités est envisagée par le pharmacien titulaire de l'officine concernée.
\n
Lorsque la demande est présentée par une société ou par plusieurs pharmaciens réunis en copropriété, elle est signée par chaque associé ou copropriétaire devant exercer dans l'officine.
\n
La demande est accompagnée d'un dossier comportant :
\n
1° Une attestation d'inscription au tableau par le conseil régional de l'ordre des pharmaciens ;
\n
2° La liste des formes pharmaceutiques envisagées ;
\n
3° Le plan des locaux de l'officine où sont exécutées les préparations, avec indications des différentes zones et leurs superficies ;
\n
4° Le nombre et la qualification des personnels affectés à l'exécution des préparations ;
\n
5° Les matériels, équipements et installations de préparation ;
\n
6° La description des systèmes informatisés dédiés à cette activité ;
\n
7° Une notice d'information décrivant l'organisation générale, les moyens et procédures mis en œuvre pour respecter les bonnes pratiques de préparation mentionnées à l'article L. 5125-1 ;
\n
8° Une évaluation quantitative du nombre de préparations réalisées ou projetées par formes pharmaceutiques ;
\n
9° Le cas échéant, la mention d'une activité de sous-traitance de préparations stériles ou dangereuses mentionnées à l'article L. 5132-2.
\n
II.-L'autorisation d'exercice de l'activité de sous-traitance ou l'autorisation d'exécution de préparations stériles et dangereuses sont délivrées après enquête de l'inspection régionale de la pharmacie. Ces autorisations sont subordonnées au respect des bonnes pratiques de préparation. La décision mentionne les formes pharmaceutiques et les activités autorisées.
\n
Elle fait l'objet d'une publication au recueil des actes administratifs.
\n
III.-Le défaut de réponse dans le délai de quatre mois à compter de la réception de la demande vaut autorisation tacite pour l'activité qui en fait l'objet.
\n
Le préfet peut requérir du demandeur les informations complémentaires à l'instruction de la demande. Dans ce cas, le délai prévu au premier alinéa est suspendu jusqu'à réception de ces informations.
\n
IV.-Fait l'objet d'une déclaration au préfet toute modification des éléments mentionnés aux 1°, 2°, 3°, 4°, 5° et 6° du I. Le respect de cette formalité dispense de procéder à la déclaration à l'inspection régionale de la pharmacie prévue à l'article R. 5125-12.
\n
V.-Le retrait ou la suspension, totale ou partielle, de l'autorisation d'exercer l'activité de sous-traitance ou de l'autorisation d'exécuter des préparations stériles ou dangereuses peut être prononcé par le représentant de l'Etat, après avis du directeur régional des affaires sanitaires et sociales, lorsqu'il a été établi, après enquête de l'inspection régionale de la pharmacie, que l'officine ne respecte plus les bonnes pratiques de préparation ou réalise les préparations dans des conditions dangereuses pour la santé publique.
\n
La décision de retrait ou de suspension de l'autorisation d'exercer l'activité de sous-traitance ou de l'autorisation d'exécuter des préparations stériles ou dangereuses ne peut intervenir qu'après que le titulaire ou le gérant de l'officine a été mis en demeure de présenter dans un délai d'un mois ses observations sur les faits de nature à justifier la décision.
\n
En cas d'urgence, le préfet peut, sans procédure préalable, prononcer une suspension d'autorisation pour une durée qui ne peut être supérieure à un mois.
\n
La décision de retrait ou de suspension est notifiée par lettre recommandée avec demande d'avis de réception.
\n
VI.-L'autorisation d'exercer l'activité de sous-traitance au titre de l'article L. 5125-1 pour l'exécution des préparations stériles ou dangereuses mentionnées à l'article L. 5132-2 vaut autorisation d'exécuter ce type de préparations au titre de l'article L. 5125-1-1." } }, "LEGIARTI000021941991": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "L5121-1", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2011-12-23", "DATE_DEBUT": "2010-02-26" } }, "META_COMMUN": { "ID": "LEGIARTI000021941991", "URL": "article/LEGI/ARTI/00/00/21/94/19/LEGIARTI000021941991.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "LIENS": { "LIEN": [ { "@id": "LEGIARTI000049923273", "@num": "2", "#text": "Arrêté du 4 août 1987 - art. 2 (VD)", "@sens": "cible", "@cidtexte": "JORFTEXT000000843609", "@nortexte": "ECOX8798330A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "1987-08-04" }, { "@id": "LEGIARTI000023731730", "@num": "3", "#text": "Arrêté du 4 août 1987 - art. 3 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000843609", "@nortexte": "ECOX8798330A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "1987-08-04" }, { "@id": "LEGIARTI000034405848", "@num": "69", "#text": "Décret n°90-1215 du 20 décembre 1990 - art. 69 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000717193", "@nortexte": "SPSS9001980D", "@numtexte": "90-1215", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1990-12-20" }, { "@id": "LEGIARTI000006699999", "@num": "1", "#text": "Décret n°95-1172 du 6 novembre 1995 - art. 1 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000737358", "@nortexte": "SANP9502594D", "@numtexte": "95-1172", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1995-11-06" }, { "@id": "LEGIARTI000006700029", "@num": "10", "#text": "Décret n°95-1172 du 6 novembre 1995 - art. 10 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000737358", "@nortexte": "SANP9502594D", "@numtexte": "95-1172", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1995-11-06" }, { "@id": "LEGIARTI000006700040", "@num": "14", "#text": "Décret n°95-1172 du 6 novembre 1995 - art. 14 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000737358", "@nortexte": "SANP9502594D", "@numtexte": "95-1172", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1995-11-06" }, { "@id": "LEGIARTI000006700043", "@num": "15", "#text": "Décret n°95-1172 du 6 novembre 1995 - art. 15 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000737358", "@nortexte": "SANP9502594D", "@numtexte": "95-1172", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1995-11-06" }, { "@id": "LEGIARTI000006700045", "@num": "16", "#text": "Décret n°95-1172 du 6 novembre 1995 - art. 16 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000737358", "@nortexte": "SANP9502594D", "@numtexte": "95-1172", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1995-11-06" }, { "@id": "LEGIARTI000006700047", "@num": "17", "#text": "Décret n°95-1172 du 6 novembre 1995 - art. 17 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000737358", "@nortexte": "SANP9502594D", "@numtexte": "95-1172", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1995-11-06" }, { "@id": "LEGIARTI000006700002", "@num": "2", "#text": "Décret n°95-1172 du 6 novembre 1995 - art. 2 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000737358", "@nortexte": "SANP9502594D", "@numtexte": "95-1172", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1995-11-06" }, { "@id": "LEGIARTI000006700054", "@num": "20", "#text": "Décret n°95-1172 du 6 novembre 1995 - art. 20 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000737358", "@nortexte": "SANP9502594D", "@numtexte": "95-1172", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1995-11-06" }, { "@id": "LEGIARTI000006700005", "@num": "3", "#text": "Décret n°95-1172 du 6 novembre 1995 - art. 3 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000737358", "@nortexte": "SANP9502594D", "@numtexte": "95-1172", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1995-11-06" }, { "@id": "LEGIARTI000006700008", "@num": "4", "#text": "Décret n°95-1172 du 6 novembre 1995 - art. 4 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000737358", "@nortexte": "SANP9502594D", "@numtexte": "95-1172", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1995-11-06" }, { "@id": "LEGIARTI000006865783", "@num": "Annexe", "#text": "Décret n°96-850 du 20 septembre 1996 - art. Annexe (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000195660", "@nortexte": "ENVP9640024D", "@numtexte": "96-850", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1996-09-20" }, { "@id": "LEGIARTI000006725129", "@num": "71", "#text": "Décret n°2001-1065 du 15 novembre 2001 - art. 71 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000403855", "@nortexte": "INTM0100035D", "@numtexte": "2001-1065", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2001-11-15" }, { "@id": "LEGIARTI000006758846", "@num": "12", "#text": "Loi n°2003-1199 du 18 décembre 2003 - art. 12 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000249276", "@nortexte": "SANX0300139L", "@numtexte": "2003-1199", "@typelien": "CITATION", "@naturetexte": "LOI", "@datesignatexte": "2003-12-18" }, { "@id": "LEGIARTI000006697606", "@num": "35", "#text": "Loi n°2004-800 du 6 août 2004 - art. 35 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000441469", "@nortexte": "SANX0100053L", "@numtexte": "2004-800", "@typelien": "CITATION", "@naturetexte": "LOI", "@datesignatexte": "2004-08-06" }, { "@id": "LEGIARTI000047109474", "@num": "14", "#text": "Décret n°2004-942 du 3 septembre 2004 - art. 14 (M)", "@sens": "cible", "@cidtexte": "JORFTEXT000000253592", "@nortexte": "SANS0422327D", "@numtexte": "2004-942", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2004-09-03" }, { "@id": "LEGIARTI000032182077", "@num": "41", "#text": "Loi n°2005-1579 du 19 décembre 2005 - art. 41 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000815414", "@nortexte": "SANX0500246L", "@numtexte": "2005-1579", "@typelien": "CITATION", "@naturetexte": "LOI", "@datesignatexte": "2005-12-19" }, { "@id": "LEGIARTI000020140266", "@num": "8", "#text": "Arrêté du 24 mai 2006 - art. 8 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000457818", "@nortexte": "SANP0622223A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-05-24" }, { "@id": "LEGIARTI000043762395", "@num": "21", "#text": "Décret n° 2007-359 du 19 mars 2007 - art. 21 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000645145", "@nortexte": "AGRG0700643D", "@numtexte": "2007-359", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2007-03-19" }, { "@id": "LEGIARTI000021869972", "@num": "26", "#text": "Ordonnance n°2010-177\n du 23 février 2010 - art. 26", "@sens": "cible", "@cidtexte": "JORFTEXT000021868310", "@nortexte": "SASX0930688R", "@numtexte": "2010-177", "@typelien": "MODIFIE", "@naturetexte": "ORDONNANCE", "@datesignatexte": "2010-02-23" }, { "@id": "LEGIARTI000022933811", "@num": "3", "#text": "Arrêté du 29 septembre 2010 - art. 3 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000022932466", "@nortexte": "SASP1025728A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2010-09-29" }, { "@id": "LEGIARTI000023501118", "@num": "4", "#text": "Arrêté du 21 janvier 2011 - art. 4 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000023491451", "@nortexte": "ETSP1101997A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2011-01-21" }, { "@id": "LEGIARTI000023824330", "@num": "1", "#text": "Arrêté du 29 mars 2011 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000023823216", "@nortexte": "ETSP1108796A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2011-03-29" }, { "@id": "LEGIARTI000046423270", "@num": "13", "#text": "Arrêté du 6 avril 2011 - art. 13 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000023865866", "@nortexte": "ETSH1109848A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2011-04-06" }, { "@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": "LEGIARTI000026041157", "@num": "2", "#text": "Arrêté du 8 juin 2012 - art. 2 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000026040448", "@nortexte": "AFSP1225501A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2012-06-08" }, { "@id": "LEGITEXT000026558683", "#text": "Décret n°2012-1201\n du 29 octobre 2012 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000026557838", "@nortexte": "AFSP1232892D", "@numtexte": "2012-1201", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2012-10-29" }, { "@id": "LEGIARTI000026589554", "@num": "2", "#text": "Décret n°2012-1236\n du 6 novembre 2012 - art. 2 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000026588856", "@nortexte": "AFSP1226229D", "@numtexte": "2012-1236", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2012-11-06" }, { "@id": "LEGIARTI000035971424", "#text": "DÉCRET n°2014-1287 du 23 octobre 2014 - art. (M)", "@sens": "cible", "@cidtexte": "JORFTEXT000029676018", "@nortexte": "AFSX1419039D", "@numtexte": "2014-1287", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2014-10-23" }, { "@id": "LEGIARTI000042293117", "#text": "DÉCRET n°2014-1288 du 23 octobre 2014 - art. (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000029676038", "@nortexte": "AFSX1419044D", "@numtexte": "2014-1288", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2014-10-23" }, { "@id": "LEGIARTI000030189762", "@num": "8", "#text": "ARRÊTÉ du 28 novembre 2014 - art. 8 (VD)", "@sens": "cible", "@cidtexte": "JORFTEXT000030189026", "@nortexte": "EINC1415451A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2014-11-28" }, { "@id": "LEGIARTI000030189876", "@num": "1", "#text": "ARRÊTÉ du 3 février 2015 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000030188934", "@nortexte": "AFSP1503244A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2015-02-03" }, { "@id": "LEGIARTI000032291698", "@num": "1", "#text": "Décret n°2016-349 du 24 mars 2016 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000032291186", "@nortexte": "AFSH1532721D", "@numtexte": "2016-349", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2016-03-24" }, { "@id": "LEGIARTI000032730970", "@num": "3", "#text": "Décret n°2016-817 du 20 juin 2016 - art. 3", "@sens": "cible", "@cidtexte": "JORFTEXT000032729458", "@nortexte": "AFSS1610671D", "@numtexte": "2016-817", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2016-06-20" }, { "@id": "LEGIARTI000034392999", "@num": "1", "#text": "Décret n°2017-500 du 6 avril 2017 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000034390458", "@nortexte": "AFSH1702718D", "@numtexte": "2017-500", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2017-04-06" }, { "@id": "LEGIARTI000038879548", "@num": "1", "#text": "Décret n°2019-818 du 1er août 2019 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000038873188", "@nortexte": "SSAS1911214D", "@numtexte": "2019-818", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2019-08-01" }, { "@id": "LEGIARTI000042267406", "@num": "1", "#text": "Décret n°2020-1090 du 25 août 2020 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000042266405", "@nortexte": "SSAS2006857D", "@numtexte": "2020-1090", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2020-08-25" }, { "@id": "LEGIARTI000044941358", "@num": "6", "#text": "Décret n°2021-1905 du 30 décembre 2021 - art. 6", "@sens": "cible", "@cidtexte": "JORFTEXT000044638030", "@nortexte": "TREP2130559D", "@numtexte": "2021-1905", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2021-12-30" }, { "@id": "LEGIARTI000045632789", "@num": "1", "#text": "Décret n°2022-597 du 21 avril 2022 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000045632039", "@nortexte": "SSAH2205181D", "@numtexte": "2022-597", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2022-04-21" }, { "@id": "LEGITEXT000049536357", "#text": "Décret n°2024-435 du 14 mai 2024 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000049535648", "@nortexte": "TSSS2408227D", "@numtexte": "2024-435", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2024-05-14" }, { "@id": "LEGITEXT000049850758", "#text": "Décret n°2024-626 du 27 juin 2024 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000049832038", "@nortexte": "TSSP2408968D", "@numtexte": "2024-626", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2024-06-27" }, { "@id": "LEGITEXT000049922585", "#text": "Arrêté du 5 juillet 2024 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000049892254", "@nortexte": "TSSS2418508A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2024-07-05" }, { "@id": "LEGITEXT000050737433", "#text": "Décret n°2024-1135 du 4 décembre 2024 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000050731183", "@nortexte": "MSAH2429400D", "@numtexte": "2024-1135", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2024-12-04" }, { "@id": "LEGIARTI000006279394", "@num": "L611-2", "#text": "Code de la propriété intellectuelle - art. 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"@debut": "2009-07-23", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000021941991", "@fin": "2011-12-23", "@num": "L5121-1", "@etat": "MODIFIE", "@debut": "2010-02-26", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000025014196", "@fin": "2011-12-31", "@num": "L5121-1", "@etat": "MODIFIE", "@debut": "2011-12-23", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000025122674", "@fin": "2012-05-01", "@num": "L5121-1", "@etat": "MODIFIE", "@debut": "2011-12-31", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000026499732", "@fin": "2012-05-08", "@num": "L5121-1", "@etat": "MODIFIE", "@debut": "2012-05-01", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000029719721", "@fin": "2013-12-25", "@num": "L5121-1", "@etat": "MODIFIE", "@debut": "2012-05-08", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000028394169", "@fin": "2014-12-25", "@num": "L5121-1", "@etat": "MODIFIE", "@debut": "2013-12-25", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000029962685", "@fin": "2016-01-28", "@num": "L5121-1", "@etat": "MODIFIE", "@debut": "2014-12-25", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000031930491", "@fin": "2016-07-17", "@num": "L5121-1", "@etat": "MODIFIE", "@debut": "2016-01-28", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000032906295", "@fin": "2017-07-01", "@num": "L5121-1", "@etat": "MODIFIE", "@debut": "2016-07-17", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000033621108", "@fin": "2019-01-01", "@num": "L5121-1", "@etat": "MODIFIE", "@debut": "2017-07-01", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000037950971", "@fin": "2021-07-01", "@num": "L5121-1", "@etat": "MODIFIE", "@debut": "2019-01-01", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000042685768", "@fin": "2021-08-04", "@num": "L5121-1", "@etat": "MODIFIE", "@debut": "2021-07-01", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000043896320", "@fin": "2021-12-25", "@num": "L5121-1", "@etat": "MODIFIE", "@debut": "2021-08-04", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000044628485", "@fin": "2023-12-28", "@num": "L5121-1", "@etat": "MODIFIE", "@debut": "2021-12-25", "@origine": "LEGI" } }, { "@etat": "VIGUEUR", "LIEN_ART": { "@id": "LEGIARTI000048701765", "@fin": "2999-01-01", "@num": "L5121-1", "@etat": "VIGUEUR", "@debut": "2023-12-28", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "

