{ "article": { "LEGIARTI000006800042": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R5115-9", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "1994-01-09", "DATE_DEBUT": "1988-05-08" } }, "META_COMMUN": { "ID": "LEGIARTI000006800042", "URL": "article/LEGI/ARTI/00/00/06/80/00/LEGIARTI000006800042.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SXXXXXXXXXX5115R0090XXAA" } }, "LIENS": { "LIEN": [ { "@id": "JORFTEXT000000312908", "#text": "Décret 88-661 1988-05-06 art. 1 JORF 8 mai 1988", "@sens": "source", "@cidtexte": "JORFTEXT000000312908", "@nortexte": "ASEM8800585D", "@numtexte": "88-661", "@typelien": "CREATION", "@naturetexte": "DECRET", "@datesignatexte": "1988-05-06" }, { "@id": "LEGIARTI000006718727", "@num": "1", "#text": "Arrêté du 5 septembre 1989 - art. 1 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000666731", "@nortexte": "SPSM8901859A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "1989-09-05" }, { "@id": "LEGIARTI000006715525", "@num": "1", "#text": "Arrêté du 20 janvier 1992 - art. 1 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000847114", "@nortexte": "SANM9200238A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "1992-01-20" }, { "@id": "LEGIARTI000006728460", "@num": "1", "#text": "Arrêté du 7 décembre 1992 - art. 1 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000725668", "@nortexte": "SANM9203116A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "1992-12-07" }, { "@id": "LEGIARTI000006693686", "@num": "L596", "#text": "Code de la santé publique - art. L596 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006915061", "@num": "R5124-54", "#text": "Code de la santé publique - art. R5124-54 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006800105", "@num": "R5125", "#text": "Code de la santé publique - art. R5125 (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": "LEGISCTA000006194977", "@fin": "1998-02-13", "#text": "2° Autres obligations relatives au fonctionnement des établissements.", "@debut": "1960-04-07" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006187144", "@fin": "1998-02-13", "#text": "Paragraphe 3 : Fonctionnement des établissements", "@debut": "1960-04-07" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006174538", "@fin": "1998-02-13", "#text": "Section 1 : Des établissements de préparation et de vente en gros", "@debut": "1956-11-28" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006157765", "@fin": "1998-02-13", "#text": "Chapitre 2 : Préparation et vente en gros des produits pharmaceutiques", "@debut": "1953-10-07" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006142899", "@fin": "2999-01-01", "#text": "Titre 2 : Dispositions particulières aux divers modes d'exercice de la pharmacie", "@debut": "1953-10-07" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006128471", "@fin": "2999-01-01", "#text": "Livre 5 : Pharmacie", "@debut": "1953-10-07" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006107982", "@fin": "2999-01-01", "#text": "Partie réglementaire ancienne", "@debut": "1953-10-07" } ] }, "@cid": "LEGITEXT000006072665", "@nature": "CODE", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Code de la santé publique", "@debut": "1953-10-07", "@id_txt": "LEGITEXT000006072665", "@c_titre_court": "Code de la santé publique" } ], "@date_publi": "2999-01-01", "@date_signature": "2999-01-01" } }, "VERSIONS": { "VERSION": [ { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006800042", "@fin": "1994-01-09", "@num": "R5115-9", "@etat": "MODIFIE", "@debut": "1988-05-08", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006800043", "@fin": "1998-02-13", "@num": "R5115-9", "@etat": "MODIFIE", "@debut": "1994-01-09", "@origine": "LEGI" } }, { "@etat": "ABROGE", "LIEN_ART": { "@id": "LEGIARTI000006800044", "@fin": "2004-08-08", "@num": "R5115-9", "@etat": "ABROGE", "@debut": "1998-02-13", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
Les établissements visés à l'article L. 596 doivent se doter de bonnes pratiques de fabrication. A cette fin, des recommandations sont énoncées par arrêté du ministre chargé de la santé.
\n
" } }, "LEGIARTI000006800061": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R5118", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "1990-09-29", "DATE_DEBUT": "1988-05-08" } }, "META_COMMUN": { "ID": "LEGIARTI000006800061", "URL": "article/LEGI/ARTI/00/00/06/80/00/LEGIARTI000006800061.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SXXXXXXXXXX5118R0000XXAB" } }, "LIENS": { "LIEN": [ { "@id": "JORFTEXT000000503843", "#text": "Décret 53-1001 1953-10-05 (Décret de codification)", "@sens": "source", "@cidtexte": "JORFTEXT000000503843", "@numtexte": "53-1001", "@typelien": "CODIFICATION", "@naturetexte": "DECRET", "@datesignatexte": "1953-10-05" }, { "@id": "JORFTEXT000000312908", "#text": "Décret 88-661 1988-05-06 art. 2 JORF 8 mai 1988", "@sens": "source", "@cidtexte": "JORFTEXT000000312908", "@nortexte": "ASEM8800585D", "@numtexte": "88-661", "@typelien": "MODIFICATION", "@naturetexte": "DECRET", "@datesignatexte": "1988-05-06" }, { "@id": "LEGIARTI000006718724", "@num": "1", "#text": "Arrêté du 5 septembre 1989 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000840430", "@nortexte": "SPSM8901858A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "1989-09-05" }, { "@id": "LEGIARTI000006732698", "@num": "ANNEXE", "#text": "Arrêté du 9 décembre 1996 - art. ANNEXE (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000747887", "@nortexte": "TASP9624370A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "1996-12-09" }, { "@id": "LEGIARTI000006800059", "@num": "R5117", "#text": "Code de la santé publique - art. R5117 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006914727", "@num": "R5121-11", "#text": "Code de la santé publique - art. R5121-11 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006800097", "@num": "R5124", "#text": "Code de la santé publique - art. R5124 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006800105", "@num": "R5125", "#text": "Code de la santé publique - art. R5125 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006800147", "@num": "R5133", "#text": "Code de la santé publique - art. R5133 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "#text": "Loi 58-356 1958-04-03 (Loi de validation)", "@sens": "source", "@typelien": "CODIFICATION" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006187146", "@fin": "1994-01-09", "#text": "Paragraphe 1 : Expérimentation des médicaments.", "@debut": "1956-11-28" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006174539", "@fin": "1994-01-09", "#text": "Section 2 : Spécialités pharmaceutiques", "@debut": "1953-10-07" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006157765", "@fin": "1998-02-13", "#text": "Chapitre 2 : Préparation et vente en gros des produits pharmaceutiques", "@debut": "1953-10-07" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006142899", "@fin": "2999-01-01", "#text": "Titre 2 : Dispositions particulières aux divers modes d'exercice de la pharmacie", "@debut": "1953-10-07" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006128471", "@fin": "2999-01-01", "#text": "Livre 5 : Pharmacie", "@debut": "1953-10-07" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006107982", "@fin": "2999-01-01", "#text": "Partie réglementaire ancienne", "@debut": "1953-10-07" } ] }, "@cid": "LEGITEXT000006072665", "@nature": "CODE", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Code de la santé publique", "@debut": "1953-10-07", "@id_txt": "LEGITEXT000006072665", "@c_titre_court": "Code de la santé publique" } ], "@date_publi": "2999-01-01", "@date_signature": "2999-01-01" } }, "VERSIONS": { "VERSION": [ { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006800060", "@fin": "1988-05-08", "@num": "R5118", "@etat": "MODIFIE", "@debut": "1956-11-28", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006800061", "@fin": "1990-09-29", "@num": "R5118", "@etat": "MODIFIE", "@debut": "1988-05-08", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006800062", "@fin": "1993-08-07", "@num": "R5118", "@etat": "MODIFIE", "@debut": "1990-09-29", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006800063", "@fin": "1994-01-09", "@num": "R5118", "@etat": "MODIFIE", "@debut": "1993-08-07", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006800064", "@fin": "1998-02-13", "@num": "R5118", "@etat": "MODIFIE", "@debut": "1994-01-09", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006800065", "@fin": "1999-03-05", "@num": "R5118", "@etat": "MODIFIE", "@debut": "1998-02-13", "@origine": "LEGI" } }, { "@etat": "ABROGE", "LIEN_ART": { "@id": "LEGIARTI000006800066", "@fin": "2004-08-08", "@num": "R5118", "@etat": "ABROGE", "@debut": "1999-03-05", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
Le ministre chargé de la santé [*autorité compétente*] fixe par arrêté les protocoles déterminant les normes et méthodes applicables à l'expérimentation des médicaments.
