{ "article": { "LEGIARTI000026596787": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R5121-177", "ETAT": "VIGUEUR", "TYPE": "AUTONOME", "DATE_FIN": "2999-01-01", "DATE_DEBUT": "2012-11-10" } }, "META_COMMUN": { "ID": "LEGIARTI000026596787", "URL": "article/LEGI/ARTI/00/00/26/59/67/LEGIARTI000026596787.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "LIENS": { "LIEN": [ { "@id": "LEGIARTI000026593806", "@num": "5", "#text": "Décret n°2012-1244\n du 8 novembre 2012 - art. 5", "@sens": "cible", "@cidtexte": "JORFTEXT000026592596", "@nortexte": "AFSP1232131D", "@numtexte": "2012-1244", "@typelien": "MODIFIE", "@naturetexte": "DECRET", "@datesignatexte": "2012-11-08" }, { "@id": "LEGIARTI000006914932", "@num": "R5121-174", "#text": "Code de la santé publique - art. R5121-174", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000026886505", "@num": "R5121-196", "#text": "Code de la santé publique - art. R5121-196 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006800617", "@num": "R5144-21", "#text": "Code de la santé publique - art. R5144-21 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006800614", "@num": "R5144-21", "#text": "Code de la santé publique - art. R5144-21 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000026595442", "@fin": "2021-01-01", "#text": "Paragraphe 5 : Entreprises ou organismes exploitant un médicament ou un produit mentionné à l'article R. 5121-150", "@debut": "2012-11-10" }, { "@id": "LEGISCTA000039659097", "@fin": "2999-01-01", "#text": "Paragraphe 4 : Entreprises ou organismes exploitant un médicament ou un produit mentionné à l'article R. 5121-150", "@debut": "2021-01-01" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006196560", "@fin": "2999-01-01", "#text": "Sous-section 2 : Organisation", "@debut": "2004-08-08" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006190672", "@fin": "2999-01-01", "#text": "Section 13 : Pharmacovigilance", "@debut": "2004-08-08" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006178649", "@fin": "2999-01-01", "#text": "Chapitre Ier : Dispositions générales", "@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": "LEGIARTI000006914936", "@fin": "2007-12-30", "@num": "R5121-177", "@etat": "MODIFIE", "@debut": "2004-08-08", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000017841615", "@fin": "2012-05-01", "@num": "R5121-177", "@etat": "MODIFIE", "@debut": "2007-12-30", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000025787825", "@fin": "2012-11-10", "@num": "R5121-177", "@etat": "MODIFIE", "@debut": "2012-05-01", "@origine": "LEGI" } }, { "@etat": "VIGUEUR", "LIEN_ART": { "@id": "LEGIARTI000026596787", "@fin": "2999-01-01", "@num": "R5121-177", "@etat": "VIGUEUR", "@debut": "2012-11-10", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "

Les modalités et le modèle type des déclarations et du rapport mentionnés aux articles R. 5121-174 à R. 5121-176 sont fixés par décision du directeur général de l'Agence nationale de sécurité du médicament et des produits de santé.