On entend par :

b) Groupe générique, le regroupement d'une spécialité de référence et des spécialités qui en sont génériques. Toutefois, une spécialité remplissant les conditions pour être une spécialité de référence, qui présente la même composition qualitative en substance active, la même composition quantitative en substance active ou, à défaut, une fraction thérapeutique active identique dans les limites prévues à l'annexe I de la directive 2001 / 83 / CE du Parlement européen et du Conseil du 6 novembre 2001 instituant un code communautaire relatif aux médicaments à usage humain, et la même forme pharmaceutique qu'une spécialité de référence d'un groupe générique déjà existant, et dont la bioéquivalence avec cette spécialité est démontrée par des études de biodisponibilité appropriées, peut aussi figurer dans ce groupe générique, à condition que ces deux spécialités soient considérées comme relevant d'une même autorisation de mise sur le marché globale, définie par voie réglementaire et qu'elles ne présentent pas de propriétés sensiblement différentes au regard de la sécurité ou de l'efficacité. En l'absence de spécialité de référence, un groupe générique peut être constitué de spécialités ayant la même composition qualitative et quantitative en principes actifs, la même forme pharmaceutique et dont les caractéristiques en termes de sécurité et d'efficacité sont équivalentes. Pour l'application du présent b, sont inscrites au répertoire des groupes génériques les spécialités qui se présentent sous une forme pharmaceutique orale à libération modifiée différente de celle de la spécialité de référence, à condition que ces spécialités et la spécialité de référence appartiennent à la même catégorie de forme pharmaceutique à libération modifiée et qu'elles ne présentent pas de propriétés sensiblement différentes au regard de la sécurité ou de l'efficacité ;

