{ "article": { "LEGIARTI000006800589": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R5144-13", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "1999-03-05", "DATE_DEBUT": "1995-03-14" } }, "META_COMMUN": { "ID": "LEGIARTI000006800589", "URL": "article/LEGI/ARTI/00/00/06/80/05/LEGIARTI000006800589.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SXXXXXXXXXX5144R0130XXAA" } }, "LIENS": { "LIEN": [ { "@id": "LEGIARTI000006699070", "@num": "1", "#text": "Décret n°95-278 du 13 mars 1995 - art. 1 () JORF 14 mars 1995", "@sens": "source", "@cidtexte": "JORFTEXT000000531081", "@nortexte": "SPSP9500721D", "@numtexte": "95-278", "@typelien": "CREATION", "@naturetexte": "DECRET", "@datesignatexte": "1995-03-13" }, { "@id": "LEGIARTI000006914920", "@num": "R5121-165", "#text": "Code de la santé publique - art. R5121-165 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006194983", "@fin": "2004-08-08", "#text": "3. Commission nationale de pharmacovigilance", "@debut": "1995-03-14" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006187169", "@fin": "2004-08-08", "#text": "§ 2. Organisation de la pharmacovigilance", "@debut": "1995-03-14" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006174545", "@fin": "2004-08-08", "#text": "Section 1 : Règles générales de pharmacovigilance", "@debut": "1995-03-14" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006157772", "@fin": "2004-08-08", "#text": "Chapitre 2 bis : Pharmacovigilance", "@debut": "1984-05-30" } ] }, "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": "LEGIARTI000006800589", "@fin": "1999-03-05", "@num": "R5144-13", "@etat": "MODIFIE", "@debut": "1995-03-14", "@origine": "LEGI" } }, { "@etat": "ABROGE", "LIEN_ART": { "@id": "LEGIARTI000006800590", "@fin": "2004-08-08", "@num": "R5144-13", "@etat": "ABROGE", "@debut": "1999-03-05", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
Le secrétariat de la commission nationale et celui du comité technique sont assurés par l'Agence du médicament.
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" } }, "LEGIARTI000006699070": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "1", "TYPE": "ENTIEREMENT_MODIF", "DATE_FIN": "2999-01-01", "DATE_DEBUT": "2999-01-01" } }, "META_COMMUN": { "ID": "LEGIARTI000006699070", "URL": "article/LEGI/ARTI/00/00/06/69/90/LEGIARTI000006699070.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SPH32XXXXXX001AAXXXXXXAA" } }, "LIENS": { "LIEN": [ { "@id": "LEGIARTI000006800543", "@num": "R5144-1", "#text": "Code de la santé publique - art. R5144-1 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006800577", "@num": "R5144-10", "#text": "Code de la santé publique - art. R5144-10 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006800583", "@num": "R5144-11", "#text": "Code de la santé publique - art. R5144-11 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006800587", "@num": "R5144-12", "#text": "Code de la santé publique - art. R5144-12 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CREATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006800589", "@num": "R5144-13", "#text": "Code de la santé publique - art. R5144-13 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CREATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006800591", "@num": "R5144-14", "#text": "Code de la santé publique - art. R5144-14 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CREATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006800594", "@num": "R5144-15", "#text": "Code de la santé publique - art. R5144-15 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CREATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006800596", "@num": "R5144-16", "#text": "Code de la santé publique - art. R5144-16 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CREATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006800600", "@num": "R5144-17", "#text": "Code de la santé publique - art. R5144-17 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CREATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006800603", "@num": "R5144-18", "#text": "Code de la santé publique - art. 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R5144-20 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CREATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006800614", "@num": "R5144-21", "#text": "Code de la santé publique - art. R5144-21 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CREATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006800618", "@num": "R5144-22", "#text": "Code de la santé publique - art. R5144-22 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CREATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006800549", "@num": "R5144-3", "#text": "Code de la santé publique - art. R5144-3 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006800555", "@num": "R5144-4", "#text": "Code de la santé publique - art. R5144-4 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006800559", "@num": "R5144-5", "#text": "Code de la santé publique - art. R5144-5 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006800563", "@num": "R5144-6", "#text": "Code de la santé publique - art. R5144-6 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006800567", "@num": "R5144-7", "#text": "Code de la santé publique - art. R5144-7 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006800570", "@num": "R5144-8", "#text": "Code de la santé publique - art. R5144-8 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006800574", "@num": "R5144-9", "#text": "Code de la santé publique - art. R5144-9 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "@cid": "JORFTEXT000000531081", "@nor": "SPSP9500721D", "@num": "95-278", "@nature": "DECRET", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Décret no 95-278 du 13 mars 1995 relatif à la pharmacovigilance et modifiant le code de la santé publique (deuxième partie : Décrets en Conseil d'Etat)", "@debut": "2999-01-01", "@id_txt": "JORFTEXT000000531081", "@c_titre_court": "Décret n°95-278 du 13 mars 1995" }, { "@fin": "2004-08-08", "#text": "Décret n°95-278 du 13 mars 1995 relatif à la pharmacovigilance et modifiant le code de la santé publique (deuxième partie : Décrets en Conseil d'Etat)", "@debut": "1995-03-14", "@id_txt": "LEGITEXT000005618022", "@c_titre_court": "Décret n°95-278 du 13 mars 1995" } ], "@ministere": "MINISTERE DES AFFAIRES SOCIALES, DE LA SANTE ET DE LA VILLE", "@date_publi": "1995-03-14", "@date_signature": "1995-03-13" } }, "VERSIONS": { "VERSION": [ { "LIEN_ART": { "@id": "LEGIARTI000006699070", "@fin": "2999-01-01", "@num": "1", "@debut": "2999-01-01", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "a modifié les dispositions suivantes
\n
" } }, "LEGIARTI000006914920": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R5121-165", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2012-11-10", "DATE_DEBUT": "2004-08-08" } }, "META_COMMUN": { "ID": "LEGIARTI000006914920", "URL": "article/LEGI/ARTI/00/00/06/91/49/LEGIARTI000006914920.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "YXXXXXXXXXX5121R1650XX0A" } }, "NOTA": { "CONTENU": "

Décret n° 2009-631 du 6 juin 2009 article 1 : Les dispositions réglementaires instituant les commissions administratives à caractère consultatif dont la liste est annexée au présent décret sont prorogées pour une durée de cinq ans. (Commission nationale de pharmacovigilance vétérinaire).

