{ "article": { "LEGIARTI000006800582": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R5144-11", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "1995-03-14", "DATE_DEBUT": "1993-08-07" } }, "META_COMMUN": { "ID": "LEGIARTI000006800582", "URL": "article/LEGI/ARTI/00/00/06/80/05/LEGIARTI000006800582.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SXXXXXXXXXX5144R0110XXAB" } }, "LIENS": { "LIEN": [ { "@id": "LEGIARTI000006716287", "@num": "1", "#text": "Arrêté du 23 novembre 1984 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000680673", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "1984-11-23" }, { "@id": "LEGIARTI000006719426", "@num": "1", "#text": "Arrêté du 12 avril 1990 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000166986", "@nortexte": "SPSM9000773A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "1990-04-12" }, { "@id": "LEGIARTI000006713446", "@num": "8", "#text": "Décret n°93-982 du 5 août 1993 - art. 8 () JORF 7 août 1993", "@sens": "source", "@cidtexte": "JORFTEXT000000727412", "@nortexte": "SPSP9302069D", "@numtexte": "93-982", "@typelien": "MODIFICATION", "@naturetexte": "DECRET", "@datesignatexte": "1993-08-05" }, { "@id": "LEGIARTI000006914921", "@num": "R5121-166", "#text": "Code de la santé publique - art. R5121-166 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006800569", "@num": "R5144-8", "#text": "Code de la santé publique - art. R5144-8 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006800573", "@num": "R5144-9", "#text": "Code de la santé publique - art. R5144-9 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006174544", "@fin": "1995-03-14", "#text": "Section 2 : Déclarations obligatoires.", "@debut": "1984-05-30" } ] }, "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": "LEGIARTI000006800581", "@fin": "1993-08-07", "@num": "R5144-11", "@etat": "MODIFIE", "@debut": "1984-05-30", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006800582", "@fin": "1995-03-14", "@num": "R5144-11", "@etat": "MODIFIE", "@debut": "1993-08-07", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006800583", "@fin": "1999-03-05", "@num": "R5144-11", "@etat": "MODIFIE", "@debut": "1995-03-14", "@origine": "LEGI" } }, { "@etat": "ABROGE", "LIEN_ART": { "@id": "LEGIARTI000006800584", "@fin": "2004-08-08", "@num": "R5144-11", "@etat": "ABROGE", "@debut": "1999-03-05", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
Les déclarations mentionnées aux articles R. 5144-8 et R. 5144-9 sont faites sur des imprimés dont le modèle est déterminé par arrêté du ministre chargé de la santé [*autorité compétente*] sur proposition du directeur général de l'Agence du médicament.
\n
" } }, "LEGIARTI000006713446": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "8", "TYPE": "ENTIEREMENT_MODIF", "DATE_FIN": "2999-01-01", "DATE_DEBUT": "2999-01-01" } }, "META_COMMUN": { "ID": "LEGIARTI000006713446", "URL": "article/LEGI/ARTI/00/00/06/71/34/LEGIARTI000006713446.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SPHZNXXXXXX008AAXXXXXXAA" } }, "LIENS": { "LIEN": [ { "@id": "LEGIARTI000006800582", "@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": "LEGIARTI000006800545", "@num": "R5144-2", "#text": "Code de la santé publique - art. R5144-2 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006800554", "@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": "LEGIARTI000006800562", "@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": "LEGIARTI000006800566", "@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" } ] }, "CONTEXTE": { "TEXTE": { "@cid": "JORFTEXT000000727412", "@nor": "SPSP9302069D", "@num": "93-982", "@nature": "DECRET", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Décret n° 93-982 du 5 août 1993 pris pour l'application de la loi n° 93-5 du 4 janvier 1993 relative à la sécurité en matière de transfusion sanguine et de médicament et modifiant le livre V du code de la santé publique (deuxième partie : Décrets en Conseil d'Etat)", "@debut": "2999-01-01", "@id_txt": "JORFTEXT000000727412", "@c_titre_court": "Décret n°93-982 du 5 août 1993" }, { "@fin": "2004-08-08", "#text": "Décret n°93-982 du 5 août 1993 pris pour l'application de la loi n° 93-5 du 4 janvier 1993 relative à la sécurité en matière de transfusion sanguine et de médicament et modifiant le livre V du code de la santé publique (deuxième partie : Décrets en Conseil d'Etat).", "@debut": "1993-08-07", "@id_txt": "LEGITEXT000006082480", "@c_titre_court": "Décret n°93-982 du 5 août 1993" } ], "@date_publi": "1993-08-07", "@date_signature": "1993-08-05" } }, "VERSIONS": { "VERSION": [ { "LIEN_ART": { "@id": "LEGIARTI000006713446", "@fin": "2999-01-01", "@num": "8", "@debut": "2999-01-01", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "a modifié les dispositions suivantes
