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R5145-37 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006800688", "@num": "R5145-38", "#text": "Code de la santé publique - art. R5145-38 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006800978", "@num": "R5146-41-20", "#text": "Code de la santé publique - art. R5146-41-20 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGITEXT000006072665", "#text": "Code de la santé publique L617-1 alinéas 1, 4, 5", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006586374", "@num": "L934-2", "#text": "Code rural - art. 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L234-2 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006071367", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006171385", "@fin": "2999-01-01", "#text": "Chapitre Ier : Dispositions générales.", "@debut": "2000-06-22" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006155087", "@fin": "2999-01-01", "#text": "Titre IV : Médicaments vétérinaires", "@debut": "2000-06-22" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006140630", "@fin": "2999-01-01", "#text": "Livre Ier : Produits pharmaceutiques", "@debut": "2000-06-22" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006125349", "@fin": "2999-01-01", "#text": "Cinquième partie : Produits de santé", "@debut": "2000-06-22" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006103419", "@fin": "2999-01-01", "#text": "Partie législative", "@debut": "2000-06-22" } ] }, "@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": "LEGIARTI000006690196", "@fin": "2001-04-14", "@num": "L5141-5", "@etat": "MODIFIE", "@debut": "2000-06-22", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006690197", "@fin": "2007-04-27", "@num": "L5141-5", "@etat": "MODIFIE", "@debut": "2001-04-14", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006690198", "@fin": "2009-05-14", "@num": "L5141-5", "@etat": "MODIFIE", "@debut": "2007-04-27", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000020627757", "@fin": "2010-02-26", "@num": "L5141-5", "@etat": "MODIFIE", "@debut": "2009-05-14", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000021941921", "@fin": "2010-07-01", "@num": "L5141-5", "@etat": "MODIFIE", "@debut": "2010-02-26", "@origine": "LEGI" } }, { "@etat": "ABROGE", "LIEN_ART": { "@id": "LEGIARTI000021666237", "@fin": "2022-03-25", "@num": "L5141-5", "@etat": "ABROGE", "@debut": "2010-07-01", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
Exception faite des aliments médicamenteux, des autovaccins et des préparations extemporanées vétérinaires, tout médicament vétérinaire qui ne fait pas l'objet d'une autorisation de mise sur le marché délivrée par l'autorité compétente de la Communauté européenne en application du règlement (CEE) n° 2309/93 du Conseil du 22 juillet 1993 établissant des procédures communautaires pour l'autorisation et la surveillance des médicaments à usage humain et à usage vétérinaire et instituant une agence européenne pour l'évaluation des médicaments doit faire l'objet, avant sa mise sur le marché à titre gratuit ou onéreux, d'une autorisation de mise sur le marché délivrée par l'Agence française de sécurité sanitaire des aliments. Le titulaire de l'autorisation de mise sur le marché doit être établi dans la Communauté européenne.
\n
L'autorisation de mise sur le marché est délivrée pour une durée de cinq ans ; elle est ensuite renouvelable par période quinquennale.
\n
Toutefois, les médicaments contenant des substances actives figurant à l'annexe III du règlement (CEE) n° 2377/90 du Conseil du 26 juin 1990 établissant une procédure communautaire pour la fixation de limites maximales de résidus de médicaments vétérinaires dans les aliments pour animaux d'origine animale ne sont autorisés que pour la période pour laquelle une limite a été fixée par le règlement ; au cas où cette période est prolongée, l'autorisation peut être reconduite pour une durée égale.
\n
A titre exceptionnel, lorsque le médicament, compte tenu de l'état des connaissances, justifie l'octroi d'une autorisation de mise sur le marché, mais qu'il nécessite une surveillance particulière après sa mise sur le marché, l'autorisation peut être soumise à un réexamen annuel et à certaines obligations spécifiques visant, après son obtention, à la réalisation d'études complémentaires ou à la notification d'effets indésirables.
\n
Cette autorisation peut être assortie :
\n
1° De l'obligation de porter sur l'étiquetage et la notice des mentions utiles pour la protection de la santé publique ou de la santé animale, telles que des précautions particulières d'emploi ;
\n
2° De l'obligation d'introduire une substance de marquage dans le médicament ;
\n
3° De conditions restrictives de délivrance nécessaires à la protection de la santé humaine ou de la santé animale.
\n
Lorsqu'elle porte sur un prémélange médicamenteux, elle comporte les conditions techniques que doit respecter le fabricant des aliments médicamenteux correspondants, ainsi que les modalités d'emploi de ces aliments.
\n
Lorsque, du fait de la rareté des indications prévues ou du fait de l'état d'avancement de la science, la demande n'est pas assortie de l'ensemble des justifications prévues, une autorisation peut être accordée, dans des conditions fixées par le décret prévu au 5° de l'article L. 5141-16, sous réserve que le médicament soit délivré sur prescription d'un vétérinaire et administré sous la responsabilité de ce dernier.
\n
Toute modification des éléments d'une autorisation de mise sur le marché délivrée par l'Agence française de sécurité sanitaire des aliments, doit être préalablement autorisée.
