{ "article": { "LEGIARTI000006915145": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R5124-48", "ETAT": "VIGUEUR", "TYPE": "AUTONOME", "DATE_FIN": "2999-01-01", "DATE_DEBUT": "2004-08-08" } }, "META_COMMUN": { "ID": "LEGIARTI000006915145", "URL": "article/LEGI/ARTI/00/00/06/91/51/LEGIARTI000006915145.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "YXXXXXXXXXX5124R0480XX0A" } }, "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": "LEGIARTI000033405057", "@num": "R4211-64", "#text": "Code de la santé publique - art. R4211-64 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006800033", "@num": "R5115-5", "#text": "Code de la santé publique - art. R5115-5 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006800030", "@num": "R5115-5", "#text": "Code de la santé publique - art. R5115-5 (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 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000026903068", "@num": "R5124-36", "#text": "Code de la santé publique - art. R5124-36 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006190684", "@fin": "2999-01-01", "#text": "Section 3 : Dispositions communes aux entreprises, organismes et établissements pharmaceutiques", "@debut": "2004-08-08" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006178652", "@fin": "2999-01-01", "#text": "Chapitre IV : Fabrication et distribution en gros", "@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": "LEGIARTI000006915145", "@fin": "2999-01-01", "@num": "R5124-48", "@etat": "VIGUEUR", "@debut": "2004-08-08", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
Les entreprises et organismes mentionnés à l'article R. 5124-2 prennent les mesures nécessaires pour que le transport et la livraison des médicaments et autres produits pharmaceutiques soient effectués dans des conditions garantissant leur bonne conservation, leur intégrité et leur sécurité.
\n
" } }, "LEGIARTI000006800030": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R5115-5", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "1993-08-07", "DATE_DEBUT": "1960-04-07" } }, "META_COMMUN": { "ID": "LEGIARTI000006800030", "URL": "article/LEGI/ARTI/00/00/06/80/00/LEGIARTI000006800030.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SXXXXXXXXXX5115R0050XXAA" } }, "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": "LEGIARTI000006915145", "@num": "R5124-48", "#text": "Code de la santé publique - art. R5124-48 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "#text": "Décret 60-326 1960-04-05 art. 4 JORF 7 avril 1960", "@sens": "source", "@typelien": "CREATION" }, { "#text": "Loi 58-356 1958-04-03 (Loi de validation)", "@sens": "source", "@typelien": "CODIFICATION" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006194977", "@fin": "1998-02-13", "#text": "2° Autres obligations relatives au fonctionnement des établissements.", "@debut": "1960-04-07" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006187144", "@fin": "1998-02-13", "#text": "Paragraphe 3 : Fonctionnement des établissements", "@debut": "1960-04-07" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006174538", "@fin": "1998-02-13", "#text": "Section 1 : Des établissements de préparation et de vente en gros", "@debut": "1956-11-28" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006157765", "@fin": "1998-02-13", "#text": "Chapitre 2 : Préparation et vente en gros des produits pharmaceutiques", "@debut": "1953-10-07" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006142899", "@fin": "2999-01-01", "#text": "Titre 2 : Dispositions particulières aux divers modes d'exercice de la pharmacie", "@debut": "1953-10-07" } ] }, "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": "LEGIARTI000006800030", "@fin": "1993-08-07", "@num": "R5115-5", "@etat": "MODIFIE", "@debut": "1960-04-07", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006800031", "@fin": "1996-10-16", "@num": "R5115-5", "@etat": "MODIFIE", "@debut": "1993-08-07", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006800032", "@fin": "1998-02-13", "@num": "R5115-5", "@etat": "MODIFIE", "@debut": "1996-10-16", "@origine": "LEGI" } }, { "@etat": "ABROGE", "LIEN_ART": { "@id": "LEGIARTI000006800033", "@fin": "2004-08-08", "@num": "R5115-5", "@etat": "ABROGE", "@debut": "1998-02-13", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
Tout pharmacien assistant doit être inscrit à l'ordre des pharmaciens et faire enregistrer son diplôme pour cette activité.
\n
En cas d'absence supérieure à deux mois, il en est donné avis par l'employeur à l'inspecteur divisionnaire de la santé (inspection de la pharmacie) et au conseil central de l'ordre et il est pourvu par ledit employeur au remplacement de l'intéressé.
" } }, "LEGIARTI000006800031": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R5115-5", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "1996-10-16", "DATE_DEBUT": "1993-08-07" } }, "META_COMMUN": { "ID": "LEGIARTI000006800031", "URL": "article/LEGI/ARTI/00/00/06/80/00/LEGIARTI000006800031.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SXXXXXXXXXX5115R0050XXAB" } }, "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": "LEGIARTI000006713444", "@num": "6", "#text": "Décret n°93-982 du 5 août 1993 - art. 6 () JORF 7 août 1993", "@sens": "source", "@cidtexte": "JORFTEXT000000727412", "@nortexte": "SPSP9302069D", "@numtexte": "93-982", "@typelien": "MODIFICATION", "@naturetexte": "DECRET", "@datesignatexte": "1993-08-05" }, { "@id": "LEGIARTI000006799952", "@num": "R5108", "#text": "Code de la santé publique - art. R5108 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006915145", "@num": "R5124-48", "#text": "Code de la santé publique - art. R5124-48 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@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": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006194977", "@fin": "1998-02-13", "#text": "2° Autres obligations relatives au fonctionnement des établissements.", "@debut": "1960-04-07" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006187144", "@fin": "1998-02-13", "#text": "Paragraphe 3 : Fonctionnement des établissements", "@debut": "1960-04-07" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006174538", "@fin": "1998-02-13", "#text": "Section 1 : Des établissements de préparation et de vente en gros", "@debut": "1956-11-28" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006157765", "@fin": "1998-02-13", "#text": "Chapitre 2 : Préparation et vente en gros des produits pharmaceutiques", "@debut": "1953-10-07" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006142899", "@fin": "2999-01-01", "#text": "Titre 2 : Dispositions particulières aux divers modes d'exercice de la pharmacie", "@debut": "1953-10-07" } ] }, "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": "LEGIARTI000006800030", "@fin": "1993-08-07", "@num": "R5115-5", "@etat": "MODIFIE", "@debut": "1960-04-07", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006800031", "@fin": "1996-10-16", "@num": "R5115-5", "@etat": "MODIFIE", "@debut": "1993-08-07", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006800032", "@fin": "1998-02-13", "@num": "R5115-5", "@etat": "MODIFIE", "@debut": "1996-10-16", "@origine": "LEGI" } }, { "@etat": "ABROGE", "LIEN_ART": { "@id": "LEGIARTI000006800033", "@fin": "2004-08-08", "@num": "R5115-5", "@etat": "ABROGE", "@debut": "1998-02-13", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
Tout pharmacien assistant doit être inscrit à l'ordre des pharmaciens et faire enregistrer son diplôme pour cette activité.
\n
En cas d'absence supérieure à deux mois, il en est donné avis par l'employeur au directeur général de l'Agence du médicament ou au pharmacien inspecteur régional de la santé selon que l'établissement relève du 1° ou du 2° de l'article R. 5108, et au conseil central de l'ordre et il est pourvu par ledit employeur au remplacement de l'intéressé.
" } }, "LEGIARTI000006800032": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R5115-5", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "1998-02-13", "DATE_DEBUT": "1996-10-16" } }, "META_COMMUN": { "ID": "LEGIARTI000006800032", "URL": "article/LEGI/ARTI/00/00/06/80/00/LEGIARTI000006800032.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SXXXXXXXXXX5115R0050XXAC" } }, "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": "LEGIARTI000006700392", "@num": "2", "#text": "Décret n°96-899 du 14 octobre 1996 - art. 2 () JORF 16 octobre 1996", "@sens": "source", "@cidtexte": "JORFTEXT000000194852", "@nortexte": "TASP9623485D", "@numtexte": "96-899", "@typelien": "MODIFICATION", "@naturetexte": "DECRET", "@datesignatexte": "1996-10-14" }, { "@id": "LEGIARTI000006799952", "@num": "R5108", "#text": "Code de la santé publique - art. R5108 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006915145", "@num": "R5124-48", "#text": "Code de la santé publique - art. R5124-48 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@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": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006194977", "@fin": "1998-02-13", "#text": "2° Autres obligations relatives au fonctionnement des établissements.", "@debut": "1960-04-07" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006187144", "@fin": "1998-02-13", "#text": "Paragraphe 3 : Fonctionnement des établissements", "@debut": "1960-04-07" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006174538", "@fin": "1998-02-13", "#text": "Section 1 : Des établissements de préparation et de vente en gros", "@debut": "1956-11-28" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006157765", "@fin": "1998-02-13", "#text": "Chapitre 2 : Préparation et vente en gros des produits pharmaceutiques", "@debut": "1953-10-07" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006142899", "@fin": "2999-01-01", "#text": "Titre 2 : Dispositions particulières aux divers modes d'exercice de la pharmacie", "@debut": "1953-10-07" } ] }, "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": "LEGIARTI000006800030", "@fin": "1993-08-07", "@num": "R5115-5", "@etat": "MODIFIE", "@debut": "1960-04-07", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006800031", "@fin": "1996-10-16", "@num": "R5115-5", "@etat": "MODIFIE", "@debut": "1993-08-07", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006800032", "@fin": "1998-02-13", "@num": "R5115-5", "@etat": "MODIFIE", "@debut": "1996-10-16", "@origine": "LEGI" } }, { "@etat": "ABROGE", "LIEN_ART": { "@id": "LEGIARTI000006800033", "@fin": "2004-08-08", "@num": "R5115-5", "@etat": "ABROGE", "@debut": "1998-02-13", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
Tout pharmacien assistant doit être inscrit à l'ordre des pharmaciens et faire enregistrer son diplôme pour cette activité.
\n
En cas d'absence supérieure à deux mois, il en est donné avis par l'employeur au directeur général de l'Agence du médicament ou au pharmacien inspecteur régional de la santé selon que l'établissement relève du 1° ou du 2° de l'article R. 5108, et au conseil central de l'ordre et il est pourvu par ledit employeur au remplacement de l'intéressé.
\n
Le présent article ne s'applique pas aux pharmaciens chimistes des armées.
" } }, "LEGIARTI000006800033": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R5115-5", "ETAT": "ABROGE", "TYPE": "AUTONOME", "DATE_FIN": "2004-08-08", "DATE_DEBUT": "1998-02-13" } }, "META_COMMUN": { "ID": "LEGIARTI000006800033", "URL": "article/LEGI/ARTI/00/00/06/80/00/LEGIARTI000006800033.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SXXXXXXXXXX5115R0050XXAD" } }, "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": "LEGIARTI000006722892", "@num": "6", "#text": "Décret n°98-79 du 11 février 1998 - art. 6 () JORF 13 février 1998", "@sens": "source", "@cidtexte": "JORFTEXT000000372654", "@nortexte": "MESP9820016D", "@numtexte": "98-79", "@typelien": "MODIFICATION", "@naturetexte": "DECRET", "@datesignatexte": "1998-02-11" }, { "@id": "LEGIARTI000006722893", "@num": "7", "#text": "Décret n°98-79 du 11 février 1998 - art. 7 () JORF 13 février 1998", "@sens": "source", "@cidtexte": "JORFTEXT000000372654", "@nortexte": "MESP9820016D", "@numtexte": "98-79", "@typelien": "MODIFICATION", "@naturetexte": "DECRET", "@datesignatexte": "1998-02-11" }, { "@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": "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": "LEGIARTI000006915145", "@num": "R5124-48", "#text": "Code de la santé publique - art. R5124-48 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006915145", "@num": "R5124-48", "#text": "Code de la santé publique - art. R5124-48 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@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": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006187369", "@fin": "2004-08-08", "#text": "Paragraphe 6 : Dispositions communes relatives au fonctionnement des entreprises, organismes et établissements pharmaceutiques", "@debut": "1998-02-13" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006174541", "@fin": "2004-08-08", "#text": "Section 1 : Des entreprises, établissements pharmaceutiques ou organismes mentionnés aux articles L. 596, L. 596-1, L. 596-3 et L. 670-3", "@debut": "1998-02-13" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006157770", "@fin": "2004-08-08", "#text": "Chapitre 2 : Fabrication, exploitation, importation, distribution en gros, exportation des médicaments et autres produits pharmaceutiques à usage humain", "@debut": "1998-02-13" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006142899", "@fin": "2999-01-01", "#text": "Titre 2 : Dispositions particulières aux divers modes d'exercice de la pharmacie", "@debut": "1953-10-07" } ] }, "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": "LEGIARTI000006800030", "@fin": "1993-08-07", "@num": "R5115-5", "@etat": "MODIFIE", "@debut": "1960-04-07", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006800031", "@fin": "1996-10-16", "@num": "R5115-5", "@etat": "MODIFIE", "@debut": "1993-08-07", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006800032", "@fin": "1998-02-13", "@num": "R5115-5", "@etat": "MODIFIE", "@debut": "1996-10-16", "@origine": "LEGI" } }, { "@etat": "ABROGE", "LIEN_ART": { "@id": "LEGIARTI000006800033", "@fin": "2004-08-08", "@num": "R5115-5", "@etat": "ABROGE", "@debut": "1998-02-13", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
Les entreprises et organismes mentionnés à l'article R. 5106 prennent toutes les mesures nécessaires pour que le transport et la livraison des médicaments et autres produits pharmaceutiques soient effectués dans des conditions garantissant leur bonne conservation, leur intégrité et leur sécurité.
\n
