{ "article": { "LEGIARTI000025787411": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R5139-12", "ETAT": "VIGUEUR", "TYPE": "AUTONOME", "DATE_FIN": "2999-01-01", "DATE_DEBUT": "2012-05-01" } }, "META_COMMUN": { "ID": "LEGIARTI000025787411", "URL": "article/LEGI/ARTI/00/00/25/78/74/LEGIARTI000025787411.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "LIENS": { "LIEN": [ { "@id": "LEGIARTI000025765496", "@num": "5", "#text": "Décret n°2012-597\n du 27 avril 2012 - art. 5", "@sens": "cible", "@cidtexte": "JORFTEXT000025757625", "@nortexte": "ETSP1206945D", "@numtexte": "2012-597", "@typelien": "MODIFIE", "@naturetexte": "DECRET", "@datesignatexte": "2012-04-27" }, { "@id": "LEGIARTI000035680281", "@num": "R5139-19", "#text": "Code de la santé publique - art. R5139-19 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000022415654", "@num": "R5139-3", "#text": "Code de la santé publique - art. R5139-3", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000022417672", "@fin": "2999-01-01", "#text": "Section 1 : Conditions de délivrance des autorisations", "@debut": "2010-07-02" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000018213362", "@fin": "2999-01-01", "#text": "Chapitre IX : Micro-organismes et toxines", "@debut": "2008-03-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006161013", "@fin": "2999-01-01", "#text": "Titre III : Autres produits et substances pharmaceutiques réglementés", "@debut": "2004-08-08" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006145489", "@fin": "2999-01-01", "#text": "Livre Ier : Produits pharmaceutiques", "@debut": "2004-07-29" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006132399", "@fin": "2999-01-01", "#text": "Cinquième partie : Produits de santé", "@debut": "2004-07-29" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006112927", "@fin": "2999-01-01", "#text": "Partie réglementaire", "@debut": "2000-12-23" } ] }, "@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": "LEGIARTI000022417628", "@fin": "2012-05-01", "@num": "R5139-12", "@etat": "MODIFIE", "@debut": "2010-07-02", "@origine": "LEGI" } }, { "@etat": "VIGUEUR", "LIEN_ART": { "@id": "LEGIARTI000025787411", "@fin": "2999-01-01", "@num": "R5139-12", "@etat": "VIGUEUR", "@debut": "2012-05-01", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "

Le titulaire de l'autorisation tient à jour la liste prévue au 1° de l'article R. 5139-3 et la transmet à l'Agence nationale de sécurité du médicament et des produits de santé au plus tard le 15 février de chaque année. Toute modification de cette liste intervenue en cours d'année est signalée sans délai au directeur général de l'agence.