\n
\n
" }, "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": "LEGIARTI000025765488", "@num": "4", "#text": "Décret n°2012-597\n du 27 avril 2012 - art. 4", "@sens": "cible", "@cidtexte": "JORFTEXT000025757625", "@nortexte": "ETSP1206945D", "@numtexte": "2012-597", "@typelien": "ABROGE", "@naturetexte": "DECRET", "@datesignatexte": "2012-04-27" }, { "@id": "LEGIARTI000027098590", "@num": "R5121-158", "#text": "Code de la santé publique - art. R5121-158 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000028083991", "@num": "R5121-175", "#text": "Code de la santé publique - art. R5121-175 (VD)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006800590", "@num": "R5144-13", "#text": "Code de la santé publique - art. R5144-13 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006800589", "@num": "R5144-13", "#text": "Code de la santé publique - art. R5144-13 (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": "LEGISCTA000006198810", "@fin": "2012-05-01", "#text": "Paragraphe 3 : Commission nationale de pharmacovigilance.", "@debut": "2004-08-08" } ] }, "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": "LEGIARTI000006914920", "@fin": "2012-11-10", "@num": "R5121-165", "@etat": "MODIFIE", "@debut": "2004-08-08", "@origine": "LEGI" } }, { "@etat": "VIGUEUR", "LIEN_ART": { "@id": "LEGIARTI000026596829", "@fin": "2999-01-01", "@num": "R5121-165", "@etat": "VIGUEUR", "@debut": "2012-11-10", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
Le secrétariat de la commission et celui du comité sont assurés par l'Agence française de sécurité sanitaire des produits de santé.
\n
" } }, "LEGIARTI000026596829": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R5121-165", "ETAT": "VIGUEUR", "TYPE": "AUTONOME", "DATE_FIN": "2999-01-01", "DATE_DEBUT": "2012-11-10" } }, "META_COMMUN": { "ID": "LEGIARTI000026596829", "URL": "article/LEGI/ARTI/00/00/26/59/68/LEGIARTI000026596829.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "LIENS": { "LIEN": [ { "@id": "JORFTEXT000000787339", "#text": "Décret n°2004-802 du 29 juillet 2004", "@sens": "source", "@cidtexte": "JORFTEXT000000787339", "@nortexte": "SANP0422530D", "@numtexte": "2004-802", "@typelien": "CODIFICATION", "@naturetexte": "DECRET", "@datesignatexte": "2004-07-29" }, { "@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": "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", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000027098590", "@num": "R5121-158", "#text": "Code de la santé publique - art. R5121-158 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000028083991", "@num": "R5121-175", "#text": "Code de la santé publique - art. R5121-175 (VD)", "@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": "LEGIARTI000006800590", "@num": "R5144-13", "#text": "Code de la santé publique - art. R5144-13 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006800589", "@num": "R5144-13", "#text": "Code de la santé publique - art. R5144-13 (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": "LEGIARTI000006914920", "@fin": "2012-11-10", "@num": "R5121-165", "@etat": "MODIFIE", "@debut": "2004-08-08", "@origine": "LEGI" } }, { "@etat": "VIGUEUR", "LIEN_ART": { "@id": "LEGIARTI000026596829", "@fin": "2999-01-01", "@num": "R5121-165", "@etat": "VIGUEUR", "@debut": "2012-11-10", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "

L'entreprise ou l'organisme exploitant un médicament ou un produit mentionné à l'article R. 5121-150 ne peut communiquer au grand public, sur ce médicament ou ce 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, à l'Agence européenne des médicaments ainsi qu'à la Commission européenne. Ces informations sont présentées de manière objective et non trompeuse.