" } }, "LEGIARTI000006915076": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R5124-2", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2006-04-27", "DATE_DEBUT": "2004-08-08" } }, "META_COMMUN": { "ID": "LEGIARTI000006915076", "URL": "article/LEGI/ARTI/00/00/06/91/50/LEGIARTI000006915076.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "YXXXXXXXXXX5124R0020XX0A" } }, "LIENS": { "LIEN": [ { "@id": "JORFTEXT000000353820", "#text": "Décret 91-685 1991-07-14", "@sens": "source", "@cidtexte": "JORFTEXT000000353820", "@nortexte": "DEFM9101666D", "@numtexte": "91-685", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1991-07-14" }, { "@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": "LEGIARTI000019330270", "@num": "Annexe", "#text": "Arrêté du 18 août 2008 - art. (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000019329886", "@nortexte": "SJSP0818923A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2008-08-18" }, { "@id": "LEGIARTI000023501125", "@num": "14", "#text": "Arrêté du 21 janvier 2011 - art. 14 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000023491451", "@nortexte": "ETSP1101997A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2011-01-21" }, { "@id": "LEGIARTI000023501114", "@num": "16", "#text": "Arrêté du 21 janvier 2011 - art. 16 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000023491451", "@nortexte": "ETSP1101997A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2011-01-21" }, { "@id": "LEGIARTI000023501129", "@num": "2", "#text": "Arrêté du 21 janvier 2011 - art. 2 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000023491451", "@nortexte": "ETSP1101997A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2011-01-21" }, { "@id": "LEGIARTI000023501118", "@num": "4", "#text": "Arrêté du 21 janvier 2011 - 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art. 2 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000041721724", "@nortexte": "TREX2007745A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-03-13" }, { "@id": "LEGIARTI000041817894", "@num": "12-4-1", "#text": "Décret n°2020-293 du 23 mars 2020 - art. 12-4-1 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000041746694", "@nortexte": "SSAZ2008253D", "@numtexte": "2020-293", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2020-03-23" }, { "@id": "LEGIARTI000041817882", "@num": "12-4-3", "#text": "Décret n°2020-293 du 23 mars 2020 - art. 12-4-3 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000041746694", "@nortexte": "SSAZ2008253D", "@numtexte": "2020-293", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2020-03-23" }, { "@id": "LEGIARTI000041808807", "@num": "12-5", "#text": "Décret n°2020-293 du 23 mars 2020 - art. 12-5 (T)", "@sens": "cible", "@cidtexte": "JORFTEXT000041746694", "@nortexte": "SSAZ2008253D", "@numtexte": "2020-293", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2020-03-23" }, { "@id": "LEGIARTI000041808796", "@num": "1", "#text": "Décret n°2020-447 du 18 avril 2020 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000041808417", "@nortexte": "SSAZ2009990D", "@numtexte": "2020-447", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2020-04-18" }, { "@id": "LEGIARTI000041817722", "@num": "1", "#text": "Décret n°2020-466 du 23 avril 2020 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000041817203", "@nortexte": "SSAZ2010164D", "@numtexte": "2020-466", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2020-04-23" }, { "@id": "LEGIARTI000041859128", "@num": "20", "#text": "Décret n°2020-545 du 11 mai 2020 - art. 20 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000041858681", "@nortexte": "SSAZ2011567D", "@numtexte": "2020-545", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2020-05-11" }, { "@id": "LEGIARTI000041859132", "@num": "22", "#text": "Décret n°2020-545 du 11 mai 2020 - art. 22 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000041858681", "@nortexte": "SSAZ2011567D", "@numtexte": "2020-545", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2020-05-11" }, { "@id": "LEGIARTI000041866853", "@num": "22", "#text": "Décret n°2020-548 du 11 mai 2020 - art. 22 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000041865329", "@nortexte": "SSAZ2011695D", "@numtexte": "2020-548", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2020-05-11" }, { "@id": "LEGIARTI000041866857", "@num": "24", "#text": "Décret n°2020-548 du 11 mai 2020 - art. 24 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000041865329", "@nortexte": "SSAZ2011695D", "@numtexte": "2020-548", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2020-05-11" }, { "@id": "LEGIARTI000041943338", "@num": "53", "#text": "Décret n°2020-663 du 31 mai 2020 - art. 53 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000041939818", "@nortexte": "SSAZ2013547D", "@numtexte": "2020-663", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2020-05-31" }, { "@id": "LEGIARTI000041943340", "@num": "55", "#text": "Décret n°2020-663 du 31 mai 2020 - art. 55 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000041939818", "@nortexte": "SSAZ2013547D", "@numtexte": "2020-663", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2020-05-31" }, { "@id": "LEGIARTI000042107249", "@num": "34", "#text": "Arrêté du 10 juillet 2020 - art. 34 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000042106233", "@nortexte": "SSAZ2018110A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-07-10" }, { "@id": "LEGIARTI000042162863", "@num": "49", "#text": "Décret n°2020-860 du 10 juillet 2020 - art. 49 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000042105897", "@nortexte": "SSAZ2018127D", "@numtexte": "2020-860", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2020-07-10" }, { "@id": "LEGIARTI000047345303", "@num": "2", "#text": "Décret n°2020-1230 du 7 octobre 2020 - art. 2 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000042410284", "@nortexte": "SSAP2021390D", "@numtexte": "2020-1230", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2020-10-07" }, { "@id": "LEGIARTI000042431395", "@num": "49", "#text": "Décret n°2020-1262 du 16 octobre 2020 - art. 49 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000042430554", "@nortexte": "SSAZ2028015D", "@numtexte": "2020-1262", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2020-10-16" }, { "@id": "LEGIARTI000042431415", "@num": "55", "#text": "Décret n°2020-1262 du 16 octobre 2020 - art. 55 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000042430554", "@nortexte": "SSAZ2028015D", "@numtexte": "2020-1262", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2020-10-16" }, { "@id": "LEGIARTI000042437333", "#text": "Arrêté du 16 octobre 2020 - art. 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R6326-6 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006190682", "@fin": "2999-01-01", "#text": "Section 1 : Champ d'application et définitions", "@debut": "2004-08-08" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006178652", "@fin": "2999-01-01", "#text": "Chapitre IV : Fabrication et distribution en gros", "@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": "LEGIARTI000006915076", "@fin": "2006-04-27", "@num": "R5124-2", "@etat": "MODIFIE", "@debut": "2004-08-08", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006915077", "@fin": "2007-08-28", "@num": "R5124-2", "@etat": "MODIFIE", "@debut": "2006-04-27", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006915078", "@fin": "2008-02-08", "@num": "R5124-2", "@etat": "MODIFIE", "@debut": "2007-08-28", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000018087912", "@fin": "2008-05-08", "@num": "R5124-2", "@etat": "MODIFIE", "@debut": "2008-02-08", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000018776676", "@fin": "2008-08-25", "@num": "R5124-2", "@etat": "MODIFIE", "@debut": "2008-05-08", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000019378341", "@fin": "2009-06-22", "@num": "R5124-2", "@etat": "MODIFIE", "@debut": "2008-08-25", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000020776282", "@fin": "2013-01-21", "@num": "R5124-2", "@etat": "MODIFIE", "@debut": "2009-06-22", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000026968598", "@fin": "2013-06-07", "@num": "R5124-2", "@etat": "MODIFIE", "@debut": "2013-01-21", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000027510058", "@fin": "2016-05-01", "@num": "R5124-2", "@etat": "MODIFIE", "@debut": "2013-06-07", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000032481760", "@fin": "2017-01-12", "@num": "R5124-2", "@etat": "MODIFIE", "@debut": "2016-05-01", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000033857013", "@fin": "2021-05-29", "@num": "R5124-2", "@etat": "MODIFIE", "@debut": "2017-01-12", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000043544717", "@fin": "2021-07-01", "@num": "R5124-2", "@etat": "MODIFIE", "@debut": "2021-05-29", "@origine": "LEGI" } }, { "@etat": "VIGUEUR", "LIEN_ART": { "@id": "LEGIARTI000043761806", "@fin": "2999-01-01", "@num": "R5124-2", "@etat": "VIGUEUR", "@debut": "2021-07-01", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
On entend par :
\n
1° Fabricant, l'entreprise ou l'organisme se livrant, en vue de leur vente en gros, de leur cession à titre gratuit ou de leur expérimentation sur l'homme à la fabrication de médicaments, produits ou objets mentionnés à l'article L. 4211-1 et au 4° de l'article L. 5121-1.
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La fabrication comprend les opérations concernant l'achat des matières premières et des articles de conditionnement, les opérations de production, de contrôle de la qualité, de libération des lots, ainsi que les opérations de stockage correspondantes, telles qu'elles sont définies par les bonnes pratiques prévues aux articles L. 5121-5 et L. 5136-3 applicables à cette activité.
\n
Pour les objets de pansement et articles présentés comme conformes à la pharmacopée mentionnés au 2° de l'article L. 4211-1 et les produits officinaux divisés mentionnés au 4° de l'article L. 5121-1, la vente en gros, la cession à titre gratuit ainsi que les opérations de suivi des lots et, s'il y a lieu, de leur retrait et, le cas échéant, de pharmacovigilance sont effectuées par le fabricant. Pour les médicaments destinés à être expérimentés sur l'homme, les opérations de suivi desdits médicaments et, s'il y a lieu, de leur retrait sont effectuées par le fabricant, sous la responsabilité du promoteur mentionné à l'article L. 1121-1 ;
\n
2° Importateur, l'entreprise ou l'organisme se livrant, en vue de leur vente en gros, de leur cession à titre gratuit ou de leur expérimentation sur l'homme, à l'importation, au stockage, au contrôle de la qualité et à la libération des lots de médicaments, produits ou objets mentionnés à l'article L. 4211-1 et au 4° de l'article L. 5121-1 en provenance :
\n
a) D'Etats non membres de la Communauté européenne et non parties à l'accord sur l'Espace économique européen ;
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b) Ou d'autres Etats membres de la Communauté européenne ou parties à l'accord sur l'Espace économique européen lorsque les médicaments, produits ou objets ont été fabriqués par un établissement non autorisé au titre l'article 40 de la directive 2001/83 du 6 novembre 2001 instituant un code communautaire relatif aux médicaments à usage humain.
\n
Pour les objets de pansement et articles présentés comme conformes à la pharmacopée mentionnés au 2° de l'article L. 4211-1 et les produits officinaux divisés mentionnés au 4° de l'article L. 5121-1, la vente en gros, la cession à titre gratuit ainsi que les opérations de suivi des lots et, s'il y a lieu, de leur retrait et, le cas échéant, de pharmacovigilance sont effectuées par l'importateur. Pour les médicaments destinés à être expérimentés sur l'homme, les opérations de suivi desdits médicaments et, s'il y a lieu, de leur retrait sont effectuées par l'importateur, sous la responsabilité du promoteur mentionné à l'article L. 1121-1 ;
\n
3° Exploitant, l'entreprise ou l'organisme se livrant à l'exploitation de médicaments autres que ceux destinés à être expérimentés sur l'homme, de générateurs, trousses et précurseurs mentionnés au 3° de l'article L. 4211-1 ou de produits mentionnés à l'article L. 5136-1.
\n
L'exploitation comprend les opérations de vente en gros ou de cession à titre gratuit, de publicité, d'information, de pharmacovigilance, de suivi des lots et, s'il y a lieu, de leur retrait ainsi que, le cas échéant, les opérations de stockage correspondantes.
\n
L'exploitation est assurée soit par le titulaire de l'autorisation de mise sur le marché mentionnée à l'article L. 5121-8, de l'autorisation temporaire d'utilisation mentionnée au a de l'article L. 5121-12, de l'autorisation mentionnée à l'article L. 5136-1 ou de l'enregistrement mentionné à l'article L. 5121-13, soit, pour le compte de ce titulaire, par une autre entreprise ou un autre organisme, soit par l'un et l'autre, chacun assurant dans ce cas une ou plusieurs catégories d'opérations constitutives de l'exploitation du médicament ou produit ;
\n
4° Dépositaire, l'entreprise se livrant, d'ordre et pour le compte :
\n
- d'un ou plusieurs exploitants de médicaments, de générateurs, trousses ou précurseurs mentionnés au 3° de l'article L. 4211-1 ou de produits mentionnés à l'article L. 5136-1 ;
\n
- ou d'un ou plusieurs fabricants ou importateurs d'objets de pansement ou articles présentés comme conformes à la Pharmacopée mentionnés au 2° de l'article L. 4211-1 ou de produits officinaux divisés mentionnés au 4° de l'article L. 5121-1, au stockage de ces médicaments, produits, objets ou articles dont elle n'est pas propriétaire, en vue de leur distribution en gros et en l'état ;
\n
5° Grossiste-répartiteur, l'entreprise se livrant à l'achat et au stockage de médicaments autres que ceux destinés à être expérimentés sur l'homme, en vue de leur distribution en gros et en l'état ;
\n
6° Distributeur en gros de produits pharmaceutiques autres que les médicaments, l'entreprise se livrant à l'achat et au stockage de produits, objets, articles, générateurs, trousses ou précurseurs mentionnés aux 2° et 3° de l'article L. 4211-1 ou de produits officinaux divisés mentionnés au 4° de l'article L. 5121-1, en vue de leur distribution en gros et en l'état ;
\n
7° Distributeur en gros à l'exportation, l'entreprise se livrant à l'achat et au stockage de médicaments autres que ceux destinés à être expérimentés sur l'homme, de produits, objets, articles, générateurs, trousses ou précurseurs mentionnés aux 2° et 3° de l'article L. 4211-1, de plantes médicinales mentionnées au 5° de l'article L. 4211-1 ou de produits officinaux divisés mentionnés au 4° de l'article L. 5121-1, en vue de leur exportation en l'état ;
\n
8° Distributeur en gros à vocation humanitaire, l'organisme à but non lucratif mentionné à l'article L. 5124-7 se livrant à l'acquisition à titre gratuit ou onéreux et au stockage de médicaments autres que ceux destinés à être expérimentés sur l'homme, en vue de leur distribution en gros ou de leur exportation dans les conditions prévues au même article ;
\n
9° Distributeur en gros de médicaments dérivés du sang, l'établissement de transfusion sanguine bénéficiant de l'autorisation mentionnée à l'article L. 1223-1, se livrant à l'achat et au stockage de médicaments dérivés du sang autres que ceux destinés à être expérimentés sur l'homme, en vue de leur distribution en gros et en l'état ;
\n
10° Distributeur de médicaments destinés à être expérimentés sur l'homme, l'entreprise se livrant, d'ordre et pour le compte d'un ou plusieurs promoteurs définis à l'article L. 1121-1, au stockage de médicaments destinés à être expérimentés sur l'homme dont elle n'est pas propriétaire, fabriqués ou importés par des entreprises ou organismes définis au 1° ou au 2° du présent article, en vue de leur distribution en l'état ;
\n
11° Distributeur en gros de plantes médicinales, l'entreprise se livrant au stockage et aux contrôles et opérations nécessaires pour la distribution en gros et en vrac, en sachets-doses, en fragments ou à l'état frais ou desséché de plantes médicinales mentionnées au 5° de l'article L. 4211-1 ;
\n
12° Distributeur en gros de gaz à usage médical, l'entreprise se livrant à l'achat et au stockage de gaz à usage médical, en vue de leur distribution en gros et en l'état ;
\n
13° Distributeur en gros du service de santé des armées, l'établissement de ravitaillement sanitaire du service de santé des armées comportant un ou plusieurs établissements pharmaceutiques se livrant, dans le cadre du décret n° 91-685 du 14 juillet 1991 fixant les attributions du service de santé des armées, à la distribution en gros et en l'état des médicaments, produits ou objets mentionnés à l'article L. 5124-8.