" } }, "LEGIARTI000022417660": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R5139-3", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2011-04-14", "DATE_DEBUT": "2010-07-02" } }, "META_COMMUN": { "ID": "LEGIARTI000022417660", "URL": "article/LEGI/ARTI/00/00/22/41/76/LEGIARTI000022417660.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "LIENS": { "LIEN": [ { "@id": "LEGIARTI000022415444", "@num": "1", "#text": "Décret n°2010-736\n du 30 juin 2010 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000022415024", "@nortexte": "SASP1005190D", "@numtexte": "2010-736", "@typelien": "CREE", "@naturetexte": "DECRET", "@datesignatexte": "2010-06-30" }, { "@id": "LEGIARTI000022417634", "@num": "R5139-10", "#text": "Code de la santé publique - art. R5139-10 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000025787414", "@num": "R5139-11", "#text": "Code de la santé publique - art. R5139-11 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000025787411", "@num": "R5139-12", "#text": "Code de la santé publique - art. R5139-12 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000022417672", "@fin": "2999-01-01", "#text": "Section 1 : Conditions de délivrance des autorisations", "@debut": "2010-07-02" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000018213362", "@fin": "2999-01-01", "#text": "Chapitre IX : Micro-organismes et toxines", "@debut": "2008-03-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006161013", "@fin": "2999-01-01", "#text": "Titre III : Autres produits et substances pharmaceutiques réglementés", "@debut": "2004-08-08" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006145489", "@fin": "2999-01-01", "#text": "Livre Ier : Produits pharmaceutiques", "@debut": "2004-07-29" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006132399", "@fin": "2999-01-01", "#text": "Cinquième partie : Produits de santé", "@debut": "2004-07-29" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006112927", "@fin": "2999-01-01", "#text": "Partie réglementaire", "@debut": "2000-12-23" } ] }, "@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": "LEGIARTI000022417660", "@fin": "2011-04-14", "@num": "R5139-3", "@etat": "MODIFIE", "@debut": "2010-07-02", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000023860670", "@fin": "2012-05-01", "@num": "R5139-3", "@etat": "MODIFIE", "@debut": "2011-04-14", "@origine": "LEGI" } }, { "@etat": "VIGUEUR", "LIEN_ART": { "@id": "LEGIARTI000025787431", "@fin": "2999-01-01", "@num": "R5139-3", "@etat": "VIGUEUR", "@debut": "2012-05-01", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "Tout dossier technique accompagnant la demande d'autorisation doit comporter les éléments suivants :
\n
1° La liste des personnes que le demandeur se propose d'habiliter pour contribuer, sous son autorité, aux opérations faisant l'objet de l'autorisation ;
\n
2° La justification que le demandeur et les personnes qu'il se propose d'habiliter possèdent les titres de formation et l'expérience professionnelle nécessaires ;
\n
3° L'engagement du directeur de l'établissement selon lequel la ou les opérations portant sur les micro-organismes ou toxines seront réalisées au sein de l'établissement dans le respect des bonnes pratiques applicables à ces activités, pendant la période de validité de l'autorisation ;
\n
4° L'engagement du demandeur selon lequel la ou les opérations portant sur les micro-organismes ou toxines seront réalisées dans le respect des bonnes pratiques applicables à ces activités ;
\n
5° L'analyse des risques induits par les opérations pour lesquelles l'autorisation est demandée et les éléments nécessaires à cette analyse.
\n
Le contenu du dossier technique ainsi défini est précisé par décision du directeur général de l'Agence française de sécurité sanitaire des produits de santé, après avis du directeur général de l'Agence nationale chargée de la sécurité sanitaire de l'alimentation, de l'environnement et du travail.
\n
En outre, lorsque la nature des opérations envisagées l'exige, le directeur général de l'Agence française de sécurité sanitaire des produits de santé, après avis du directeur général de l'Agence nationale chargée de la sécurité sanitaire de l'alimentation, de l'environnement et du travail peut fixer par décision les autres éléments d'information nécessaires." } }, "LEGIARTI000023860670": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R5139-3", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2012-05-01", "DATE_DEBUT": "2011-04-14" } }, "META_COMMUN": { "ID": "LEGIARTI000023860670", "URL": "article/LEGI/ARTI/00/00/23/86/06/LEGIARTI000023860670.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "LIENS": { "LIEN": [ { "@id": "LEGIARTI000023851512", "@num": "2", "#text": "Décret n°2011-385 du 11 avril 2011 - art. 2", "@sens": "cible", "@cidtexte": "JORFTEXT000023850479", "@nortexte": "ETSP1027706D", "@numtexte": "2011-385", "@typelien": "MODIFIE", "@naturetexte": "DECRET", "@datesignatexte": "2011-04-11" }, { "@id": "LEGIARTI000022417634", "@num": "R5139-10", "#text": "Code de la santé publique - art. R5139-10 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000025787414", "@num": "R5139-11", "#text": "Code de la santé publique - art. R5139-11 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000025787411", "@num": "R5139-12", "#text": "Code de la santé publique - art. R5139-12 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000022417672", "@fin": "2999-01-01", "#text": "Section 1 : Conditions de délivrance des autorisations", "@debut": "2010-07-02" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000018213362", "@fin": "2999-01-01", "#text": "Chapitre IX : Micro-organismes et toxines", "@debut": "2008-03-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006161013", "@fin": "2999-01-01", "#text": "Titre III : Autres produits et substances pharmaceutiques réglementés", "@debut": "2004-08-08" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006145489", "@fin": "2999-01-01", "#text": "Livre Ier : Produits pharmaceutiques", "@debut": "2004-07-29" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006132399", "@fin": "2999-01-01", "#text": "Cinquième partie : Produits de santé", "@debut": "2004-07-29" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006112927", "@fin": "2999-01-01", "#text": "Partie réglementaire", "@debut": "2000-12-23" } ] }, "@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": "LEGIARTI000022417660", "@fin": "2011-04-14", "@num": "R5139-3", "@etat": "MODIFIE", "@debut": "2010-07-02", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000023860670", "@fin": "2012-05-01", "@num": "R5139-3", "@etat": "MODIFIE", "@debut": "2011-04-14", "@origine": "LEGI" } }, { "@etat": "VIGUEUR", "LIEN_ART": { "@id": "LEGIARTI000025787431", "@fin": "2999-01-01", "@num": "R5139-3", "@etat": "VIGUEUR", "@debut": "2012-05-01", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "

Tout dossier technique accompagnant la demande d'autorisation doit comporter les éléments suivants :

1° La liste des personnes que le demandeur se propose d'habiliter pour contribuer, sous son autorité, aux opérations faisant l'objet de l'autorisation ;

2° La justification que le demandeur et les personnes qu'il se propose d'habiliter possèdent les titres de formation et l'expérience professionnelle nécessaires ;

3° L'engagement du directeur de l'établissement selon lequel la ou les opérations portant sur les micro-organismes ou toxines seront réalisées au sein de l'établissement dans le respect des bonnes pratiques applicables à ces activités, pendant la période de validité de l'autorisation ;

4° L'engagement du demandeur selon lequel la ou les opérations portant sur les micro-organismes ou toxines seront réalisées dans le respect des bonnes pratiques applicables à ces activités ;

5° L'analyse des risques induits par les opérations pour lesquelles l'autorisation est demandée et les éléments nécessaires à cette analyse.

Le contenu du dossier technique ainsi défini est précisé par décision du directeur général de l'Agence française de sécurité sanitaire des produits de santé, après avis du directeur général de l'Agence nationale de sécurité sanitaire de l'alimentation, de l'environnement et du travail.

En outre, lorsque la nature des opérations envisagées l'exige, le directeur général de l'Agence française de sécurité sanitaire des produits de santé, après avis du directeur général de l'Agence nationale de sécurité sanitaire de l'alimentation, de l'environnement et du travail peut fixer par décision les autres éléments d'information nécessaires.