6° Médicament immunologique, tout médicament consistant en :

a) Allergène, défini comme tout produit destiné à identifier ou provoquer une modification spécifique et acquise de la réponse immunologique à un agent allergisant ;

b) Vaccin, toxine ou sérum, définis comme tous agents utilisés en vue de provoquer une immunité active ou passive ou en vue de diagnostiquer l'état d'immunité ;

9° Trousse, toute préparation qui doit être reconstituée ou combinée avec des radionucléides dans le produit radiopharmaceutique final ;

10° Précurseur, tout autre radionucléide produit pour le marquage radioactif d'une autre substance avant administration ;

11° Médicament homéopathique, tout médicament obtenu à partir de substances appelées souches homéopathiques, selon un procédé de fabrication homéopathique décrit par la pharmacopée européenne, la pharmacopée française ou, à défaut, par les pharmacopées utilisées de façon officielle dans un autre Etat membre de l'Union européenne. Un médicament homéopathique peut aussi contenir plusieurs principes ;

13° Préparation de thérapie cellulaire xénogénique, tout médicament autre que les spécialités pharmaceutiques et les médicaments fabriqués industriellement mentionnés à l'article L. 5121-8, consistant en des cellules d'origine animale et leurs dérivés utilisés à des fins thérapeutiques, y compris les cellules servant à transférer du matériel génétique, quel que soit leur niveau de transformation. Ces préparations sont préparées à l'avance et dispensées sur prescription médicale à un ou plusieurs patients. Elles font l'objet d'une autorisation de l'Agence française de sécurité sanitaire des produits de santé pour une indication thérapeutique donnée. Cette autorisation peut être assortie de conditions particulières ou de restrictions d'utilisation. Elle peut être modifiée, suspendue ou retirée.L'Agence de la biomédecine est informée des décisions relatives à ces préparations prises en application du présent alinéa ;

" } }, "LEGIARTI000022055139": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R5125-33-1", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2014-11-17", "DATE_DEBUT": "2010-04-01" } }, "META_COMMUN": { "ID": "LEGIARTI000022055139", "URL": "article/LEGI/ARTI/00/00/22/05/51/LEGIARTI000022055139.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "NOTA": { "CONTENU": "

Le décret 2010-336 du 31 mars 2010 art. 1 a créé les agences régionales de santé à compter du 1er avril 2010.

" }, "LIENS": { "LIEN": [ { "@id": "LEGIARTI000022043864", "@num": "154", "#text": "Décret n°2010-344\n du 31 mars 2010 - art. 154", "@sens": "cible", "@cidtexte": "JORFTEXT000022041034", "@nortexte": "SASX1008846D", "@numtexte": "2010-344", "@typelien": "MODIFIE", "@naturetexte": "DECRET", "@datesignatexte": "2010-03-31" }, { "@id": "LEGIARTI000029764207", "@num": "4", "#text": "DÉCRET n°2014-1367 du 14 novembre 2014 - art. 4 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000029762609", "@nortexte": "AFSP1320938D", "@numtexte": "2014-1367", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2014-11-14" }, { "@id": "LEGIARTI000006690015", "@num": "L5125-1", "#text": "Code de la santé publique - art. L5125-1", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006690016", "@num": "L5125-1-1", "#text": "Code de la santé publique - art. L5125-1-1", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006690127", "@num": "L5132-2", "#text": "Code de la santé publique - art. L5132-2", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006915188", "@num": "R5125-12", "#text": "Code de la santé publique - art. R5125-12", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000029774339", "@num": "R5125-33-2", "#text": "Code de la santé publique - art. R5125-33-2 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000022055160", "@num": "R5125-33-3", "#text": "Code de la santé publique - art. R5125-33-3 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000021199802", "@fin": "2014-11-17", "#text": "Sous-section 9 : Dispositions communes à la sous-traitance de préparations et à l'exécution de préparations stériles ou dangereuses.", "@debut": "2009-10-25" }, { "@id": "LEGISCTA000029774336", "@fin": "2999-01-01", "#text": "Sous-section 9 : Dispositions relatives à l'exécution de préparations pouvant présenter un risque pour la santé", "@debut": "2014-11-17" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006190690", "@fin": "2999-01-01", "#text": "Section 1 : Officines de pharmacie", "@debut": "2004-08-08" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006178653", "@fin": "2999-01-01", "#text": "Chapitre V : Distribution au détail", "@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": "LEGIARTI000021199796", "@fin": "2010-04-01", "@num": "R5125-33-1", "@etat": "MODIFIE", "@debut": "2009-10-25", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000022055139", "@fin": "2014-11-17", "@num": "R5125-33-1", "@etat": "MODIFIE", "@debut": "2010-04-01", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000029774329", "@fin": "2018-08-01", "@num": "R5125-33-1", "@etat": "MODIFIE", "@debut": "2014-11-17", "@origine": "LEGI" } }, { "@etat": "VIGUEUR", "LIEN_ART": { "@id": "LEGIARTI000037269786", "@fin": "2999-01-01", "@num": "R5125-33-1", "@etat": "VIGUEUR", "@debut": "2018-08-01", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "

I.-L'autorisation d'exercice de l'activité de sous-traitance mentionnée au deuxième alinéa de l'article L. 5125-1 et l'autorisation d'exécution de préparations stériles ou dangereuses mentionnée au deuxième alinéa de l'article L. 5125-1-1 sont demandées au directeur général de l'agence régionale de santé où l'exécution de ces activités est envisagée par le pharmacien titulaire de l'officine concernée.

Lorsque la demande est présentée par une société ou par plusieurs pharmaciens réunis en copropriété, elle est signée par chaque associé ou copropriétaire devant exercer dans l'officine.

La demande est accompagnée d'un dossier comportant :

1° Une attestation d'inscription au tableau par le conseil régional de l'ordre des pharmaciens ;

2° La liste des formes pharmaceutiques envisagées ;

3° Le plan des locaux de l'officine où sont exécutées les préparations, avec indications des différentes zones et leurs superficies ;

4° Le nombre et la qualification des personnels affectés à l'exécution des préparations ;

5° Les matériels, équipements et installations de préparation ;

6° La description des systèmes informatisés dédiés à cette activité ;

7° Une notice d'information décrivant l'organisation générale, les moyens et procédures mis en œuvre pour respecter les bonnes pratiques de préparation mentionnées à l'article L. 5125-1 ;

8° Une évaluation quantitative du nombre de préparations réalisées ou projetées par formes pharmaceutiques ;

9° Le cas échéant, la mention d'une activité de sous-traitance de préparations stériles ou dangereuses mentionnées à l'article L. 5132-2.

II.-L'autorisation d'exercice de l'activité de sous-traitance ou l'autorisation d'exécution de préparations stériles et dangereuses sont délivrées après enquête de l'inspection régionale de la pharmacie. Ces autorisations sont subordonnées au respect des bonnes pratiques de préparation. La décision mentionne les formes pharmaceutiques et les activités autorisées.

Elle fait l'objet d'une publication au recueil des actes administratifs.

III.-Le défaut de réponse dans le délai de quatre mois à compter de la réception de la demande vaut autorisation tacite pour l'activité qui en fait l'objet.

Le directeur général de l'agence régionale de santé peut requérir du demandeur les informations complémentaires à l'instruction de la demande. Dans ce cas, le délai prévu au premier alinéa est suspendu jusqu'à réception de ces informations.

IV.-Fait l'objet d'une déclaration au directeur général de l'agence régionale de santé toute modification des éléments mentionnés aux 1°, 2°, 3°, 4°, 5° et 6° du I. Le respect de cette formalité dispense de procéder à la déclaration à l'inspection régionale de la pharmacie prévue à l'article R. 5125-12.

V.-Le retrait ou la suspension, totale ou partielle, de l'autorisation d'exercer l'activité de sous-traitance ou de l'autorisation d'exécuter des préparations stériles ou dangereuses peut être prononcé par le représentant de l'Etat, après avis du directeur régional des affaires sanitaires et sociales, lorsqu'il a été établi, après enquête de l'inspection régionale de la pharmacie, que l'officine ne respecte plus les bonnes pratiques de préparation ou réalise les préparations dans des conditions dangereuses pour la santé publique.

La décision de retrait ou de suspension de l'autorisation d'exercer l'activité de sous-traitance ou de l'autorisation d'exécuter des préparations stériles ou dangereuses ne peut intervenir qu'après que le titulaire ou le gérant de l'officine a été mis en demeure de présenter dans un délai d'un mois ses observations sur les faits de nature à justifier la décision.

En cas d'urgence, le directeur général de l'agence régionale de santé peut, sans procédure préalable, prononcer une suspension d'autorisation pour une durée qui ne peut être supérieure à un mois.

La décision de retrait ou de suspension est notifiée par lettre recommandée avec demande d'avis de réception.