\n
" } }, "LEGIARTI000006800569": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R5144-8", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "1995-03-14", "DATE_DEBUT": "1984-05-30" } }, "META_COMMUN": { "ID": "LEGIARTI000006800569", "URL": "article/LEGI/ARTI/00/00/06/80/05/LEGIARTI000006800569.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SXXXXXXXXXX5144R0080XXAA" } }, "LIENS": { "LIEN": [ { "@id": "JORFTEXT000000882402", "#text": "Décret 84-402 1984-05-24 ART. 1 JORF 30 MAI 1984", "@sens": "source", "@cidtexte": "JORFTEXT000000882402", "@numtexte": "84-402", "@typelien": "CREATION", "@naturetexte": "DECRET", "@datesignatexte": "1984-05-24" }, { "@id": "LEGIARTI000006914910", "@num": "R5121-157", "#text": "Code de la santé publique - art. R5121-157 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006800362", "@num": "R5142-26", "#text": "Code de la santé publique - art. R5142-26 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006800582", "@num": "R5144-11", "#text": "Code de la santé publique - art. R5144-11 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006800566", "@num": "R5144-7", "#text": "Code de la santé publique - art. R5144-7 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006174544", "@fin": "1995-03-14", "#text": "Section 2 : Déclarations obligatoires.", "@debut": "1984-05-30" } ] }, "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": "LEGIARTI000006800569", "@fin": "1995-03-14", "@num": "R5144-8", "@etat": "MODIFIE", "@debut": "1984-05-30", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006800570", "@fin": "1999-03-05", "@num": "R5144-8", "@etat": "MODIFIE", "@debut": "1995-03-14", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006800571", "@fin": "2004-01-31", "@num": "R5144-8", "@etat": "MODIFIE", "@debut": "1999-03-05", "@origine": "LEGI" } }, { "@etat": "ABROGE", "LIEN_ART": { "@id": "LEGIARTI000006800572", "@fin": "2004-08-08", "@num": "R5144-8", "@etat": "ABROGE", "@debut": "2004-01-31", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
Tout médecin, chirurgien-dentiste ou sage-femme, ayant constaté un effet inattendu ou toxique susceptible d'être dû à un médicament qu'il a prescrit doit [*obligation*] en faire la déclaration immédiate au centre régional de pharmacovigilance.
\n
" } }, "LEGIARTI000006800570": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R5144-8", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "1999-03-05", "DATE_DEBUT": "1995-03-14" } }, "META_COMMUN": { "ID": "LEGIARTI000006800570", "URL": "article/LEGI/ARTI/00/00/06/80/05/LEGIARTI000006800570.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SXXXXXXXXXX5144R0080XXAB" } }, "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": "MODIFICATION", "@naturetexte": "DECRET", "@datesignatexte": "1995-03-13" }, { "@id": "LEGIARTI000006914910", "@num": "R5121-157", "#text": "Code de la santé publique - art. R5121-157 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006800362", "@num": "R5142-26", "#text": "Code de la santé publique - art. R5142-26 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006800582", "@num": "R5144-11", "#text": "Code de la santé publique - art. R5144-11 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006800566", "@num": "R5144-7", "#text": "Code de la santé publique - art. R5144-7 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006195080", "@fin": "1999-03-05", "#text": "2. Rôle de l'Agence du médicament", "@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": "LEGIARTI000006800569", "@fin": "1995-03-14", "@num": "R5144-8", "@etat": "MODIFIE", "@debut": "1984-05-30", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006800570", "@fin": "1999-03-05", "@num": "R5144-8", "@etat": "MODIFIE", "@debut": "1995-03-14", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006800571", "@fin": "2004-01-31", "@num": "R5144-8", "@etat": "MODIFIE", "@debut": "1999-03-05", "@origine": "LEGI" } }, { "@etat": "ABROGE", "LIEN_ART": { "@id": "LEGIARTI000006800572", "@fin": "2004-08-08", "@num": "R5144-8", "@etat": "ABROGE", "@debut": "2004-01-31", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
Le directeur général de l'Agence du médicament informe l'Agence européenne pour l'évaluation des médicaments de tout effet indésirable grave concernant un médicament qui lui a été déclaré ou notifié, au plus tard quinze jours après cette déclaration ou cette notification.
