{ "article": { "LEGIARTI000006690221": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "L5141-12-1", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2010-07-01", "DATE_DEBUT": "2007-04-27" } }, "META_COMMUN": { "ID": "LEGIARTI000006690221", "URL": "article/LEGI/ARTI/00/00/06/69/02/LEGIARTI000006690221.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SPANXXXXXXX1X5141L12XXBA" } }, "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": "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": "LEGIARTI000006698456", "@num": "37", "#text": "Ordonnance n°2007-613 du 26 avril 2007 - art. 37 () JORF 27 avril 2007", "@sens": "source", "@cidtexte": "JORFTEXT000000646989", "@nortexte": "SANX0700046R", "@numtexte": "2007-613", "@typelien": "CREATION", "@naturetexte": "ORDONNANCE", "@datesignatexte": "2007-04-26" }, { "@id": "LEGIARTI000047291490", "@num": "L5141-16", "#text": "Code de la santé publique - art. L5141-16 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@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": "LEGIARTI000006690221", "@fin": "2010-07-01", "@num": "L5141-12-1", "@etat": "MODIFIE", "@debut": "2007-04-27", "@origine": "LEGI" } }, { "@etat": "ABROGE", "LIEN_ART": { "@id": "LEGIARTI000021666205", "@fin": "2022-03-25", "@num": "L5141-12-1", "@etat": "ABROGE", "@debut": "2010-07-01", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
La préparation des allergènes pour un seul animal doit être effectuée par une personne qualifiée ou une entreprise ou un organisme employant une personne qualifiée ayant obtenu à cet effet une autorisation délivrée par le directeur général de l'Agence française de sécurité sanitaire des aliments.
\n
" } }, "LEGIARTI000006698456": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "37", "TYPE": "ENTIEREMENT_MODIF", "DATE_FIN": "2999-01-01", "DATE_DEBUT": "2999-01-01" } }, "META_COMMUN": { "ID": "LEGIARTI000006698456", "URL": "article/LEGI/ARTI/00/00/06/69/84/LEGIARTI000006698456.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SPFBEXXXXXX037AAXXXXXXAA" } }, "LIENS": { "LIEN": [ { "@id": "LEGIARTI000006690221", "@num": "L5141-12-1", "#text": "Code de la santé publique - art. L5141-12-1 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CREATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006125543", "@fin": "2999-01-01", "#text": "Section 2 : Autorisations de mise sur le marché et enregistrements.", "@debut": "2007-04-28" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006103666", "@fin": "2999-01-01", "#text": "Chapitre VI : Médicaments vétérinaires", "@debut": "2007-04-28" } ] }, "@cid": "JORFTEXT000000646989", "@nor": "SANX0700046R", "@num": "2007-613", "@nature": "ORDONNANCE", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Ordonnance n° 2007-613 du 26 avril 2007 portant diverses dispositions d'adaptation au droit communautaire dans le domaine du médicament", "@debut": "2999-01-01", "@id_txt": "JORFTEXT000000646989", "@c_titre_court": "Ordonnance n° 2007-613 du 26 avril 2007" }, { "@fin": "2999-01-01", "#text": "Ordonnance n° 2007-613 du 26 avril 2007 portant diverses dispositions d'adaptation au droit communautaire dans le domaine du médicament", "@debut": "2008-04-17", "@id_txt": "LEGITEXT000018652169", "@c_titre_court": "Ordonnance n° 2007-613 du 26 avril 2007" }, { "@fin": "2008-04-17", "#text": "Ordonnance n° 2007-613 du 26 avril 2007 portant diverses dispositions d'adaptation au droit communautaire dans le domaine du médicament", "@debut": "2007-04-28", "@id_txt": "LEGITEXT000006056023", "@c_titre_court": "Ordonnance n° 2007-613 du 26 avril 2007" } ], "@ministere": "MINISTERE DE LA SANTE ET DES SOLIDARITES", "@date_publi": "2007-04-27", "@date_signature": "2007-04-26", "@num_parution_jo": "0099" } }, "VERSIONS": { "VERSION": [ { "LIEN_ART": { "@id": "LEGIARTI000006698456", "@fin": "2999-01-01", "@num": "37", "@debut": "2999-01-01", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "a modifié les dispositions suivantes
\n
" } }, "LEGIARTI000020627760": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "L5141-16", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2010-07-01", "DATE_DEBUT": "2009-05-14" } }, "META_COMMUN": { "ID": "LEGIARTI000020627760", "URL": "article/LEGI/ARTI/00/00/20/62/77/LEGIARTI000020627760.