VI.-L'autorisation d'exercer l'activité de sous-traitance au titre de l'article L. 5125-1 pour l'exécution des préparations stériles ou dangereuses mentionnées à l'article L. 5132-2 vaut autorisation d'exécuter ce type de préparations au titre de l'article L. 5125-1-1.

" } }, "LEGIARTI000022055163": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R5125-33-2", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2014-11-17", "DATE_DEBUT": "2010-04-01" } }, "META_COMMUN": { "ID": "LEGIARTI000022055163", "URL": "article/LEGI/ARTI/00/00/22/05/51/LEGIARTI000022055163.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "LIENS": { "LIEN": [ { "@id": "LEGIARTI000022043864", "@num": "154", "#text": "Décret n°2010-344\n du 31 mars 2010 - art. 154", "@sens": "cible", "@cidtexte": "JORFTEXT000022041034", "@nortexte": "SASX1008846D", "@numtexte": "2010-344", "@typelien": "MODIFIE", "@naturetexte": "DECRET", "@datesignatexte": "2010-03-31" }, { "@id": "LEGIARTI000029764207", "@num": "4", "#text": "DÉCRET n°2014-1367 du 14 novembre 2014 - art. 4 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000029762609", "@nortexte": "AFSP1320938D", "@numtexte": "2014-1367", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2014-11-14" }, { "@id": "LEGIARTI000006690015", "@num": "L5125-1", "#text": "Code de la santé publique - art. L5125-1", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006690021", "@num": "L5125-5", "#text": "Code de la santé publique - art. L5125-5", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000021199541", "@num": "R5125-33-1", "#text": "Code de la santé publique - art. R5125-33-1", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000021199794", "@fin": "2014-11-17", "#text": "Sous-section 10 : Dispositions particulières à l'activité de sous-traitance de préparations", "@debut": "2009-10-25" }, { "@id": "LEGISCTA000029774347", "@fin": "2999-01-01", "#text": "Sous-section 10 : Dispositions relatives à l'activité de sous-traitance de l'exécution de préparations", "@debut": "2014-11-17" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006190690", "@fin": "2999-01-01", "#text": "Section 1 : Officines de pharmacie", "@debut": "2004-08-08" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006178653", "@fin": "2999-01-01", "#text": "Chapitre V : Distribution au détail", "@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": "LEGIARTI000021199789", "@fin": "2010-04-01", "@num": "R5125-33-2", "@etat": "MODIFIE", "@debut": "2009-10-25", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000022055163", "@fin": "2014-11-17", "@num": "R5125-33-2", "@etat": "MODIFIE", "@debut": "2010-04-01", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000029774339", "@fin": "2018-08-01", "@num": "R5125-33-2", "@etat": "MODIFIE", "@debut": "2014-11-17", "@origine": "LEGI" } }, { "@etat": "VIGUEUR", "LIEN_ART": { "@id": "LEGIARTI000037269772", "@fin": "2999-01-01", "@num": "R5125-33-2", "@etat": "VIGUEUR", "@debut": "2018-08-01", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "I.-Le contrat écrit de sous-traitance mentionné au deuxième alinéa de l'article L. 5125-1 est établi conformément aux bonnes pratiques de préparation mentionnées à l'article L. 5121-5.
\n
II.-Un relevé annuel des contrats de sous-traitance indiquant les coordonnées des donneurs d'ordre, les formes pharmaceutiques des préparations sous-traitées et les principes actifs qu'elles contiennent est transmis par le titulaire de l'autorisation d'exercer l'activité de sous-traitance au directeur général de l'agence régionale de santé au plus tard le 31 mars de l'année suivante.
\n
A défaut de transmission, l'autorisation pourra être retirée dans les conditions prévues au V de l'article R. 5125-33-1." } }, "LEGIARTI000024026448": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "L5125-1-2", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2018-07-31", "DATE_DEBUT": "2011-05-19" } }, "META_COMMUN": { "ID": "LEGIARTI000024026448", "URL": "article/LEGI/ARTI/00/00/24/02/64/LEGIARTI000024026448.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "LIENS": { "LIEN": [ { "@id": "LEGIARTI000024023518", "@num": "40", "#text": "LOI n°2011-525\n du 17 mai 2011 - art. 40", "@sens": "cible", "@cidtexte": "JORFTEXT000024021430", "@nortexte": "BCRX0929142L", "@numtexte": "2011-525", "@typelien": "CREE", "@naturetexte": "LOI", "@datesignatexte": "2011-05-17" }, { "@id": "LEGIARTI000006690015", "@num": "L5125-1", "#text": "Code de la santé publique - art. L5125-1", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006690019", "@num": "L5125-4", "#text": "Code de la santé publique - art. L5125-4", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006171370", "@fin": "2009-07-23", "#text": "Chapitre V : Distribution au détail.", "@debut": "2000-06-22" }, { "@id": "LEGISCTA000020890194", "@fin": "2999-01-01", "#text": "Chapitre V : Pharmacie d'officine.", "@debut": "2009-07-23" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006155085", "@fin": "2999-01-01", "#text": "Titre II : Médicaments à usage humain", "@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": "LEGIARTI000024026448", "@fin": "2018-07-31", "@num": "L5125-1-2", "@etat": "MODIFIE", "@debut": "2011-05-19", "@origine": "LEGI" } }, { "@etat": "VIGUEUR", "LIEN_ART": { "@id": "LEGIARTI000036408368", "@fin": "2999-01-01", "@num": "L5125-1-2", "@etat": "VIGUEUR", "@debut": "2018-07-31", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "Une officine régulièrement établie dans un autre Etat membre de la Communauté européenne ou partie à l'accord sur l'Espace économique européen peut exercer, pour le compte d'une officine bénéficiant de la licence prévue à l'article L. 5125-4, l'activité de sous-traitance de préparations prévue au deuxième alinéa de l'article L. 5125-1 dans les conditions définies aux alinéas suivants.
\n
Lorsque l'officine est installée dans un Etat membre de la Communauté européenne ou partie à l'accord sur l'Espace économique européen dont les conditions d'autorisation de l'activité de sous-traitance de préparations ont été préalablement reconnues équivalentes à celles prévues par l'article L. 5125-1, elle adresse une déclaration attestant qu'elle bénéficie d'une autorisation ou d'un agrément délivré par les autorités compétentes.
\n
Lorsque l'officine ne répond pas aux conditions définies à l'alinéa précédent, l'exercice de l'activité de sous-traitance de préparations est subordonné à l'obtention d'une autorisation administrative qui lui est délivrée après vérification que les conditions de réalisation de la sous-traitance sont équivalentes à celles définies par l'article L. 5125-1." } }, "LEGIARTI000024039679": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "L5125-32", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2018-07-31", "DATE_DEBUT": "2011-05-19" } }, "META_COMMUN": { "ID": "LEGIARTI000024039679", "URL": "article/LEGI/ARTI/00/00/24/03/96/LEGIARTI000024039679.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "LIENS": { "LIEN": [ { "@id": "JORFTEXT000000198392", "#text": "Loi 99-641 1999-07-27 art. 65 V alinéa 3", "@sens": "source", "@cidtexte": "JORFTEXT000000198392", "@nortexte": "MESX9900011L", "@numtexte": "99-641", "@typelien": "CONCORDANCE", "@naturetexte": "LOI", "@datesignatexte": "1999-07-27" }, { "@id": "LEGIARTI000006697047", "@num": "38", "#text": "Loi n°2007-248 du 26 février 2007 - art. 38 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000613381", "@nortexte": "SANX0600004L", "@numtexte": "2007-248", "@typelien": "CITATION", "@naturetexte": "LOI", "@datesignatexte": "2007-02-26" }, { "@id": "LEGIARTI000024023518", "@num": "40", "#text": "LOI n°2011-525\n du 17 mai 2011 - art. 40", "@sens": "cible", "@cidtexte": "JORFTEXT000024021430", "@nortexte": "BCRX0929142L", "@numtexte": "2011-525", "@typelien": "MODIFIE", "@naturetexte": "LOI", "@datesignatexte": "2011-05-17" }, { "@id": "LEGITEXT000037266235", "#text": "Décret n°2018-672 du 30 juillet 2018 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000037262247", "@nortexte": "SSAH1814456D", "@numtexte": "2018-672", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2018-07-30" }, { "@id": "LEGIARTI000006693428", "@num": "L512-3", "#text": "Code de la santé publique - art. L512-3 (Ab)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693428", "@num": "L512-3", "#text": "Code de la santé publique - art. L512-3 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006690015", "@num": "L5125-1", "#text": "Code de la santé publique - art. L5125-1", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006690016", "@num": "L5125-1-1", "#text": "Code de la santé publique - art. L5125-1-1", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006690035", "@num": "L5125-14", "#text": "Code de la santé publique - art. L5125-14 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000036408442", "@num": "L5125-20", "#text": "Code de la santé publique - art. L5125-20 (VD)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006690047", "@num": "L5125-21", "#text": "Code de la santé publique - art. L5125-21", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006690049", "@num": "L5125-23", "#text": "Code de la santé publique - art. L5125-23", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000017842129", "@num": "L5125-5", "#text": "Code de la santé publique - art. L5125-5 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000017842133", "@num": "L5125-6", "#text": "Code de la santé publique - art. L5125-6 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006690505", "@num": "L5424-18", "#text": "Code de la santé publique - art. L5424-18 (VT)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000042655980", "@num": "L5424-2", "#text": "Code de la santé publique - art. L5424-2 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693526", "@num": "L551-11", "#text": "Code de la santé publique - art. L551-11 (Ab)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693526", "@num": "L551-11", "#text": "Code de la santé publique - art. L551-11 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000017842185", "@num": "L5511-1", "#text": "Code de la santé publique - art. L5511-1 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000047468775", "@num": "L5521-1", "#text": "Code de la santé publique - art. L5521-1 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000042655940", "@num": "L5521-2", "#text": "Code de la santé publique - art. L5521-2 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693640", "@num": "L578", "#text": "Code de la santé publique - art. L578 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693638", "@num": "L578", "#text": "Code de la santé publique - art. L578 (Ab)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693643", "@num": "L580", "#text": "Code de la santé publique - art. L580 (Ab)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693643", "@num": "L580", "#text": "Code de la santé publique - art. L580 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693661", "@num": "L589", "#text": "Code de la santé publique - art. L589 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693660", "@num": "L589", "#text": "Code de la santé publique - art. L589 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006171370", "@fin": "2009-07-23", "#text": "Chapitre V : Distribution au détail.", "@debut": "2000-06-22" }, { "@id": "LEGISCTA000020890194", "@fin": "2999-01-01", "#text": "Chapitre V : Pharmacie d'officine.", "@debut": "2009-07-23" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006155085", "@fin": "2999-01-01", "#text": "Titre II : Médicaments à usage humain", "@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": "LEGIARTI000006690061", "@fin": "2007-02-27", "@num": "L5125-32", "@etat": "MODIFIE", "@debut": "2000-06-22", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006690062", "@fin": "2007-12-22", "@num": "L5125-32", "@etat": "MODIFIE", "@debut": "2007-02-27", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000017842179", "@fin": "2008-04-17", "@num": "L5125-32", "@etat": "MODIFIE", "@debut": "2007-12-22", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000018652221", "@fin": "2011-05-19", "@num": "L5125-32", "@etat": "MODIFIE", "@debut": "2008-04-17", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000024039679", "@fin": "2018-07-31", "@num": "L5125-32", "@etat": "MODIFIE", "@debut": "2011-05-19", "@origine": "LEGI" } }, { "@etat": "VIGUEUR", "LIEN_ART": { "@id": "LEGIARTI000036408467", "@fin": "2999-01-01", "@num": "L5125-32", "@etat": "VIGUEUR", "@debut": "2018-07-31", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "

Sont fixées par décret en Conseil d'Etat :

2° (Paragraphe supprimé) ;

4° Les modalités d'application des articles L. 5125-23 et L. 5125-25 ;

5° Les conditions dans lesquelles peut être faite la publicité en faveur des officines de pharmacie ;

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"@debut": "2009-07-23", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000021941991", "@fin": "2011-12-23", "@num": "L5121-1", "@etat": "MODIFIE", "@debut": "2010-02-26", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000025014196", "@fin": "2011-12-31", "@num": "L5121-1", "@etat": "MODIFIE", "@debut": "2011-12-23", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000025122674", "@fin": "2012-05-01", "@num": "L5121-1", "@etat": "MODIFIE", "@debut": "2011-12-31", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000026499732", "@fin": "2012-05-08", "@num": "L5121-1", "@etat": "MODIFIE", "@debut": "2012-05-01", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000029719721", "@fin": "2013-12-25", "@num": "L5121-1", "@etat": "MODIFIE", "@debut": "2012-05-08", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000028394169", "@fin": "2014-12-25", "@num": "L5121-1", "@etat": "MODIFIE", "@debut": "2013-12-25", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000029962685", "@fin": "2016-01-28", "@num": "L5121-1", "@etat": "MODIFIE", "@debut": "2014-12-25", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000031930491", "@fin": "2016-07-17", "@num": "L5121-1", "@etat": "MODIFIE", "@debut": "2016-01-28", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000032906295", "@fin": "2017-07-01", "@num": "L5121-1", "@etat": "MODIFIE", "@debut": "2016-07-17", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000033621108", "@fin": "2019-01-01", "@num": "L5121-1", "@etat": "MODIFIE", "@debut": "2017-07-01", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000037950971", "@fin": "2021-07-01", "@num": "L5121-1", "@etat": "MODIFIE", "@debut": "2019-01-01", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000042685768", "@fin": "2021-08-04", "@num": "L5121-1", "@etat": "MODIFIE", "@debut": "2021-07-01", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000043896320", "@fin": "2021-12-25", "@num": "L5121-1", "@etat": "MODIFIE", "@debut": "2021-08-04", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000044628485", "@fin": "2023-12-28", "@num": "L5121-1", "@etat": "MODIFIE", "@debut": "2021-12-25", "@origine": "LEGI" } }, { "@etat": "VIGUEUR", "LIEN_ART": { "@id": "LEGIARTI000048701765", "@fin": "2999-01-01", "@num": "L5121-1", "@etat": "VIGUEUR", "@debut": "2023-12-28", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "

On entend par :

b) Groupe générique, le regroupement d'une spécialité de référence et des spécialités qui en sont génériques. Toutefois, une spécialité remplissant les conditions pour être une spécialité de référence, qui présente la même composition qualitative en substance active, la même composition quantitative en substance active ou, à défaut, une fraction thérapeutique active identique dans les limites prévues à l'annexe I de la directive 2001 / 83 / CE du Parlement européen et du Conseil du 6 novembre 2001 instituant un code communautaire relatif aux médicaments à usage humain, et la même forme pharmaceutique qu'une spécialité de référence d'un groupe générique déjà existant, et dont la bioéquivalence avec cette spécialité est démontrée par des études de biodisponibilité appropriées, peut aussi figurer dans ce groupe générique, à condition que ces deux spécialités soient considérées comme relevant d'une même autorisation de mise sur le marché globale, définie par voie réglementaire et qu'elles ne présentent pas de propriétés sensiblement différentes au regard de la sécurité ou de l'efficacité. En l'absence de spécialité de référence, un groupe générique peut être constitué de spécialités ayant la même composition qualitative et quantitative en principes actifs, la même forme pharmaceutique et dont les caractéristiques en termes de sécurité et d'efficacité sont équivalentes. Pour l'application du présent b, sont inscrites au répertoire des groupes génériques les spécialités qui se présentent sous une forme pharmaceutique orale à libération modifiée différente de celle de la spécialité de référence, à condition que ces spécialités et la spécialité de référence appartiennent à la même catégorie de forme pharmaceutique à libération modifiée et qu'elles ne présentent pas de propriétés sensiblement différentes au regard de la sécurité ou de l'efficacité ;

Pour l'application du présent b, sont inscrites, après avis du directeur général de l'Agence nationale de sécurité du médicament et des produits de santé, au répertoire des spécialités génériques les spécialités dont le principe actif est d'origine végétale ou minérale qui présentent la même composition quantitative que ce principe actif et qui ont une activité thérapeutique équivalente à celle de la spécialité de référence, à condition que ces spécialités et la spécialité de référence ne présentent pas de propriétés sensiblement différentes au regard de la sécurité ou de l'efficacité ;

6° Médicament immunologique, tout médicament consistant en :

a) Allergène, défini comme tout produit destiné à identifier ou provoquer une modification spécifique et acquise de la réponse immunologique à un agent allergisant ;

b) Vaccin, toxine ou sérum, définis comme tous agents utilisés en vue de provoquer une immunité active ou passive ou en vue de diagnostiquer l'état d'immunité ;

9° Trousse, toute préparation qui doit être reconstituée ou combinée avec des radionucléides dans le produit radiopharmaceutique final ;

10° Précurseur, tout autre radionucléide produit pour le marquage radioactif d'une autre substance avant administration ;

11° Médicament homéopathique, tout médicament obtenu à partir de substances appelées souches homéopathiques, selon un procédé de fabrication homéopathique décrit par la pharmacopée européenne, la pharmacopée française ou, à défaut, par les pharmacopées utilisées de façon officielle dans un autre Etat membre de l'Union européenne. Un médicament homéopathique peut aussi contenir plusieurs principes ;

13° Préparation de thérapie cellulaire xénogénique, tout médicament autre que les spécialités pharmaceutiques et les médicaments fabriqués industriellement mentionnés à l'article L. 5121-8, consistant en des cellules d'origine animale et leurs dérivés utilisés à des fins thérapeutiques, y compris les cellules servant à transférer du matériel génétique, quel que soit leur niveau de transformation. Ces préparations sont préparées à l'avance et dispensées sur prescription médicale à un ou plusieurs patients. Elles font l'objet d'une autorisation de l'Agence française de sécurité sanitaire des produits de santé pour une indication thérapeutique donnée. Cette autorisation peut être assortie de conditions particulières ou de restrictions d'utilisation. Elle peut être modifiée, suspendue ou retirée.L'Agence de la biomédecine est informée des décisions relatives à ces préparations prises en application du présent alinéa ;