" } }, "LEGIARTI000025765496": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "5", "TYPE": "ENTIEREMENT_MODIF", "DATE_FIN": "2999-01-01", "DATE_DEBUT": "2999-01-01" } }, "META_COMMUN": { "ID": "LEGIARTI000025765496", "URL": "article/LEGI/ARTI/00/00/25/76/54/LEGIARTI000025765496.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "LIENS": { "LIEN": [ { "@id": "LEGIARTI000025788792", "@num": "1", "#text": "Décret n°2003-224 du 7 mars 2003 - art. 1 (M)", "@sens": "source", "@cidtexte": "JORFTEXT000000412057", "@nortexte": "SANG0320319D", "@numtexte": "2003-224", "@typelien": "MODIFIE", "@naturetexte": "DECRET", "@datesignatexte": "2003-03-07" }, { "@id": "LEGIARTI000028444959", "@num": "R523-5", "#text": "Code de l'environnement - art. R523-5 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006074220", "@typelien": "MODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000025788955", "@num": "R613-10", "#text": "Code de la propriété intellectuelle - art. R613-10 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006069414", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000025788960", "@num": "R613-25-4", "#text": "Code de la propriété intellectuelle - art. R613-25-4 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006069414", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000025788947", "@num": "A1", "#text": "Code de procédure pénale - art. A1 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006071154", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGISCTA000025788964", "#text": "Code de la santé publique - Chapitre II : Inspecteurs de l'Agence nationale... (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGISCTA000025788966", "#text": "Code de la santé publique - Livre III : Agence nationale de sécurité du méd... (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGISCTA000025788971", "#text": "Code de la santé publique - Paragraphe 1 : Agence nationale de sécurité du ... (Ab)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGISCTA000025788969", "#text": "Code de la santé publique - Paragraphe 1 : Agence nationale de sécurité du ... (Ab)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGISCTA000025788975", "#text": "Code de la santé publique - Paragraphe 2 : Rôle de l'Agence nationale de sé... (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGISCTA000025788973", "#text": "Code de la santé publique - Section 9 : Dispositifs soumis à communication ... (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGISCTA000025788979", "#text": "Code de la santé publique - Sous-section 3 : Rôle de l'Agence nationale de ... (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGISCTA000025788977", "#text": "Code de la santé publique - Sous-section 3 : Rôle de l'Agence nationale de ... (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGISCTA000025788962", "#text": "Code de la santé publique - Titre V : Agence nationale de sécurité du médic... (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000025788536", "@num": "D1221-58", "#text": "Code de la santé publique - art. D1221-58 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000025788532", "@num": "D1221-63", "#text": "Code de la santé publique - art. D1221-63 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000025788527", "@num": "D1221-66", "#text": "Code de la santé publique - art. D1221-66 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000025788274", "@num": "D1414-51", "#text": "Code de la santé publique - art. 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R521-2-7 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006074220", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000025788837", "@num": "R523-5", "#text": "Code de l'environnement - art. R523-5 (MMN)", "@sens": "source", "@cidtexte": "LEGITEXT000006074220", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000025788817", "@num": "R235-10", "#text": "Code de la route. - art. R235-10 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006074228", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000025788835", "@num": "R235-4", "#text": "Code de la route. - art. R235-4 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006074228", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000025788831", "@num": "R235-6", "#text": "Code de la route. - art. R235-6 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006074228", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000025788826", "@num": "R235-8", "#text": "Code de la route. - art. R235-8 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006074228", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000025788821", "@num": "R235-9", "#text": "Code de la route. - art. R235-9 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006074228", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000025788805", "@num": "R244-2", "#text": "Code de la route. - art. R244-2 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006074228", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000025788794", "@num": "R245-2", "#text": "Code de la route. - art. R245-2 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006074228", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "@cid": "JORFTEXT000025757625", "@nor": "ETSP1206945D", "@num": "2012-597", "@nature": "DECRET", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Décret n° 2012-597 du 27 avril 2012 relatif à l'Agence nationale de sécurité du médicament et des produits de santé", "@debut": "2999-01-01", "@id_txt": "JORFTEXT000025757625", "@c_titre_court": "Décret n°2012-597 du 27 avril 2012" }, { "@fin": "2999-01-01", "#text": "Décret n° 2012-597 du 27 avril 2012 relatif à l'Agence nationale de sécurité du médicament et des produits de santé", "@debut": "2012-05-01", "@id_txt": "LEGITEXT000025765483", "@c_titre_court": "Décret n°2012-597 du 27 avril 2012" } ], "@ministere": "Ministère du travail, de l'emploi et de la santé", "@date_publi": "2012-04-29", "@date_signature": "2012-04-27", "@num_parution_jo": "0102" } }, "VERSIONS": { "VERSION": [ { "LIEN_ART": { "@id": "LEGIARTI000025765496", "@fin": "2999-01-01", "@num": "5", "@debut": "2999-01-01", "@origine": "LEGI" } }, { "LIEN_ART": { "@id": "JORFARTI000025757630", "@fin": "2999-01-01", "@num": "5", "@debut": "2999-01-01", "@origine": "JORF" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
A modifié les dispositions suivantes :