\n
Les expertises doivent être exécutées en conformité avec les bonnes pratiques de laboratoire dont les principes sont fixés par arrêté du ministre chargé de la santé.
" } }, "LEGIARTI000006800142": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R5133", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "1993-08-07", "DATE_DEBUT": "1988-05-08" } }, "META_COMMUN": { "ID": "LEGIARTI000006800142", "URL": "article/LEGI/ARTI/00/00/06/80/01/LEGIARTI000006800142.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SXXXXXXXXXX5133R0000XXAB" } }, "LIENS": { "LIEN": [ { "@id": "JORFTEXT000000503843", "#text": "Décret 53-1001 1953-10-05 (Décret de codification)", "@sens": "source", "@cidtexte": "JORFTEXT000000503843", "@numtexte": "53-1001", "@typelien": "CODIFICATION", "@naturetexte": "DECRET", "@datesignatexte": "1953-10-05" }, { "@id": "LEGIARTI000006701352", "@num": "2", "#text": "Décret n°72-642 du 3 juillet 1972 - art. 2 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000858492", "@numtexte": "72-642", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1972-07-03" }, { "@id": "JORFTEXT000000312908", "#text": "Décret 88-661 1988-05-06 art. 3 JORF 8 mai 1988", "@sens": "source", "@cidtexte": "JORFTEXT000000312908", "@nortexte": "ASEM8800585D", "@numtexte": "88-661", "@typelien": "MODIFICATION", "@naturetexte": "DECRET", "@datesignatexte": "1988-05-06" }, { "@id": "LEGIARTI000006713571", "@num": "1", "#text": "Décret n°93-1322 du 20 décembre 1993 - art. 1 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000518210", "@nortexte": "SPSM9302869D", "@numtexte": "93-1322", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1993-12-20" }, { "@id": "LEGIARTI000006700475", "@num": "1", "#text": "Décret n°96-653 du 16 juillet 1996 - art. 1 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000548104", "@nortexte": "TASM9620899D", "@numtexte": "96-653", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1996-07-16" }, { "@id": "LEGIARTI000006732698", "@num": "ANNEXE", "#text": "Arrêté du 9 décembre 1996 - art. ANNEXE (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000747887", "@nortexte": "TASP9624370A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "1996-12-09" }, { "@id": "LEGIARTI000006723667", "@num": "8", "#text": "Décret n°99-486 du 11 juin 1999 - art. 8 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000760344", "@nortexte": "MESP9921746D", "@numtexte": "99-486", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1999-06-11" }, { "@id": "LEGIARTI000006232079", "@num": "1", "#text": "Décret n°2004-651 du 2 juillet 2004 - art. 1 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000436350", "@nortexte": "SANG0421846D", "@numtexte": "2004-651", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2004-07-02" }, { "@id": "LEGIARTI000006800060", "@num": "R5118", "#text": "Code de la santé publique - art. R5118 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006914754", "@num": "R5121-29", "#text": "Code de la santé publique - art. R5121-29 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006914756", "@num": "R5121-30", "#text": "Code de la santé publique - art. R5121-30 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006914758", "@num": "R5121-31", "#text": "Code de la santé publique - art. R5121-31 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006800117", "@num": "R5128", "#text": "Code de la santé publique - art. R5128 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006800126", "@num": "R5129", "#text": "Code de la santé publique - art. R5129 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006800176", "@num": "R5136", "#text": "Code de la santé publique - art. R5136 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006800272", "@num": "R5143", "#text": "Code de la santé publique - art. R5143 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "#text": "Loi 58-356 1958-04-03 (Loi de validation)", "@sens": "source", "@typelien": "CODIFICATION" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006187147", "@fin": "1994-01-09", "#text": "PARAGRAPHE 2 : AUTORISATION DE MISE SUR LE MARCHE.", "@debut": "1953-10-07" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006174539", "@fin": "1994-01-09", "#text": "Section 2 : Spécialités pharmaceutiques", "@debut": "1953-10-07" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006157765", "@fin": "1998-02-13", "#text": "Chapitre 2 : Préparation et vente en gros des produits pharmaceutiques", "@debut": "1953-10-07" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006142899", "@fin": "2999-01-01", "#text": "Titre 2 : Dispositions particulières aux divers modes d'exercice de la pharmacie", "@debut": "1953-10-07" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006128471", "@fin": "2999-01-01", "#text": "Livre 5 : Pharmacie", "@debut": "1953-10-07" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006107982", "@fin": "2999-01-01", "#text": "Partie réglementaire ancienne", "@debut": "1953-10-07" } ] }, "@cid": "LEGITEXT000006072665", "@nature": "CODE", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Code de la santé publique", "@debut": "1953-10-07", "@id_txt": "LEGITEXT000006072665", "@c_titre_court": "Code de la santé publique" } ], "@date_publi": "2999-01-01", "@date_signature": "2999-01-01" } }, "VERSIONS": { "VERSION": [ { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006800141", "@fin": "1988-05-08", "@num": "R5133", "@etat": "MODIFIE", "@debut": "1956-11-28", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006800142", "@fin": "1993-08-07", "@num": "R5133", "@etat": "MODIFIE", "@debut": "1988-05-08", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006800143", "@fin": "1994-01-09", "@num": "R5133", "@etat": "MODIFIE", "@debut": "1993-08-07", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006800144", "@fin": "1998-01-30", "@num": "R5133", "@etat": "MODIFIE", "@debut": "1994-01-09", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006800145", "@fin": "1998-02-13", "@num": "R5133", "@etat": "MODIFIE", "@debut": "1998-01-30", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006800146", "@fin": "1999-03-05", "@num": "R5133", "@etat": "MODIFIE", "@debut": "1998-02-13", "@origine": "LEGI" } }, { "@etat": "ABROGE", "LIEN_ART": { "@id": "LEGIARTI000006800147", "@fin": "2004-08-08", "@num": "R5133", "@etat": "ABROGE", "@debut": "1999-03-05", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
Par dérogation aux dispositions des articles R. 5128 et R. 5129 :
\n
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a) Lorsque la demande porte sur une modification d'autorisation de mise sur le marché, le ministre chargé de la santé peut dispenser le demandeur de produire certaines des indications ou justifications exigées par les articles R. 5128 et R. 5129 s'il apparaît que celles-ci sont manifestement sans objet ;
\n
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b) Lorsque la demande concerne une spécialité correspondant à une préparation figurant à la Pharmacopée française ou au formulaire national, le demandeur peut être dispensé des expertises pharmacologiques, toxicologiques et cliniques ;
\n
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c) Le demandeur n'est pas tenu de fournir les résultats des essais pharmacologiques et toxicologiques ni les résultats des essais cliniques s'il peut démontrer :
\n
1. Soit que la spécialité pharmaceutique est essentiellement similaire à une spécialité autorisée et que la personne responsable de la mise sur le marché de la spécialité originale a consenti qu'il soit fait recours en vue de l'examen de la présente demande à la documentation pharmacologique, toxicologique ou clinique figurant au dossier de la spécialité originale ;
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2. Soit, par référence détaillée à la littérature scientifique publiée, que le ou les composants de la spécialité pharmaceutique sont d'un usage médical bien établi et présentent une efficacité reconnue, ainsi qu'un niveau acceptable de sécurité ;
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3. Soit que la spécialité pharmaceutique est essentiellement similaire à une spécialité autorisée depuis au moins dix ans [*délai*] en France ou dans un autre pays membre des communautés européennes selon les dispositions communautaires en vigueur et commercialisée en France.
\n
Cependant, dans le cas où la spécialité pharmaceutique est destinée à un usage thérapeutique différent ou doit être administrée par des voies différentes ou sous un dosage différent, par rapport aux autres médicaments commercialisés, les résultats des essais pharmacologiques, toxicologiques et cliniques appropriés doivent être fournis.
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d) En ce qui concerne une spécialité nouvelle renfermant des composants connus, mais qui n'ont pas encore été associés dans un but thérapeutique, les résultats des essais pharmacologiques, toxicologiques et cliniques relatifs à l'association doivent être fournis sans qu'il soit nécessaire de fournir la documentation relative à chaque composant individuel.
\n
Lorsqu'il est fait référence à la littérature scientifique publiée, des experts doivent justifier le recours à cette documentation bibliographique et démontrer qu'elle satisfait aux exigences des protocoles arrêtés en application de l'article R. 5118, compte tenu notamment de la forme pharmaceutique et des constituants de l'excipient.