" } }, "LEGIARTI000025086102": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "L5125-1-1-1", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2018-07-31", "DATE_DEBUT": "2011-12-31" } }, "META_COMMUN": { "ID": "LEGIARTI000025086102", "URL": "article/LEGI/ARTI/00/00/25/08/61/LEGIARTI000025086102.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "LIENS": { "LIEN": [ { "@id": "LEGIARTI000025071101", "@num": "17", "#text": "LOI n°2011-2012\n du 29 décembre 2011 - art. 17", "@sens": "cible", "@cidtexte": "JORFTEXT000025053440", "@nortexte": "ETSX1119227L", "@numtexte": "2011-2012", "@typelien": "CREE", "@naturetexte": "LOI", "@datesignatexte": "2011-12-29" }, { "@id": "LEGIARTI000006690015", "@num": "L5125-1", "#text": "Code de la santé publique - art. L5125-1", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006690016", "@num": "L5125-1-1", "#text": "Code de la santé publique - art. L5125-1-1", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006171370", "@fin": "2009-07-23", "#text": "Chapitre V : Distribution au détail.", "@debut": "2000-06-22" }, { "@id": "LEGISCTA000020890194", "@fin": "2999-01-01", "#text": "Chapitre V : Pharmacie d'officine.", "@debut": "2009-07-23" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006155085", "@fin": "2999-01-01", "#text": "Titre II : Médicaments à usage humain", "@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": "LEGIARTI000025086102", "@fin": "2018-07-31", "@num": "L5125-1-1-1", "@etat": "MODIFIE", "@debut": "2011-12-31", "@origine": "LEGI" } }, { "@etat": "VIGUEUR", "LIEN_ART": { "@id": "LEGIARTI000036408371", "@fin": "2999-01-01", "@num": "L5125-1-1-1", "@etat": "VIGUEUR", "@debut": "2018-07-31", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "Le directeur général de l'agence régionale de santé suspend ou interdit l'exécution des préparations, autres que celles visées à l'article L. 5125-1-1, lorsque l'officine ne respecte pas les bonnes pratiques de préparation ou réalise les préparations dans des conditions dangereuses pour la santé publique.
\n
Le directeur général de l'agence régionale de santé suspend ou retire l'autorisation d'exercice de l'activité de sous-traitance visée à l'article L. 5125-1 ou celle visée à l'article L. 5125-1-1 lorsque l'officine ne respecte plus les bonnes pratiques de préparation ou réalise les préparations dans des conditions dangereuses pour la santé publique.
\n
Sauf en cas d'urgence, le pharmacien d'officine concerné est mis à même de présenter ses observations avant l'intervention des mesures prévues au présent article." } }, "LEGIARTI000025122674": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "L5121-1", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2012-05-01", "DATE_DEBUT": "2011-12-31" } }, "META_COMMUN": { "ID": "LEGIARTI000025122674", "URL": "article/LEGI/ARTI/00/00/25/12/26/LEGIARTI000025122674.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "LIENS": { "LIEN": [ { "@id": "LEGIARTI000049923273", "@num": "2", "#text": "Arrêté du 4 août 1987 - art. 2 (VD)", "@sens": "cible", "@cidtexte": "JORFTEXT000000843609", "@nortexte": "ECOX8798330A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "1987-08-04" }, { "@id": "LEGIARTI000023731730", "@num": "3", "#text": "Arrêté du 4 août 1987 - art. 3 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000843609", "@nortexte": "ECOX8798330A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "1987-08-04" }, { "@id": "LEGIARTI000034405848", "@num": "69", "#text": "Décret n°90-1215 du 20 décembre 1990 - art. 69 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000717193", "@nortexte": "SPSS9001980D", "@numtexte": "90-1215", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1990-12-20" }, { "@id": "LEGIARTI000006699999", "@num": "1", "#text": "Décret n°95-1172 du 6 novembre 1995 - art. 1 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000737358", "@nortexte": "SANP9502594D", "@numtexte": "95-1172", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1995-11-06" }, { "@id": "LEGIARTI000006700029", "@num": "10", "#text": "Décret n°95-1172 du 6 novembre 1995 - art. 10 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000737358", "@nortexte": "SANP9502594D", "@numtexte": "95-1172", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1995-11-06" }, { "@id": "LEGIARTI000006700040", "@num": "14", "#text": "Décret n°95-1172 du 6 novembre 1995 - art. 14 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000737358", "@nortexte": "SANP9502594D", "@numtexte": "95-1172", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1995-11-06" }, { "@id": "LEGIARTI000006700043", "@num": "15", "#text": "Décret n°95-1172 du 6 novembre 1995 - art. 15 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000737358", "@nortexte": "SANP9502594D", "@numtexte": "95-1172", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1995-11-06" }, { "@id": "LEGIARTI000006700045", "@num": "16", "#text": "Décret n°95-1172 du 6 novembre 1995 - art. 16 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000737358", "@nortexte": "SANP9502594D", "@numtexte": "95-1172", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1995-11-06" }, { "@id": "LEGIARTI000006700047", "@num": "17", "#text": "Décret n°95-1172 du 6 novembre 1995 - art. 17 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000737358", "@nortexte": "SANP9502594D", "@numtexte": "95-1172", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1995-11-06" }, { "@id": "LEGIARTI000006700002", "@num": "2", "#text": "Décret n°95-1172 du 6 novembre 1995 - art. 2 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000737358", "@nortexte": "SANP9502594D", "@numtexte": "95-1172", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1995-11-06" }, { "@id": "LEGIARTI000006700054", "@num": "20", "#text": "Décret n°95-1172 du 6 novembre 1995 - art. 20 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000737358", "@nortexte": "SANP9502594D", "@numtexte": "95-1172", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1995-11-06" }, { "@id": "LEGIARTI000006700005", "@num": "3", "#text": "Décret n°95-1172 du 6 novembre 1995 - art. 3 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000737358", "@nortexte": "SANP9502594D", "@numtexte": "95-1172", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1995-11-06" }, { "@id": "LEGIARTI000006700008", "@num": "4", "#text": "Décret n°95-1172 du 6 novembre 1995 - art. 4 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000737358", "@nortexte": "SANP9502594D", "@numtexte": "95-1172", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1995-11-06" }, { "@id": "LEGIARTI000006865783", "@num": "Annexe", "#text": "Décret n°96-850 du 20 septembre 1996 - art. 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"@debut": "2009-07-23", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000021941991", "@fin": "2011-12-23", "@num": "L5121-1", "@etat": "MODIFIE", "@debut": "2010-02-26", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000025014196", "@fin": "2011-12-31", "@num": "L5121-1", "@etat": "MODIFIE", "@debut": "2011-12-23", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000025122674", "@fin": "2012-05-01", "@num": "L5121-1", "@etat": "MODIFIE", "@debut": "2011-12-31", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000026499732", "@fin": "2012-05-08", "@num": "L5121-1", "@etat": "MODIFIE", "@debut": "2012-05-01", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000029719721", "@fin": "2013-12-25", "@num": "L5121-1", "@etat": "MODIFIE", "@debut": "2012-05-08", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000028394169", "@fin": "2014-12-25", "@num": "L5121-1", "@etat": "MODIFIE", "@debut": "2013-12-25", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000029962685", "@fin": "2016-01-28", "@num": "L5121-1", "@etat": "MODIFIE", "@debut": "2014-12-25", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000031930491", "@fin": "2016-07-17", "@num": "L5121-1", "@etat": "MODIFIE", "@debut": "2016-01-28", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000032906295", "@fin": "2017-07-01", "@num": "L5121-1", "@etat": "MODIFIE", "@debut": "2016-07-17", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000033621108", "@fin": "2019-01-01", "@num": "L5121-1", "@etat": "MODIFIE", "@debut": "2017-07-01", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000037950971", "@fin": "2021-07-01", "@num": "L5121-1", "@etat": "MODIFIE", "@debut": "2019-01-01", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000042685768", "@fin": "2021-08-04", "@num": "L5121-1", "@etat": "MODIFIE", "@debut": "2021-07-01", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000043896320", "@fin": "2021-12-25", "@num": "L5121-1", "@etat": "MODIFIE", "@debut": "2021-08-04", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000044628485", "@fin": "2023-12-28", "@num": "L5121-1", "@etat": "MODIFIE", "@debut": "2021-12-25", "@origine": "LEGI" } }, { "@etat": "VIGUEUR", "LIEN_ART": { "@id": "LEGIARTI000048701765", "@fin": "2999-01-01", "@num": "L5121-1", "@etat": "VIGUEUR", "@debut": "2023-12-28", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "

On entend par :

1° Préparation magistrale, tout médicament préparé selon une prescription médicale destinée à un malade déterminé en raison de l'absence de spécialité pharmaceutique disponible disposant d'une autorisation de mise sur le marché, de l'une des autorisations mentionnées aux articles L. 5121-9-1 et L. 5121-12, d'une autorisation d'importation parallèle ou d'une autorisation d'importation délivrée à un établissement pharmaceutique dans le cadre d'une rupture de stock d'un médicament,, soit extemporanément en pharmacie, soit dans les conditions prévues à l'article L. 5125-1 ou à l'article L. 5126-2 ;