\n
Le cas échéant, il informe dans le même délai l'entreprise ou l'organisme exploitant le médicament ou le produit concerné.
" } }, "LEGIARTI000006800571": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R5144-8", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2004-01-31", "DATE_DEBUT": "1999-03-05" } }, "META_COMMUN": { "ID": "LEGIARTI000006800571", "URL": "article/LEGI/ARTI/00/00/06/80/05/LEGIARTI000006800571.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SXXXXXXXXXX5144R0080XXAC" } }, "LIENS": { "LIEN": [ { "@id": "LEGIARTI000006723508", "@num": "1", "#text": "Décret n°99-144 du 4 mars 1999 - art. 1 () JORF 5 mars 1999", "@sens": "source", "@cidtexte": "JORFTEXT000000758693", "@nortexte": "MESP9824093D", "@numtexte": "99-144", "@typelien": "MODIFICATION", "@naturetexte": "DECRET", "@datesignatexte": "1999-03-04" }, { "@id": "LEGIARTI000006914910", "@num": "R5121-157", "#text": "Code de la santé publique - art. R5121-157 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006800362", "@num": "R5142-26", "#text": "Code de la santé publique - art. R5142-26 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006800582", "@num": "R5144-11", "#text": "Code de la santé publique - art. R5144-11 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006800566", "@num": "R5144-7", "#text": "Code de la santé publique - art. R5144-7 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006194982", "@fin": "2004-08-08", "#text": "2. Rôle de l'Agence française de sécurité sanitaire des produits de santé", "@debut": "1999-03-05" } ] }, "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": "LEGIARTI000006800569", "@fin": "1995-03-14", "@num": "R5144-8", "@etat": "MODIFIE", "@debut": "1984-05-30", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006800570", "@fin": "1999-03-05", "@num": "R5144-8", "@etat": "MODIFIE", "@debut": "1995-03-14", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006800571", "@fin": "2004-01-31", "@num": "R5144-8", "@etat": "MODIFIE", "@debut": "1999-03-05", "@origine": "LEGI" } }, { "@etat": "ABROGE", "LIEN_ART": { "@id": "LEGIARTI000006800572", "@fin": "2004-08-08", "@num": "R5144-8", "@etat": "ABROGE", "@debut": "2004-01-31", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
Le directeur général de l'Agence française de sécurité sanitaire des produits de santé informe l'Agence européenne pour l'évaluation des médicaments de tout effet indésirable grave concernant un médicament qui lui a été déclaré ou notifié, au plus tard quinze jours après cette déclaration ou cette notification.
\n
Le cas échéant, il informe dans le même délai l'entreprise ou l'organisme exploitant le médicament ou le produit concerné.