" } }, "LEGIARTI000006800148": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R5133-1", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "1994-01-09", "DATE_DEBUT": "1988-05-08" } }, "META_COMMUN": { "ID": "LEGIARTI000006800148", "URL": "article/LEGI/ARTI/00/00/06/80/01/LEGIARTI000006800148.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SXXXXXXXXXX5133R0010XXAA" } }, "LIENS": { "LIEN": [ { "@id": "JORFTEXT000000503843", "#text": "Décret 53-1001 1953-10-05 (Décret de codification)", "@sens": "source", "@cidtexte": "JORFTEXT000000503843", "@numtexte": "53-1001", "@typelien": "CODIFICATION", "@naturetexte": "DECRET", "@datesignatexte": "1953-10-05" }, { "@id": "JORFTEXT000000312908", "#text": "Décret 88-661 1988-05-06 art. 4 JORF 8 mai 1988", "@sens": "source", "@cidtexte": "JORFTEXT000000312908", "@nortexte": "ASEM8800585D", "@numtexte": "88-661", "@typelien": "CREATION", "@naturetexte": "DECRET", "@datesignatexte": "1988-05-06" }, { "#text": "Loi 58-356 1958-04-03 (Loi de validation)", "@sens": "source", "@typelien": "CODIFICATION" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006187147", "@fin": "1994-01-09", "#text": "PARAGRAPHE 2 : AUTORISATION DE MISE SUR LE MARCHE.", "@debut": "1953-10-07" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006174539", "@fin": "1994-01-09", "#text": "Section 2 : Spécialités pharmaceutiques", "@debut": "1953-10-07" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006157765", "@fin": "1998-02-13", "#text": "Chapitre 2 : Préparation et vente en gros des produits pharmaceutiques", "@debut": "1953-10-07" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006142899", "@fin": "2999-01-01", "#text": "Titre 2 : Dispositions particulières aux divers modes d'exercice de la pharmacie", "@debut": "1953-10-07" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006128471", "@fin": "2999-01-01", "#text": "Livre 5 : Pharmacie", "@debut": "1953-10-07" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006107982", "@fin": "2999-01-01", "#text": "Partie réglementaire ancienne", "@debut": "1953-10-07" } ] }, "@cid": "LEGITEXT000006072665", "@nature": "CODE", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Code de la santé publique", "@debut": "1953-10-07", "@id_txt": "LEGITEXT000006072665", "@c_titre_court": "Code de la santé publique" } ], "@date_publi": "2999-01-01", "@date_signature": "2999-01-01" } }, "VERSIONS": { "VERSION": [ { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006800148", "@fin": "1994-01-09", "@num": "R5133-1", "@etat": "MODIFIE", "@debut": "1988-05-08", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006800149", "@fin": "1998-02-13", "@num": "R5133-1", "@etat": "MODIFIE", "@debut": "1994-01-09", "@origine": "LEGI" } }, { "@etat": "ABROGE", "LIEN_ART": { "@id": "LEGIARTI000006800150", "@fin": "2004-08-08", "@num": "R5133-1", "@etat": "ABROGE", "@debut": "1998-02-13", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
Une spécialité est considérée comme étant essentiellement similaire à une autre spécialité [*définition*] si elle a la même composition qualitative et quantitative en principes actifs, la même forme pharmaceutique et si, le cas échéant, la bioéquivalence entre les deux spécialités a été démontrée par des études appropriées de biodisponibilité.
\n
" } }, "LEGIARTI000006800179": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R5136-1", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "1993-08-07", "DATE_DEBUT": "1988-05-08" } }, "META_COMMUN": { "ID": "LEGIARTI000006800179", "URL": "article/LEGI/ARTI/00/00/06/80/01/LEGIARTI000006800179.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SXXXXXXXXXX5136R0010XXAC" } }, "LIENS": { "LIEN": [ { "#text": "CEE DIRECTIVE 319 1975 ART. 8, ART. 9 CONSEIL", "@sens": "source", "@typelien": "CITATION" }, { "@id": "JORFTEXT000000312908", "#text": "Décret 88-661 1988-05-06 art. 5 JORF 8 mai 1988", "@sens": "source", "@cidtexte": "JORFTEXT000000312908", "@nortexte": "ASEM8800585D", "@numtexte": "88-661", "@typelien": "MODIFICATION", "@naturetexte": "DECRET", "@datesignatexte": "1988-05-06" }, { "@id": "LEGIARTI000006800216", "@num": "R5140-1", "#text": "Code de la santé publique - art. R5140-1 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006800221", "@num": "R5140-2", "#text": "Code de la santé publique - art. R5140-2 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006187147", "@fin": "1994-01-09", "#text": "PARAGRAPHE 2 : AUTORISATION DE MISE SUR LE MARCHE.", "@debut": "1953-10-07" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006174539", "@fin": "1994-01-09", "#text": "Section 2 : Spécialités pharmaceutiques", "@debut": "1953-10-07" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006157765", "@fin": "1998-02-13", "#text": "Chapitre 2 : Préparation et vente en gros des produits pharmaceutiques", "@debut": "1953-10-07" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006142899", "@fin": "2999-01-01", "#text": "Titre 2 : Dispositions particulières aux divers modes d'exercice de la pharmacie", "@debut": "1953-10-07" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006128471", "@fin": "2999-01-01", "#text": "Livre 5 : Pharmacie", "@debut": "1953-10-07" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006107982", "@fin": "2999-01-01", "#text": "Partie réglementaire ancienne", "@debut": "1953-10-07" } ] }, "@cid": "LEGITEXT000006072665", "@nature": "CODE", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Code de la santé publique", "@debut": "1953-10-07", "@id_txt": "LEGITEXT000006072665", "@c_titre_court": "Code de la santé publique" } ], "@date_publi": "2999-01-01", "@date_signature": "2999-01-01" } }, "VERSIONS": { "VERSION": [ { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006800177", "@fin": "1985-11-21", "@num": "R5136-1", "@etat": "MODIFIE", "@debut": "1978-10-06", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006800178", "@fin": "1988-05-08", "@num": "R5136-1", "@etat": "MODIFIE", "@debut": "1985-11-21", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006800179", "@fin": "1993-08-07", "@num": "R5136-1", "@etat": "MODIFIE", "@debut": "1988-05-08", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006800180", "@fin": "1994-01-09", "@num": "R5136-1", "@etat": "MODIFIE", "@debut": "1993-08-07", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006800181", "@fin": "1998-02-13", "@num": "R5136-1", "@etat": "MODIFIE", "@debut": "1994-01-09", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006800182", "@fin": "1999-03-05", "@num": "R5136-1", "@etat": "MODIFIE", "@debut": "1998-02-13", "@origine": "LEGI" } }, { "@etat": "ABROGE", "LIEN_ART": { "@id": "LEGIARTI000006800183", "@fin": "2004-08-08", "@num": "R5136-1", "@etat": "ABROGE", "@debut": "1999-03-05", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
Lorsque la demande a été présentée en vue de l'extension en France d'une autorisation de mise sur le marché obtenue dans un autre pays membre de la Communauté économique européenne le ministre accorde l'autorisation ou fait usage de son droit d'opposition dans un délai de cent vingt jours à compter de la date qui lui est notifiée par le comité des spécialités pharmaceutiques [*point de départ*] institué par l'article 8 de la directive 75/319/C.E.E. du Conseil des communautés européennes.
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Si le ministre estime ne pas pouvoir accorder l'autorisation de mise sur le marché, il transmet son opposition motivée au comité et au responsable de la mise sur le marché de la spécialité pharmaceutique.
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Après réception de l'avis du comité, le ministre se prononce sur la suite à donner à cet avis dans un délai de soixante jours. Ce délai est de trente jours lorsque l'avis du comité est donné en application des articles R. 5140-1 et R. 5140-2. Le comité est informé de cette décision.