2° Préparation hospitalière, tout médicament, à l'exception des produits de thérapies génique ou cellulaire, préparé selon les indications de la pharmacopée et en conformité avec les bonnes pratiques mentionnées à l'article L. 5121-5, en raison de l'absence de spécialité pharmaceutique disponible ou adaptée disposant d'une autorisation de mise sur le marché, de l'une des autorisations mentionnées aux articles L. 5121-9-1 et L. 5121-12, d'une autorisation d'importation parallèle ou d'une autorisation d'importation délivrée à un établissement pharmaceutique dans le cadre d'une rupture de stock d'un médicament, par une pharmacie à usage intérieur d'un établissement de santé, ou par l'établissement pharmaceutique de cet établissement de santé autorisé en application de l'article L. 5124-9 ou dans les conditions prévues à l'article L. 5126-2. Les préparations hospitalières sont dispensées sur prescription médicale à un ou plusieurs patients par une pharmacie à usage intérieur dudit établissement. Elles font l'objet d'une déclaration auprès de l'Agence française de sécurité sanitaire des produits de santé, dans des conditions définies par arrêté du ministre chargé de la santé ;

b) Groupe générique, le regroupement d'une spécialité de référence et des spécialités qui en sont génériques. Toutefois, une spécialité remplissant les conditions pour être une spécialité de référence, qui présente la même composition qualitative en substance active, la même composition quantitative en substance active ou, à défaut, une fraction thérapeutique active identique dans les limites prévues à l'annexe I de la directive 2001/83/ CE du Parlement européen et du Conseil du 6 novembre 2001 instituant un code communautaire relatif aux médicaments à usage humain, et la même forme pharmaceutique qu'une spécialité de référence d'un groupe générique déjà existant, et dont la bioéquivalence avec cette spécialité est démontrée par des études de biodisponibilité appropriées, peut aussi figurer dans ce groupe générique, à condition que ces deux spécialités soient considérées comme relevant d'une même autorisation de mise sur le marché globale, définie par voie réglementaire et qu'elles ne présentent pas de propriétés sensiblement différentes au regard de la sécurité ou de l'efficacité. En l'absence de spécialité de référence, un groupe générique peut être constitué de spécialités ayant la même composition qualitative et quantitative en principes actifs, la même forme pharmaceutique et dont les caractéristiques en termes de sécurité et d'efficacité sont équivalentes. Pour l'application du présent b, sont inscrites au répertoire des groupes génériques les spécialités qui se présentent sous une forme pharmaceutique orale à libération modifiée différente de celle de la spécialité de référence, à condition que ces spécialités et la spécialité de référence appartiennent à la même catégorie de forme pharmaceutique à libération modifiée et qu'elles ne présentent pas de propriétés sensiblement différentes au regard de la sécurité ou de l'efficacité ;

6° Médicament immunologique, tout médicament consistant en :

a) Allergène, défini comme tout produit destiné à identifier ou provoquer une modification spécifique et acquise de la réponse immunologique à un agent allergisant ;

b) Vaccin, toxine ou sérum, définis comme tous agents utilisés en vue de provoquer une immunité active ou passive ou en vue de diagnostiquer l'état d'immunité ;

8° Générateur, tout système contenant un radionucléide parent déterminé en raison de l'absence de spécialité pharmaceutique disponible disposant d'une autorisation de mise sur le marché, de l'une des autorisations mentionnées aux articles L. 5121-9-1 et L. 5121-12, d'une autorisation d'importation parallèle ou d'une autorisation d'importation délivrée à un établissement pharmaceutique dans le cadre d'une rupture de stock d'un médicament, servant à la production d'un radionucléide de filiation obtenu par élution ou par toute autre méthode et utilisé dans un médicament radiopharmaceutique ;

9° Trousse, toute préparation qui doit être reconstituée ou combinée avec des radionucléides dans le produit radiopharmaceutique final ;

10° Précurseur, tout autre radionucléide produit pour le marquage radioactif d'une autre substance avant administration ;

11° Médicament homéopathique, tout médicament obtenu à partir de substances appelées souches homéopathiques, selon un procédé de fabrication homéopathique décrit par la pharmacopée européenne, la pharmacopée française ou, à défaut, par les pharmacopées utilisées de façon officielle dans un autre Etat membre de l'Union européenne. Un médicament homéopathique peut aussi contenir plusieurs principes ;

12° Préparation de thérapie génique, tout médicament autre que les spécialités pharmaceutiques et les médicaments fabriqués industriellement mentionnés à l'article L. 5121-8, servant à transférer du matériel génétique et ne consistant pas en des cellules d'origine humaine ou animale. Ces préparations sont préparées à l'avance et dispensées sur prescription médicale à un ou plusieurs patients. Elles font l'objet d'une autorisation de l'Agence nationale de sécurité du médicament et des produits de santé pour une indication thérapeutique donnée. Cette autorisation peut être assortie de conditions particulières ou de restrictions d'utilisation. Elle peut être modifiée, suspendue ou retirée ;

13° Préparation de thérapie cellulaire xénogénique, tout médicament autre que les spécialités pharmaceutiques et les médicaments fabriqués industriellement mentionnés à l'article L. 5121-8, consistant en des cellules d'origine animale et leurs dérivés utilisés à des fins thérapeutiques, y compris les cellules servant à transférer du matériel génétique, quel que soit leur niveau de transformation. Ces préparations sont préparées à l'avance et dispensées sur prescription médicale à un ou plusieurs patients. Elles font l'objet d'une autorisation de l'Agence nationale de sécurité du médicament et des produits de santé pour une indication thérapeutique donnée. Cette autorisation peut être assortie de conditions particulières ou de restrictions d'utilisation. Elle peut être modifiée, suspendue ou retirée. L'Agence de la biomédecine est informée des décisions relatives à ces préparations prises en application du présent alinéa ;

" } }, "LEGIARTI000025541502": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "4", "ETAT": "VIGUEUR", "TYPE": "AUTONOME", "DATE_FIN": "2999-01-01", "DATE_DEBUT": "2012-03-21" } }, "META_COMMUN": { "ID": "LEGIARTI000025541502", "URL": "article/LEGI/ARTI/00/00/25/54/15/LEGIARTI000025541502.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "NOTA": { "CONTENU": "
" }, "LIENS": { "LIEN": [ { "@id": "LEGIARTI000006690015", "@num": "L5125-1", "#text": "Code de la santé publique - art. L5125-1", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "@cid": "JORFTEXT000025541141", "@nor": "ETSP1207340A", "@nature": "ARRETE", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Arrêté du 9 mars 2012 portant application de la réglementation des stupéfiants aux médicaments à base de flunitrazépam administrés par voie orale, aux médicaments à base de buprénorphine administrés par voie orale, aux médicaments à base de clonazépam administrés par voie orale et à certains médicaments à base de clorazépate dipotassique administrés par voie orale", "@debut": "2999-01-01", "@id_txt": "JORFTEXT000025541141", "@c_titre_court": "Arrêté du 9 mars 2012" }, { "@fin": "2999-01-01", "#text": "Arrêté du 9 mars 2012 portant application de la réglementation des stupéfiants aux médicaments à base de flunitrazépam administrés par voie orale, aux médicaments à base de buprénorphine administrés par voie orale, aux médicaments à base de clonazépam administrés par voie orale et à certains médicaments à base de clorazépate dipotassique administrés par voie orale", "@debut": "2012-03-21", "@id_txt": "LEGITEXT000025541492", "@c_titre_court": "Arrêté du 9 mars 2012" } ], "@ministere": "Ministère du travail, de l'emploi et de la santé", "@date_publi": "2012-03-20", "@date_signature": "2012-03-09" } }, "VERSIONS": { "VERSION": [ { "@etat": "VIGUEUR", "LIEN_ART": { "@id": "LEGIARTI000025541502", "@fin": "2999-01-01", "@num": "4", "@etat": "VIGUEUR", "@debut": "2012-03-21", "@origine": "LEGI" } }, { "LIEN_ART": { "@id": "JORFARTI000025541149", "@fin": "2999-01-01", "@num": "4", "@debut": "2999-01-01", "@origine": "JORF" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "

\n
Les dispositions des articles 1er à 3 sont applicables aux prescriptions exécutées en officine telles que définies à l'article L. 5125-1 du code de la santé publique.

" } }, "LEGIARTI000026228844": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "2", "ETAT": "VIGUEUR", "TYPE": "AUTONOME", "DATE_FIN": "2999-01-01", "DATE_DEBUT": "2012-09-03" } }, "META_COMMUN": { "ID": "LEGIARTI000026228844", "URL": "article/LEGI/ARTI/00/00/26/22/88/LEGIARTI000026228844.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "NOTA": { "CONTENU": "
" }, "LIENS": { "LIEN": [ { "@id": "LEGIARTI000006690015", "@num": "L5125-1", "#text": "Code de la santé publique - art. L5125-1", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "@cid": "JORFTEXT000026227512", "@nor": "AFSP1227710A", "@nature": "ARRETE", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Arrêté du 28 juin 2012 portant application d'une partie de la réglementation des stupéfiants aux médicaments à base de tianeptine administrés par voie orale", "@debut": "2999-01-01", "@id_txt": "JORFTEXT000026227512", "@c_titre_court": "Arrêté du 28 juin 2012" }, { "@fin": "2999-01-01", "#text": "Arrêté du 28 juin 2012 portant application d'une partie de la réglementation des stupéfiants aux médicaments à base de tianeptine administrés par voie orale", "@debut": "2012-09-03", "@id_txt": "LEGITEXT000026228840", "@c_titre_court": "Arrêté du 28 juin 2012" } ], "@ministere": "Ministère des affaires sociales et de la santé", "@date_publi": "2012-07-27", "@date_signature": "2012-06-28" } }, "VERSIONS": { "VERSION": [ { "@etat": "VIGUEUR", "LIEN_ART": { "@id": "LEGIARTI000026228844", "@fin": "2999-01-01", "@num": "2", "@etat": "VIGUEUR", "@debut": "2012-09-03", "@origine": "LEGI" } }, { "LIEN_ART": { "@id": "JORFARTI000026227516", "@fin": "2999-01-01", "@num": "2", "@debut": "2999-01-01", "@origine": "JORF" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "

\n
Les dispositions de l'article 1er ne sont applicables qu'aux prescriptions exécutées par les officines définies à l'article L. 5125-1 du code de la santé publique et les pharmacies prévues à l'article L. 5125-19 du même code.