" } }, "LEGIARTI000006914932": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R5121-174", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2007-12-30", "DATE_DEBUT": "2004-08-08" } }, "META_COMMUN": { "ID": "LEGIARTI000006914932", "URL": "article/LEGI/ARTI/00/00/06/91/49/LEGIARTI000006914932.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "YXXXXXXXXXX5121R1740XX0A" } }, "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": "LEGIARTI000006689983", "@num": "L5124-6", "#text": "Code de la santé publique - art. L5124-6 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006914902", "@num": "R5121-150", "#text": "Code de la santé publique - art. R5121-150 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000026596787", "@num": "R5121-177", "#text": "Code de la santé publique - art. R5121-177 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006914783", "@num": "R5121-47", "#text": "Code de la santé publique - art. R5121-47 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006800611", "@num": "R5144-20-1", "#text": "Code de la santé publique - art. R5144-20-1 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006800610", "@num": "R5144-20-1", "#text": "Code de la santé publique - art. R5144-20-1 (T)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006196561", "@fin": "2012-11-10", "#text": "Sous-section 3 : Obligations de signalement.", "@debut": "2004-08-08" }, { "@id": "LEGISCTA000026596785", "@fin": "2999-01-01", "#text": "Sous-section 3 : Surveillance des études de sécurité post-autorisation", "@debut": "2012-11-10" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006190672", "@fin": "2999-01-01", "#text": "Section 13 : Pharmacovigilance", "@debut": "2004-08-08" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006178649", "@fin": "2999-01-01", "#text": "Chapitre Ier : Dispositions générales", "@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": "LEGIARTI000006914932", "@fin": "2007-12-30", "@num": "R5121-174", "@etat": "MODIFIE", "@debut": "2004-08-08", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000017841610", "@fin": "2012-05-01", "@num": "R5121-174", "@etat": "MODIFIE", "@debut": "2007-12-30", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000025787832", "@fin": "2012-11-10", "@num": "R5121-174", "@etat": "MODIFIE", "@debut": "2012-05-01", "@origine": "LEGI" } }, { "@etat": "VIGUEUR", "LIEN_ART": { "@id": "LEGIARTI000026596799", "@fin": "2999-01-01", "@num": "R5121-174", "@etat": "VIGUEUR", "@debut": "2012-11-10", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
L'entreprise ou l'organisme exploitant un médicament ou produit mentionné à l'article R. 5121-150 qui informe, en application de l'article L. 5124-6, le directeur général de l'Agence française de sécurité sanitaire des produits de santé qu'il a engagé une action pour suspendre la commercialisation d'un médicament ou produit ou le retirer du marché, ou pour en retirer un lot déterminé, indique la teneur des messages de communication, le cas échéant, prévus pour accompagner cette action, ainsi que les modalités de leur diffusion, lorsque la suspension ou le retrait est justifié par un des motifs mentionnés à l'article R. 5121-47.
\n
L'entreprise ou l'organisme exploitant un médicament ou produit mentionné à l'article R. 5121-150 communique en outre immédiatement toute interdiction ou restriction imposée par les autorités compétentes de tout pays dans lequel le médicament ou produit est mis sur le marché, ainsi que toute autre information nouvelle qui pourrait influencer l'évaluation des bénéfices et des risques du médicament ou produit concerné.
" } }, "LEGIARTI000017841610": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R5121-174", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2012-05-01", "DATE_DEBUT": "2007-12-30" } }, "META_COMMUN": { "ID": "LEGIARTI000017841610", "URL": "article/LEGI/ARTI/00/00/17/84/16/LEGIARTI000017841610.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "LIENS": { "LIEN": [ { "@id": "LEGIARTI000017833549", "@num": "1", "#text": "Décret n°2007-1860\n du 26 décembre 2007 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000017762708", "@nortexte": "SJSP0771467D", "@numtexte": "2007-1860", "@typelien": "MODIFIE", "@naturetexte": "DECRET", "@datesignatexte": "2007-12-26" }, { "@id": "LEGIARTI000006689983", "@num": "L5124-6", "#text": "Code de la santé publique - art. L5124-6", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006914902", "@num": "R5121-150", "#text": "Code de la santé publique - art. R5121-150", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000026596787", "@num": "R5121-177", "#text": "Code de la santé publique - art. R5121-177 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006914783", "@num": "R5121-47", "#text": "Code de la santé publique - art. R5121-47", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006800611", "@num": "R5144-20-1", "#text": "Code de la santé publique - art. R5144-20-1 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006800610", "@num": "R5144-20-1", "#text": "Code de la santé publique - art. R5144-20-1 (T)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006196561", "@fin": "2012-11-10", "#text": "Sous-section 3 : Obligations de signalement.", "@debut": "2004-08-08" }, { "@id": "LEGISCTA000026596785", "@fin": "2999-01-01", "#text": "Sous-section 3 : Surveillance des études de sécurité post-autorisation", "@debut": "2012-11-10" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006190672", "@fin": "2999-01-01", "#text": "Section 13 : Pharmacovigilance", "@debut": "2004-08-08" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006178649", "@fin": "2999-01-01", "#text": "Chapitre Ier : Dispositions générales", "@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": "LEGIARTI000006914932", "@fin": "2007-12-30", "@num": "R5121-174", "@etat": "MODIFIE", "@debut": "2004-08-08", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000017841610", "@fin": "2012-05-01", "@num": "R5121-174", "@etat": "MODIFIE", "@debut": "2007-12-30", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000025787832", "@fin": "2012-11-10", "@num": "R5121-174", "@etat": "MODIFIE", "@debut": "2012-05-01", "@origine": "LEGI" } }, { "@etat": "VIGUEUR", "LIEN_ART": { "@id": "LEGIARTI000026596799", "@fin": "2999-01-01", "@num": "R5121-174", "@etat": "VIGUEUR", "@debut": "2012-11-10", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "

L'entreprise ou l'organisme exploitant un médicament ou produit mentionné à l'article R. 5121-150 ne peut communiquer au grand public, sur ce médicament ou produit, des informations portant sur la pharmacovigilance sans les transmettre, au préalable ou, en cas d'urgence, simultanément, au directeur général de l'Agence française de sécurité sanitaire des produits de santé. Ces informations sont présentées de manière objective et non trompeuse.

L'entreprise ou l'organisme exploitant un médicament ou produit mentionné à l'article R. 5121-150 qui informe, en application de l'article L. 5124-6, le directeur général de l'Agence française de sécurité sanitaire des produits de santé qu'il a engagé une action pour suspendre la commercialisation d'un médicament ou produit ou le retirer du marché, ou pour en retirer un lot déterminé, indique la teneur des messages de communication, le cas échéant, prévus pour accompagner cette action, ainsi que les modalités de leur diffusion, lorsque la suspension ou le retrait est justifié par un des motifs mentionnés à l'article R. 5121-47.

L'entreprise ou l'organisme exploitant un médicament ou produit mentionné à l'article R. 5121-150 communique en outre immédiatement toute interdiction ou restriction imposée par les autorités compétentes de tout pays dans lequel le médicament ou produit est mis sur le marché, ainsi que toute autre information nouvelle qui pourrait influencer l'évaluation des bénéfices et des risques du médicament ou produit concerné.

" } }, "LEGIARTI000025787832": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R5121-174", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2012-11-10", "DATE_DEBUT": "2012-05-01" } }, "META_COMMUN": { "ID": "LEGIARTI000025787832", "URL": "article/LEGI/ARTI/00/00/25/78/78/LEGIARTI000025787832.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "LIENS": { "LIEN": [ { "@id": "LEGIARTI000025765496", "@num": "5", "#text": "Décret n°2012-597\n du 27 avril 2012 - art. 5", "@sens": "cible", "@cidtexte": "JORFTEXT000025757625", "@nortexte": "ETSP1206945D", "@numtexte": "2012-597", "@typelien": "MODIFIE", "@naturetexte": "DECRET", "@datesignatexte": "2012-04-27" }, { "@id": "LEGIARTI000006689983", "@num": "L5124-6", "#text": "Code de la santé publique - art. L5124-6 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006914902", "@num": "R5121-150", "#text": "Code de la santé publique - art. R5121-150 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000026596787", "@num": "R5121-177", "#text": "Code de la santé publique - art. R5121-177 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006914783", "@num": "R5121-47", "#text": "Code de la santé publique - art. R5121-47 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006800611", "@num": "R5144-20-1", "#text": "Code de la santé publique - art. R5144-20-1 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006800610", "@num": "R5144-20-1", "#text": "Code de la santé publique - art. R5144-20-1 (T)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006196561", "@fin": "2012-11-10", "#text": "Sous-section 3 : Obligations de signalement.", "@debut": "2004-08-08" }, { "@id": "LEGISCTA000026596785", "@fin": "2999-01-01", "#text": "Sous-section 3 : Surveillance des études de sécurité post-autorisation", "@debut": "2012-11-10" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006190672", "@fin": "2999-01-01", "#text": "Section 13 : Pharmacovigilance", "@debut": "2004-08-08" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006178649", "@fin": "2999-01-01", "#text": "Chapitre Ier : Dispositions générales", "@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": "LEGIARTI000006914932", "@fin": "2007-12-30", "@num": "R5121-174", "@etat": "MODIFIE", "@debut": "2004-08-08", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000017841610", "@fin": "2012-05-01", "@num": "R5121-174", "@etat": "MODIFIE", "@debut": "2007-12-30", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000025787832", "@fin": "2012-11-10", "@num": "R5121-174", "@etat": "MODIFIE", "@debut": "2012-05-01", "@origine": "LEGI" } }, { "@etat": "VIGUEUR", "LIEN_ART": { "@id": "LEGIARTI000026596799", "@fin": "2999-01-01", "@num": "R5121-174", "@etat": "VIGUEUR", "@debut": "2012-11-10", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "

L'entreprise ou l'organisme exploitant un médicament ou produit mentionné à l'article R. 5121-150 ne peut communiquer au grand public, sur ce médicament ou produit, des informations portant sur la pharmacovigilance sans les transmettre, au préalable ou, en cas d'urgence, simultanément, au directeur général de l'Agence nationale de sécurité du médicament et des produits de santé. Ces informations sont présentées de manière objective et non trompeuse.