" } }, "LEGIARTI000006800205": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R5139-1", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "1994-01-09", "DATE_DEBUT": "1988-05-08" } }, "META_COMMUN": { "ID": "LEGIARTI000006800205", "URL": "article/LEGI/ARTI/00/00/06/80/02/LEGIARTI000006800205.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SXXXXXXXXXX5139R0010XXAA" } }, "LIENS": { "LIEN": [ { "@id": "JORFTEXT000000503843", "#text": "Décret 53-1001 1953-10-05 (Décret de codification)", "@sens": "source", "@cidtexte": "JORFTEXT000000503843", "@numtexte": "53-1001", "@typelien": "CODIFICATION", "@naturetexte": "DECRET", "@datesignatexte": "1953-10-05" }, { "@id": "JORFTEXT000000312908", "#text": "Décret 88-661 1988-05-06 art. 6 JORF 8 mai 1988", "@sens": "source", "@cidtexte": "JORFTEXT000000312908", "@nortexte": "ASEM8800585D", "@numtexte": "88-661", "@typelien": "CREATION", "@naturetexte": "DECRET", "@datesignatexte": "1988-05-06" }, { "@id": "LEGIARTI000022416789", "@num": "1", "#text": "Arrêté du 30 juin 2010 - art. 1 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000022415149", "@nortexte": "SASP1017123A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2010-06-30" }, { "@id": "LEGIARTI000022416465", "@num": "1", "#text": "Arrêté du 30 juin 2010 - art. 1 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000022415125", "@nortexte": "SASP1017105A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2010-06-30" }, { "@id": "LEGIARTI000022416474", "@num": "1", "#text": "Arrêté du 30 juin 2010 - art. 1 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000022415141", "@nortexte": "SASP1017114A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2010-06-30" }, { "@id": "LEGIARTI000006914786", "@num": "R5121-49", "#text": "Code de la santé publique - art. R5121-49 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006800198", "@num": "R5139", "#text": "Code de la santé publique - art. R5139 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006800216", "@num": "R5140-1", "#text": "Code de la santé publique - art. R5140-1 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006800221", "@num": "R5140-2", "#text": "Code de la santé publique - art. R5140-2 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "#text": "Loi 58-356 1958-04-03 (Loi de validation)", "@sens": "source", "@typelien": "CODIFICATION" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006187147", "@fin": "1994-01-09", "#text": "PARAGRAPHE 2 : AUTORISATION DE MISE SUR LE MARCHE.", "@debut": "1953-10-07" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006174539", "@fin": "1994-01-09", "#text": "Section 2 : Spécialités pharmaceutiques", "@debut": "1953-10-07" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006157765", "@fin": "1998-02-13", "#text": "Chapitre 2 : Préparation et vente en gros des produits pharmaceutiques", "@debut": "1953-10-07" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006142899", "@fin": "2999-01-01", "#text": "Titre 2 : Dispositions particulières aux divers modes d'exercice de la pharmacie", "@debut": "1953-10-07" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006128471", "@fin": "2999-01-01", "#text": "Livre 5 : Pharmacie", "@debut": "1953-10-07" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006107982", "@fin": "2999-01-01", "#text": "Partie réglementaire ancienne", "@debut": "1953-10-07" } ] }, "@cid": "LEGITEXT000006072665", "@nature": "CODE", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Code de la santé publique", "@debut": "1953-10-07", "@id_txt": "LEGITEXT000006072665", "@c_titre_court": "Code de la santé publique" } ], "@date_publi": "2999-01-01", "@date_signature": "2999-01-01" } }, "VERSIONS": { "VERSION": [ { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006800205", "@fin": "1994-01-09", "@num": "R5139-1", "@etat": "MODIFIE", "@debut": "1988-05-08", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006800206", "@fin": "1998-02-13", "@num": "R5139-1", "@etat": "MODIFIE", "@debut": "1994-01-09", "@origine": "LEGI" } }, { "@etat": "ABROGE", "LIEN_ART": { "@id": "LEGIARTI000006800207", "@fin": "2004-08-08", "@num": "R5139-1", "@etat": "ABROGE", "@debut": "1998-02-13", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
Lorsqu'une autorisation de mise sur le marché a été accordée à une spécialité pharmaceutique relevant des listes mentionnées aux articles R. 5140-1 et R. 5140-2 après un avis favorable du comité des spécialités pharmaceutiques les décisions mentionnées à l'article R. 5139 concernant cette spécialité pharmaceutique sont prises après avis de ce comité. Toutefois, en cas d'urgence, la décision de suspension est prise sans attendre l'avis du comité ; cette décision est transmise au comité, ainsi que la justification de l'urgence et la motivation de la suspension.
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" } }, "LEGIARTI000006800216": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R5140-1", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "1993-08-07", "DATE_DEBUT": "1988-05-08" } }, "META_COMMUN": { "ID": "LEGIARTI000006800216", "URL": "article/LEGI/ARTI/00/00/06/80/02/LEGIARTI000006800216.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SXXXXXXXXXX5140R0010XXAA" } }, "LIENS": { "LIEN": [ { "@id": "JORFTEXT000000503843", "#text": "Décret 53-1001 1953-10-05 (Décret de codification)", "@sens": "source", "@cidtexte": "JORFTEXT000000503843", "@numtexte": "53-1001", "@typelien": "CODIFICATION", "@naturetexte": "DECRET", "@datesignatexte": "1953-10-05" }, { "@id": "JORFTEXT000000312908", "#text": "Décret 88-661 1988-05-06 art. 7 JORF 8 mai 1988", "@sens": "source", "@cidtexte": "JORFTEXT000000312908", "@nortexte": "ASEM8800585D", "@numtexte": "88-661", "@typelien": "CREATION", "@naturetexte": "DECRET", "@datesignatexte": "1988-05-06" }, { "@id": "LEGIARTI000006914789", "@num": "R5121-51", "#text": "Code de la santé publique - art. R5121-51 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006800183", "@num": "R5136-1", "#text": "Code de la santé publique - art. R5136-1 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006800207", "@num": "R5139-1", "#text": "Code de la santé publique - art. R5139-1 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGITEXT000006072665", "#text": "Code de la santé publique R5136-1", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "#text": "Loi 58-356 1958-04-03 (Loi de validation)", "@sens": "source", "@typelien": "CODIFICATION" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006187147", "@fin": "1994-01-09", "#text": "PARAGRAPHE 2 : AUTORISATION DE MISE SUR LE MARCHE.", "@debut": "1953-10-07" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006174539", "@fin": "1994-01-09", "#text": "Section 2 : Spécialités pharmaceutiques", "@debut": "1953-10-07" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006157765", "@fin": "1998-02-13", "#text": "Chapitre 2 : Préparation et vente en gros des produits pharmaceutiques", "@debut": "1953-10-07" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006142899", "@fin": "2999-01-01", "#text": "Titre 2 : Dispositions particulières aux divers modes d'exercice de la pharmacie", "@debut": "1953-10-07" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006128471", "@fin": "2999-01-01", "#text": "Livre 5 : Pharmacie", "@debut": "1953-10-07" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006107982", "@fin": "2999-01-01", "#text": "Partie réglementaire ancienne", "@debut": "1953-10-07" } ] }, "@cid": "LEGITEXT000006072665", "@nature": "CODE", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Code de la santé publique", "@debut": "1953-10-07", "@id_txt": "LEGITEXT000006072665", "@c_titre_court": "Code de la santé publique" } ], "@date_publi": "2999-01-01", "@date_signature": "2999-01-01" } }, "VERSIONS": { "VERSION": [ { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006800216", "@fin": "1993-08-07", "@num": "R5140-1", "@etat": "MODIFIE", "@debut": "1988-05-08", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006800217", "@fin": "1994-01-09", "@num": "R5140-1", "@etat": "MODIFIE", "@debut": "1993-08-07", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006800218", "@fin": "1998-02-13", "@num": "R5140-1", "@etat": "MODIFIE", "@debut": "1994-01-09", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006800219", "@fin": "1999-03-05", "@num": "R5140-1", "@etat": "MODIFIE", "@debut": "1998-02-13", "@origine": "LEGI" } }, { "@etat": "ABROGE", "LIEN_ART": { "@id": "LEGIARTI000006800220", "@fin": "2004-08-08", "@num": "R5140-1", "@etat": "ABROGE", "@debut": "1999-03-05", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
Toute demande d'autorisation de mise sur le marché présentée pour des médicaments de haute technologie issus de certains procédés biotechnologiques figurant sur une liste A fixée par arrêté conjoint du ministre chargé de la santé et du ministre chargé de l'industrie est soumise pour avis au comité des spécialités pharmaceutiques [*autorité compétente*] mentionné à l'article R. 5136-1.
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Toutefois, cette disposition ne s'applique pas lorsque le demandeur certifie que ni lui, ni aucune autre personne physique ou morale avec laquelle il est lié, n'a demandé, au cours des cinq années précédentes [*délai*], l'autorisation de mettre sur le marché d'un autre Etat membre un produit contenant le ou les mêmes principes actifs ou n'envisage de demander, dans les cinq ans suivant la date d'introduction de la demande, l'autorisation de mettre sur le marché d'un autre Etat membre un produit contenant le ou les mêmes principes actifs.