" } }, "LEGIARTI000026499732": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "L5121-1", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2012-05-08", "DATE_DEBUT": "2012-05-01" } }, "META_COMMUN": { "ID": "LEGIARTI000026499732", "URL": "article/LEGI/ARTI/00/00/26/49/97/LEGIARTI000026499732.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "LIENS": { "LIEN": [ { "@id": "LEGIARTI000049923273", "@num": "2", "#text": "Arrêté du 4 août 1987 - art. 2 (VD)", "@sens": "cible", "@cidtexte": "JORFTEXT000000843609", "@nortexte": "ECOX8798330A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "1987-08-04" }, { "@id": "LEGIARTI000023731730", "@num": "3", "#text": "Arrêté du 4 août 1987 - art. 3 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000843609", "@nortexte": "ECOX8798330A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "1987-08-04" }, { "@id": "LEGIARTI000034405848", "@num": "69", "#text": "Décret n°90-1215 du 20 décembre 1990 - art. 69 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000717193", "@nortexte": "SPSS9001980D", "@numtexte": "90-1215", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1990-12-20" }, { "@id": "LEGIARTI000006699999", "@num": "1", "#text": "Décret n°95-1172 du 6 novembre 1995 - art. 1 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000737358", "@nortexte": "SANP9502594D", "@numtexte": "95-1172", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1995-11-06" }, { "@id": "LEGIARTI000006700029", "@num": "10", "#text": "Décret n°95-1172 du 6 novembre 1995 - art. 10 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000737358", "@nortexte": "SANP9502594D", "@numtexte": "95-1172", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1995-11-06" }, { "@id": "LEGIARTI000006700040", "@num": "14", "#text": "Décret n°95-1172 du 6 novembre 1995 - art. 14 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000737358", "@nortexte": "SANP9502594D", "@numtexte": "95-1172", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1995-11-06" }, { "@id": "LEGIARTI000006700043", "@num": "15", "#text": "Décret n°95-1172 du 6 novembre 1995 - art. 15 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000737358", "@nortexte": "SANP9502594D", "@numtexte": "95-1172", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1995-11-06" }, { "@id": "LEGIARTI000006700045", "@num": "16", "#text": "Décret n°95-1172 du 6 novembre 1995 - art. 16 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000737358", "@nortexte": "SANP9502594D", "@numtexte": "95-1172", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1995-11-06" }, { "@id": "LEGIARTI000006700047", "@num": "17", "#text": "Décret n°95-1172 du 6 novembre 1995 - art. 17 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000737358", "@nortexte": "SANP9502594D", "@numtexte": "95-1172", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1995-11-06" }, { "@id": "LEGIARTI000006700002", "@num": "2", "#text": "Décret n°95-1172 du 6 novembre 1995 - art. 2 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000737358", "@nortexte": "SANP9502594D", "@numtexte": "95-1172", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1995-11-06" }, { "@id": "LEGIARTI000006700054", "@num": "20", "#text": "Décret n°95-1172 du 6 novembre 1995 - art. 20 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000737358", "@nortexte": "SANP9502594D", "@numtexte": "95-1172", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1995-11-06" }, { "@id": "LEGIARTI000006700005", "@num": "3", "#text": "Décret n°95-1172 du 6 novembre 1995 - art. 3 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000737358", "@nortexte": "SANP9502594D", "@numtexte": "95-1172", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1995-11-06" }, { "@id": "LEGIARTI000006700008", "@num": "4", "#text": "Décret n°95-1172 du 6 novembre 1995 - art. 4 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000737358", "@nortexte": "SANP9502594D", "@numtexte": "95-1172", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1995-11-06" }, { "@id": "LEGIARTI000006865783", "@num": "Annexe", "#text": "Décret n°96-850 du 20 septembre 1996 - art. 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(M)", "@sens": "cible", "@cidtexte": "JORFTEXT000029676018", "@nortexte": "AFSX1419039D", "@numtexte": "2014-1287", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2014-10-23" }, { "@id": "LEGIARTI000042293117", "#text": "DÉCRET n°2014-1288 du 23 octobre 2014 - art. (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000029676038", "@nortexte": "AFSX1419044D", "@numtexte": "2014-1288", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2014-10-23" }, { "@id": "LEGIARTI000030189762", "@num": "8", "#text": "ARRÊTÉ du 28 novembre 2014 - art. 8 (VD)", "@sens": "cible", "@cidtexte": "JORFTEXT000030189026", "@nortexte": "EINC1415451A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2014-11-28" }, { "@id": "LEGIARTI000030189876", "@num": "1", "#text": "ARRÊTÉ du 3 février 2015 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000030188934", "@nortexte": "AFSP1503244A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2015-02-03" }, { "@id": "LEGIARTI000032291698", "@num": "1", "#text": "Décret n°2016-349 du 24 mars 2016 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000032291186", "@nortexte": "AFSH1532721D", "@numtexte": "2016-349", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2016-03-24" }, { "@id": "LEGIARTI000032730970", "@num": "3", "#text": "Décret n°2016-817 du 20 juin 2016 - art. 3", "@sens": "cible", "@cidtexte": "JORFTEXT000032729458", "@nortexte": "AFSS1610671D", "@numtexte": "2016-817", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2016-06-20" }, { "@id": "LEGIARTI000034392999", "@num": "1", "#text": "Décret n°2017-500 du 6 avril 2017 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000034390458", "@nortexte": "AFSH1702718D", "@numtexte": "2017-500", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2017-04-06" }, { "@id": "LEGIARTI000038879548", "@num": "1", "#text": "Décret n°2019-818 du 1er août 2019 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000038873188", "@nortexte": "SSAS1911214D", "@numtexte": "2019-818", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2019-08-01" }, { "@id": "LEGIARTI000042267406", "@num": "1", "#text": "Décret n°2020-1090 du 25 août 2020 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000042266405", "@nortexte": "SSAS2006857D", "@numtexte": "2020-1090", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2020-08-25" }, { "@id": "LEGIARTI000044941358", "@num": "6", "#text": "Décret n°2021-1905 du 30 décembre 2021 - art. 6", "@sens": "cible", "@cidtexte": "JORFTEXT000044638030", "@nortexte": "TREP2130559D", "@numtexte": "2021-1905", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2021-12-30" }, { "@id": "LEGIARTI000045632789", "@num": "1", "#text": "Décret n°2022-597 du 21 avril 2022 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000045632039", "@nortexte": "SSAH2205181D", "@numtexte": "2022-597", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2022-04-21" }, { "@id": "LEGITEXT000049536357", "#text": "Décret n°2024-435 du 14 mai 2024 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000049535648", "@nortexte": "TSSS2408227D", "@numtexte": "2024-435", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2024-05-14" }, { "@id": "LEGITEXT000049850758", "#text": "Décret n°2024-626 du 27 juin 2024 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000049832038", "@nortexte": "TSSP2408968D", "@numtexte": "2024-626", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2024-06-27" }, { "@id": "LEGITEXT000049922585", "#text": "Arrêté du 5 juillet 2024 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000049892254", "@nortexte": "TSSS2418508A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2024-07-05" }, { "@id": "LEGITEXT000050737433", "#text": "Décret n°2024-1135 du 4 décembre 2024 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000050731183", "@nortexte": "MSAH2429400D", "@numtexte": "2024-1135", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2024-12-04" }, { "@id": "LEGIARTI000006279394", "@num": "L611-2", "#text": "Code de la propriété intellectuelle - art. 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On entend par :

2° Préparation hospitalière, tout médicament, à l'exception des produits de thérapies génique ou cellulaire, préparé selon les indications de la pharmacopée et en conformité avec les bonnes pratiques mentionnées à l'article L. 5121-5, en raison de l'absence de spécialité pharmaceutique disponible ou adaptée disposant d'une autorisation de mise sur le marché, de l'une des autorisations mentionnées aux articles L. 5121-9-1 et L. 5121-12, d'une autorisation d'importation parallèle ou d'une autorisation d'importation délivrée à un établissement pharmaceutique dans le cadre d'une rupture de stock d'un médicament, par une pharmacie à usage intérieur d'un établissement de santé, ou par l'établissement pharmaceutique de cet établissement de santé autorisé en application de l'article L. 5124-9 ou dans les conditions prévues à l'article L. 5126-2. Les préparations hospitalières sont dispensées sur prescription médicale à un ou plusieurs patients par une pharmacie à usage intérieur dudit établissement. Elles font l'objet d'une déclaration auprès de l'Agence nationale de sécurité du médicament et des produits de santé, dans des conditions définies par arrêté du ministre chargé de la santé ;

Article L5125-1 AUTONOME MODIFIE, en vigueur du 22/06/2000 au 17/04/2008 (Code de la santé publique)