L'entreprise ou l'organisme exploitant un médicament ou produit mentionné à l'article R. 5121-150 qui informe, en application de l'article L. 5124-6, le directeur général de l'Agence nationale de sécurité du médicament et des produits de santé qu'il a engagé une action pour suspendre la commercialisation d'un médicament ou produit ou le retirer du marché, ou pour en retirer un lot déterminé, indique la teneur des messages de communication, le cas échéant, prévus pour accompagner cette action, ainsi que les modalités de leur diffusion, lorsque la suspension ou le retrait est justifié par un des motifs mentionnés à l'article R. 5121-47.

" } }, "LEGIARTI000026593806": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "5", "TYPE": "ENTIEREMENT_MODIF", "DATE_FIN": "2999-01-01", "DATE_DEBUT": "2999-01-01" } }, "META_COMMUN": { "ID": "LEGIARTI000026593806", "URL": "article/LEGI/ARTI/00/00/26/59/38/LEGIARTI000026593806.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "LIENS": { "LIEN": [ { "@id": "LEGISCTA000026596723", "#text": "Code de la santé publique - Paragraphe 3 : Centres régionaux de pharmacovig... 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R5121-154 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000026596728", "@num": "R5121-155", "#text": "Code de la santé publique - art. R5121-155 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000026596709", "@num": "R5121-156", "#text": "Code de la santé publique - art. R5121-156 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000026596725", "@num": "R5121-157", "#text": "Code de la santé publique - art. R5121-157 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000026596864", "@num": "R5121-158", "#text": "Code de la santé publique - art. R5121-158 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000026596859", "@num": "R5121-159", "#text": "Code de la santé publique - art. R5121-159 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000026596857", "@num": "R5121-160", "#text": "Code de la santé publique - art. R5121-160 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000026596852", "@num": "R5121-161", "#text": "Code de la santé publique - art. R5121-161 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000026596847", "@num": "R5121-162", "#text": "Code de la santé publique - art. R5121-162 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000026596841", "@num": "R5121-163", "#text": "Code de la santé publique - art. R5121-163 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000026596834", "@num": "R5121-164", "#text": "Code de la santé publique - art. R5121-164 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000026596829", "@num": "R5121-165", "#text": "Code de la santé publique - art. R5121-165 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000026596825", "@num": "R5121-166", "#text": "Code de la santé publique - art. R5121-166 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000025787852", "@num": "R5121-167", "#text": "Code de la santé publique - art. R5121-167 (T)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "TRANSFERE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000026595674", "@num": "R5121-167", "#text": "Code de la santé publique - art. R5121-167 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CREE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006914925", "@num": "R5121-168", "#text": "Code de la santé publique - art. R5121-168 (T)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "TRANSFERE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000026596074", "@num": "R5121-168", "#text": "Code de la santé publique - art. R5121-168 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CREE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000025787847", "@num": "R5121-169", "#text": "Code de la santé publique - art. R5121-169 (T)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "TRANSFERE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000026595703", "@num": "R5121-169", "#text": "Code de la santé publique - art. R5121-169 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CREE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000026596816", "@num": "R5121-170", "#text": "Code de la santé publique - art. R5121-170 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000026596810", "@num": "R5121-171", "#text": "Code de la santé publique - art. R5121-171 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000026596805", "@num": "R5121-172", "#text": "Code de la santé publique - art. R5121-172 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000026596802", "@num": "R5121-173", "#text": "Code de la santé publique - art. R5121-173 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000026596799", "@num": "R5121-174", "#text": "Code de la santé publique - art. R5121-174 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000026596794", "@num": "R5121-175", "#text": "Code de la santé publique - art. R5121-175 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000026596790", "@num": "R5121-176", "#text": "Code de la santé publique - art. R5121-176 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000026596787", "@num": "R5121-177", "#text": "Code de la santé publique - art. R5121-177 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000026596781", "@num": "R5121-178", "#text": "Code de la santé publique - art. 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R5121-180 (Ab)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "ABROGE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "@cid": "JORFTEXT000026592596", "@nor": "AFSP1232131D", "@num": "2012-1244", "@nature": "DECRET", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Décret n° 2012-1244 du 8 novembre 2012 relatif au renforcement des dispositions en matière de sécurité des médicaments à usage humain soumis à autorisation de mise sur le marché et à la pharmacovigilance", "@debut": "2999-01-01", "@id_txt": "JORFTEXT000026592596", "@c_titre_court": "Décret n°2012-1244 du 8 novembre 2012" }, { "@fin": "2999-01-01", "#text": "Décret n° 2012-1244 du 8 novembre 2012 relatif au renforcement des dispositions en matière de sécurité des médicaments à usage humain soumis à autorisation de mise sur le marché et à la pharmacovigilance", "@debut": "2012-11-10", "@id_txt": "LEGITEXT000026593781", "@c_titre_court": "Décret n°2012-1244 du 8 novembre 2012" } ], "@ministere": "Ministère des affaires sociales et de la santé", "@date_publi": "2012-11-09", "@date_signature": "2012-11-08", "@num_parution_jo": "0261" } }, "VERSIONS": { "VERSION": [ { "LIEN_ART": { "@id": "LEGIARTI000026593806", "@fin": "2999-01-01", "@num": "5", "@debut": "2999-01-01", "@origine": "LEGI" } }, { "LIEN_ART": { "@id": "JORFARTI000026592669", "@fin": "2999-01-01", "@num": "5", "@debut": "2999-01-01", "@origine": "JORF" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
A modifié les dispositions suivantes :