" } }, "LEGIARTI000006800572": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R5144-8", "ETAT": "ABROGE", "TYPE": "AUTONOME", "DATE_FIN": "2004-08-08", "DATE_DEBUT": "2004-01-31" } }, "META_COMMUN": { "ID": "LEGIARTI000006800572", "URL": "article/LEGI/ARTI/00/00/06/80/05/LEGIARTI000006800572.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SXXXXXXXXXX5144R0080XXAD" } }, "LIENS": { "LIEN": [ { "@id": "LEGIARTI000006228287", "@num": "2", "#text": "Décret n°2004-99 du 29 janvier 2004 - art. 2 () JORF 31 janvier 2004", "@sens": "source", "@cidtexte": "JORFTEXT000000608303", "@nortexte": "SANP0325028D", "@numtexte": "2004-99", "@typelien": "MODIFICATION", "@naturetexte": "DECRET", "@datesignatexte": "2004-01-29" }, { "@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": "LEGIARTI000006914910", "@num": "R5121-157", "#text": "Code de la santé publique - art. R5121-157 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006914910", "@num": "R5121-157", "#text": "Code de la santé publique - art. R5121-157 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006800362", "@num": "R5142-26", "#text": "Code de la santé publique - art. R5142-26 (M)", "@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": "LEGIARTI000006800582", "@num": "R5144-11", "#text": "Code de la santé publique - art. R5144-11 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006800566", "@num": "R5144-7", "#text": "Code de la santé publique - art. R5144-7 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006194982", "@fin": "2004-08-08", "#text": "2. Rôle de l'Agence française de sécurité sanitaire des produits de santé", "@debut": "1999-03-05" } ] }, "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": "LEGIARTI000006800569", "@fin": "1995-03-14", "@num": "R5144-8", "@etat": "MODIFIE", "@debut": "1984-05-30", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006800570", "@fin": "1999-03-05", "@num": "R5144-8", "@etat": "MODIFIE", "@debut": "1995-03-14", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006800571", "@fin": "2004-01-31", "@num": "R5144-8", "@etat": "MODIFIE", "@debut": "1999-03-05", "@origine": "LEGI" } }, { "@etat": "ABROGE", "LIEN_ART": { "@id": "LEGIARTI000006800572", "@fin": "2004-08-08", "@num": "R5144-8", "@etat": "ABROGE", "@debut": "2004-01-31", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
Le directeur général de l'Agence française de sécurité sanitaire des produits de santé informe l'Agence européenne pour l'évaluation des médicaments et les autres Etats membres de la Communauté européenne, notamment au moyen du réseau informatique européen de pharmacovigilance mis en place par l'Agence européenne pour l'évaluation des médicaments, de tout effet indésirable grave survenu en France susceptible d'être dû à un médicament qui lui a été déclaré ou notifié, en mettant à leur disposition, au plus tard dans un délai de quinze jours à compter de la déclaration ou de la notification, les éléments que celle-ci contient.
\n
Il informe également l'entreprise ou l'organisme exploitant le médicament concerné de tout effet indésirable grave susceptible d'être dû au médicament, qui lui a été déclaré ou notifié en mettant à sa disposition, au plus tard dans un délai de quinze jours à compter de la déclaration ou de la notification, les éléments que celle-ci contient.
\n
Lorsque le signalement porte sur un produit mentionné à l'article R. 5144-1 autre qu'une spécialité pharmaceutique, il informe le pharmacien qui est responsable de la production ou de la mise sur le marché du produit.
" } }, "LEGIARTI000006800573": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R5144-9", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "1995-03-14", "DATE_DEBUT": "1984-05-30" } }, "META_COMMUN": { "ID": "LEGIARTI000006800573", "URL": "article/LEGI/ARTI/00/00/06/80/05/LEGIARTI000006800573.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SXXXXXXXXXX5144R0090XXAA" } }, "LIENS": { "LIEN": [ { "@id": "JORFTEXT000000882402", "#text": "Décret 84-402 1984-05-24 ART. 1 JORF 30 MAI 1984", "@sens": "source", "@cidtexte": "JORFTEXT000000882402", "@numtexte": "84-402", "@typelien": "CREATION", "@naturetexte": "DECRET", "@datesignatexte": "1984-05-24" }, { "@id": "LEGIARTI000006220797", "@num": "2", "#text": "Décret n°2003-633 du 2 juillet 2003 - art. 2 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000778009", "@nortexte": "SANG0322249D", "@numtexte": "2003-633", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2003-07-02" }, { "@id": "LEGIARTI000006914912", "@num": "R5121-159", "#text": "Code de la santé publique - art. R5121-159 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006800582", "@num": "R5144-11", "#text": "Code de la santé publique - art. R5144-11 (M)", "@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": { "TITRE_TM": [ { "@id": "LEGISCTA000006174544", "@fin": "1995-03-14", "#text": "Section 2 : Déclarations obligatoires.", "@debut": "1984-05-30" } ] }, "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": "LEGIARTI000006800573", "@fin": "1995-03-14", "@num": "R5144-9", "@etat": "MODIFIE", "@debut": "1984-05-30", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006800574", "@fin": "1999-03-05", "@num": "R5144-9", "@etat": "MODIFIE", "@debut": "1995-03-14", "@origine": "LEGI" } }, { "@etat": "ABROGE", "LIEN_ART": { "@id": "LEGIARTI000006800575", "@fin": "2004-08-08", "@num": "R5144-9", "@etat": "ABROGE", "@debut": "1999-03-05", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "Le titulaire de l'autorisation de mise sur le marché d'un médicament doit déclarer à la Commission nationale de la pharmacovigilance tout effet inattendu ou toxique susceptible d'être dû à ce médicament et dont il a connaissance.