\n
L'entreprise ou l'organisme exploitant un médicament ou un 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 d'un 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
\n

\n
" } }, "LEGIARTI000006800587": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R5144-12", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "1999-09-30", "DATE_DEBUT": "1995-03-14" } }, "META_COMMUN": { "ID": "LEGIARTI000006800587", "URL": "article/LEGI/ARTI/00/00/06/80/05/LEGIARTI000006800587.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SXXXXXXXXXX5144R0120XXAA" } }, "LIENS": { "LIEN": [ { "@id": "LEGIARTI000006699070", "@num": "1", "#text": "Décret n°95-278 du 13 mars 1995 - art. 1 () JORF 14 mars 1995", "@sens": "source", "@cidtexte": "JORFTEXT000000531081", "@nortexte": "SPSP9500721D", "@numtexte": "95-278", "@typelien": "CREATION", "@naturetexte": "DECRET", "@datesignatexte": "1995-03-13" }, { "@id": "LEGIARTI000006910613", "@num": "R1341-17", "#text": "Code de la santé publique - art. R1341-17 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006798645", "@num": "R145-5-9", "#text": "Code de la santé publique - art. R145-5-9 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006914919", "@num": "R5121-164", "#text": "Code de la santé publique - art. R5121-164 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006800542", "@num": "R5144-1", "#text": "Code de la santé publique - art. R5144-1 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006800576", "@num": "R5144-10", "#text": "Code de la santé publique - art. R5144-10 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006800598", "@num": "R5144-16", "#text": "Code de la santé publique - art. R5144-16 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006800560", "@num": "R5144-5", "#text": "Code de la santé publique - art. R5144-5 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006194983", "@fin": "2004-08-08", "#text": "3. Commission nationale de pharmacovigilance", "@debut": "1995-03-14" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006187169", "@fin": "2004-08-08", "#text": "§ 2. Organisation de la pharmacovigilance", "@debut": "1995-03-14" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006174545", "@fin": "2004-08-08", "#text": "Section 1 : Règles générales de pharmacovigilance", "@debut": "1995-03-14" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006157772", "@fin": "2004-08-08", "#text": "Chapitre 2 bis : Pharmacovigilance", "@debut": "1984-05-30" } ] }, "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": "LEGIARTI000006800587", "@fin": "1999-09-30", "@num": "R5144-12", "@etat": "MODIFIE", "@debut": "1995-03-14", "@origine": "LEGI" } }, { "@etat": "ABROGE", "LIEN_ART": { "@id": "LEGIARTI000006800588", "@fin": "2004-08-08", "@num": "R5144-12", "@etat": "ABROGE", "@debut": "1999-09-30", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
Sauf cas d'urgence, les travaux de la commission nationale sont préparés par un comité technique présidé par le président de la commission nationale ou, en son absence, par le vice-président.
\n
Le comité comprend les membres de droit de la commission nationale et un représentant de chacun des centres régionaux de pharmacovigilance.
\n
Il est chargé :
\n
- de coordonner la collecte des informations sur les effets indésirables des médicaments et produits mentionnés à l'article R. 5144-1 ;
\n
- d'évaluer les informations collectées ;
\n
- de coordonner, de recenser et d'évaluer les enquêtes et travaux demandés aux centres régionaux de pharmacovigilance et aux entreprises ou organismes exploitant des médicaments ou produits mentionnés à l'article R. 5144-1.
\n
Le comité peut faire appel pour tout ou partie de ses travaux aux experts mentionnés au I de l'article R. 5144-10.
" } }, "LEGIARTI000006800591": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R5144-14", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "1999-03-05", "DATE_DEBUT": "1995-03-14" } }, "META_COMMUN": { "ID": "LEGIARTI000006800591", "URL": "article/LEGI/ARTI/00/00/06/80/05/LEGIARTI000006800591.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SXXXXXXXXXX5144R0140XXAA" } }, "LIENS": { "LIEN": [ { "@id": "LEGIARTI000006699070", "@num": "1", "#text": "Décret n°95-278 du 13 mars 1995 - art. 1 () JORF 14 mars 1995", "@sens": "source", "@cidtexte": "JORFTEXT000000531081", "@nortexte": "SPSP9500721D", "@numtexte": "95-278", "@typelien": "CREATION", "@naturetexte": "DECRET", "@datesignatexte": "1995-03-13" }, { "@id": "LEGIARTI000006240494", "@num": "2", "#text": "Arrêté du 12 avril 2005 - art. 2 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000256880", "@nortexte": "SANH0521417A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2005-04-12" }, { "@id": "LEGIARTI000006691802", "@num": "D711-9-1", "#text": "Code de la santé publique - art. D711-9-1 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006914923", "@num": "R5121-167", "#text": "Code de la santé publique - art. R5121-167 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006800542", "@num": "R5144-1", "#text": "Code de la santé publique - art. R5144-1 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006800606", "@num": "R5144-19", "#text": "Code de la santé publique - art. R5144-19 (Ab)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006800560", "@num": "R5144-5", "#text": "Code de la santé publique - art. R5144-5 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006800564", "@num": "R5144-6", "#text": "Code de la santé publique - art. R5144-6 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006800967", "@num": "R5146-41-14", "#text": "Code de la santé publique - art. R5146-41-14 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006800974", "@num": "R5146-41-18", "#text": "Code de la santé publique - art. R5146-41-18 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006194984", "@fin": "2004-08-08", "#text": "4. Centres