- Code de la santé publique
\n Art. R5121-150, Art. R5121-151, Art. R5121-152, Art. R5121-153, Art. R5121-154, Art. R5121-155, Art. R5121-156, Art. R5121-157, Sct. Paragraphe 3 : Centres régionaux de pharmacovigilance
\n

\n
\n
A modifié les dispositions suivantes :

- Code de la santé publique
\n Art. R5121-167, Art. R5121-158, Art. R5121-168, Art. R5121-159, Art. R5121-169, Art. R5121-160, Art. R5121-161, Sct. Paragraphe 4 : Professionnels de santé et patients, Sct. Paragraphe 5 : Entreprises ou organismes exploitant un médicament ou un produit mentionné à l'article R. 5121-150, Art. R5121-162, Art. R5121-163, Art. R5121-164, Art. R5121-165, Art. R5121-166, Art. R5121-167, Art. R5121-168, Art. R5121-169, Art. R5121-170, Art. R5121-171, Art. R5121-172, Art. R5121-173, Art. R5121-174, Art. R5121-175, Art. R5121-176, Art. R5121-177, Sct. Sous-section 3 : Surveillance des études de sécurité post-autorisation ., Art. R5121-178, Art. R5121-178-1, Art. R5121-178-2, Sct. Sous-section 4 : Bonnes pratiques de pharmacovigilance., Art. R5121-179, Art. R5121-180\n
\n

\n
\n
\n
\n
\n
\n
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Le titulaire de l'autorisation prévue à l'article L. 4211-6 est tenu de déclarer au directeur général de l'Agence nationale de sécurité du médicament et des produits de santé :
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1° Tout effet indésirable grave suspecté d'être dû aux allergènes qu'il a préparés et délivrés, dont il a connaissance, sans délai et au plus tard dans les quinze jours suivant la réception de l'information ;
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2° Tout effet indésirable non grave suspecté d'être dû aux allergènes qu'il a préparés et délivrés, dont il a connaissance, et ce dans les quatre-vingt-dix jours suivant la réception de l'information.
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Le titulaire d'une autorisation prévue à l'article L. 4211-6 transmet au directeur général de l'Agence, annuellement et immédiatement sur demande, un rapport présentant la synthèse des informations relatives aux effets indésirables qu'il a déclarés ou qui lui ont été signalés et de toutes les informations utiles à l'évaluation des risques et des bénéfices liés à l'emploi des produits qu'il utilise.
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Article R5121-177 AUTONOME VIGUEUR, en vigueur depuis le 10/11/2012 (Code de la santé publique)