" } }, "LEGIARTI000006915077": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R5124-2", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2007-08-28", "DATE_DEBUT": "2006-04-27" } }, "META_COMMUN": { "ID": "LEGIARTI000006915077", "URL": "article/LEGI/ARTI/00/00/06/91/50/LEGIARTI000006915077.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "YXXXXXXXXXX5124R0020XX0B" } }, "LIENS": { "LIEN": [ { "@id": "JORFTEXT000000353820", "#text": "Décret 91-685 1991-07-14", "@sens": "source", "@cidtexte": "JORFTEXT000000353820", "@nortexte": "DEFM9101666D", "@numtexte": "91-685", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1991-07-14" }, { "@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": "JORFTEXT000000458901", "#text": "Décret 2006-477 2006-04-26 art. 7 I, II, IV JORF 27 avril 2006", "@sens": "source", "@cidtexte": "JORFTEXT000000458901", "@nortexte": "SANP0524369D", "@numtexte": "2006-477", "@typelien": "MODIFICATION", "@naturetexte": "DECRET", "@datesignatexte": "2006-04-26" }, { "@id": "LEGIARTI000006250976", "@num": "7", "#text": "Décret n°2006-477 du 26 avril 2006 - art. 7 () JORF 27 avril 2006", "@sens": "source", "@cidtexte": "JORFTEXT000000458901", "@nortexte": "SANP0524369D", "@numtexte": "2006-477", "@typelien": "MODIFICATION", "@naturetexte": "DECRET", "@datesignatexte": "2006-04-26" }, { "@id": "LEGIARTI000019330270", "@num": "Annexe", "#text": "Arrêté du 18 août 2008 - art. (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000019329886", "@nortexte": "SJSP0818923A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2008-08-18" }, { "@id": "LEGIARTI000023501125", "@num": "14", "#text": "Arrêté du 21 janvier 2011 - art. 14 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000023491451", "@nortexte": "ETSP1101997A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2011-01-21" }, { "@id": "LEGIARTI000023501114", "@num": "16", "#text": "Arrêté du 21 janvier 2011 - art. 16 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000023491451", "@nortexte": "ETSP1101997A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2011-01-21" }, { "@id": "LEGIARTI000023501129", "@num": "2", "#text": "Arrêté du 21 janvier 2011 - art. 2 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000023491451", "@nortexte": "ETSP1101997A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2011-01-21" }, { "@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": "LEGIARTI000023501147", "@num": "8", "#text": "Arrêté du 21 janvier 2011 - art. 8 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000023491451", "@nortexte": "ETSP1101997A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2011-01-21" }, { "@id": "LEGIARTI000045746740", "@num": "2", "#text": "Arrêté du 20 avril 2012 - art. 2 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000025794925", "@nortexte": "ETSP1221356A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2012-04-20" }, { "@id": "LEGITEXT000032924021", "#text": "Décret n°2016-993 du 20 juillet 2016 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000032922434", "@nortexte": "AFSP1605997D", "@numtexte": "2016-993", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2016-07-20" }, { "@id": "LEGIARTI000041811290", "@num": "2", "#text": "Arrêté du 13 mars 2020 - art. 2 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000041721724", "@nortexte": "TREX2007745A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-03-13" }, { "@id": "LEGIARTI000041817894", "@num": "12-4-1", "#text": "Décret n°2020-293 du 23 mars 2020 - art. 12-4-1 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000041746694", "@nortexte": "SSAZ2008253D", "@numtexte": "2020-293", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2020-03-23" }, { "@id": "LEGIARTI000041817882", "@num": "12-4-3", "#text": "Décret n°2020-293 du 23 mars 2020 - art. 12-4-3 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000041746694", "@nortexte": "SSAZ2008253D", "@numtexte": "2020-293", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2020-03-23" }, { "@id": "LEGIARTI000041808807", "@num": "12-5", "#text": "Décret n°2020-293 du 23 mars 2020 - art. 12-5 (T)", "@sens": "cible", "@cidtexte": "JORFTEXT000041746694", "@nortexte": "SSAZ2008253D", "@numtexte": "2020-293", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2020-03-23" }, { "@id": "LEGIARTI000041808796", "@num": "1", "#text": "Décret n°2020-447 du 18 avril 2020 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000041808417", "@nortexte": "SSAZ2009990D", "@numtexte": "2020-447", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2020-04-18" }, { "@id": "LEGIARTI000041817722", "@num": "1", "#text": "Décret n°2020-466 du 23 avril 2020 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000041817203", "@nortexte": "SSAZ2010164D", "@numtexte": "2020-466", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2020-04-23" }, { "@id": "LEGIARTI000041859128", "@num": "20", "#text": "Décret n°2020-545 du 11 mai 2020 - art. 20 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000041858681", "@nortexte": "SSAZ2011567D", "@numtexte": "2020-545", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2020-05-11" }, { "@id": "LEGIARTI000041859132", "@num": "22", "#text": "Décret n°2020-545 du 11 mai 2020 - art. 22 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000041858681", "@nortexte": "SSAZ2011567D", "@numtexte": "2020-545", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2020-05-11" }, { "@id": "LEGIARTI000041866853", "@num": "22", "#text": "Décret n°2020-548 du 11 mai 2020 - art. 22 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000041865329", "@nortexte": "SSAZ2011695D", "@numtexte": "2020-548", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2020-05-11" }, { "@id": "LEGIARTI000041866857", "@num": "24", "#text": "Décret n°2020-548 du 11 mai 2020 - art. 24 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000041865329", "@nortexte": "SSAZ2011695D", "@numtexte": "2020-548", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2020-05-11" }, { "@id": "LEGIARTI000041943338", "@num": "53", "#text": "Décret n°2020-663 du 31 mai 2020 - art. 53 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000041939818", "@nortexte": "SSAZ2013547D", "@numtexte": "2020-663", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2020-05-31" }, { "@id": "LEGIARTI000041943340", "@num": "55", "#text": "Décret n°2020-663 du 31 mai 2020 - art. 55 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000041939818", "@nortexte": "SSAZ2013547D", "@numtexte": "2020-663", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2020-05-31" }, { "@id": "LEGIARTI000042107249", "@num": "34", "#text": "Arrêté du 10 juillet 2020 - 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art. 55 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000042430554", "@nortexte": "SSAZ2028015D", "@numtexte": "2020-1262", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2020-10-16" }, { "@id": "LEGIARTI000042437333", "#text": "Arrêté du 16 octobre 2020 - art. 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R5124-60-2 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000018087934", "@num": "R5124-62", "#text": "Code de la santé publique - art. R5124-62 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000019343520", "@num": "R5124-63-1", "#text": "Code de la santé publique - art. R5124-63-1 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000033856952", "@num": "R5124-7", "#text": "Code de la santé publique - art. R5124-7 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000033856943", "@num": "R5124-8", "#text": "Code de la santé publique - art. R5124-8 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000043544691", "@num": "R5124-9", "#text": "Code de la santé publique - art. R5124-9 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000033851841", "@num": "R5124-9-1", "#text": "Code de la santé publique - art. R5124-9-1 (V)", "@sens": "cible", "@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": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006915468", "@num": "R5127-1", "#text": "Code de la santé publique - art. R5127-1 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006915573", "@num": "R5132-26", "#text": "Code de la santé publique - art. R5132-26 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000032106042", "@num": "R5132-83", "#text": "Code de la santé publique - art. R5132-83 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000026903119", "@num": "R5138-1", "#text": "Code de la santé publique - art. R5138-1 (VD)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000026897789", "@num": "R5138-2-1", "#text": "Code de la santé publique - art. R5138-2-1 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006916113", "@num": "R5142-31", "#text": "Code de la santé publique - art. R5142-31 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000033856706", "@num": "R5313-5", "#text": "Code de la santé publique - art. R5313-5 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000048494603", "@num": "R6326-6", "#text": "Code de la santé publique - art. R6326-6 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006190682", "@fin": "2999-01-01", "#text": "Section 1 : Champ d'application et définitions", "@debut": "2004-08-08" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006178652", "@fin": "2999-01-01", "#text": "Chapitre IV : Fabrication et distribution en gros", "@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": "LEGIARTI000006915076", "@fin": "2006-04-27", "@num": "R5124-2", "@etat": "MODIFIE", "@debut": "2004-08-08", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006915077", "@fin": "2007-08-28", "@num": "R5124-2", "@etat": "MODIFIE", "@debut": "2006-04-27", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006915078", "@fin": "2008-02-08", "@num": "R5124-2", "@etat": "MODIFIE", "@debut": "2007-08-28", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000018087912", "@fin": "2008-05-08", "@num": "R5124-2", "@etat": "MODIFIE", "@debut": "2008-02-08", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000018776676", "@fin": "2008-08-25", "@num": "R5124-2", "@etat": "MODIFIE", "@debut": "2008-05-08", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000019378341", "@fin": "2009-06-22", "@num": "R5124-2", "@etat": "MODIFIE", "@debut": "2008-08-25", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000020776282", "@fin": "2013-01-21", "@num": "R5124-2", "@etat": "MODIFIE", "@debut": "2009-06-22", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000026968598", "@fin": "2013-06-07", "@num": "R5124-2", "@etat": "MODIFIE", "@debut": "2013-01-21", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000027510058", "@fin": "2016-05-01", "@num": "R5124-2", "@etat": "MODIFIE", "@debut": "2013-06-07", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000032481760", "@fin": "2017-01-12", "@num": "R5124-2", "@etat": "MODIFIE", "@debut": "2016-05-01", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000033857013", "@fin": "2021-05-29", "@num": "R5124-2", "@etat": "MODIFIE", "@debut": "2017-01-12", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000043544717", "@fin": "2021-07-01", "@num": "R5124-2", "@etat": "MODIFIE", "@debut": "2021-05-29", "@origine": "LEGI" } }, { "@etat": "VIGUEUR", "LIEN_ART": { "@id": "LEGIARTI000043761806", "@fin": "2999-01-01", "@num": "R5124-2", "@etat": "VIGUEUR", "@debut": "2021-07-01", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
On entend par :
\n
1° Fabricant, l'entreprise ou l'organisme se livrant, en vue de leur vente en gros, de leur cession à titre gratuit ou de leur expérimentation sur l'homme à la fabrication de médicaments, produits ou objets mentionnés à l'article L. 4211-1 et au 4° de l'article L. 5121-1.
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La fabrication comprend les opérations concernant l'achat des matières premières et des articles de conditionnement, les opérations de production, de contrôle de la qualité, de libération des lots, ainsi que les opérations de stockage correspondantes, telles qu'elles sont définies par les bonnes pratiques prévues aux articles L. 5121-5 et L. 5136-3 applicables à cette activité.
\n
Pour les objets de pansement et articles présentés comme conformes à la pharmacopée mentionnés au 2° de l'article L. 4211-1 et les produits officinaux divisés mentionnés au 4° de l'article L. 5121-1, la vente en gros, la cession à titre gratuit ainsi que les opérations de suivi des lots et, s'il y a lieu, de leur retrait et, le cas échéant, de pharmacovigilance sont effectuées par le fabricant. Pour les médicaments expérimentaux, les opérations de suivi desdits médicaments et, s'il y a lieu, de leur retrait sont effectuées par le fabricant, sous la responsabilité du promoteur mentionné à l'article L. 1121-1 ;
\n
2° Importateur, l'entreprise ou l'organisme se livrant, en vue de leur vente en gros, de leur cession à titre gratuit ou de leur expérimentation sur l'homme, à l'importation, au stockage, au contrôle de la qualité et à la libération des lots de médicaments, produits ou objets mentionnés à l'article L. 4211-1 et au 4° de l'article L. 5121-1 en provenance :
\n
a) D'Etats non membres de la Communauté européenne et non parties à l'accord sur l'Espace économique européen ;
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b) Ou d'autres Etats membres de la Communauté européenne ou parties à l'accord sur l'Espace économique européen lorsque les médicaments, produits ou objets ont été fabriqués par un établissement non autorisé au titre l'article 40 de la directive 2001/83 du 6 novembre 2001 instituant un code communautaire relatif aux médicaments à usage humain.
\n
Pour les objets de pansement et articles présentés comme conformes à la pharmacopée mentionnés au 2° de l'article L. 4211-1 et les produits officinaux divisés mentionnés au 4° de l'article L. 5121-1, la vente en gros, la cession à titre gratuit ainsi que les opérations de suivi des lots et, s'il y a lieu, de leur retrait et, le cas échéant, de pharmacovigilance sont effectuées par l'importateur. Pour les médicaments expérimentaux, les opérations de suivi desdits médicaments et, s'il y a lieu, de leur retrait sont effectuées par l'importateur, sous la responsabilité du promoteur mentionné à l'article L. 1121-1 ;
\n
3° Exploitant, l'entreprise ou l'organisme se livrant à l'exploitation de médicaments autres que des médicaments expérimentaux, de générateurs, trousses et précurseurs mentionnés au 3° de l'article L. 4211-1 ou de produits mentionnés à l'article L. 5136-1.
\n
L'exploitation comprend les opérations de vente en gros ou de cession à titre gratuit, de publicité, d'information, de pharmacovigilance, de suivi des lots et, s'il y a lieu, de leur retrait ainsi que, le cas échéant, les opérations de stockage correspondantes.
\n
L'exploitation est assurée soit par le titulaire de l'autorisation de mise sur le marché mentionnée à l'article L. 5121-8, de l'autorisation temporaire d'utilisation mentionnée au a de l'article L. 5121-12, de l'autorisation mentionnée à l'article L. 5136-1 ou de l'enregistrement mentionné à l'article L. 5121-13, soit, pour le compte de ce titulaire, par une autre entreprise ou un autre organisme, soit par l'un et l'autre, chacun assurant dans ce cas une ou plusieurs catégories d'opérations constitutives de l'exploitation du médicament ou produit ;
\n
4° Dépositaire, l'entreprise se livrant, d'ordre et pour le compte :
\n
- d'un ou plusieurs exploitants de médicaments, de générateurs, trousses ou précurseurs mentionnés au 3° de l'article L. 4211-1 ou de produits mentionnés à l'article L. 5136-1 ;
\n
- ou d'un ou plusieurs fabricants ou importateurs d'objets de pansement ou articles présentés comme conformes à la Pharmacopée mentionnés au 2° de l'article L. 4211-1 ou de produits officinaux divisés mentionnés au 4° de l'article L. 5121-1, au stockage de ces médicaments, produits, objets ou articles dont elle n'est pas propriétaire, en vue de leur distribution en gros et en l'état ;
\n
5° Grossiste-répartiteur, l'entreprise se livrant à l'achat et au stockage de médicaments autres que des médicaments expérimentaux, en vue de leur distribution en gros et en l'état ;
\n
6° Distributeur en gros de produits pharmaceutiques autres que les médicaments, l'entreprise se livrant à l'achat et au stockage de produits, objets, articles, générateurs, trousses ou précurseurs mentionnés aux 2° et 3° de l'article L. 4211-1 ou de produits officinaux divisés mentionnés au 4° de l'article L. 5121-1, en vue de leur distribution en gros et en l'état ;
\n
7° Distributeur en gros à l'exportation, l'entreprise se livrant à l'achat et au stockage de médicaments autres que des médicaments expérimentaux, de produits, objets, articles, générateurs, trousses ou précurseurs mentionnés aux 2° et 3° de l'article L. 4211-1, de plantes médicinales mentionnées au 5° de l'article L. 4211-1 ou de produits officinaux divisés mentionnés au 4° de l'article L. 5121-1, en vue de leur exportation en l'état ;
\n
8° Distributeur en gros à vocation humanitaire, l'organisme à but non lucratif mentionné à l'article L. 5124-7 se livrant à l'acquisition à titre gratuit ou onéreux et au stockage de médicaments autres que des médicaments expérimentaux, en vue de leur distribution en gros ou de leur exportation dans les conditions prévues au même article ;
\n
9° Distributeur en gros de médicaments dérivés du sang, l'établissement de transfusion sanguine bénéficiant de l'autorisation mentionnée à l'article L. 1223-1, se livrant à l'achat et au stockage de médicaments dérivés du sang autres que des médicaments expérimentaux, en vue de leur distribution en gros et en l'état ;
\n
10° Distributeurs de médicaments expérimentaux, toute entreprise se livrant, le cas échéant d'ordre et pour le compte d'un ou plusieurs promoteurs définis à l'article L. 1121-1, au stockage de médicaments expérimentaux fabriqués ou importés par des entreprises ou organismes définis au 1° ou au 2° du présent article, en vue de leur distribution en l'état ;
\n
11° Distributeur en gros de plantes médicinales, l'entreprise se livrant au stockage et aux contrôles et opérations nécessaires pour la distribution en gros et en vrac, en sachets-doses, en fragments ou à l'état frais ou desséché de plantes médicinales mentionnées au 5° de l'article L. 4211-1 ;
\n
12° Distributeur en gros de gaz à usage médical, l'entreprise se livrant à l'achat et au stockage de gaz à usage médical, en vue de leur distribution en gros et en l'état ;
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13° Distributeur en gros du service de santé des armées, l'établissement de ravitaillement sanitaire du service de santé des armées comportant un ou plusieurs établissements pharmaceutiques se livrant, dans le cadre du décret n° 91-685 du 14 juillet 1991 fixant les attributions du service de santé des armées, à la distribution en gros et en l'état des médicaments, produits ou objets mentionnés à l'article L. 5124-8.