régionaux de pharmacovigilance", "@debut": "1995-03-14" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006187169", "@fin": "2004-08-08", "#text": "§ 2. Organisation de la pharmacovigilance", "@debut": "1995-03-14" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006174545", "@fin": "2004-08-08", "#text": "Section 1 : Règles générales de pharmacovigilance", "@debut": "1995-03-14" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006157772", "@fin": "2004-08-08", "#text": "Chapitre 2 bis : Pharmacovigilance", "@debut": "1984-05-30" } ] }, "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": "LEGIARTI000006800591", "@fin": "1999-03-05", "@num": "R5144-14", "@etat": "MODIFIE", "@debut": "1995-03-14", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006800592", "@fin": "2004-01-31", "@num": "R5144-14", "@etat": "MODIFIE", "@debut": "1999-03-05", "@origine": "LEGI" } }, { "@etat": "ABROGE", "LIEN_ART": { "@id": "LEGIARTI000006800593", "@fin": "2004-08-08", "@num": "R5144-14", "@etat": "ABROGE", "@debut": "2004-01-31", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
Les centres régionaux de pharmacovigilance sont chargés :
\n
1° De recueillir les déclarations que doivent leur adresser, en application de l'article R. 5144-19, les médecins, les chirurgiens-dentistes, les sages-femmes et les pharmaciens ;
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2° De recueillir les informations relatives aux effets indésirables des médicaments ou produits mentionnés à l'article R. 5144-1 qui doivent leur être communiquées par les établissements publics de santé, par les centres antipoison et par les établissements de santé privés qui assurent l'exécution du service public hospitalier ou sont associés à son fonctionnement ;
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3° De réunir les informations de même nature qui leur sont transmises par les autres établissements de santé ou, à titre individuel, par les membres de professions de santé ;
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4° De transmettre au directeur général de l'Agence du médicament les informations recueillies en application des 1°, 2° et 3°, celles qui concernent des effets indésirables graves devant lui être transmises sans délai ;
\n
5° De remplir auprès du ministre chargé de la santé et du directeur général de l'Agence du médicament une mission d'expertise, en conduisant les études et travaux qui leur sont demandés par ces autorités et en procédant à l'évaluation des informations relatives aux effets indésirables ;
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6° De contribuer au développement des connaissances sur les méthodes de la pharmacovigilance et sur la nature et les mécanismes des effets indésirables des médicaments et produits mentionnés à l'article R. 5144-1.
" } }, "LEGIARTI000006800594": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R5144-15", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "1999-04-01", "DATE_DEBUT": "1995-03-14" } }, "META_COMMUN": { "ID": "LEGIARTI000006800594", "URL": "article/LEGI/ARTI/00/00/06/80/05/LEGIARTI000006800594.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SXXXXXXXXXX5144R0150XXAA" } }, "LIENS": { "LIEN": [ { "@id": "LEGIARTI000006699070", "@num": "1", "#text": "Décret n°95-278 du 13 mars 1995 - art. 1 () JORF 14 mars 1995", "@sens": "source", "@cidtexte": "JORFTEXT000000531081", "@nortexte": "SPSP9500721D", "@numtexte": "95-278", "@typelien": "CREATION", "@naturetexte": "DECRET", "@datesignatexte": "1995-03-13" }, { "@id": "LEGIARTI000006914925", "@num": "R5121-168", "#text": "Code de la santé publique - art. R5121-168 (T)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006194984", "@fin": "2004-08-08", "#text": "4. Centres régionaux de pharmacovigilance", "@debut": "1995-03-14" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006187169", "@fin": "2004-08-08", "#text": "§ 2. Organisation de la pharmacovigilance", "@debut": "1995-03-14" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006174545", "@fin": "2004-08-08", "#text": "Section 1 : Règles générales de pharmacovigilance", "@debut": "1995-03-14" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006157772", "@fin": "2004-08-08", "#text": "Chapitre 2 bis : Pharmacovigilance", "@debut": "1984-05-30" } ] }, "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": "LEGIARTI000006800594", "@fin": "1999-04-01", "@num": "R5144-15", "@etat": "MODIFIE", "@debut": "1995-03-14", "@origine": "LEGI" } }, { "@etat": "ABROGE", "LIEN_ART": { "@id": "LEGIARTI000006800595", "@fin": "2004-08-08", "@num": "R5144-15", "@etat": "ABROGE", "@debut": "1999-04-01", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
Les centres régionaux de pharmacovigilance doivent en outre, sur leur territoire géographique d'intervention :
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- contribuer au développement de l'information en matière de pharmacovigilance, notamment en renseignant les membres des professions de santé et en participant à leur formation,
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- remplir une mission d'expertise et de conseil en matière de pharmacovigilance auprès des établissements de santé, en collaboration avec les pharmacies à usage intérieur de ces établissements,
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- porter à la connaissance des instances compétentes en matière de pharmacodépendance les constatations d'usage abusif ou détourné d'un médicament.
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Ils doivent, au sein de l'établissement dans lequel ils sont implantés, donner avis et conseils en matière de pharmacovigilance aux membres des professions de santé et aux patients, participer aux activités de pharmacologie clinique et de pharmaco-épidémiologie et remplir une mission d'expertise et de conseil auprès des instances consultatives spécialisées de l'établissement.