- Code de la santé publique
\n Art. R1121-1, Art. R1121-12, Art. R1123-20, Art. R1123-22, Art. R1123-30, Art. R1123-31, Art. R1123-32, Art. R1123-35, Art. R1123-41, Art. R1123-47, Art. R1123-48, Art. R1123-49, Art. R1123-50, Art. R1123-51, Art. R1123-52, Art. R1123-53, Art. R1123-59, Art. R1123-60, Art. R1123-61, Art. R1125-7, Art. R1125-8, Art. R1125-9, Art. R1125-10, Art. R1125-11, Art. R1131-3, Art. R1161-8, Art. R1161-10, Art. R1161-13, Art. R1161-15, Art. R1161-17, Art. R1161-18, Art. R1161-19, Art. R1161-21, Art. R1161-25, Art. R1211-21, Art. R1211-22, Art. R1211-32, Art. R1211-33, Art. R1211-34, Art. R1211-35, Art. R1211-41, Art. R1211-42, Art. R1211-43, Art. R1211-45, Art. R1211-46, Art. R1211-47, Art. R1221-5, Art. R1221-18, Art. R1221-20-2, Art. R1221-24, Art. R1221-25, Art. R1221-26, Art. R1221-27, Art. R1221-32, Art. R1221-33, Art. R1221-34, Art. R1221-37, Art. R1221-38, Art. R1221-39, Art. R1221-40, Art. R1221-41, Art. R1221-42, Art. R1221-43, Art. R1221-47, Art. R1221-48, Art. R1221-50, Art. R1221-51, Art. D1221-58, Art. D1221-63, Art. D1221-66, Art. R1222-2, Art. R1222-9, Art. R1222-9-1, Art. R1222-9-4, Art. R1222-10, Art. R1223-3, Art. R1223-4, Art. R1223-4-1, Art. R1223-4-2, Art. R1223-5, Art. R1223-6, Art. R1223-7, Art. R1223-7-1, Art. R1223-8, Art. R1223-13, Art. R1223-31, Art. R1223-34, Art. R1235-6, Art. R1235-9, Art. R1235-10, Art. R1235-11, Art. R1243-4, Art. R1243-5, Art. R1243-6, Art. R1243-7, Art. R1243-8, Art. R1243-10, Art. R1243-11, Art. R1243-14, Art. R1243-19, Art. R1243-22, Art. R1243-23, Art. R1243-27, Art. R1243-28, Art. R1243-30, Art. R1243-33, Art. R1243-34, Art. R1243-35, Art. R1243-36, Art. R1243-37, Art. R1243-51, Art. R1245-2, Art. R1245-3, Art. R1245-4, Art. R1245-5, Art. R1245-6, Art. R1245-7, Art. R1245-11, Art. R1245-12, Art. R1245-13, Art. R1245-14, Art. R1245-16, Art. R1245-17, Art. R1245-19, Art. R1261-2, Art. R1261-4, Art. R1261-5, Art. R1261-7, Art. R1261-9, Art. R1313-3, Art. R1313-24, Art. R1323-2, Art. R1323-4, Art. R1333-28, Art. R1333-36, Art. R1413-14, Art. D1414-51, Art. R1417-9, Art. R1418-4, Art. R1418-6, Art. R1418-26, Art. R1521-3, Art. R2131-1-1, Art. R2141-1-7, Art. R2141-35, Art. R2142-24, Art. R2142-27, Art. R2142-42, Art. R2151-17, Art. R2151-21, Art. D2323-6, Art. R3114-3, Art. R3114-8, Art. R4211-1, Art. R4211-8, Art. R4211-21, Art. R4234-1, Art. R4234-5, Art. R4234-12, Art. R4234-24, Art. R5112-2, Art. R5112-5, Art. R5121-5-1, Art. R5121-5-2