" } }, "LEGIARTI000006915078": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R5124-2", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2008-02-08", "DATE_DEBUT": "2007-08-28" } }, "META_COMMUN": { "ID": "LEGIARTI000006915078", "URL": "article/LEGI/ARTI/00/00/06/91/50/LEGIARTI000006915078.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "YXXXXXXXXXX5124R0020XX0C" } }, "LIENS": { "LIEN": [ { "@id": "JORFTEXT000000353820", "#text": "Décret 91-685 1991-07-14", "@sens": "source", "@cidtexte": "JORFTEXT000000353820", "@nortexte": "DEFM9101666D", "@numtexte": "91-685", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1991-07-14" }, { "@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": "LEGIARTI000006722523", "@num": "3", "#text": "Décret n°2007-1273 du 27 août 2007 - art. 3 () JORF 28 août 2007", "@sens": "source", "@cidtexte": "JORFTEXT000000792006", "@nortexte": "SJSP0759404D", "@numtexte": "2007-1273", "@typelien": "MODIFICATION", "@naturetexte": "DECRET", "@datesignatexte": "2007-08-27" }, { "@id": "LEGIARTI000019330270", "@num": "Annexe", "#text": "Arrêté du 18 août 2008 - art. 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art. 4 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000023491451", "@nortexte": "ETSP1101997A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2011-01-21" }, { "@id": "LEGIARTI000023501147", "@num": "8", "#text": "Arrêté du 21 janvier 2011 - art. 8 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000023491451", "@nortexte": "ETSP1101997A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2011-01-21" }, { "@id": "LEGIARTI000045746740", "@num": "2", "#text": "Arrêté du 20 avril 2012 - art. 2 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000025794925", "@nortexte": "ETSP1221356A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2012-04-20" }, { "@id": "LEGITEXT000032924021", "#text": "Décret n°2016-993 du 20 juillet 2016 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000032922434", "@nortexte": "AFSP1605997D", "@numtexte": "2016-993", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2016-07-20" }, { "@id": "LEGIARTI000041811290", "@num": "2", "#text": "Arrêté du 13 mars 2020 - art. 2 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000041721724", "@nortexte": "TREX2007745A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-03-13" }, { "@id": "LEGIARTI000041817894", "@num": "12-4-1", "#text": "Décret n°2020-293 du 23 mars 2020 - art. 12-4-1 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000041746694", "@nortexte": "SSAZ2008253D", "@numtexte": "2020-293", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2020-03-23" }, { "@id": "LEGIARTI000041817882", "@num": "12-4-3", "#text": "Décret n°2020-293 du 23 mars 2020 - art. 12-4-3 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000041746694", "@nortexte": "SSAZ2008253D", "@numtexte": "2020-293", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2020-03-23" }, { "@id": "LEGIARTI000041808807", "@num": "12-5", "#text": "Décret n°2020-293 du 23 mars 2020 - art. 12-5 (T)", "@sens": "cible", "@cidtexte": "JORFTEXT000041746694", "@nortexte": "SSAZ2008253D", "@numtexte": "2020-293", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2020-03-23" }, { "@id": "LEGIARTI000041808796", "@num": "1", "#text": "Décret n°2020-447 du 18 avril 2020 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000041808417", "@nortexte": "SSAZ2009990D", "@numtexte": "2020-447", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2020-04-18" }, { "@id": "LEGIARTI000041817722", "@num": "1", "#text": "Décret n°2020-466 du 23 avril 2020 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000041817203", "@nortexte": "SSAZ2010164D", "@numtexte": "2020-466", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2020-04-23" }, { "@id": "LEGIARTI000041859128", "@num": "20", "#text": "Décret n°2020-545 du 11 mai 2020 - art. 20 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000041858681", "@nortexte": "SSAZ2011567D", "@numtexte": "2020-545", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2020-05-11" }, { "@id": "LEGIARTI000041859132", "@num": "22", "#text": "Décret n°2020-545 du 11 mai 2020 - art. 22 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000041858681", "@nortexte": "SSAZ2011567D", "@numtexte": "2020-545", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2020-05-11" }, { "@id": "LEGIARTI000041866853", "@num": "22", "#text": "Décret n°2020-548 du 11 mai 2020 - art. 22 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000041865329", "@nortexte": "SSAZ2011695D", "@numtexte": "2020-548", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2020-05-11" }, { "@id": "LEGIARTI000041866857", "@num": "24", "#text": "Décret n°2020-548 du 11 mai 2020 - art. 24 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000041865329", "@nortexte": "SSAZ2011695D", "@numtexte": "2020-548", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2020-05-11" }, { "@id": "LEGIARTI000041943338", "@num": "53", "#text": "Décret n°2020-663 du 31 mai 2020 - art. 53 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000041939818", "@nortexte": "SSAZ2013547D", "@numtexte": "2020-663", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2020-05-31" }, { "@id": "LEGIARTI000041943340", "@num": "55", "#text": "Décret n°2020-663 du 31 mai 2020 - art. 55 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000041939818", "@nortexte": "SSAZ2013547D", "@numtexte": "2020-663", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2020-05-31" }, { "@id": "LEGIARTI000042107249", "@num": "34", "#text": "Arrêté du 10 juillet 2020 - art. 34 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000042106233", "@nortexte": "SSAZ2018110A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-07-10" }, { "@id": "LEGIARTI000042162863", "@num": "49", "#text": "Décret n°2020-860 du 10 juillet 2020 - art. 49 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000042105897", "@nortexte": "SSAZ2018127D", "@numtexte": "2020-860", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2020-07-10" }, { "@id": "LEGIARTI000047345303", "@num": "2", "#text": "Décret n°2020-1230 du 7 octobre 2020 - art. 2 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000042410284", "@nortexte": "SSAP2021390D", "@numtexte": "2020-1230", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2020-10-07" }, { "@id": "LEGIARTI000042431395", "@num": "49", "#text": "Décret n°2020-1262 du 16 octobre 2020 - art. 49 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000042430554", "@nortexte": "SSAZ2028015D", "@numtexte": "2020-1262", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2020-10-16" }, { "@id": "LEGIARTI000042431415", "@num": "55", "#text": "Décret n°2020-1262 du 16 octobre 2020 - art. 55 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000042430554", "@nortexte": "SSAZ2028015D", "@numtexte": "2020-1262", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2020-10-16" }, { "@id": "LEGIARTI000042437333", "#text": "Arrêté du 16 octobre 2020 - art. (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000042434518", "@nortexte": "SSAP2027328A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-10-16" }, { "@id": "LEGIARTI000042477774", "@num": "49", "#text": "Décret n°2020-1310 du 29 octobre 2020 - art. 49 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000042475143", "@nortexte": "SSAZ2029612D", "@numtexte": "2020-1310", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2020-10-29" }, { "@id": "LEGIARTI000042477838", "@num": "53", "#text": "Décret n°2020-1310 du 29 octobre 2020 - art. 53 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000042475143", "@nortexte": "SSAZ2029612D", "@numtexte": "2020-1310", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2020-10-29" }, { "@id": "LEGIARTI000042675496", "@num": "13", "#text": "Arrêté du 10 décembre 2020 - art. 13", "@sens": "cible", "@cidtexte": "JORFTEXT000042671830", "@nortexte": "TREP2034127A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-12-10" }, { "@id": "LEGIARTI000042899833", "@num": "11", "#text": "Décret n°2020-1725 du 29 décembre 2020 - art. 11", "@sens": "cible", "@cidtexte": "JORFTEXT000042754025", "@nortexte": "TREP2024571D", "@numtexte": "2020-1725", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2020-12-29" }, { "@id": "LEGIARTI000043102681", "@num": "1", "#text": "Décret n°2021-123 du 5 février 2021 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000043099846", "@nortexte": "SSAZ2104133D", "@numtexte": "2021-123", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2021-02-05" }, { "@id": "LEGIARTI000043102683", "@num": "2", "#text": "Décret n°2021-123 du 5 février 2021 - art. 2", "@sens": "cible", "@cidtexte": "JORFTEXT000043099846", "@nortexte": "SSAZ2104133D", "@numtexte": "2021-123", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2021-02-05" }, { "@id": "LEGIARTI000043329386", "@num": "1", "#text": "Décret n°2021-384 du 2 avril 2021 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000043327303", "@nortexte": "SSAZ2110799D", "@numtexte": "2021-384", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2021-04-02" }, { "@id": "LEGIARTI000043329388", "@num": "2", "#text": "Décret n°2021-384 du 2 avril 2021 - art. 2", "@sens": "cible", "@cidtexte": "JORFTEXT000043327303", "@nortexte": "SSAZ2110799D", "@numtexte": "2021-384", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2021-04-02" }, { "@id": "LEGITEXT000043542323", "#text": "Décret n°2021-667 du 26 mai 2021 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000043541966", "@nortexte": "SSAP2030330D", "@numtexte": "2021-667", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2021-05-26" }, { "@id": "LEGIARTI000047009237", "@num": "5", "#text": "Arrêté du 1 juin 2021 - art. 5 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000043575801", "@nortexte": "SSAZ2116944A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2021-06-01" }, { "@id": "LEGIARTI000043770208", "@num": "40", "#text": "Arrêté du 1er juin 2021 - art. 40 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000043575801", "@nortexte": "SSAZ2116944A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2021-06-01" }, { "@id": "LEGIARTI000043579314", "@num": "49", "#text": "Décret n°2021-699 du 1er juin 2021 - art. 49 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000043575238", "@nortexte": "SSAZ2116809D", "@numtexte": "2021-699", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2021-06-01" }, { "@id": "LEGITEXT000045300786", "#text": "Décret n°2022-324 du 4 mars 2022 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000045300080", "@nortexte": "SSAP2201125D", "@numtexte": "2022-324", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2022-03-04" }, { "@id": "LEGIARTI000046285779", "@num": "2", "#text": "Décret n°2022-1228 du 13 septembre 2022 - art. 2 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000046285336", "@nortexte": "SPRP2216106D", "@numtexte": "2022-1228", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2022-09-13" }, { "@id": "LEGIARTI000046819055", "@num": "13", "#text": "Arrêté du 19 décembre 2022 - art. 13", "@sens": "cible", "@cidtexte": "JORFTEXT000046793680", "@nortexte": "TREP2235813A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2022-12-19" }, { "@id": "LEGIARTI000006685825", "@num": "L1121-1", "#text": "Code de la santé publique - art. L1121-1 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006686121", "@num": "L1223-1", "#text": "Code de la santé publique - art. L1223-1 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006689004", "@num": "L4211-1", "#text": "Code de la santé publique - art. L4211-1 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006689870", "@num": "L5121-1", "#text": "Code de la santé publique - art. L5121-1 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006689900", "@num": "L5121-12", "#text": "Code de la santé publique - art. 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R5124-12 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000045303269", "@num": "R5124-16", "#text": "Code de la santé publique - art. R5124-16 (VD)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000045303265", "@num": "R5124-18", "#text": "Code de la santé publique - art. R5124-18 (VD)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000026592337", "@num": "R5124-23", "#text": "Code de la santé publique - art. R5124-23 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000022054886", "@num": "R5124-29", "#text": "Code de la santé publique - art. R5124-29 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000033857003", "@num": "R5124-3", "#text": "Code de la santé publique - art. R5124-3 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000026592324", "@num": "R5124-30", "#text": "Code de la santé publique - art. R5124-30 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006915119", "@num": "R5124-32", "#text": "Code de la santé publique - art. R5124-32 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006915129", "@num": "R5124-38", "#text": "Code de la santé publique - art. R5124-38 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000020776259", "@num": "R5124-39", "#text": "Code de la santé publique - art. R5124-39 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006915134", "@num": "R5124-42", "#text": "Code de la santé publique - art. R5124-42 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000033856858", "@num": "R5124-43", "#text": "Code de la santé publique - art. R5124-43 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000050149633", "@num": "R5124-45", "#text": "Code de la santé publique - art. R5124-45 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000032926258", "@num": "R5124-47", "#text": "Code de la santé publique - art. R5124-47 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006915145", "@num": "R5124-48", "#text": "Code de la santé publique - art. R5124-48 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000043308954", "@num": "R5124-48-1", "#text": "Code de la santé publique - art. R5124-48-1 (VD)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000026897100", "@num": "R5124-48-2", "#text": "Code de la santé publique - art. R5124-48-2 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000050772534", "@num": "R5124-49-1", "#text": "Code de la santé publique - art. R5124-49-1 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000026897126", "@num": "R5124-49-2", "#text": "Code de la santé publique - art. R5124-49-2 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000026903086", "@num": "R5124-58", "#text": "Code de la santé publique - art. R5124-58 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000033856695", "@num": "R5124-6", "#text": "Code de la santé publique - art. R5124-6 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000018087972", "@num": "R5124-60", "#text": "Code de la santé publique - art. R5124-60 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000038636684", "@num": "R5124-60-1", "#text": "Code de la santé publique - art. R5124-60-1 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000038633567", "@num": "R5124-60-2", "#text": "Code de la santé publique - art. R5124-60-2 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000018087934", "@num": "R5124-62", "#text": "Code de la santé publique - art. R5124-62 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000019343520", "@num": "R5124-63-1", "#text": "Code de la santé publique - art. R5124-63-1 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000033856952", "@num": "R5124-7", "#text": "Code de la santé publique - art. R5124-7 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000033856943", "@num": "R5124-8", "#text": "Code de la santé publique - art. R5124-8 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000043544691", "@num": "R5124-9", "#text": "Code de la santé publique - art. R5124-9 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000033851841", "@num": "R5124-9-1", "#text": "Code de la santé publique - art. R5124-9-1 (V)", "@sens": "cible", "@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": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006915468", "@num": "R5127-1", "#text": "Code de la santé publique - art. R5127-1 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006915573", "@num": "R5132-26", "#text": "Code de la santé publique - art. R5132-26 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000032106042", "@num": "R5132-83", "#text": "Code de la santé publique - art. R5132-83 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000026903119", "@num": "R5138-1", "#text": "Code de la santé publique - art. R5138-1 (VD)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000026897789", "@num": "R5138-2-1", "#text": "Code de la santé publique - art. R5138-2-1 