\n
\n
Cette déclaration est effectuée semestriellement [*périodicité*] au cours de la première année qui suit la commercialisation du médicament ou la modification de l'autorisation de mise sur le marché, consécutive à un changement de composants, à de nouvelles indications thérapeutiques ou à de nouveaux modes d'administration. Elle est effectuée annuellement pour les années suivantes.
\n
" } }, "LEGIARTI000006800574": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R5144-9", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "1999-03-05", "DATE_DEBUT": "1995-03-14" } }, "META_COMMUN": { "ID": "LEGIARTI000006800574", "URL": "article/LEGI/ARTI/00/00/06/80/05/LEGIARTI000006800574.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SXXXXXXXXXX5144R0090XXAB" } }, "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": "MODIFICATION", "@naturetexte": "DECRET", "@datesignatexte": "1995-03-13" }, { "@id": "LEGIARTI000006220797", "@num": "2", "#text": "Décret n°2003-633 du 2 juillet 2003 - art. 2 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000778009", "@nortexte": "SANG0322249D", "@numtexte": "2003-633", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2003-07-02" }, { "@id": "LEGIARTI000006914912", "@num": "R5121-159", "#text": "Code de la santé publique - art. R5121-159 (Ab)", "@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": "LEGIARTI000006800582", "@num": "R5144-11", "#text": "Code de la santé publique - art. R5144-11 (M)", "@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": "LEGIARTI000006800573", "@fin": "1995-03-14", "@num": "R5144-9", "@etat": "MODIFIE", "@debut": "1984-05-30", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006800574", "@fin": "1999-03-05", "@num": "R5144-9", "@etat": "MODIFIE", "@debut": "1995-03-14", "@origine": "LEGI" } }, { "@etat": "ABROGE", "LIEN_ART": { "@id": "LEGIARTI000006800575", "@fin": "2004-08-08", "@num": "R5144-9", "@etat": "ABROGE", "@debut": "1999-03-05", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
Il est institué auprès du ministre chargé de la santé une Commission nationale de pharmacovigilance dont la mission est :
\n
1° D'évaluer les informations sur les effets indésirables des médicaments et produits mentionnés à l'article R. 5144-1 ;
\n
2° De donner un avis au ministre chargé de la santé et au directeur général de l'Agence du médicament sur les mesures à prendre pour faire cesser les incidents et accidents qui se sont révélés liés à l'emploi de ces médicaments et produits ;
\n
3° De proposer au ministre chargé de la santé et au directeur général de l'Agence du médicament les enquêtes et travaux qu'elle estime utiles à l'exercice de la pharmacovigilance.
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La Commission nationale de pharmacovigilance siège auprès de l'Agence française de sécurité sanitaire des produits de santé et a pour mission :
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1° D'évaluer les informations sur les effets indésirables des médicaments et produits mentionnés à l'article R. 5144-1 ;
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2° De donner un avis au directeur général de l'Agence française de sécurité sanitaire des produits de santé sur les mesures à prendre pour faire cesser les incidents et accidents qui se sont révélés liés à l'emploi de ces médicaments et produits ;
\n
3° De proposer au directeur général de l'Agence française de sécurité sanitaire des produits de santé les enquêtes et travaux qu'elle estime utiles à l'exercice de la pharmacovigilance.
\n
Le ministre chargé de la santé peut demander l'avis de la commission sur toute question ayant trait au domaine de compétence de cette commission.
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Article R5144-11 AUTONOME MODIFIE, en vigueur du 07/08/1993 au 14/03/1995 (Code de la santé publique)