, Art. R5121-6, Art. R5121-11, Art. R5121-13, Art. R5121-16, Art. R5121-21, Art. R5121-21-1, Art. R5121-25, Art. R5121-29-1, Art. R5121-34, Art. R5121-35, Art. R5121-36, Art. R5121-36-1, Art. R5121-38, Art. R5121-38-1, Art. R5121-39, Art. R5121-40, Art. R5121-41, Art. R5121-41-2, Art. R5121-41-3, Art. R5121-41-4, Art. R5121-41-5, Art. R5121-41-5-1, Art. R5121-41-6, Art. R5121-41-7, Art. R5121-42, Art. R5121-43, Art. R5121-45, Art. R5121-45-1, Art. R5121-46, Art. R5121-47, Art. R5121-48, Art. R5121-50, Art. R5121-51-1, Art. R5121-51-2, Art. R5121-51-3, Art. R5121-51-4, Art. R5121-51-5, Art. R5121-51-6, Art. R5121-51-8, Art. R5121-51-9, Art. R5121-51-10, Art. R5121-51-11, Art. R5121-51-12, Art. R5121-61, Art. R5121-62, Art. R5121-68, Art. R5121-69, Art. R5121-70, Art. R5121-70-1, Art. R5121-70-2, Art. R5121-71, Art. R5121-72, Art. R5121-73, Art. R5121-75, Art. R5121-76, Art. R5121-79, Art. R5121-97, Art. R5121-108, Art. R5121-109, Art. R5121-112, Art. R5121-113, Art. R5121-114, Art. R5121-115, Art. R5121-116, Art. R5121-120, Art. R5121-122, Art. R5121-123, Art. R5121-124, Art. R5121-125, Art. R5121-126, Art. R5121-127, Art. R5121-129, Art. R5121-131, Art. R5121-132-1, Art. R5121-133, Art. R5121-134, Art. R5121-135, Art. R5121-135-1, Art. R5121-137, Art. R5121-138, Art. R5121-139, Art. R5121-140, Art. R5121-147, Art. R5121-148, Art. R5121-154, Art. R5121-155, Art. R5121-156, Art. R5121-157, Art. R5121-158, Art. R5121-167, Art. R5121-169, Art. R5121-171, Art. R5121-173, Art. R5121-174, Art. R5121-176, Art. R5121-177, Art. R5121-178, Art. R5121-179, Art. R5121-184, Art. R5121-198, Art. R5121-199, Art. R5121-200, Art. R5121-202, Art. R5121-203, Art. R5121-204, Art. R5121-206, Art. R5121-207, Art. R5122-2, Art. R5122-5, Art. R5122-7, Art. R5122-13, Art. R5122-17, Art. R5122-20, Art. R5122-22, Art. R5122-26, Art. R5124-5, Art. R5124-6, Art. R5124-9, Art. R5124-10, Art. R5124-10-1, Art. R5124-11, Art. R5124-12, Art. R5124-13, Art. R5124-15, Art. R5124-35, Art. R5124-36, Art. R5124-46, Art. R5124-47, Art. R5124-49, Art. R5124-55, Art. R5124-57-2, Art. R5124-57-5, Art. R5124-59, Art. R5124-69, Art. D5125-63, Art. R5126-10, Art. R5126-16, Art. R5126-16-1, Art. R5126-105, Art. R5127-11, Art. R5127-14, Art. R5127-15, Art. R5127-16, Art. R5127-18, Art. R5131-1, Art. R5131-3, Art. R5131-7, Art. R5131-8, Art. R5131-9, Art. R5131-10, Art. R5131-11, Art. R5132-1, Art. R5132-2, Art. R5132-5, Art. R5132-21, Art. R5132-23, Art. R5132-30, Art. R5132-31, Art. R5132-36, Art. R5132-39, Art. R5132-42, Art. R5132-44, Art. R5132-74, Art. R5132-75, Art. R5132-78, Art. R5132-80, Art. R5132-81, Art. R5132-82, Art. R5132-83, Art. R5132-84, Art. R5132-85, Art. R5132-86, Art. R5132-87, Art. R5132-88, Art. R5132-92, Art. R5132-93, Art. R5132-94, Art. R5132-95, Art. R5132-99, Art. R5132-100, Art. R5132-101, Art. R5132-102, Art. R5132-112, Art. R5132-113, Art. R5132-115, Art. R5132-116, Art. R5133-3, Art. R5133-4, Art. R5133-5, Art. R5138-1, Art. R5138-2, Art. R5138-4, Art. R5138-5, Art. R5138-6, Art. R5139-1, Art. R5139-3, Art. R5139-3-1, Art. R5139-4, Art. R5139-5, Art. R5139-6, Art. R5139-7, Art. R5139-11, Art. R5139-12, Art. R5139-13, Art. R5139-14, Art. R5139-17, Art. R5139-20, Art. R5139-24, Art. R5139-25, Art. R5139-26, Art. R5139-31, Art. R513-10-2, Art. R513-10-3, Art. R513-10-4, Art. R513-10-8, Art. R513-10-10, Art. R513-10-11, Art. R513-10-12, Art. R5141-95, Art. R5141-96, Art. R5141-122, Art. R5141-123-3, Art. R5142-6, Art. R5142-10, Art. R5142-13, Art. R5142-15, Art. R5211-5, Art. R5211-7, Art. R5211-11, Art. R5211-19, Art. R5211-22, Art. R5211-23, Art. R5211-23-2, Art. R5211-24, Art. R5211-26, Art. R5211-35, Art. R5211-37, Art. R5211-40, Art. R5211-41, Art. R5211-41-1, Art. R5211-43, Art. R5211-46, Art. R5211-53, Art. R5211-54, Art. R5211-55, Art. R5211-56, Art. R5211-57, Art. R5211-57-1, Art. R5211-58, Art. R5211-61, Art. R5211-64, Art. R5211-65, Art. R5211-65-1, Art. R5211-66, Art. R5211-67, Art. R5212-4, Art. R5212-5, Art. R5212-6, Art. R5212-12, Art. R5212-13, Art. R5212-17, Art. R5212-18, Art. R5212-19, Art. R5212-20, Art. R5212-21, Art. R5212-22, Art. R5212-23, Art. R5212-24, Art. R5212-26, Art. R5212-27, Art. R5212-28, Art. R5212-29, Art. R5212-32, Art. R5212-33, Art. R5212-34, Art. R5212-35, Art. R5212-36, Art. R5221-6, Art. R5221-7, Art. R5221-16, Art. R5221-17, Art. R5221-29, Art. R5221-32, Art. R5221-35, Art. R5221-36, Art. R5221-37, Art. R5222-3, Art. R5222-4, Art. R5222-10, Art. R5222-11, Art. R5222-12, Art. R5222-13, Art. R5222-14, Art. R5222-15, Art. R5222-16, Art. R5222-17, Art. R5222-18, Art. R5313-1, Art. R5313-3, Art. R5313-4, Art. R5313-5, Art. R5313-6, Art. R5313-7, Art. R5313-8, Art. R5433-1, Art. R5433-3, Art. R5438-3, Art. R5461-1, Art. R5461-2, Art. R5462-1, Art. R5462-2, Art. D6211-35, Art. D6213-9, Art. D6213-10, Art. D6213-14, Art. D6213-15, Art. D6213-16, Art. D6213-17, Art. D6213-18, Art. R1221-35\n
\n