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006916113", "@num": "R5142-31", "#text": "Code de la santé publique - art. R5142-31 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000033856706", "@num": "R5313-5", "#text": "Code de la santé publique - art. R5313-5 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000048494603", "@num": "R6326-6", "#text": "Code de la santé publique - art. R6326-6 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006190682", "@fin": "2999-01-01", "#text": "Section 1 : Champ d'application et définitions", "@debut": "2004-08-08" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006178652", "@fin": "2999-01-01", "#text": "Chapitre IV : Fabrication et distribution en gros", "@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": "LEGIARTI000006915076", "@fin": "2006-04-27", "@num": "R5124-2", "@etat": "MODIFIE", "@debut": "2004-08-08", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006915077", "@fin": "2007-08-28", "@num": "R5124-2", "@etat": "MODIFIE", "@debut": "2006-04-27", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006915078", "@fin": "2008-02-08", "@num": "R5124-2", "@etat": "MODIFIE", "@debut": "2007-08-28", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000018087912", "@fin": "2008-05-08", "@num": "R5124-2", "@etat": "MODIFIE", "@debut": "2008-02-08", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000018776676", "@fin": "2008-08-25", "@num": "R5124-2", "@etat": "MODIFIE", "@debut": "2008-05-08", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000019378341", "@fin": "2009-06-22", "@num": "R5124-2", "@etat": "MODIFIE", "@debut": "2008-08-25", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000020776282", "@fin": "2013-01-21", "@num": "R5124-2", "@etat": "MODIFIE", "@debut": "2009-06-22", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000026968598", "@fin": "2013-06-07", "@num": "R5124-2", "@etat": "MODIFIE", "@debut": "2013-01-21", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000027510058", "@fin": "2016-05-01", "@num": "R5124-2", "@etat": "MODIFIE", "@debut": "2013-06-07", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000032481760", "@fin": "2017-01-12", "@num": "R5124-2", "@etat": "MODIFIE", "@debut": "2016-05-01", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000033857013", "@fin": "2021-05-29", "@num": "R5124-2", "@etat": "MODIFIE", "@debut": "2017-01-12", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000043544717", "@fin": "2021-07-01", "@num": "R5124-2", "@etat": "MODIFIE", "@debut": "2021-05-29", "@origine": "LEGI" } }, { "@etat": "VIGUEUR", "LIEN_ART": { "@id": "LEGIARTI000043761806", "@fin": "2999-01-01", "@num": "R5124-2", "@etat": "VIGUEUR", "@debut": "2021-07-01", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
On entend par :
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1° Fabricant, l'entreprise ou l'organisme se livrant, en vue de leur vente en gros, de leur cession à titre gratuit ou de leur expérimentation sur l'homme à la fabrication de médicaments, produits ou objets mentionnés à l'article L. 4211-1 et au 4° de l'article L. 5121-1.
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La fabrication comprend les opérations concernant l'achat des matières premières et des articles de conditionnement, les opérations de production, de contrôle de la qualité, de libération des lots, ainsi que les opérations de stockage correspondantes, telles qu'elles sont définies par les bonnes pratiques prévues aux articles L. 5121-5 et L. 5136-3 applicables à cette activité.
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Pour les objets de pansement et articles présentés comme conformes à la pharmacopée mentionnés au 2° de l'article L. 4211-1 et les produits officinaux divisés mentionnés au 4° de l'article L. 5121-1, la vente en gros, la cession à titre gratuit ainsi que les opérations de suivi des lots et, s'il y a lieu, de leur retrait et, le cas échéant, de pharmacovigilance sont effectuées par le fabricant. Pour les médicaments expérimentaux, les opérations de suivi desdits médicaments et, s'il y a lieu, de leur retrait sont effectuées par le fabricant, sous la responsabilité du promoteur mentionné à l'article L. 1121-1 ;
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2° Importateur, l'entreprise ou l'organisme se livrant, en vue de leur vente en gros, de leur cession à titre gratuit ou de leur expérimentation sur l'homme, à l'importation, au stockage, au contrôle de la qualité et à la libération des lots de médicaments, produits ou objets mentionnés à l'article L. 4211-1 et au 4° de l'article L. 5121-1 en provenance :
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a) D'Etats non membres de la Communauté européenne et non parties à l'accord sur l'Espace économique européen ;
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b) Ou d'autres Etats membres de la Communauté européenne ou parties à l'accord sur l'Espace économique européen lorsque les médicaments, produits ou objets ont été fabriqués par un établissement non autorisé au titre l'article 40 de la directive 2001/83 du 6 novembre 2001 instituant un code communautaire relatif aux médicaments à usage humain.
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Pour les objets de pansement et articles présentés comme conformes à la pharmacopée mentionnés au 2° de l'article L. 4211-1 et les produits officinaux divisés mentionnés au 4° de l'article L. 5121-1, la vente en gros, la cession à titre gratuit ainsi que les opérations de suivi des lots et, s'il y a lieu, de leur retrait et, le cas échéant, de pharmacovigilance sont effectuées par l'importateur. Pour les médicaments expérimentaux, les opérations de suivi desdits médicaments et, s'il y a lieu, de leur retrait sont effectuées par l'importateur, sous la responsabilité du promoteur mentionné à l'article L. 1121-1 ;
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3° Exploitant, l'entreprise ou l'organisme se livrant à l'exploitation de médicaments autres que des médicaments expérimentaux, de générateurs, trousses et précurseurs mentionnés au 3° de l'article L. 4211-1 ou de produits mentionnés à l'article L. 5136-1.
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L'exploitation comprend les opérations de vente en gros ou de cession à titre gratuit, de publicité, d'information, de pharmacovigilance, de suivi des lots et, s'il y a lieu, de leur retrait ainsi que, le cas échéant, les opérations de stockage correspondantes.
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L'exploitation est assurée soit par le titulaire de l'autorisation de mise sur le marché mentionnée à l'article L. 5121-8, de l'autorisation temporaire d'utilisation mentionnée au a de l'article L. 5121-12, de l'autorisation mentionnée à l'article L. 5136-1 ou de l'enregistrement mentionné à l'article L. 5121-13, soit, pour le compte de ce titulaire, par une autre entreprise ou un autre organisme, soit par l'un et l'autre, chacun assurant dans ce cas une ou plusieurs catégories d'opérations constitutives de l'exploitation du médicament ou produit ;
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4° Dépositaire, l'entreprise se livrant, d'ordre et pour le compte :
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- d'un ou plusieurs exploitants de médicaments, de générateurs, trousses ou précurseurs mentionnés au 3° de l'article L. 4211-1 ou de produits mentionnés à l'article L. 5136-1 ;
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- ou d'un ou plusieurs fabricants ou importateurs d'objets de pansement ou articles présentés comme conformes à la Pharmacopée mentionnés au 2° de l'article L. 4211-1 ou de produits officinaux divisés mentionnés au 4° de l'article L. 5121-1, au stockage de ces médicaments, produits, objets ou articles dont elle n'est pas propriétaire, en vue de leur distribution en gros et en l'état ;
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5° Grossiste-répartiteur, l'entreprise se livrant à l'achat et au stockage de médicaments autres que des médicaments expérimentaux, en vue de leur distribution en gros et en l'état ;
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6° Distributeur en gros de produits pharmaceutiques autres que les médicaments, l'entreprise se livrant à l'achat et au stockage de produits, objets, articles, générateurs, trousses ou précurseurs mentionnés aux 2° et 3° de l'article L. 4211-1 ou de produits officinaux divisés mentionnés au 4° de l'article L. 5121-1, en vue de leur distribution en gros et en l'état ;
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7° Distributeur en gros à l'exportation, l'entreprise se livrant à l'achat et au stockage de médicaments autres que des médicaments expérimentaux, de produits, objets, articles, générateurs, trousses ou précurseurs mentionnés aux 2° et 3° de l'article L. 4211-1, de plantes médicinales mentionnées au 5° de l'article L. 4211-1 ou de produits officinaux divisés mentionnés au 4° de l'article L. 5121-1, en vue de leur exportation en l'état ;
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8° Distributeur en gros à vocation humanitaire, l'organisme à but non lucratif mentionné à l'article L. 5124-7 se livrant à l'acquisition à titre gratuit ou onéreux et au stockage de médicaments autres que des médicaments expérimentaux, en vue de leur distribution en gros ou de leur exportation dans les conditions prévues au même article ;
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9° Distributeur en gros de médicaments dérivés du sang, l'établissement de transfusion sanguine bénéficiant de l'autorisation mentionnée à l'article L. 1223-1, se livrant à l'achat et au stockage de médicaments dérivés du sang autres que des médicaments expérimentaux, en vue de leur distribution en gros et en l'état ;
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10° Distributeurs de médicaments expérimentaux, toute entreprise se livrant, le cas échéant d'ordre et pour le compte d'un ou plusieurs promoteurs définis à l'article L. 1121-1, au stockage de médicaments expérimentaux fabriqués ou importés par des entreprises ou organismes définis au 1° ou au 2° du présent article, en vue de leur distribution en l'état ;
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11° Distributeur en gros de plantes médicinales, l'entreprise se livrant au stockage et aux contrôles et opérations nécessaires pour la distribution en gros et en vrac, en sachets-doses, en fragments ou à l'état frais ou desséché de plantes médicinales mentionnées au 5° de l'article L. 4211-1 ;
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12° Distributeur en gros de gaz à usage médical, l'entreprise se livrant à l'achat et au stockage de gaz à usage médical, en vue de leur distribution en gros et en l'état ;
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13° Distributeur en gros du service de santé des armées, l'établissement de ravitaillement sanitaire du service de santé des armées comportant un ou plusieurs établissements pharmaceutiques se livrant, dans le cadre du décret n° 91-685 du 14 juillet 1991 fixant les attributions du service de santé des armées, à la distribution en gros et en l'état des médicaments, produits ou objets mentionnés à l'article L. 5124-8 ;
\n
14° Distributeur en gros de produits nécessaires à la protection de la population face aux menaces sanitaires graves, l'Etablissement de préparation et de réponse aux urgences sanitaires se livrant à l'achat et au stockage de produits mentionnés à l'article L. 4211-1, en vue de leur distribution aux structures énumérées à l'article R. 5124-45.
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art. 55 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000042430554", "@nortexte": "SSAZ2028015D", "@numtexte": "2020-1262", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2020-10-16" }, { "@id": "LEGIARTI000042437333", "#text": "Arrêté du 16 octobre 2020 - art. (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000042434518", "@nortexte": "SSAP2027328A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-10-16" }, { "@id": "LEGIARTI000042477774", "@num": "49", "#text": "Décret n°2020-1310 du 29 octobre 2020 - art. 49 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000042475143", "@nortexte": "SSAZ2029612D", "@numtexte": "2020-1310", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2020-10-29" }, { "@id": "LEGIARTI000042477838", "@num": "53", "#text": "Décret n°2020-1310 du 29 octobre 2020 - art. 53 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000042475143", "@nortexte": "SSAZ2029612D", "@numtexte": "2020-1310", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2020-10-29" }, { "@id": "LEGIARTI000042675496", "@num": "13", "#text": "Arrêté du 10 décembre 2020 - art. 13", "@sens": "cible", "@cidtexte": "JORFTEXT000042671830", "@nortexte": "TREP2034127A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-12-10" }, { "@id": "LEGIARTI000042899833", "@num": "11", "#text": "Décret n°2020-1725 du 29 décembre 2020 - art. 11", "@sens": "cible", "@cidtexte": "JORFTEXT000042754025", "@nortexte": "TREP2024571D", "@numtexte": "2020-1725", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2020-12-29" }, { "@id": "LEGIARTI000043102681", "@num": "1", "#text": "Décret n°2021-123 du 5 février 2021 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000043099846", "@nortexte": "SSAZ2104133D", "@numtexte": "2021-123", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2021-02-05" }, { "@id": "LEGIARTI000043102683", "@num": "2", "#text": "Décret n°2021-123 du 5 février 2021 - art. 2", "@sens": "cible", "@cidtexte": "JORFTEXT000043099846", "@nortexte": "SSAZ2104133D", "@numtexte": "2021-123", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2021-02-05" }, { "@id": "LEGIARTI000043329386", "@num": "1", "#text": "Décret n°2021-384 du 2 avril 2021 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000043327303", "@nortexte": "SSAZ2110799D", "@numtexte": "2021-384", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2021-04-02" }, { "@id": "LEGIARTI000043329388", "@num": "2", "#text": "Décret n°2021-384 du 2 avril 2021 - art. 2", "@sens": "cible", "@cidtexte": "JORFTEXT000043327303", "@nortexte": "SSAZ2110799D", "@numtexte": "2021-384", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2021-04-02" }, { "@id": "LEGITEXT000043542323", "#text": "Décret n°2021-667 du 26 mai 2021 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000043541966", "@nortexte": "SSAP2030330D", "@numtexte": "2021-667", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2021-05-26" }, { "@id": "LEGIARTI000047009237", "@num": "5", "#text": "Arrêté du 1 juin 2021 - art. 5 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000043575801", "@nortexte": "SSAZ2116944A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2021-06-01" }, { "@id": "LEGIARTI000043770208", "@num": "40", "#text": "Arrêté du 1er juin 2021 - art. 40 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000043575801", "@nortexte": "SSAZ2116944A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2021-06-01" }, { "@id": "LEGIARTI000043579314", "@num": "49", "#text": "Décret n°2021-699 du 1er juin 2021 - art. 49 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000043575238", "@nortexte": "SSAZ2116809D", "@numtexte": "2021-699", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2021-06-01" }, { "@id": "LEGITEXT000045300786", "#text": "Décret n°2022-324 du 4 mars 2022 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000045300080", "@nortexte": "SSAP2201125D", "@numtexte": "2022-324", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2022-03-04" }, { "@id": "LEGIARTI000046285779", "@num": "2", "#text": "Décret n°2022-1228 du 13 septembre 2022 - art. 2 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000046285336", "@nortexte": "SPRP2216106D", "@numtexte": "2022-1228", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2022-09-13" }, { "@id": "LEGIARTI000046819055", "@num": "13", "#text": "Arrêté du 19 décembre 2022 - art. 13", "@sens": "cible", "@cidtexte": "JORFTEXT000046793680", "@nortexte": "TREP2235813A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2022-12-19" }, { "@id": "LEGIARTI000019497867", "@num": "R1243-29", "#text": "Code de la santé publique - art. 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R5124-60-2 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000018087934", "@num": "R5124-62", "#text": "Code de la santé publique - art. R5124-62 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000019343520", "@num": "R5124-63-1", "#text": "Code de la santé publique - art. R5124-63-1 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000033856952", "@num": "R5124-7", "#text": "Code de la santé publique - art. 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On entend par :

