{ "article": { "LEGIARTI000018650940": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "9", "TYPE": "ENTIEREMENT_MODIF", "DATE_FIN": "2999-01-01", "DATE_DEBUT": "2999-01-01" } }, "META_COMMUN": { "ID": "LEGIARTI000018650940", "URL": "article/LEGI/ARTI/00/00/18/65/09/LEGIARTI000018650940.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "LIENS": { "LIEN": [ { "@id": "LEGIARTI000018652237", "@num": "L5121-1", "#text": "Code de la santé publique - art. L5121-1 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000018652233", "@num": "L5125-1", "#text": "Code de la santé publique - art. L5125-1 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000018652221", "@num": "L5125-32", "#text": "Code de la santé publique - art. L5125-32 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "@cid": "JORFTEXT000018649718", "@nor": "SJSX0755912L", "@num": "2008-337", "@nature": "LOI", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "LOI n° 2008-337 du 15 avril 2008 ratifiant l'ordonnance n° 2007-613 du 26 avril 2007 portant diverses dispositions d'adaptation au droit communautaire dans le domaine du médicament (1)", "@debut": "2999-01-01", "@id_txt": "JORFTEXT000018649718", "@c_titre_court": "LOI n°2008-337 du 15 avril 2008" }, { "@fin": "2999-01-01", "#text": "LOI n° 2008-337 du 15 avril 2008 ratifiant l'ordonnance n° 2007-613 du 26 avril 2007 portant diverses dispositions d'adaptation au droit communautaire dans le domaine du médicament (1)", "@debut": "2008-04-17", "@id_txt": "LEGITEXT000018650929", "@c_titre_court": "LOI n° 2008-337 du 15 avril 2008" } ], "@date_publi": "2008-04-16", "@date_signature": "2008-04-15" } }, "VERSIONS": { "VERSION": [ { "LIEN_ART": { "@id": "LEGIARTI000018650940", "@fin": "2999-01-01", "@num": "9", "@debut": "2999-01-01", "@origine": "LEGI" } }, { "LIEN_ART": { "@id": "JORFARTI000018649740", "@fin": "2999-01-01", "@num": "9", "@debut": "2999-01-01", "@origine": "JORF" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
\n
A modifié les dispositions suivantes :

- Code de la santé publique
\n Art. L5121-1, Art. L5125-1, Art. L5125-32\n
\n

\n
" } }, "LEGIARTI000018652221": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "L5125-32", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2011-05-19", "DATE_DEBUT": "2008-04-17" } }, "META_COMMUN": { "ID": "LEGIARTI000018652221", "URL": "article/LEGI/ARTI/00/00/18/65/22/LEGIARTI000018652221.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": "LEGIARTI000018650940", "@num": "9", "#text": "LOI n°2008-337\n du 15 avril 2008 - art. 9", "@sens": "cible", "@cidtexte": "JORFTEXT000018649718", "@nortexte": "SJSX0755912L", "@numtexte": "2008-337", "@typelien": "MODIFIE", "@naturetexte": "LOI", "@datesignatexte": "2008-04-15" }, { "@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 :

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.