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Lorsque, en application de l'alinéa précédent, l'avis du comité des spécialités pharmaceutiques n'a pas été sollicité et que, dans les cinq ans qui suivent le dépôt de la demande [*délai*], une ou plusieurs demandes d'autorisation de mise sur le marché d'un produit contenant le ou les mêmes principes actifs issus du ou des mêmes procédés de synthèse sont adressées aux autorités compétentes des autres Etats membres par le responsable de la mise sur le marché de la spécialité pharmaceutique déjà autorisée ou avec son consentement, ce dernier en informe immédiatement les autorités françaises qui saisissent pour avis le comité des spécialités pharmaceutiques.
" } }, "LEGIARTI000006800221": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R5140-2", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "1993-08-07", "DATE_DEBUT": "1988-05-08" } }, "META_COMMUN": { "ID": "LEGIARTI000006800221", "URL": "article/LEGI/ARTI/00/00/06/80/02/LEGIARTI000006800221.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SXXXXXXXXXX5140R0020XXAA" } }, "LIENS": { "LIEN": [ { "@id": "JORFTEXT000000503843", "#text": "Décret 53-1001 1953-10-05 (Décret de codification)", "@sens": "source", "@cidtexte": "JORFTEXT000000503843", "@numtexte": "53-1001", "@typelien": "CODIFICATION", "@naturetexte": "DECRET", "@datesignatexte": "1953-10-05" }, { "@id": "JORFTEXT000000312908", "#text": "Décret 88-661 1988-05-06 art. 7 JORF 8 mai 1988", "@sens": "source", "@cidtexte": "JORFTEXT000000312908", "@nortexte": "ASEM8800585D", "@numtexte": "88-661", "@typelien": "CREATION", "@naturetexte": "DECRET", "@datesignatexte": "1988-05-06" }, { "@id": "LEGIARTI000006914790", "@num": "R5121-52", "#text": "Code de la santé publique - art. R5121-52 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006800183", "@num": "R5136-1", "#text": "Code de la santé publique - art. R5136-1 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006800207", "@num": "R5139-1", "#text": "Code de la santé publique - art. R5139-1 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "#text": "Loi 58-356 1958-04-03 (Loi de validation)", "@sens": "source", "@typelien": "CODIFICATION" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006187147", "@fin": "1994-01-09", "#text": "PARAGRAPHE 2 : AUTORISATION DE MISE SUR LE MARCHE.", "@debut": "1953-10-07" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006174539", "@fin": "1994-01-09", "#text": "Section 2 : Spécialités pharmaceutiques", "@debut": "1953-10-07" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006157765", "@fin": "1998-02-13", "#text": "Chapitre 2 : Préparation et vente en gros des produits pharmaceutiques", "@debut": "1953-10-07" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006142899", "@fin": "2999-01-01", "#text": "Titre 2 : Dispositions particulières aux divers modes d'exercice de la pharmacie", "@debut": "1953-10-07" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006128471", "@fin": "2999-01-01", "#text": "Livre 5 : Pharmacie", "@debut": "1953-10-07" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006107982", "@fin": "2999-01-01", "#text": "Partie réglementaire ancienne", "@debut": "1953-10-07" } ] }, "@cid": "LEGITEXT000006072665", "@nature": "CODE", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Code de la santé publique", "@debut": "1953-10-07", "@id_txt": "LEGITEXT000006072665", "@c_titre_court": "Code de la santé publique" } ], "@date_publi": "2999-01-01", "@date_signature": "2999-01-01" } }, "VERSIONS": { "VERSION": [ { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006800221", "@fin": "1993-08-07", "@num": "R5140-2", "@etat": "MODIFIE", "@debut": "1988-05-08", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006800222", "@fin": "1994-01-09", "@num": "R5140-2", "@etat": "MODIFIE", "@debut": "1993-08-07", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006800223", "@fin": "1998-02-13", "@num": "R5140-2", "@etat": "MODIFIE", "@debut": "1994-01-09", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006800224", "@fin": "1999-03-05", "@num": "R5140-2", "@etat": "MODIFIE", "@debut": "1998-02-13", "@origine": "LEGI" } }, { "@etat": "ABROGE", "LIEN_ART": { "@id": "LEGIARTI000006800225", "@fin": "2004-08-08", "@num": "R5140-2", "@etat": "ABROGE", "@debut": "1999-03-05", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
Lorsque la demande d'autorisation de mise sur le marché concerne d'autres médicaments de haute technologie figurant sur une liste B fixée par arrêté conjoint du ministre chargé de la santé et du ministre chargé de l'industrie, le demandeur doit préciser s'il désire que sa demande soit soumise pour avis au comité des spécialités pharmaceutiques [*autorité compétente*].
\n
" } }, "LEGIARTI000006800729": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R5146-8", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "1994-10-18", "DATE_DEBUT": "1988-05-08" } }, "META_COMMUN": { "ID": "LEGIARTI000006800729", "URL": "article/LEGI/ARTI/00/00/06/80/07/LEGIARTI000006800729.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SXXXXXXXXXX5146R0080XXAB" } }, "LIENS": { "LIEN": [ { "@id": "JORFTEXT000000503843", "#text": "Décret 53-1001 1953-10-05 (Décret de codification)", "@sens": "source", "@cidtexte": "JORFTEXT000000503843", "@numtexte": "53-1001", "@typelien": "CODIFICATION", "@naturetexte": "DECRET", "@datesignatexte": "1953-10-05" }, { "@id": "JORFTEXT000000312908", "#text": "Décret 88-661 1988-05-06 art. 9 JORF 8 mai 1988", "@sens": "source", "@cidtexte": "JORFTEXT000000312908", "@nortexte": "ASEM8800585D", "@numtexte": "88-661", "@typelien": "MODIFICATION", "@naturetexte": "DECRET", "@datesignatexte": "1988-05-06" }, { "@id": "LEGIARTI000006731410", "@num": "2", "#text": "Arrêté du 9 mai 1995 - art. 2 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000169597", "@nortexte": "SANP9501525A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "1995-05-09" }, { "@id": "LEGIARTI000006693773", "@num": "L606", "#text": "Code de la santé publique - art. L606 (Ab)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693774", "@num": "L607", "#text": "Code de la santé publique - art. L607 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006800725", "@num": "R5146-6", "#text": "Code de la santé publique - art. R5146-6 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "#text": "Loi 58-356 1958-04-03 (Loi de validation)", "@sens": "source", "@typelien": "CODIFICATION" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006187185", "@fin": "2003-03-22", "#text": "PARAGRAPHE 2 : DES SOCIETES PROPRIETAIRES D'ETABLISSEMENTS DE PREPARATION, DE VENTE EN GROS OU DE DISTRIBUTION EN GROS DES MEDICAMENTS VETERINAIRES.", "@debut": "1977-06-23" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006174549", "@fin": "2003-03-22", "#text": "SECTION 1 : DES ETABLISSEMENTS DE PREPARATION, DE VENTE EN GROS ET DE DISTRIBUTION EN GROS.", "@debut": "1977-06-23" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006157773", "@fin": "2004-08-08", "#text": "CHAPITRE 3 : PHARMACIE VETERINAIRE", "@debut": "1977-06-23" } ] }, "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": "LEGIARTI000006800728", "@fin": "1988-05-08", "@num": "R5146-8", "@etat": "MODIFIE", "@debut": "1977-06-23", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006800729", "@fin": "1994-10-18", "@num": "R5146-8", "@etat": "MODIFIE", "@debut": "1988-05-08", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006800730", "@fin": "1999-03-28", "@num": "R5146-8", "@etat": "MODIFIE", "@debut": "1994-10-18", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006800731", "@fin": "1999-07-04", "@num": "R5146-8", "@etat": "MODIFIE", "@debut": "1999-03-28", "@origine": "LEGI" } }, { "@etat": "ABROGE", "LIEN_ART": { "@id": "LEGIARTI000006800732", "@fin": "2003-03-22", "@num": "R5146-8", "@etat": "ABROGE", "@debut": "1999-07-04", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
En vue de l'application des règles édictées dans l'intérêt de la santé publique, le pharmacien ou le docteur vétérinaire désigné à l'article R. 5146-6 exerce au moins les attributions suivantes :
\n
Il participe à l'élaboration du programme de recherches et d'études de la société ;
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Il signe, après avoir pris connaissance des rapports d'expertise, les demandes d'autorisation de mise sur le marché des médicaments vétérinaires ;
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Il organise et surveille la fabrication, le conditionnement, le stockage, le contrôle et la délivrance à titre onéreux ou gratuit des médicaments définis aux articles L. 606 et L. 607, ainsi que la publicité les concernant ;
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Il a autorité sur les pharmaciens ou docteurs vétérinaires assistants ;
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Il signale aux autres dirigeants de la société les difficultés inhérentes aux conditions d'exploitation qui sont de nature à faire obstacle à l'exercice de ses attributions.