" } }, "LEGIARTI000006800596": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R5144-16", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "1999-03-05", "DATE_DEBUT": "1995-03-14" } }, "META_COMMUN": { "ID": "LEGIARTI000006800596", "URL": "article/LEGI/ARTI/00/00/06/80/05/LEGIARTI000006800596.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SXXXXXXXXXX5144R0160XXAA" } }, "LIENS": { "LIEN": [ { "@id": "LEGIARTI000006699070", "@num": "1", "#text": "Décret n°95-278 du 13 mars 1995 - art. 1 () JORF 14 mars 1995", "@sens": "source", "@cidtexte": "JORFTEXT000000531081", "@nortexte": "SPSP9500721D", "@numtexte": "95-278", "@typelien": "CREATION", "@naturetexte": "DECRET", "@datesignatexte": "1995-03-13" }, { "@id": "LEGIARTI000006699073", "@num": "3", "#text": "Décret n°95-278 du 13 mars 1995 - art. 3 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000531081", "@nortexte": "SPSP9500721D", "@numtexte": "95-278", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1995-03-13" }, { "@id": "LEGIARTI000006691820", "@num": "D711-9-7", "#text": "Code de la santé publique - art. D711-9-7 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006695143", "@num": "L714-25-2", "#text": "Code de la santé publique - art. L714-25-2 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006914926", "@num": "R5121-169", "#text": "Code de la santé publique - art. R5121-169 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006800587", "@num": "R5144-12", "#text": "Code de la santé publique - art. R5144-12 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006194984", "@fin": "2004-08-08", "#text": "4. Centres régionaux de pharmacovigilance", "@debut": "1995-03-14" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006187169", "@fin": "2004-08-08", "#text": "§ 2. Organisation de la pharmacovigilance", "@debut": "1995-03-14" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006174545", "@fin": "2004-08-08", "#text": "Section 1 : Règles générales de pharmacovigilance", "@debut": "1995-03-14" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006157772", "@fin": "2004-08-08", "#text": "Chapitre 2 bis : Pharmacovigilance", "@debut": "1984-05-30" } ] }, "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": "LEGIARTI000006800596", "@fin": "1999-03-05", "@num": "R5144-16", "@etat": "MODIFIE", "@debut": "1995-03-14", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006800597", "@fin": "2004-01-31", "@num": "R5144-16", "@etat": "MODIFIE", "@debut": "1999-03-05", "@origine": "LEGI" } }, { "@etat": "ABROGE", "LIEN_ART": { "@id": "LEGIARTI000006800598", "@fin": "2004-08-08", "@num": "R5144-16", "@etat": "ABROGE", "@debut": "2004-01-31", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
Les centres régionaux de pharmacovigilance sont agréés par arrêtés du ministre chargé de la santé pris sur proposition du directeur général de l'Agence du médicament. L'arrêté agréant un centre détermine son territoire d'intervention.
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Pour être agréés, les centres régionaux de pharmacovigilance doivent être constitués au sein d'une structure de pharmacologie, de pharmacologie clinique ou de toxicologie clinique d'un établissement public de santé, sous la forme d'une unité fonctionnelle ou, si l'établissement a fait usage de la faculté prévue par l'article L. 714-25-2, d'une unité distincte.
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Le responsable du centre doit être un médecin formé à la pharmacologie ou à la toxicologie clinique.
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L'agrément mentionné au premier alinéa peut être retiré en cas de non-respect des dispositions du présent chapitre.
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Les modalités de fonctionnement des centres régionaux de pharmacovigilance, notamment les conditions dans lesquelles ils accomplissent les missions qui leur sont confiées par l'Agence du médicament, ainsi que la désignation de leurs représentants au comité technique mentionné à l'article R. 5144-12, font l'objet de conventions conclues entre le directeur général de l'Agence du médicament et les établissements de santé dans lesquels les centres sont agréés. Ces conventions doivent respecter les dispositions du présent chapitre et être conformes à une convention type établie par un arrêté du ministre chargé de la santé pris sur proposition du directeur général de l'Agence du médicament. Elles sont communiquées pour information au ministre chargé de la santé.
" } }, "LEGIARTI000006800600": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R5144-17", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "1999-03-05", "DATE_DEBUT": "1995-03-14" } }, "META_COMMUN": { "ID": "LEGIARTI000006800600", "URL": "article/LEGI/ARTI/00/00/06/80/06/LEGIARTI000006800600.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SXXXXXXXXXX5144R0170XXAA" } }, "LIENS": { "LIEN": [ { "@id": "LEGIARTI000006699070", "@num": "1", "#text": "Décret n°95-278 du 13 mars 1995 - art. 1 () JORF 14 mars 1995", "@sens": "source", "@cidtexte": "JORFTEXT000000531081", "@nortexte": "SPSP9500721D", "@numtexte": "95-278", "@typelien": "CREATION", "@naturetexte": "DECRET", "@datesignatexte": "1995-03-13" }, { "@id": "LEGIARTI000006914937", "@num": "R5121-178", "#text": "Code de la santé publique - art. R5121-178 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006800542", "@num": "R5144-1", "#text": "Code de la santé publique - art. R5144-1 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006800607", "@num": "R5144-20", "#text": "Code de la santé publique - art. R5144-20 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006800561", "@num": "R5144-6", "#text": "Code de la santé publique - art. R5144-6 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006194985", "@fin": "2004-08-08", "#text": "5. Dispositions diverses", "@debut": "1995-03-14" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006187169", "@fin": "2004-08-08", "#text": "§ 2. Organisation de la pharmacovigilance", "@debut": "1995-03-14" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006174545", "@fin": "2004-08-08", "#text": "Section 1 : Règles générales de pharmacovigilance", "@debut": "1995-03-14" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006157772", "@fin": "2004-08-08", "#text": "Chapitre 2 bis : Pharmacovigilance", "@debut": "1984-05-30" } ] }, "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": "LEGIARTI000006800600", "@fin": "1999-03-05", "@num": "R5144-17", "@etat": "MODIFIE", "@debut": "1995-03-14", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006800601", "@fin": "2004-01-31", "@num": "R5144-17", "@etat": "MODIFIE", "@debut": "1999-03-05", "@origine": "LEGI" } }, { "@etat": "ABROGE", "LIEN_ART": { "@id": "LEGIARTI000006800602", "@fin": "2004-08-08", "@num": "R5144-17", "@etat": "ABROGE", "@debut": "2004-01-31", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
Toute entreprise ou tout organisme exploitant un médicament ou produit mentionné à l'article R. 5144-1 doit se doter d'un service de pharmacovigilance. Le nom du responsable de ce service, médecin ou pharmacien, doit être communiqué à l'Agence du médicament par le pharmacien responsable de l'entreprise ou de l'organisme.