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "LIENS": { "LIEN": [ { "@id": "LEGIARTI000020606480", "@num": "67", "#text": "LOI n°2009-526\n du 12 mai 2009 - art. 67", "@sens": "cible", "@cidtexte": "JORFTEXT000020604162", "@nortexte": "BCFX0824886L", "@numtexte": "2009-526", "@typelien": "MODIFIE", "@naturetexte": "LOI", "@datesignatexte": "2009-05-12" }, { "@id": "LEGITEXT000033235928", "#text": "Décret n°2016-1363 du 12 octobre 2016 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000033234570", "@nortexte": "AFSP1618848D", "@numtexte": "2016-1363", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2016-10-12" }, { "@id": "LEGITEXT000033660783", "#text": "Décret n°2016-1788 du 19 décembre 2016 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000033659554", "@nortexte": "AGRG1630018D", "@numtexte": "2016-1788", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2016-12-19" }, { "@id": "LEGIARTI000006690187", "@num": "L5141-1", "#text": "Code de la santé publique - art. L5141-1", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006690214", "@num": "L5141-10", "#text": "Code de la santé publique - art. L5141-10", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006690217", "@num": "L5141-11", "#text": "Code de la santé publique - art. L5141-11", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006690219", "@num": "L5141-12", "#text": "Code de la santé publique - art. L5141-12", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006690221", "@num": "L5141-12-1", "#text": "Code de la santé publique - art. L5141-12-1", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006690225", "@num": "L5141-15", "#text": "Code de la santé publique - art. L5141-15", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006690225", "@num": "L5141-15", "#text": "Code de la santé publique - art. L5141-15 (T)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006690225", "@num": "L5141-15", "#text": "Code de la santé publique - art. L5141-15 (T)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006690188", "@num": "L5141-2", "#text": "Code de la santé publique - art. L5141-2", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006690197", "@num": "L5141-5", "#text": "Code de la santé publique - art. L5141-5 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006690203", "@num": "L5141-6", "#text": "Code de la santé publique - art. L5141-6", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006690211", "@num": "L5141-9", "#text": "Code de la santé publique - art. L5141-9", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000045405145", "@num": "L5142-7", "#text": "Code de la santé publique - art. L5142-7 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006690255", "@num": "L5143-4", "#text": "Code de la santé publique - art. L5143-4", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000045405326", "@num": "L5145-3", "#text": "Code de la santé publique - art. L5145-3 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000045405497", "@num": "L5442-10", "#text": "Code de la santé publique - art. L5442-10 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000033666929", "@num": "R5141-144", "#text": "Code de la santé publique - art. 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R5141-48 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000045405624", "@num": "L234-2", "#text": "Code rural et de la pêche maritime - art. 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": "LEGIARTI000006690228", "@fin": "2004-08-11", "@num": "L5141-16", "@etat": "MODIFIE", "@debut": "2001-04-14", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006690229", "@fin": "2007-04-27", "@num": "L5141-16", "@etat": "MODIFIE", "@debut": "2004-08-11", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006690230", "@fin": "2009-05-14", "@num": "L5141-16", "@etat": "MODIFIE", "@debut": "2007-04-27", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000020627760", "@fin": "2010-07-01", "@num": "L5141-16", "@etat": "MODIFIE", "@debut": "2009-05-14", "@origine": "LEGI" } }, { "@etat": "MODIFIE_MORT_NE", "LIEN_ART": { "@id": "LEGIARTI000021666192", "@fin": "2010-03-27", "@num": "L5141-16", "@etat": "MODIFIE_MORT_NE", "@debut": "2010-07-01", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000022037258", "@fin": "2014-10-15", "@num": "L5141-16", "@etat": "MODIFIE", "@debut": "2010-07-01", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000029595035", "@fin": "2017-07-22", "@num": "L5141-16", "@etat": "MODIFIE", "@debut": "2014-10-15", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000035253899", "@fin": "2020-12-05", "@num": "L5141-16", "@etat": "MODIFIE", "@debut": "2017-07-22", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000042623972", "@fin": "2022-03-25", "@num": "L5141-16", "@etat": "MODIFIE", "@debut": "2020-12-05", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000045404972", "@fin": "2023-03-11", "@num": "L5141-16", "@etat": "MODIFIE", "@debut": "2022-03-25", "@origine": "LEGI" } }, { "@etat": "VIGUEUR", "LIEN_ART": { "@id": "LEGIARTI000047291490", "@fin": "2999-01-01", "@num": "L5141-16", "@etat": "VIGUEUR", "@debut": "2023-03-11", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "