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Dans le cas où un désaccord, portant sur l'application des règles édictées dans l'intérêt de la santé publique, oppose un organe de gestion d'administration, de direction ou de surveillance au pharmacien ou au docteur vétérinaire responsable, celui-ci doit en informer le pharmacien inspecteur régional de la santé et le directeur départemental des services vétérinaires.
\n
Les expertises doivent être exécutées en conformité avec les bonnes pratiques de laboratoire dont les principes sont fixés par un arrêté du ministre chargé de la santé et du ministre chargé de l'agriculture.
" } }, "LEGIARTI000006800750": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R5146-17 ter", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "1994-10-18", "DATE_DEBUT": "1988-05-08" } }, "META_COMMUN": { "ID": "LEGIARTI000006800750", "URL": "article/LEGI/ARTI/00/00/06/80/07/LEGIARTI000006800750.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SXXXXXXXXXX5146R0170XXCA" } }, "LIENS": { "LIEN": [ { "@id": "JORFTEXT000000312908", "#text": "Décret 88-661 1988-05-06 art. 8 JORF 8 mai 1988", "@sens": "source", "@cidtexte": "JORFTEXT000000312908", "@nortexte": "ASEM8800585D", "@numtexte": "88-661", "@typelien": "CREATION", "@naturetexte": "DECRET", "@datesignatexte": "1988-05-06" }, { "@id": "LEGIARTI000006732754", "@num": "1", "#text": "Arrêté du 5 mai 1997 - art. 1 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000199774", "@nortexte": "TASP9721627A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "1997-05-05" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006187186", "@fin": "2003-03-22", "#text": "Paragraphe 3 : Fonctionnement des établissements", "@debut": "1977-06-23" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006174549", "@fin": "2003-03-22", "#text": "SECTION 1 : DES ETABLISSEMENTS DE PREPARATION, DE VENTE EN GROS ET DE DISTRIBUTION EN GROS.", "@debut": "1977-06-23" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006157773", "@fin": "2004-08-08", "#text": "CHAPITRE 3 : PHARMACIE VETERINAIRE", "@debut": "1977-06-23" } ] }, "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": "LEGIARTI000006800750", "@fin": "1994-10-18", "@num": "R5146-17 ter", "@etat": "MODIFIE", "@debut": "1988-05-08", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006800751", "@fin": "1999-03-28", "@num": "R5146-17 ter", "@etat": "MODIFIE", "@debut": "1994-10-18", "@origine": "LEGI" } }, { "@etat": "ABROGE", "LIEN_ART": { "@id": "LEGIARTI000006800752", "@fin": "2003-03-22", "@num": "R5146-17 ter", "@etat": "ABROGE", "@debut": "1999-03-28", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
Les établissements doivent se doter de bonnes pratiques de fabrication. A cette fin, des recommandations sont énoncées par arrêté conjoint du ministre chargé de la santé et du ministre chargé de l'agriculture [*autorités compétentes*].
\n
" } }, "LEGIARTI000006800837": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R5146-33-2", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "1994-10-18", "DATE_DEBUT": "1988-05-08" } }, "META_COMMUN": { "ID": "LEGIARTI000006800837", "URL": "article/LEGI/ARTI/00/00/06/80/08/LEGIARTI000006800837.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SXXXXXXXXXX5146R0330XX2A" } }, "LIENS": { "LIEN": [ { "@id": "JORFTEXT000000503843", "#text": "Décret 53-1001 1953-10-05 (Décret de codification)", "@sens": "source", "@cidtexte": "JORFTEXT000000503843", "@numtexte": "53-1001", "@typelien": "CODIFICATION", "@naturetexte": "DECRET", "@datesignatexte": "1953-10-05" }, { "@id": "JORFTEXT000000312908", "#text": "Décret 88-661 1988-05-06 art. 10 JORF 8 mai 1988", "@sens": "source", "@cidtexte": "JORFTEXT000000312908", "@nortexte": "ASEM8800585D", "@numtexte": "88-661", "@typelien": "CREATION", "@naturetexte": "DECRET", "@datesignatexte": "1988-05-06" }, { "@id": "LEGIARTI000006915825", "@num": "R5141-28", "#text": "Code de la santé publique - art. R5141-28 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006800836", "@num": "R5146-33-1", "#text": "Code de la santé publique - art. R5146-33-1 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006800913", "@num": "R5146-33-7", "#text": "Code de la santé publique - art. R5146-33-7 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006800918", "@num": "R5146-33-9", "#text": "Code de la santé publique - art. R5146-33-9 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006800866", "@num": "R5146-37-1", "#text": "Code de la santé publique - art. R5146-37-1 (P)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "#text": "Loi 58-356 1958-04-03 (Loi de validation)", "@sens": "source", "@typelien": "CODIFICATION" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006187189", "@fin": "1999-07-04", "#text": "Paragraphe 3 : Décisions accordant, renouvelant, suspendant ou supprimant une autorisation de mise sur le marché.", "@debut": "1977-06-23" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006174551", "@fin": "2000-07-21", "#text": "Section 2 : Médicaments vétérinaires : l'autorisation de mise sur le marché", "@debut": "1977-06-23" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006157773", "@fin": "2004-08-08", "#text": "CHAPITRE 3 : PHARMACIE VETERINAIRE", "@debut": "1977-06-23" } ] }, "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": "LEGIARTI000006800837", "@fin": "1994-10-18", "@num": "R5146-33-2", "@etat": "MODIFIE", "@debut": "1988-05-08", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006800838", "@fin": "1999-03-28", "@num": "R5146-33-2", "@etat": "MODIFIE", "@debut": "1994-10-18", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006800839", "@fin": "1999-07-04", "@num": "R5146-33-2", "@etat": "MODIFIE", "@debut": "1999-03-28", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006800840", "@fin": "2000-07-21", "@num": "R5146-33-2", "@etat": "MODIFIE", "@debut": "1999-07-04", "@origine": "LEGI" } }, { "@etat": "ABROGE", "LIEN_ART": { "@id": "LEGIARTI000006800841", "@fin": "2004-08-08", "@num": "R5146-33-2", "@etat": "ABROGE", "@debut": "2000-07-21", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
Toute demande d'autorisation de mise sur le marché présentée pour des médicaments de haute technologie issus de certains procédés biotechnologiques figurant sur une liste A fixée par arrêté conjoint des ministres chargés de la santé, de l'industrie et de l'agriculture est soumise pour avis au comité des médicaments vétérinaires [*autorité compétente*] mentionné à l'article R. 5146-33-1.
\n
Toutefois, cette disposition ne s'applique pas lorsque le demandeur certifie que ni lui, ni aucune autre personne physique ou morale avec laquelle il est lié n'a demandé, au cours des cinq années précédentes [*délai*], l'autorisation de mettre sur le marché d'un autre Etat membre un produit contenant le ou les mêmes principes actifs ou n'envisage de demander, dans les cinq ans suivant la date d'introduction de la demande, l'autorisation de mettre sur le marché d'un autre Etat membre un produit contenant le ou les mêmes principes actifs.
\n
Lorsque, en application de l'alinéa précédent, l'avis du comité des médicaments vétérinaires n'a pas été sollicité et que, dans les cinq ans qui suivent le dépôt de la demande [*délai, point de départ*], une ou plusieurs demandes d'autorisation de mise sur le marché d'un produit contenant le ou les mêmes principes actifs issus du ou des mêmes procédés de synthèse sont adressées aux autorités compétentes des autres Etats membres par le responsable de la mise sur le marché de la spécialité pharmaceutique déjà autorisée ou avec son consentement, ce dernier en informe les autorités françaises qui saisissent pour avis le comité des médicaments vétérinaires [*autorité compétente*].