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Le service est chargé de recueillir l'ensemble des informations portées à la connaissance de l'entreprise ou de l'organisme et relatives aux effets indésirables des médicaments ou produits qu'il exploite, de préparer les déclarations et rapports mentionnés à l'article R. 5144-20 et de veiller à ce que les demandes du directeur général de l'Agence du médicament mentionnées au dernier alinéa de l'article R. 5144-6 trouvent une réponse complète et rapide.
" } }, "LEGIARTI000006800603": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R5144-18", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "1999-03-05", "DATE_DEBUT": "1995-03-14" } }, "META_COMMUN": { "ID": "LEGIARTI000006800603", "URL": "article/LEGI/ARTI/00/00/06/80/06/LEGIARTI000006800603.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SXXXXXXXXXX5144R0180XXAA" } }, "LIENS": { "LIEN": [ { "@id": "LEGIARTI000006699070", "@num": "1", "#text": "Décret n°95-278 du 13 mars 1995 - art. 1 () JORF 14 mars 1995", "@sens": "source", "@cidtexte": "JORFTEXT000000531081", "@nortexte": "SPSP9500721D", "@numtexte": "95-278", "@typelien": "CREATION", "@naturetexte": "DECRET", "@datesignatexte": "1995-03-13" }, { "@id": "LEGIARTI000006914938", "@num": "R5121-179", "#text": "Code de la santé publique - art. R5121-179 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006800542", "@num": "R5144-1", "#text": "Code de la santé publique - art. R5144-1 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006800609", "@num": "R5144-20", "#text": "Code de la santé publique - art. R5144-20 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006800620", "@num": "R5144-24", "#text": "Code de la santé publique - art. R5144-24 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006194985", "@fin": "2004-08-08", "#text": "5. Dispositions diverses", "@debut": "1995-03-14" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006187169", "@fin": "2004-08-08", "#text": "§ 2. Organisation de la pharmacovigilance", "@debut": "1995-03-14" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006174545", "@fin": "2004-08-08", "#text": "Section 1 : Règles générales de pharmacovigilance", "@debut": "1995-03-14" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006157772", "@fin": "2004-08-08", "#text": "Chapitre 2 bis : Pharmacovigilance", "@debut": "1984-05-30" } ] }, "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": "LEGIARTI000006800603", "@fin": "1999-03-05", "@num": "R5144-18", "@etat": "MODIFIE", "@debut": "1995-03-14", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006800604", "@fin": "2004-01-31", "@num": "R5144-18", "@etat": "MODIFIE", "@debut": "1999-03-05", "@origine": "LEGI" } }, { "@etat": "ABROGE", "LIEN_ART": { "@id": "LEGIARTI000006800605", "@fin": "2004-08-08", "@num": "R5144-18", "@etat": "ABROGE", "@debut": "2004-01-31", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
Les centres régionaux de pharmacovigilance et les services de pharmacovigilance des entreprises ou organismes exploitant un médicament ou produit mentionné à l'article R. 5144-1 sont soumis aux bonnes pratiques de pharmacovigilance dont les principes sont définis par arrêté du ministre chargé de la santé pris sur proposition du directeur général de l'Agence du médicament.