1° Fabricant, l'entreprise ou l'organisme se livrant, en vue de leur vente en gros, de leur cession à titre gratuit ou de leur expérimentation sur l'homme à la fabrication de médicaments, produits ou objets mentionnés à l'article L. 4211-1 et au 4° de l'article L. 5121-1.

La fabrication comprend les opérations concernant l'achat des matières premières et des articles de conditionnement, les opérations de production, de contrôle de la qualité, de libération des lots, ainsi que les opérations de stockage correspondantes, telles qu'elles sont définies par les bonnes pratiques prévues à l'article L. 5121-5 applicables à cette activité.

Pour les objets de pansement et articles présentés comme conformes à la pharmacopée mentionnés au 2° de l'article L. 4211-1 et les produits officinaux divisés mentionnés au 4° de l'article L. 5121-1, la vente en gros, la cession à titre gratuit ainsi que les opérations de suivi des lots et, s'il y a lieu, de leur retrait et, le cas échéant, de pharmacovigilance sont effectuées par le fabricant. Pour les médicaments expérimentaux, les opérations de suivi desdits médicaments et, s'il y a lieu, de leur retrait sont effectuées par le fabricant, sous la responsabilité du promoteur mentionné à l'article L. 1121-1 ;

2° Importateur, l'entreprise ou l'organisme se livrant, en vue de leur vente en gros, de leur cession à titre gratuit ou de leur expérimentation sur l'homme, à l'importation, au stockage, au contrôle de la qualité et à la libération des lots de médicaments, produits ou objets mentionnés à l'article L. 4211-1 et au 4° de l'article L. 5121-1 en provenance :