" } }, "LEGIARTI000006800842": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R5146-33-3", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "1994-10-18", "DATE_DEBUT": "1988-05-08" } }, "META_COMMUN": { "ID": "LEGIARTI000006800842", "URL": "article/LEGI/ARTI/00/00/06/80/08/LEGIARTI000006800842.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SXXXXXXXXXX5146R0330XX3A" } }, "LIENS": { "LIEN": [ { "@id": "JORFTEXT000000503843", "#text": "Décret 53-1001 1953-10-05 (Décret de codification)", "@sens": "source", "@cidtexte": "JORFTEXT000000503843", "@numtexte": "53-1001", "@typelien": "CODIFICATION", "@naturetexte": "DECRET", "@datesignatexte": "1953-10-05" }, { "@id": "JORFTEXT000000312908", "#text": "Décret 88-661 1988-05-06 art. 10 JORF 8 mai 1988", "@sens": "source", "@cidtexte": "JORFTEXT000000312908", "@nortexte": "ASEM8800585D", "@numtexte": "88-661", "@typelien": "CREATION", "@naturetexte": "DECRET", "@datesignatexte": "1988-05-06" }, { "@id": "LEGIARTI000006915826", "@num": "R5141-29", "#text": "Code de la santé publique - art. R5141-29 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006800866", "@num": "R5146-37-1", "#text": "Code de la santé publique - art. R5146-37-1 (P)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "#text": "Loi 58-356 1958-04-03 (Loi de validation)", "@sens": "source", "@typelien": "CODIFICATION" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006187189", "@fin": "1999-07-04", "#text": "Paragraphe 3 : Décisions accordant, renouvelant, suspendant ou supprimant une autorisation de mise sur le marché.", "@debut": "1977-06-23" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006174551", "@fin": "2000-07-21", "#text": "Section 2 : Médicaments vétérinaires : l'autorisation de mise sur le marché", "@debut": "1977-06-23" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006157773", "@fin": "2004-08-08", "#text": "CHAPITRE 3 : PHARMACIE VETERINAIRE", "@debut": "1977-06-23" } ] }, "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": "LEGIARTI000006800842", "@fin": "1994-10-18", "@num": "R5146-33-3", "@etat": "MODIFIE", "@debut": "1988-05-08", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006800843", "@fin": "1999-03-28", "@num": "R5146-33-3", "@etat": "MODIFIE", "@debut": "1994-10-18", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006800844", "@fin": "1999-07-04", "@num": "R5146-33-3", "@etat": "MODIFIE", "@debut": "1999-03-28", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006800845", "@fin": "2000-07-21", "@num": "R5146-33-3", "@etat": "MODIFIE", "@debut": "1999-07-04", "@origine": "LEGI" } }, { "@etat": "ABROGE", "LIEN_ART": { "@id": "LEGIARTI000006800846", "@fin": "2004-08-08", "@num": "R5146-33-3", "@etat": "ABROGE", "@debut": "2000-07-21", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
Lorsque la demande d'autorisation de mise sur le marché concerne d'autres médicaments de haute technologie figurant sur une liste B fixée par arrêté conjoint des ministres chargés de la santé, de l'industrie et de l'agriculture, le demandeur doit préciser s'il désire que sa demande soit soumise pour avis au comité des médicaments vétérinaires [*autorité compétente*].
\n
" } }, "LEGIARTI000006800866": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R5146-37-1", "ETAT": "PERIME", "TYPE": "AUTONOME", "DATE_FIN": "1999-07-04", "DATE_DEBUT": "1988-05-08" } }, "META_COMMUN": { "ID": "LEGIARTI000006800866", "URL": "article/LEGI/ARTI/00/00/06/80/08/LEGIARTI000006800866.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SXXXXXXXXXX5146R0370XX1A" } }, "LIENS": { "LIEN": [ { "@id": "JORFTEXT000000503843", "#text": "Décret 53-1001 1953-10-05 (Décret de codification)", "@sens": "source", "@cidtexte": "JORFTEXT000000503843", "@numtexte": "53-1001", "@typelien": "CODIFICATION", "@naturetexte": "DECRET", "@datesignatexte": "1953-10-05" }, { "@id": "JORFTEXT000000312908", "#text": "Décret 88-661 1988-05-06 art. 11 JORF 8 mai 1988", "@sens": "source", "@cidtexte": "JORFTEXT000000312908", "@nortexte": "ASEM8800585D", "@numtexte": "88-661", "@typelien": "CREATION", "@naturetexte": "DECRET", "@datesignatexte": "1988-05-06" }, { "@id": "LEGIARTI000006723744", "@num": "7", "#text": "Décret n°99-553 du 2 juillet 1999 - art. 7 () JORF 4 juillet 1999", "@sens": "source", "@cidtexte": "JORFTEXT000000395915", "@nortexte": "MESP9921964D", "@numtexte": "99-553", "@typelien": "PEREMPTION", "@naturetexte": "DECRET", "@datesignatexte": "1999-07-02" }, { "@id": "LEGIARTI000006915843", "@num": "R5141-46", "#text": "Code de la santé publique - art. R5141-46 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006800837", "@num": "R5146-33-2", "#text": "Code de la santé publique - art. R5146-33-2 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006800842", "@num": "R5146-33-3", "#text": "Code de la santé publique - art. R5146-33-3 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006800860", "@num": "R5146-37", "#text": "Code de la santé publique - art. R5146-37 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "#text": "Loi 58-356 1958-04-03 (Loi de validation)", "@sens": "source", "@typelien": "CODIFICATION" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006187189", "@fin": "1999-07-04", "#text": "Paragraphe 3 : Décisions accordant, renouvelant, suspendant ou supprimant une autorisation de mise sur le marché.", "@debut": "1977-06-23" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006174551", "@fin": "2000-07-21", "#text": "Section 2 : Médicaments vétérinaires : l'autorisation de mise sur le marché", "@debut": "1977-06-23" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006157773", "@fin": "2004-08-08", "#text": "CHAPITRE 3 : PHARMACIE VETERINAIRE", "@debut": "1977-06-23" } ] }, "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": "PERIME", "LIEN_ART": { "@id": "LEGIARTI000006800866", "@fin": "1999-07-04", "@num": "R5146-37-1", "@etat": "PERIME", "@debut": "1988-05-08", "@origine": "LEGI" } }, { "@etat": "ABROGE", "LIEN_ART": { "@id": "LEGIARTI000006800867", "@fin": "2004-08-08", "@num": "R5146-37-1", "@etat": "ABROGE", "@debut": "2003-08-06", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
Lorsqu'une autorisation de mise sur le marché a été accordée à une spécialité pharmaceutique relevant des listes mentionnées aux articles R. 5146-33-2 et R. 5146-33-3 après un avis favorable du comité des médicaments vétérinaires *autorité compétente*, les décisions mentionnées à l'article R. 5146-37 concernant cette spécialité pharmaceutique sont prises après avis de ce comité. Toutefois, en cas d'urgence, la décision de suspension est prise sans attendre l'avis du comité ; cette décision est transmise au comité, ainsi que la justification de l'urgence et la motivation de la suspension.