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" } }, "LEGIARTI000006800606": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R5144-19", "ETAT": "ABROGE", "TYPE": "AUTONOME", "DATE_FIN": "2004-08-08", "DATE_DEBUT": "1995-03-14" } }, "META_COMMUN": { "ID": "LEGIARTI000006800606", "URL": "article/LEGI/ARTI/00/00/06/80/06/LEGIARTI000006800606.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SXXXXXXXXXX5144R0190XXAA" } }, "LIENS": { "LIEN": [ { "@id": "LEGIARTI000006699070", "@num": "1", "#text": "Décret n°95-278 du 13 mars 1995 - art. 1 () JORF 14 mars 1995", "@sens": "source", "@cidtexte": "JORFTEXT000000531081", "@nortexte": "SPSP9500721D", "@numtexte": "95-278", "@typelien": "CREATION", "@naturetexte": "DECRET", "@datesignatexte": "1995-03-13" }, { "@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": "LEGIARTI000006914927", "@num": "R5121-170", "#text": "Code de la santé publique - art. R5121-170 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006914927", "@num": "R5121-170", "#text": "Code de la santé publique - art. R5121-170 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006800347", "@num": "R5142-22", "#text": "Code de la santé publique - art. R5142-22 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006800542", "@num": "R5144-1", "#text": "Code de la santé publique - art. R5144-1 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006800593", "@num": "R5144-14", "#text": "Code de la santé publique - art. R5144-14 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006800610", "@num": "R5144-20-1", "#text": "Code de la santé publique - art. R5144-20-1 (T)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006800612", "@num": "R5144-20-2", "#text": "Code de la santé publique - art. R5144-20-2 (Ab)", "@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": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006187170", "@fin": "2004-08-08", "#text": "§ 3. Obligations de signalement", "@debut": "1995-03-14" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006174545", "@fin": "2004-08-08", "#text": "Section 1 : Règles générales de pharmacovigilance", "@debut": "1995-03-14" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006157772", "@fin": "2004-08-08", "#text": "Chapitre 2 bis : Pharmacovigilance", "@debut": "1984-05-30" } ] }, "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": "ABROGE", "LIEN_ART": { "@id": "LEGIARTI000006800606", "@fin": "2004-08-08", "@num": "R5144-19", "@etat": "ABROGE", "@debut": "1995-03-14", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
Tout médecin, chirurgien-dentiste ou sage-femme ayant constaté un effet indésirable grave ou inattendu susceptible d'être dû à un médicament ou produit mentionné à l'article R. 5144-1, qu'il l'ait ou non prescrit, doit en faire la déclaration immédiate au centre régional de pharmacovigilance.
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De même, tout pharmacien ayant eu connaissance d'un effet indésirable grave ou inattendu susceptible d'être dû à un médicament ou produit mentionné à l'article R. 5144-1 qu'il a délivré doit également le déclarer aussitôt au centre régional de pharmacovigilance.
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Tout membre d'une profession de santé ayant fait la même constatation peut également en informer le centre régional de pharmacovigilance.
" } }, "LEGIARTI000006800607": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R5144-20", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "1999-03-05", "DATE_DEBUT": "1995-03-14" } }, "META_COMMUN": { "ID": "LEGIARTI000006800607", "URL": "article/LEGI/ARTI/00/00/06/80/06/LEGIARTI000006800607.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SXXXXXXXXXX5144R0200XXAA" } }, "LIENS": { "LIEN": [ { "@id": "LEGIARTI000006699070", "@num": "1", "#text": "Décret n°95-278 du 13 mars 1995 - art. 1 () JORF 14 mars 1995", "@sens": "source", "@cidtexte": "JORFTEXT000000531081", "@nortexte": "SPSP9500721D", "@numtexte": "95-278", "@typelien": "CREATION", "@naturetexte": "DECRET", "@datesignatexte": "1995-03-13" }, { "@id": "LEGIARTI000006693520", "@num": "L551-7", "#text": "Code de la santé publique - art. L551-7 (Ab)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006914929", "@num": "R5121-171", "#text": "Code de la santé publique - art. R5121-171 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006914930", "@num": "R5121-172", "#text": "Code de la santé publique - art. R5121-172 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006914931", "@num": "R5121-173", "#text": "Code de la santé publique - art. R5121-173 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006800347", "@num": "R5142-22", "#text": "Code de la santé publique - art. R5142-22 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006800366", "@num": "R5142-27", "#text": "Code de la santé publique - art. R5142-27 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006800542", "@num": "R5144-1", "#text": "Code de la santé publique - art. R5144-1 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006800602", "@num": "R5144-17", "#text": "Code de la santé publique - art. R5144-17 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006800610", "@num": "R5144-20-1", "#text": "Code de la santé publique - art. R5144-20-1 (T)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006800612", "@num": "R5144-20-2", "#text": "Code de la santé publique - art. R5144-20-2 (Ab)", "@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": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006800639", "@num": "R5144-38", "#text": "Code de la santé publique - art. R5144-38 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006800564", "@num": "R5144-6", "#text": "Code de la santé publique - art. R5144-6 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006187170", "@fin": "2004-08-08", "#text": "§ 3. Obligations de signalement", "@debut": "1995-03-14" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006174545", "@fin": "2004-08-08", "#text": "Section 1 : Règles générales de pharmacovigilance", "@debut": "1995-03-14" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006157772", "@fin": "2004-08-08", "#text": "Chapitre 2 bis : Pharmacovigilance", "@debut": "1984-05-30" } ] }, "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": "LEGIARTI000006800607", "@fin": "1999-03-05", "@num": "R5144-20", "@etat": "MODIFIE", "@debut": "1995-03-14", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006800608", "@fin": "2004-01-31", "@num": "R5144-20", "@etat": "MODIFIE", "@debut": "1999-03-05", "@origine": "LEGI" } }, { "@etat": "ABROGE", "LIEN_ART": { "@id": "LEGIARTI000006800609", "@fin": "2004-08-08", "@num": "R5144-20", "@etat": "ABROGE", "@debut": "2004-01-31", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
L'entreprise ou l'organisme exploitant un médicament ou produit mentionné à l'article R. 5144-1 doit déclarer immédiatement au directeur général de l'Agence du médicament tout effet indésirable grave susceptible d'être dû à ce médicament ou produit qui lui a été signalé, notamment par les personnes mentionnées à l'article L. 551-7 qui font de l'information par démarchage ou de la prospection pour des médicaments.