a) D'Etats non membres de la Communauté européenne et non parties à l'accord sur l'Espace économique européen ;

b) Ou d'autres Etats membres de la Communauté européenne ou parties à l'accord sur l'Espace économique européen lorsque les médicaments, produits ou objets ont été fabriqués par un établissement non autorisé au titre l'article 40 de la directive 2001/83 du 6 novembre 2001 instituant un code communautaire relatif aux médicaments à usage humain.

Pour les objets de pansement et articles présentés comme conformes à la pharmacopée mentionnés au 2° de l'article L. 4211-1 et les produits officinaux divisés mentionnés au 4° de l'article L. 5121-1, la vente en gros, la cession à titre gratuit ainsi que les opérations de suivi des lots et, s'il y a lieu, de leur retrait et, le cas échéant, de pharmacovigilance sont effectuées par l'importateur. Pour les médicaments expérimentaux, les opérations de suivi desdits médicaments et, s'il y a lieu, de leur retrait sont effectuées par l'importateur, sous la responsabilité du promoteur mentionné à l'article L. 1121-1 ;

3° Exploitant, l'entreprise ou l'organisme se livrant à l'exploitation de médicaments autres que des médicaments expérimentaux, de générateurs, trousses et précurseurs mentionnés au 3° de l'article L. 4211-1.

L'exploitation comprend les opérations de vente en gros ou de cession à titre gratuit, de publicité, d'information, de pharmacovigilance, de suivi des lots et, s'il y a lieu, de leur retrait ainsi que, le cas échéant, les opérations de stockage correspondantes.

L'exploitation est assurée soit par le titulaire de l'autorisation de mise sur le marché mentionnée à l'article L. 5121-8, de l'autorisation temporaire d'utilisation mentionnée au a de l'article L. 5121-12 ou de l'enregistrement mentionné à l'article L. 5121-13, soit, pour le compte de ce titulaire, par une autre entreprise ou un autre organisme, soit par l'un et l'autre, chacun assurant dans ce cas une ou plusieurs catégories d'opérations constitutives de l'exploitation du médicament ou produit ;

4° Dépositaire, l'entreprise se livrant, d'ordre et pour le compte :

- d'un ou plusieurs exploitants de médicaments, de générateurs, trousses ou précurseurs mentionnés au 3° de l'article L. 4211-1 ;

- ou d'un ou plusieurs fabricants ou importateurs d'objets de pansement ou articles présentés comme conformes à la Pharmacopée mentionnés au 2° de l'article L. 4211-1 ou de produits officinaux divisés mentionnés au 4° de l'article L. 5121-1, au stockage de ces médicaments, produits, objets ou articles dont elle n'est pas propriétaire, en vue de leur distribution en gros et en l'état ;

5° Grossiste-répartiteur, l'entreprise se livrant à l'achat et au stockage de médicaments autres que des médicaments expérimentaux, en vue de leur distribution en gros et en l'état ;

6° Distributeur en gros de produits pharmaceutiques autres que les médicaments, l'entreprise se livrant à l'achat et au stockage de produits, objets, articles, générateurs, trousses ou précurseurs mentionnés aux 2° et 3° de l'article L. 4211-1 ou de produits officinaux divisés mentionnés au 4° de l'article L. 5121-1, en vue de leur distribution en gros et en l'état ;

7° Distributeur en gros à l'exportation, l'entreprise se livrant à l'achat et au stockage de médicaments autres que des médicaments expérimentaux, de produits, objets, articles, générateurs, trousses ou précurseurs mentionnés aux 2° et 3° de l'article L. 4211-1, de plantes médicinales mentionnées au 5° de l'article L. 4211-1 ou de produits officinaux divisés mentionnés au 4° de l'article L. 5121-1, en vue de leur exportation en l'état ;

8° Distributeur en gros à vocation humanitaire, l'organisme à but non lucratif mentionné à l'article L. 5124-7 se livrant à l'acquisition à titre gratuit ou onéreux et au stockage de médicaments autres que des médicaments expérimentaux, en vue de leur distribution en gros ou de leur exportation dans les conditions prévues au même article ;

9° Distributeur en gros de médicaments dérivés du sang, l'établissement de transfusion sanguine bénéficiant de l'autorisation mentionnée à l'article L. 1223-1, se livrant à l'achat et au stockage de médicaments dérivés du sang autres que des médicaments expérimentaux, en vue de leur distribution en gros et en l'état ;

10° Distributeurs de médicaments expérimentaux, toute entreprise se livrant, le cas échéant d'ordre et pour le compte d'un ou plusieurs promoteurs définis à l'article L. 1121-1, au stockage de médicaments expérimentaux fabriqués ou importés par des entreprises ou organismes définis au 1° ou au 2° du présent article, en vue de leur distribution en l'état ;

11° Distributeur en gros de plantes médicinales, l'entreprise se livrant au stockage et aux contrôles et opérations nécessaires pour la distribution en gros et en vrac, en sachets-doses, en fragments ou à l'état frais ou desséché de plantes médicinales mentionnées au 5° de l'article L. 4211-1 ;

12° Distributeur en gros de gaz à usage médical, l'entreprise se livrant à l'achat et au stockage de gaz à usage médical, en vue de leur distribution en gros et en l'état ;

13° Distributeur en gros du service de santé des armées, l'établissement de ravitaillement sanitaire du service de santé des armées comportant un ou plusieurs établissements pharmaceutiques se livrant, dans le cadre du décret n° 91-685 du 14 juillet 1991 fixant les attributions du service de santé des armées, à la distribution en gros et en l'état des médicaments, produits ou objets mentionnés à l'article L. 5124-8 ;

14° Distributeur en gros de produits nécessaires à la protection de la population face aux menaces sanitaires graves, l'Etablissement de préparation et de réponse aux urgences sanitaires se livrant à l'achat et au stockage de produits mentionnés à l'article L. 4211-1, en vue de leur distribution aux structures énumérées à l'article R. 5124-45.