" } }, "LEGIARTI000018652233": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "L5125-1", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2010-02-26", "DATE_DEBUT": "2008-04-17" } }, "META_COMMUN": { "ID": "LEGIARTI000018652233", "URL": "article/LEGI/ARTI/00/00/18/65/22/LEGIARTI000018652233.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "LIENS": { "LIEN": [ { "@id": "LEGIARTI000018650940", "@num": "9", "#text": "LOI n°2008-337\n du 15 avril 2008 - art. 9", "@sens": "cible", "@cidtexte": "JORFTEXT000018649718", "@nortexte": "SJSX0755912L", "@numtexte": "2008-337", "@typelien": "MODIFIE", "@naturetexte": "LOI", "@datesignatexte": "2008-04-15" }, { "@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 - art. 4 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000025541141", "@nortexte": "ETSP1207340A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2012-03-09" }, { "@id": "LEGIARTI000026228844", "@num": "2", "#text": "Arrêté du 28 juin 2012 - art. 2 (VD)", "@sens": "cible", "@cidtexte": "JORFTEXT000026227512", "@nortexte": "AFSP1227710A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2012-06-28" }, { "@id": "LEGITEXT000029764186", "#text": "DÉCRET n°2014-1367 du 14 novembre 2014 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000029762609", "@nortexte": "AFSP1320938D", "@numtexte": "2014-1367", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2014-11-14" }, { "@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": "LEGIARTI000041699926", "@num": "1", "#text": "Arrêté du 6 mars 2020 - art. 1 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000041697131", "@nortexte": "SSAZ2006830A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-03-06" }, { "@id": "LEGIARTI000041891855", "@num": "2", "#text": "Arrêté du 23 mars 2020 - art. 2 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000041746744", "@nortexte": "SSAX2007864A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-03-23" }, { "@id": "LEGIARTI000042041895", "@num": "3", "#text": "Arrêté du 23 mars 2020 - art. 3 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000041746744", "@nortexte": "SSAX2007864A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-03-23" }, { "@id": "LEGIARTI000041890409", "@num": "1", "#text": "Arrêté du 18 mai 2020 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000041889362", "@nortexte": "SSAZ2011564A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-05-18" }, { "@id": "LEGIARTI000042107185", "@num": "2", "#text": "Arrêté du 10 juillet 2020 - art. 2 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000042106233", "@nortexte": "SSAZ2018110A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-07-10" }, { "@id": "LEGIARTI000042396133", "@num": "3", "#text": "Arrêté du 10 juillet 2020 - art. 3 (M)", "@sens": "cible", "@cidtexte": "JORFTEXT000042106233", "@nortexte": "SSAZ2018110A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-07-10" }, { "@id": "LEGIARTI000043510080", "@num": "55-1", "#text": "Décret n°2020-1262 du 16 octobre 2020 - art. 55-1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000042430554", "@nortexte": "SSAZ2028015D", "@numtexte": "2020-1262", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2020-10-16" }, { "@id": "LEGIARTI000042470139", "@num": "1", "#text": "Arrêté du 26 octobre 2020 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000042469123", "@nortexte": "SSAZ2029050A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-10-26" }, { "@id": "LEGIARTI000043510117", "@num": "53-1", "#text": "Décret n°2020-1310 du 29 octobre 2020 - 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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.

Une officine peut confier l'exécution d'une préparation, par un contrat écrit, à une autre officine qui est soumise, pour l'exercice de cette activité de sous-traitance, à une autorisation préalable délivrée par le représentant de l'Etat dans le département après avis du directeur régional des affaires sanitaires et sociales.
\n
Pour certaines catégories de préparations, une officine peut, par un contrat écrit, confier l'exécution d'une préparation à un établissement pharmaceutique autorisé à fabriquer des médicaments par l'Agence française de sécurité sanitaire des produits de santé. Cette activité de sous-traitance fait l'objet d'un rapport annuel transmis par le pharmacien responsable de l'établissement pharmaceutique au directeur général de l'Agence française de sécurité sanitaire des produits de santé.
\n
Ces préparations sont réalisées en conformité avec les bonnes pratiques mentionnées à l'article L. 5121-5.

" } }, "LEGIARTI000018652237": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "L5121-1", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2008-12-19", "DATE_DEBUT": "2008-04-17" } }, "META_COMMUN": { "ID": "LEGIARTI000018652237", "URL": "article/LEGI/ARTI/00/00/18/65/22/LEGIARTI000018652237.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": "LEGIARTI000018650940", "@num": "9", "#text": "LOI n°2008-337\n du 15 avril 2008 - art. 9", "@sens": "cible", "@cidtexte": "JORFTEXT000018649718", "@nortexte": "SJSX0755912L", "@numtexte": "2008-337", "@typelien": "MODIFIE", "@naturetexte": "LOI", "@datesignatexte": "2008-04-15" }, { "@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. L611-2", "@sens": "source", "@cidtexte": "LEGITEXT000006069414", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000044404516", "@num": "L251-2", "#text": "Code de l'action sociale et des familles - art. L251-2 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006074069", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000044962600", "@num": "R533-49", "#text": "Code de l'environnement - art. R533-49 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006074220", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000025546628", "@num": "D5321-6-1", "#text": "Code de la santé publique - 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 ;

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 dans 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. 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 ;

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 ;

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 et quantitative en principes actifs 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. 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 ;

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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Article 9 ENTIEREMENT_MODIF (LOI n° 2008-337 du 15 avril 2008 ratifiant l'ordonnance n° 2007-613 du 26 avril 2007 portant diverses dispositions d'adaptation au droit communautaire dans le domaine du médicament (1))