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L'entreprise ou l'organisme mentionné ci-dessus transmet au directeur général de l'Agence du médicament un rapport présentant la synthèse des informations relatives à l'ensemble des 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 médicaments ou produits qu'il exploite :
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- immédiatement sur demande ;
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- semestriellement durant les deux ans suivant l'autorisation de mise sur le marché du médicament ou produit, ou sa modification lorsqu'elle est consécutive à un changement de composants, à de nouvelles indications thérapeutiques ou à de nouveaux modes d'administration ;
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- annuellement les trois années suivantes, puis tous les cinq ans.
" } }, "LEGIARTI000006800614": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R5144-21", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "1999-03-05", "DATE_DEBUT": "1995-03-14" } }, "META_COMMUN": { "ID": "LEGIARTI000006800614", "URL": "article/LEGI/ARTI/00/00/06/80/06/LEGIARTI000006800614.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SXXXXXXXXXX5144R0210XXAA" } }, "LIENS": { "LIEN": [ { "@id": "LEGIARTI000006699070", "@num": "1", "#text": "Décret n°95-278 du 13 mars 1995 - art. 1 () JORF 14 mars 1995", "@sens": "source", "@cidtexte": "JORFTEXT000000531081", "@nortexte": "SPSP9500721D", "@numtexte": "95-278", "@typelien": "CREATION", "@naturetexte": "DECRET", "@datesignatexte": "1995-03-13" }, { "@id": "LEGIARTI000006914936", "@num": "R5121-177", "#text": "Code de la santé publique - art. R5121-177 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006800606", "@num": "R5144-19", "#text": "Code de la santé publique - art. R5144-19 (Ab)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006800607", "@num": "R5144-20", "#text": "Code de la santé publique - art. R5144-20 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006800633", "@num": "R5144-35", "#text": "Code de la santé publique - art. R5144-35 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006187170", "@fin": "2004-08-08", "#text": "§ 3. Obligations de signalement", "@debut": "1995-03-14" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006174545", "@fin": "2004-08-08", "#text": "Section 1 : Règles générales de pharmacovigilance", "@debut": "1995-03-14" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006157772", "@fin": "2004-08-08", "#text": "Chapitre 2 bis : Pharmacovigilance", "@debut": "1984-05-30" } ] }, "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": "LEGIARTI000006800614", "@fin": "1999-03-05", "@num": "R5144-21", "@etat": "MODIFIE", "@debut": "1995-03-14", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006800615", "@fin": "2004-01-31", "@num": "R5144-21", "@etat": "MODIFIE", "@debut": "1999-03-05", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006800616", "@fin": "2004-02-28", "@num": "R5144-21", "@etat": "MODIFIE", "@debut": "2004-01-31", "@origine": "LEGI" } }, { "@etat": "ABROGE", "LIEN_ART": { "@id": "LEGIARTI000006800617", "@fin": "2004-08-08", "@num": "R5144-21", "@etat": "ABROGE", "@debut": "2004-02-28", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
Les modalités des déclarations et du rapport de synthèse mentionnés aux articles R. 5144-19 et R. 5144-20 sont déterminées par arrêté du ministre chargé de la santé, pris sur proposition du directeur général de l'Agence du médicament.
\n
" } }, "LEGIARTI000006800618": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R5144-22", "ETAT": "ABROGE", "TYPE": "AUTONOME", "DATE_FIN": "2004-08-08", "DATE_DEBUT": "1995-03-14" } }, "META_COMMUN": { "ID": "LEGIARTI000006800618", "URL": "article/LEGI/ARTI/00/00/06/80/06/LEGIARTI000006800618.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SXXXXXXXXXX5144R0220XXAA" } }, "LIENS": { "LIEN": [ { "@id": "LEGIARTI000006699070", "@num": "1", "#text": "Décret n°95-278 du 13 mars 1995 - art. 1 () JORF 14 mars 1995", "@sens": "source", "@cidtexte": "JORFTEXT000000531081", "@nortexte": "SPSP9500721D", "@numtexte": "95-278", "@typelien": "CREATION", "@naturetexte": "DECRET", "@datesignatexte": "1995-03-13" }, { "@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": "LEGIARTI000006914941", "@num": "R5121-180", "#text": "Code de la santé publique - art. R5121-180 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006914941", "@num": "R5121-180", "#text": "Code de la santé publique - art. R5121-180 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "#text": "Règlement CEE Conseil 2309-93 1993-07-22", "@sens": "source", "@typelien": "CITATION" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006187170", "@fin": "2004-08-08", "#text": "§ 3. Obligations de signalement", "@debut": "1995-03-14" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006174545", "@fin": "2004-08-08", "#text": "Section 1 : Règles générales de pharmacovigilance", "@debut": "1995-03-14" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006157772", "@fin": "2004-08-08", "#text": "Chapitre 2 bis : Pharmacovigilance", "@debut": "1984-05-30" } ] }, "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": "ABROGE", "LIEN_ART": { "@id": "LEGIARTI000006800618", "@fin": "2004-08-08", "@num": "R5144-22", "@etat": "ABROGE", "@debut": "1995-03-14", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
Les obligations de déclaration et de signalement prévues par la présente section s'appliquent sans préjudice de celles que prévoit, pour les médicaments autorisés par l'Agence européenne pour l'évaluation des médicaments, le règlement (CEE) n° 2309/93 du Conseil du 22 juillet 1993.
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Article R5144-13 AUTONOME MODIFIE, en vigueur du 14/03/1995 au 05/03/1999 (Code de la santé publique)