Sont déterminées, en tant que de besoin, par décret en Conseil d'Etat :

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1° Les règles relatives à l'étiquetage, la notice et la dénomination des médicaments vétérinaires mentionnés aux articles L. 5141-1 et L. 5141-2 ;

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2° Les conditions dans lesquelles des autorisations de mise sur le marché peuvent être considérées comme faisant partie d'une autorisation de mise sur le marché globale ;

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3° Les modalités de présentation des demandes tendant à obtenir l'autorisation de mise sur le marché prévue à l'article L. 5141-5, le contenu du dossier présenté à l'appui de ces demandes, ainsi qu'après la délivrance de l'autorisation les modalités de son actualisation, les conditions dans lesquelles le demandeur peut être dispensé de produire certains éléments du dossier et celles dans lesquelles interviennent les décisions accordant, modifiant, soumettant à des obligations spécifiques, renouvelant, suspendant ou supprimant ces autorisations ;

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4° Les justifications, y compris celles qui sont relatives à l'étiquetage, qui doivent être fournies à l'appui des demandes d'autorisation de mise sur le marché et qui comprennent obligatoirement la vérification de l'existence des propriétés définies à l'article L. 5141-6 par des experts possédant les qualifications techniques et professionnelles fixées par le même décret ;

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5° Les modalités de présentation des demandes tendant à obtenir l'enregistrement d'un médicament vétérinaire homéopathique prévu à l'article L. 5141-9, le contenu du dossier présenté à l'appui de ces demandes, y compris les documents permettant de démontrer la qualité des lots de fabrication de ces médicaments homéopathiques vétérinaires, ainsi que les conditions dans lesquelles interviennent les décisions accordant, modifiant, renouvelant, suspendant, ou supprimant cet enregistrement ;

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6° Les règles applicables à l'expérimentation des médicaments ;

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7° Les modalités de présentation des demandes tendant à obtenir les autorisations temporaires d'utilisation d'un médicament vétérinaire prévues à l'article L. 5141-10, le contenu du dossier présenté à l'appui de ces demandes, ainsi que les conditions dans lesquelles interviennent les décisions accordant, modifiant, suspendant ou supprimant ces autorisations ;

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8° Les règles applicables en cas de changement de titulaire de l'autorisation de mise sur le marché d'un médicament vétérinaire ou de l'enregistrement d'un médicament homéopathique vétérinaire ;

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9° Les conditions auxquelles est subordonnée la publicité pour les médicaments vétérinaires ;

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10° Les règles applicables à la pharmacovigilance des médicaments vétérinaires et des médicaments à usage humain utilisés au titre du 3° de l'article L. 5143-4 ;

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11° Les modalités de présentation des demandes tendant à obtenir les autorisations de préparer les autovaccins prévus à l'article L. 5141-12 ou de préparer les allergènes pour un seul animal prévues à l'article L. 5141-12-1, le contenu du dossier présenté à l'appui de ces demandes, ainsi que les conditions dans lesquelles interviennent les décisions accordant, modifiant, renouvelant, suspendant ou supprimant ces autorisations ;

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12° Les modalités d'application du présent titre aux départements d'outre-mer ;

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13° Les conditions dans lesquelles les vétérinaires mentionnés à l'article L. 5141-15 peuvent utiliser les médicaments vétérinaires mentionnés au même article ;

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14° Les règles de procédure applicables aux recours ouverts contre les décisions visées aux 3°, 5°, 7° et 11° du présent article ;

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15° Les conditions d'application de l'article L. 5141-11 ;

16° Les conditions dans lesquelles la déclaration mentionnée au sixième alinéa de l'article L. 5141-5 est effectuée.

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Sauf dans le cas mentionné au 12° du présent article, les décrets mentionnés au premier alinéa sont pris après avis de l'Agence française de sécurité sanitaire des aliments.

\n
" } }, "LEGIARTI000021666192": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "L5141-16", "ETAT": "MODIFIE_MORT_NE", "TYPE": "AUTONOME", "DATE_FIN": "2010-03-27", "DATE_DEBUT": "2010-07-01" } }, "META_COMMUN": { "ID": "LEGIARTI000021666192", "URL": "article/LEGI/ARTI/00/00/21/66/61/LEGIARTI000021666192.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "NOTA": { "CONTENU": "

Ordonnance n° 2010-18 du 7 janvier 2010 art 5 : La présente ordonnance entre en vigueur à une date et dans les conditions fixées par décret et au plus tard le 1er juillet 2010.

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Article L5141-12-1 AUTONOME MODIFIE, en vigueur du 27/04/2007 au 01/07/2010 (Code de la santé publique)