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art. 2 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000041721724", "@nortexte": "TREX2007745A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-03-13" }, { "@id": "LEGIARTI000041817894", "@num": "12-4-1", "#text": "Décret n°2020-293 du 23 mars 2020 - art. 12-4-1 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000041746694", "@nortexte": "SSAZ2008253D", "@numtexte": "2020-293", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2020-03-23" }, { "@id": "LEGIARTI000041817882", "@num": "12-4-3", "#text": "Décret n°2020-293 du 23 mars 2020 - art. 12-4-3 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000041746694", "@nortexte": "SSAZ2008253D", "@numtexte": "2020-293", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2020-03-23" }, { "@id": "LEGIARTI000041808807", "@num": "12-5", "#text": "Décret n°2020-293 du 23 mars 2020 - art. 12-5 (T)", "@sens": "cible", "@cidtexte": "JORFTEXT000041746694", "@nortexte": "SSAZ2008253D", "@numtexte": "2020-293", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2020-03-23" }, { "@id": "LEGIARTI000041808796", "@num": "1", "#text": "Décret n°2020-447 du 18 avril 2020 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000041808417", "@nortexte": "SSAZ2009990D", "@numtexte": "2020-447", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2020-04-18" }, { "@id": "LEGIARTI000041817722", "@num": "1", "#text": "Décret n°2020-466 du 23 avril 2020 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000041817203", "@nortexte": "SSAZ2010164D", "@numtexte": "2020-466", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2020-04-23" }, { "@id": "LEGIARTI000041859128", "@num": "20", "#text": "Décret n°2020-545 du 11 mai 2020 - art. 20 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000041858681", "@nortexte": "SSAZ2011567D", "@numtexte": "2020-545", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2020-05-11" }, { "@id": "LEGIARTI000041859132", "@num": "22", "#text": "Décret n°2020-545 du 11 mai 2020 - art. 22 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000041858681", "@nortexte": "SSAZ2011567D", "@numtexte": "2020-545", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2020-05-11" }, { "@id": "LEGIARTI000041866853", "@num": "22", "#text": "Décret n°2020-548 du 11 mai 2020 - art. 22 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000041865329", "@nortexte": "SSAZ2011695D", "@numtexte": "2020-548", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2020-05-11" }, { "@id": "LEGIARTI000041866857", "@num": "24", "#text": "Décret n°2020-548 du 11 mai 2020 - art. 24 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000041865329", "@nortexte": "SSAZ2011695D", "@numtexte": "2020-548", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2020-05-11" }, { "@id": "LEGIARTI000041943338", "@num": "53", "#text": "Décret n°2020-663 du 31 mai 2020 - art. 53 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000041939818", "@nortexte": "SSAZ2013547D", "@numtexte": "2020-663", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2020-05-31" }, { "@id": "LEGIARTI000041943340", "@num": "55", "#text": "Décret n°2020-663 du 31 mai 2020 - art. 55 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000041939818", "@nortexte": "SSAZ2013547D", "@numtexte": "2020-663", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2020-05-31" }, { "@id": "LEGIARTI000042107249", "@num": "34", "#text": "Arrêté du 10 juillet 2020 - art. 34 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000042106233", "@nortexte": "SSAZ2018110A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-07-10" }, { "@id": "LEGIARTI000042162863", "@num": "49", "#text": "Décret n°2020-860 du 10 juillet 2020 - art. 49 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000042105897", "@nortexte": "SSAZ2018127D", "@numtexte": "2020-860", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2020-07-10" }, { "@id": "LEGIARTI000047345303", "@num": "2", "#text": "Décret n°2020-1230 du 7 octobre 2020 - art. 2 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000042410284", "@nortexte": "SSAP2021390D", "@numtexte": "2020-1230", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2020-10-07" }, { "@id": "LEGIARTI000042431395", "@num": "49", "#text": "Décret n°2020-1262 du 16 octobre 2020 - art. 49 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000042430554", "@nortexte": "SSAZ2028015D", "@numtexte": "2020-1262", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2020-10-16" }, { "@id": "LEGIARTI000042431415", "@num": "55", "#text": "Décret n°2020-1262 du 16 octobre 2020 - art. 55 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000042430554", "@nortexte": "SSAZ2028015D", "@numtexte": "2020-1262", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2020-10-16" }, { "@id": "LEGIARTI000042437333", "#text": "Arrêté du 16 octobre 2020 - art. (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000042434518", "@nortexte": "SSAP2027328A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-10-16" }, { "@id": "LEGIARTI000042477774", "@num": "49", "#text": "Décret n°2020-1310 du 29 octobre 2020 - art. 49 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000042475143", "@nortexte": "SSAZ2029612D", "@numtexte": "2020-1310", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2020-10-29" }, { "@id": "LEGIARTI000042477838", "@num": "53", "#text": "Décret n°2020-1310 du 29 octobre 2020 - art. 53 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000042475143", "@nortexte": "SSAZ2029612D", "@numtexte": "2020-1310", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2020-10-29" }, { "@id": "LEGIARTI000042675496", "@num": "13", "#text": "Arrêté du 10 décembre 2020 - art. 13", "@sens": "cible", "@cidtexte": "JORFTEXT000042671830", "@nortexte": "TREP2034127A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-12-10" }, { "@id": "LEGIARTI000042899833", "@num": "11", "#text": "Décret n°2020-1725 du 29 décembre 2020 - art. 11", "@sens": "cible", "@cidtexte": "JORFTEXT000042754025", "@nortexte": "TREP2024571D", "@numtexte": "2020-1725", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2020-12-29" }, { "@id": "LEGIARTI000043102681", "@num": "1", "#text": "Décret n°2021-123 du 5 février 2021 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000043099846", "@nortexte": "SSAZ2104133D", "@numtexte": "2021-123", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2021-02-05" }, { "@id": "LEGIARTI000043102683", "@num": "2", "#text": "Décret n°2021-123 du 5 février 2021 - art. 2", "@sens": "cible", "@cidtexte": "JORFTEXT000043099846", "@nortexte": "SSAZ2104133D", "@numtexte": "2021-123", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2021-02-05" }, { "@id": "LEGIARTI000043329386", "@num": "1", "#text": "Décret n°2021-384 du 2 avril 2021 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000043327303", "@nortexte": "SSAZ2110799D", "@numtexte": "2021-384", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2021-04-02" }, { "@id": "LEGIARTI000043329388", "@num": "2", "#text": "Décret n°2021-384 du 2 avril 2021 - art. 2", "@sens": "cible", "@cidtexte": "JORFTEXT000043327303", "@nortexte": "SSAZ2110799D", "@numtexte": "2021-384", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2021-04-02" }, { "@id": "LEGITEXT000043542323", "#text": "Décret n°2021-667 du 26 mai 2021 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000043541966", "@nortexte": "SSAP2030330D", "@numtexte": "2021-667", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2021-05-26" }, { "@id": "LEGIARTI000047009237", "@num": "5", "#text": "Arrêté du 1 juin 2021 - art. 5 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000043575801", "@nortexte": "SSAZ2116944A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2021-06-01" }, { "@id": "LEGIARTI000043770208", "@num": "40", "#text": "Arrêté du 1er juin 2021 - art. 40 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000043575801", "@nortexte": "SSAZ2116944A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2021-06-01" }, { "@id": "LEGIARTI000043579314", "@num": "49", "#text": "Décret n°2021-699 du 1er juin 2021 - art. 49 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000043575238", "@nortexte": "SSAZ2116809D", "@numtexte": "2021-699", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2021-06-01" }, { "@id": "LEGITEXT000045300786", "#text": "Décret n°2022-324 du 4 mars 2022 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000045300080", "@nortexte": "SSAP2201125D", "@numtexte": "2022-324", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2022-03-04" }, { "@id": "LEGIARTI000046285779", "@num": "2", "#text": "Décret n°2022-1228 du 13 septembre 2022 - art. 2 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000046285336", "@nortexte": "SPRP2216106D", "@numtexte": "2022-1228", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2022-09-13" }, { "@id": "LEGIARTI000046819055", "@num": "13", "#text": "Arrêté du 19 décembre 2022 - art. 13", "@sens": "cible", "@cidtexte": "JORFTEXT000046793680", "@nortexte": "TREP2235813A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2022-12-19" }, { "@id": "LEGIARTI000019497867", "@num": "R1243-29", "#text": "Code de la santé publique - art. R1243-29 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000044038634", "@num": "R1335-8-2", "#text": "Code de la santé publique - art. R1335-8-2 (VD)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000042962910", "@num": "R4211-24", "#text": "Code de la santé publique - art. R4211-24 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000020763345", "@num": "R4212-2", "#text": "Code de la santé publique - art. 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On entend par :

a) D'Etats non membres de la Communauté européenne et non parties à l'accord sur l'Espace économique européen ;

b) Ou d'autres Etats membres de la Communauté européenne ou parties à l'accord sur l'Espace économique européen lorsque les médicaments, produits ou objets ont été fabriqués par un établissement non autorisé au titre l'article 40 de la directive 2001 / 83 du 6 novembre 2001 instituant un code communautaire relatif aux médicaments à usage humain.

Pour les objets de pansement et articles présentés comme conformes à la pharmacopée mentionnés au 2° de l'article L. 4211-1 et les produits officinaux divisés mentionnés au 4° de l'article L. 5121-1, la vente en gros, la cession à titre gratuit ainsi que les opérations de suivi des lots et, s'il y a lieu, de leur retrait et, le cas échéant, de pharmacovigilance sont effectuées par l'importateur. Pour les médicaments expérimentaux, les opérations de suivi desdits médicaments et, s'il y a lieu, de leur retrait sont effectuées par l'importateur, sous la responsabilité du promoteur mentionné à l'article L. 1121-1 ;

L'exploitation est assurée soit par le titulaire de l'autorisation de mise sur le marché mentionnée à l'article L. 5121-8, de l'autorisation temporaire d'utilisation mentionnée au a de l'article L. 5121-12 ou de l'un des enregistrements mentionnés aux articles L. 5121-13 et L. 5121-14-1, soit, pour le compte de ce titulaire, par une autre entreprise ou un autre organisme, soit par l'un et l'autre, chacun assurant dans ce cas une ou plusieurs catégories d'opérations constitutives de l'exploitation du médicament ou produit ;

4° Dépositaire, l'entreprise se livrant, d'ordre et pour le compte :

-d'un ou plusieurs exploitants de médicaments, de générateurs, trousses ou précurseurs mentionnés au 3° de l'article L. 4211-1 ;

-ou d'un ou plusieurs fabricants ou importateurs d'objets de pansement ou articles présentés comme conformes à la Pharmacopée mentionnés au 2° de l'article L. 4211-1 ou de produits officinaux divisés mentionnés au 4° de l'article L. 5121-1, au stockage de ces médicaments, produits, objets ou articles dont elle n'est pas propriétaire, en vue de leur distribution en gros et en l'état ;

5° Grossiste-répartiteur, l'entreprise se livrant à l'achat et au stockage de médicaments autres que des médicaments expérimentaux, en vue de leur distribution en gros et en l'état ;

12° Distributeur en gros de gaz à usage médical, l'entreprise se livrant à l'achat et au stockage de gaz à usage médical, en vue de leur distribution en gros et en l'état ;

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art. 55 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000042430554", "@nortexte": "SSAZ2028015D", "@numtexte": "2020-1262", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2020-10-16" }, { "@id": "LEGIARTI000042437333", "#text": "Arrêté du 16 octobre 2020 - art. 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Article R5124-48 AUTONOME VIGUEUR, en vigueur depuis le 08/08/2004 (Code de la santé publique)