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A modifié les dispositions suivantes :

- Code de la santé publique
\n Sct. Sous-section 4 : Commission nationale des médicaments vétérinaires., Art. R5141-48, Art. R5141-49, Art. R5141-50\n
\n

\n
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Le titulaire de l'autorisation de mise sur le marché responsable de l'étude mentionnée à l'article R. 5141-30 tient à la disposition du directeur général de l'Agence nationale de sécurité sanitaire de l'alimentation, de l'environnement et du travail le protocole de l'étude et son rapport.

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Les études post-autorisation peuvent être réalisées, pour le compte de ce titulaire et sous sa responsabilité, par une autre entreprise ou un autre organisme.
\n
Toute étude doit faire l'objet d'un protocole validé par le responsable décrivant notamment l'objectif et la méthodologie de l'étude. A l'issue de l'étude, le responsable valide un rapport analysant notamment l'incidence sur le rapport entre les bénéfices et les risques liés au médicament, accompagné d'un résumé des résultats de l'étude.
\n
Les modalités de réalisation de ces études ne doivent en aucun cas promouvoir l'utilisation du médicament vétérinaire.

" } }, "LEGIARTI000033240296": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R5141-48", "ETAT": "ABROGE", "TYPE": "AUTONOME", "DATE_FIN": "2023-11-25", "DATE_DEBUT": "2016-10-15" } }, "META_COMMUN": { "ID": "LEGIARTI000033240296", "URL": "article/LEGI/ARTI/00/00/33/24/02/LEGIARTI000033240296.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "NOTA": { "CONTENU": "

\n
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On entend par \" études portant sur des médicaments vétérinaires bénéficiant déjà d'une autorisation de mise sur le marché \" au sens du 6° de l'article L. 5141-16, ci-après dénommés \" études post-autorisation \", les études réalisées sous la responsabilité du titulaire de l'autorisation de mise sur le marché, mentionnée à l'article L. 5141-5, qui en assure la gestion, ou sous la responsabilité de l'exploitant, tel que défini à l'article R. 5142-1, et relevant d'une des catégories suivantes :
\n
1° Les \" études de surveillance après mise sur le marché \" définies au 6° de l'article R. 5141-92 ;
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2° Les essais d'innocuité, y compris les essais évaluant le risque pour l'environnement, l'étude des résidus et les essais précliniques, ainsi que les essais cliniques portant sur des médicaments vétérinaires bénéficiant déjà d'une autorisation de mise sur le marché et qui ne sont pas réalisés en vue d'une modification de l'autorisation de mise sur le marché.

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Article 1 ENTIEREMENT_MODIF (Décret n° 2016-1363 du 12 octobre 2016 fixant les règles applicables aux études portant sur des médicaments vétérinaires bénéficiant déjà d'une autorisation de mise sur le marché)