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" } }, "LEGIARTI000006801291": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R5204", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "1988-12-31", "DATE_DEBUT": "1988-05-08" } }, "META_COMMUN": { "ID": "LEGIARTI000006801291", "URL": "article/LEGI/ARTI/00/00/06/80/12/LEGIARTI000006801291.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SXXXXXXXXXX5204R0000XXAB" } }, "LIENS": { "LIEN": [ { "@id": "JORFTEXT000000503843", "#text": "Décret 53-1001 1953-10-05 (Décret de codification)", "@sens": "source", "@cidtexte": "JORFTEXT000000503843", "@numtexte": "53-1001", "@typelien": "CODIFICATION", "@naturetexte": "DECRET", "@datesignatexte": "1953-10-05" }, { "@id": "JORFTEXT000000312908", "#text": "Décret 88-661 1988-05-06 art. 12 JORF 8 mai 1988", "@sens": "source", "@cidtexte": "JORFTEXT000000312908", "@nortexte": "ASEM8800585D", "@numtexte": "88-661", "@typelien": "MODIFICATION", "@naturetexte": "DECRET", "@datesignatexte": "1988-05-06" }, { "@id": "LEGIARTI000006705043", "@num": "1", "#text": "Décret n°88-1232 du 28 décembre 1988 - art. 1 () JORF 31 décembre 1988", "@sens": "source", "@cidtexte": "JORFTEXT000000512284", "@nortexte": "SPSM8801466D", "@numtexte": "88-1232", "@typelien": "MODIFICATION", "@naturetexte": "DECRET", "@datesignatexte": "1988-12-28" }, { "@id": "LEGIARTI000006714046", "@num": "2", "#text": "Arrêté du 21 décembre 1990 - art. 2 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000351973", "@nortexte": "DEFD9101003A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "1990-12-21" }, { "@id": "LEGITEXT000025882865", "#text": "Arrêté du 24 avril 2012 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000025837104", "@nortexte": "ETSP1221693A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2012-04-24" }, { "@id": "LEGITEXT000026293964", "#text": "Arrêté du 8 août 2012 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000026292918", "@nortexte": "AFSP1232079A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2012-08-08" }, { "@id": "LEGITEXT000036947672", "#text": "Arrêté du 5 mai 2018 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000036944375", "@nortexte": "AGRG1813166A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2018-05-05" }, { "@id": "LEGIARTI000006690133", "@num": "L5132-6", "#text": "Code de la santé publique - art. L5132-6 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006690134", "@num": "L5132-6", "#text": "Code de la santé publique - art. L5132-6 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006799706", "@num": "R5093", "#text": "Code de la santé publique - art. R5093 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006800090", "@num": "R5123", "#text": "Code de la santé publique - art. R5123 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006800166", "@num": "R5135", "#text": "Code de la santé publique - art. R5135 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006801070", "@num": "R5149", "#text": "Code de la santé publique - art. R5149 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006801146", "@num": "R5170", "#text": "Code de la santé publique - art. R5170 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006801243", "@num": "R5190", "#text": "Code de la santé publique - art. R5190 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006801252", "@num": "R5193", "#text": "Code de la santé publique - art. R5193 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGITEXT000006072665", "#text": "Code de la santé publique R5170 : NON APPLICATION AUX PREPARATIONS MEDICAMENTEUSES DESTINEES A LA MEDECINE HUMAINE RENFERMANT DES SUBSTANCES VENENEUSES A DES DOSES FIXEES PAR ARRETE", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "SPEC_APPLI", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "#text": "Loi 58-356 1958-04-03 (Loi de validation)", "@sens": "source", "@typelien": "CODIFICATION" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006194994", "@fin": "1988-12-31", "#text": "2 : OPERATIONS EFFECTUEES DANS UNE OFFICINE DE PHARMACIE.", "@debut": "1956-11-28" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006187206", "@fin": "1988-12-31", "#text": "PARAGRAPHE 4 : REGIME DES STUPEFIANTS (TABLEAU B) ET DES PREPARATIONS QUI LES CONTIENNENT.", "@debut": "1956-11-28" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006174568", "@fin": "1988-12-31", "#text": "SECTION 3 : REGIME DES SUBSTANCES VENENEUSES LORSQU'ELLES SONT DESTINEES A LA MEDECINE", "@debut": "1956-11-28" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006157778", "@fin": "2004-08-08", "#text": "CHAPITRE 1 : SUBSTANCES VENENEUSES", "@debut": "1956-11-28" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006142908", "@fin": "2004-08-08", "#text": "TITRE 3 : RESTRICTION AU COMMERCE DE CERTAINES SUBSTANCES ET DE CERTAINS OBJETS", "@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": "LEGIARTI000006801290", "@fin": "1988-05-08", "@num": "R5204", "@etat": "MODIFIE", "@debut": "1956-11-28", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006801291", "@fin": "1988-12-31", "@num": "R5204", "@etat": "MODIFIE", "@debut": "1988-05-08", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006801292", "@fin": "1994-12-03", "@num": "R5204", "@etat": "MODIFIE", "@debut": "1988-12-31", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006801293", "@fin": "1999-04-01", "@num": "R5204", "@etat": "MODIFIE", "@debut": "1994-12-03", "@origine": "LEGI" } }, { "@etat": "ABROGE", "LIEN_ART": { "@id": "LEGIARTI000006801294", "@fin": "2000-06-22", "@num": "R5204", "@etat": "ABROGE", "@debut": "1999-04-01", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
Les préparations magistrales contenant des substances du tableau B doivent porter sur une étiquette le nom, l'adresse du pharmacien, le numéro d'inscription à l'ordonnancier et le mode d'emploi du médicament.
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Si le médicament est destiné à la médecine humaine, et à être administré par les voies : orale, perlinguale, rectale, vaginale, urétrale ou transcutanée, cette étiquette est blanche et la préparation reçoit en outre une contre-étiquette portant imprimée en noir sur fond rouge orangé [*couleur*] la mention \"Ne pas dépasser la dose prescrite\".
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Dans les autres cas l'étiquette est rouge orangé avec la mention \"Ne pas avaler\" imprimée en noir. Elle peut comporter un espace blanc suffisant pour permettre l'inscription du mode d'emploi du médicament.
\n
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Les médicaments spécialisés contenant une ou plusieurs substances du tableau B doivent en outre comporter, sur les étiquettes intérieure et extérieure, le nom de la substance tel qu'il figure au tableau B, sa concentration en toutes lettres, la quantité contenue dans le récipient et, sur l'emballage extérieur, un espace blanc encadré d'un filet rouge-orangé, dans lequel le pharmacien détaillant doit inscrire son nom, son adresse, le numéro d'inscription à l'ordonnancier et le mode d'emploi indiqué par l'auteur de la prescription.
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Si la spécialité comprend en outre des substances inscrites à d'autres tableaux, seul doit figurer le filet rouge-orangé.
\n
Si le médicament est destiné à la médecine vétérinaire, la préparation reçoit en outre, dans tous les cas, une étiquette portant, imprimée en noir sur fond rouge orangé, la mention \"Usage vétérinaire\".
" } } }, "article_lien": [ { "article_id": "LEGIARTI000006800837", "cible": false, "cidtexte": "JORFTEXT000000312908", "id": "JORFTEXT000000312908", "typelien": "CREATION" }, { "article_id": "LEGIARTI000006800842", "cible": false, "cidtexte": "JORFTEXT000000312908", "id": "JORFTEXT000000312908", "typelien": "CREATION" }, { "article_id": "LEGIARTI000006800216", "cible": false, "cidtexte": "JORFTEXT000000312908", "id": "JORFTEXT000000312908", "typelien": "CREATION" }, { "article_id": "LEGIARTI000006800221", "cible": false, "cidtexte": "JORFTEXT000000312908", "id": "JORFTEXT000000312908", "typelien": "CREATION" }, { "article_id": "LEGIARTI000006800866", "cible": false, "cidtexte": "JORFTEXT000000312908", "id": "JORFTEXT000000312908", "typelien": "CREATION" }, { "article_id": "LEGIARTI000006800061", "cible": false, "cidtexte": "JORFTEXT000000312908", "id": "JORFTEXT000000312908", "typelien": "MODIFICATION" }, { "article_id": "LEGIARTI000006800179", "cible": false, "cidtexte": "JORFTEXT000000312908", "id": "JORFTEXT000000312908", "typelien": "MODIFICATION" }, { "article_id": "LEGIARTI000006800729", "cible": false, "cidtexte": "JORFTEXT000000312908", "id": "JORFTEXT000000312908", "typelien": "MODIFICATION" }, { "article_id": "LEGIARTI000006800205", "cible": false, "cidtexte": "JORFTEXT000000312908", "id": "JORFTEXT000000312908", "typelien": "CREATION" }, { "article_id": "LEGIARTI000006800148", "cible": false, "cidtexte": "JORFTEXT000000312908", "id": "JORFTEXT000000312908", "typelien": "CREATION" }, { "article_id": "LEGIARTI000006800750", "cible": false, "cidtexte": "JORFTEXT000000312908", "id": "JORFTEXT000000312908", "typelien": "CREATION" }, { "article_id": "LEGIARTI000006800042", "cible": false, "cidtexte": "JORFTEXT000000312908", "id": "JORFTEXT000000312908", "typelien": "CREATION" }, { "article_id": "LEGIARTI000006800142", "cible": false, "cidtexte": "JORFTEXT000000312908", "id": "JORFTEXT000000312908", "typelien": "MODIFICATION" }, { "article_id": "LEGIARTI000006801291", "cible": false, "cidtexte": "JORFTEXT000000312908", "id": "JORFTEXT000000312908", "typelien": "MODIFICATION" } ], "texte_version": { "JORFTEXT000000312908": { "SM": { "CONTENU": "MODIFICATION DES ART. R5118,R5133,R5136-1,R5146-8,R5204; AJOUT DES ART. R5115-9,R5133-1,R5139-1,R5140-1,R5140-2,R5146-TER,R5146-33-2,R5146-33-3 ET R5146-37-1.
OBLIGATION DU RESPECT DES BONNES PRATIQUES DE LABORATOIRE POUR LES ESSAIS PHARMACOLOGIQUES ET TOXICOLOGIQUES DES MEDICAMENTS DESTINES A L'HOMME ET A L'ANIMAL.
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