" } }, "LEGIARTI000006690204": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "L5141-6", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2007-04-27", "DATE_DEBUT": "2001-04-14" } }, "META_COMMUN": { "ID": "LEGIARTI000006690204", "URL": "article/LEGI/ARTI/00/00/06/69/02/LEGIARTI000006690204.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SPANXXXXXXX1X5141L06XXAB" } }, "LIENS": { "LIEN": [ { "@id": "JORFTEXT000000217229", "#text": "Ordonnance 2000-548 2000-06-15", "@sens": "source", "@cidtexte": "JORFTEXT000000217229", "@nortexte": "MESX0000036P", "@typelien": "CODIFICATION", "@naturetexte": "RAPPORT", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006698287", "@num": "2", "#text": "Rapport - art. 2 () JORF 14 avril 2001", "@sens": "source", "@cidtexte": "JORFTEXT000000588385", "@nortexte": "MESX0100033R", "@numtexte": "2001-313", "@typelien": "MODIFICATION", "@naturetexte": "ORDONNANCE", "@datesignatexte": "2001-04-11" }, { "@id": "JORFTEXT000000227015", "#text": "Loi 2002-303 2002-03-04 art. 92 JORF 5 mars 2002", "@sens": "source", "@cidtexte": "JORFTEXT000000227015", "@nortexte": "MESX0100092L", "@numtexte": "2002-303", "@typelien": "CODIFICATION", "@naturetexte": "LOI", "@datesignatexte": "2002-03-04" }, { "@id": "LEGIARTI000006690225", "@num": "L5141-15", "#text": "Code de la santé publique - art. 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L5144-1 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006690631", "@num": "L5511-14", "#text": "Code de la santé publique - art. L5511-14 (VT)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693816", "@num": "L617-2", "#text": "Code de la santé publique - art. L617-2 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693815", "@num": "L617-2", "#text": "Code de la santé publique - art. L617-2 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693820", "@num": "L617-3", "#text": "Code de la santé publique - art. L617-3 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000023860201", "@num": "R5141-35", "#text": "Code de la santé publique - art. R5141-35 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000023860181", "@num": "R5141-41", "#text": "Code de la santé publique - art. R5141-41 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000023860177", "@num": "R5141-42", "#text": "Code de la santé publique - art. R5141-42 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006915840", "@num": "R5141-43", "#text": "Code de la santé publique - art. R5141-43 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006800865", "@num": "R5146-37", "#text": "Code de la santé publique - art. R5146-37 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGITEXT000006072665", "#text": "Code de la santé publique L617-2, L617-3 alinéa 4", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006582729", "@num": "L234-2", "#text": "Code rural - art. 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L934-2 (T)", "@sens": "cible", "@cidtexte": "LEGITEXT000006071367", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006171385", "@fin": "2999-01-01", "#text": "Chapitre Ier : Dispositions générales.", "@debut": "2000-06-22" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006155087", "@fin": "2999-01-01", "#text": "Titre IV : Médicaments vétérinaires", "@debut": "2000-06-22" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006140630", "@fin": "2999-01-01", "#text": "Livre Ier : Produits pharmaceutiques", "@debut": "2000-06-22" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006125349", "@fin": "2999-01-01", "#text": "Cinquième partie : Produits de santé", "@debut": "2000-06-22" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006103419", "@fin": "2999-01-01", "#text": "Partie législative", "@debut": "2000-06-22" } ] }, "@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": "LEGIARTI000006690203", "@fin": "2001-04-14", "@num": "L5141-6", "@etat": "MODIFIE", "@debut": "2000-06-22", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006690204", "@fin": "2007-04-27", "@num": "L5141-6", "@etat": "MODIFIE", "@debut": "2001-04-14", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006690205", "@fin": "2011-06-18", "@num": "L5141-6", "@etat": "MODIFIE", "@debut": "2007-04-27", "@origine": "LEGI" } }, { "@etat": "ABROGE", "LIEN_ART": { "@id": "LEGIARTI000024198064", "@fin": "2022-03-25", "@num": "L5141-6", "@etat": "ABROGE", "@debut": "2011-06-18", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
L'autorisation de mise sur le marché est refusée s'il apparaît :
\n
1° Soit que le médicament vétérinaire n'a pas la composition qualitative ou quantitative déclarée ou qu'il est nocif dans les conditions d'emploi indiquées dans le dossier de demande, ou que l'effet thérapeutique annoncé fait défaut sur l'espèce animale de destination ;
\n
2° Soit que le médicament vétérinaire est présenté pour une utilisation interdite ;
\n
3° Soit, pour les médicaments destinés à être administrés à des animaux dont la chair ou les produits sont destinés à la consommation humaine :
\n
a) Que le temps d'attente indiqué dans le dossier est insuffisant pour que les denrées alimentaires provenant de l'animal traité ne contiennent pas de résidus à des niveaux supérieurs aux limites maximales de résidus fixées par le règlement (CEE) n° 2377/90 du Conseil du 26 juin 1990 précité ou qu'il est insuffisamment justifié ;
\n
b) Ou que la ou les substances à action pharmacologique présentes dans le médicament ne figurent pas dans l'une des annexes I, II et III du même règlement.
\n
L'autorisation peut être refusée s'il apparaît que la mise sur le marché d'un médicament vétérinaire est de nature à compromettre gravement la protection de la santé humaine ou de la santé animale.
\n
Elle peut être modifiée, suspendue ou supprimée pour les mêmes motifs.
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Comme il est dit au VII de l'article L. 234-2 du code rural, ci-après reproduit :
\n
\" Art.L. 234-2.-VII.-Un médicament vétérinaire soumis à autorisation de mise sur le marché en application de l'article L. 5141-5 du code de la santé publique ne peut être administré à un animal que si cette autorisation a été délivrée et dans les conditions prévues par elle ou par la prescription d'un vétérinaire. \"
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Article 2 ENTIEREMENT_MODIF (Ordonnance no 2001-313 du 11 avril 2001 portant transposition de directives relatives aux médicaments vétérinaires)