\n
\n
A modifié les dispositions suivantes :

- Code de la santé publique
\n Sct. Sous-section 3 : Rôle de l'Agence nationale de sécurité du médicament et des produits de santé, Sct. Sous-section 3 : Rôle de l'Agence nationale de sécurité du médicament et des produits de santé., Sct. Paragraphe 2 : Rôle de l'Agence nationale de sécurité du médicament et des produits de santé., Sct. Section 9 : Dispositifs soumis à communication auprès de l'Agence nationale de sécurité du médicament et des produits de santé, Sct. Paragraphe 1 : Agence nationale de sécurité du médicament et des produits de santé., Sct. Paragraphe 1 : Agence nationale de sécurité du médicament et des produits de santé., Sct. Livre III : Agence nationale de sécurité du médicament et des produits de santé, Sct. Chapitre II : Inspecteurs de l'Agence nationale de sécurité du médicament et des produits de santé, Sct. Titre V : Agence nationale de sécurité du médicament et des produits de santé.\n
\n

- Code de la propriété intellectuelle
\n Art. R613-10, Art. R613-25-4\n
\n

- Code de procédure pénale
\n Art. A1\n
\n

- Code de la sécurité sociale.
\n Art. R161-72, Art. D162-2-2, Art. R163-2, Art. R163-7, Art. R163-15, Art. R163-20, Art. R163-26, Art. R163-28, Art. R165-4-1, Art. R165-5-1, Art. R165-18, Art. R165-32, Art. R165-33\n
\n

- Code de l'action sociale et des familles
\n Art. D247-5\n
\n

- Code de l'environnement
\n Art. R521-2-7, Art. R523-5\n
\n

- Code de la route.
\n Art. R235-4, Art. R235-6, Art. R235-8, Art. R235-9, Art. R235-10, Art. R244-2, Art. R245-2\n
\n

- Décret n°2003-224 du 7 mars 2003
\n Art. 1\n
\n

- Code de l'environnement
\n Art. Annexe I à l'article D523-8\n
\n

\n
" } }, "LEGIARTI000025787431": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R5139-3", "ETAT": "VIGUEUR", "TYPE": "AUTONOME", "DATE_FIN": "2999-01-01", "DATE_DEBUT": "2012-05-01" } }, "META_COMMUN": { "ID": "LEGIARTI000025787431", "URL": "article/LEGI/ARTI/00/00/25/78/74/LEGIARTI000025787431.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "LIENS": { "LIEN": [ { "@id": "LEGIARTI000025765496", "@num": "5", "#text": "Décret n°2012-597\n du 27 avril 2012 - art. 5", "@sens": "cible", "@cidtexte": "JORFTEXT000025757625", "@nortexte": "ETSP1206945D", "@numtexte": "2012-597", "@typelien": "MODIFIE", "@naturetexte": "DECRET", "@datesignatexte": "2012-04-27" }, { "@id": "LEGIARTI000022417634", "@num": "R5139-10", "#text": "Code de la santé publique - art. R5139-10 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000025787414", "@num": "R5139-11", "#text": "Code de la santé publique - art. R5139-11 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000025787411", "@num": "R5139-12", "#text": "Code de la santé publique - art. R5139-12 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000022417672", "@fin": "2999-01-01", "#text": "Section 1 : Conditions de délivrance des autorisations", "@debut": "2010-07-02" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000018213362", "@fin": "2999-01-01", "#text": "Chapitre IX : Micro-organismes et toxines", "@debut": "2008-03-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006161013", "@fin": "2999-01-01", "#text": "Titre III : Autres produits et substances pharmaceutiques réglementés", "@debut": "2004-08-08" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006145489", "@fin": "2999-01-01", "#text": "Livre Ier : Produits pharmaceutiques", "@debut": "2004-07-29" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006132399", "@fin": "2999-01-01", "#text": "Cinquième partie : Produits de santé", "@debut": "2004-07-29" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006112927", "@fin": "2999-01-01", "#text": "Partie réglementaire", "@debut": "2000-12-23" } ] }, "@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": "LEGIARTI000022417660", "@fin": "2011-04-14", "@num": "R5139-3", "@etat": "MODIFIE", "@debut": "2010-07-02", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000023860670", "@fin": "2012-05-01", "@num": "R5139-3", "@etat": "MODIFIE", "@debut": "2011-04-14", "@origine": "LEGI" } }, { "@etat": "VIGUEUR", "LIEN_ART": { "@id": "LEGIARTI000025787431", "@fin": "2999-01-01", "@num": "R5139-3", "@etat": "VIGUEUR", "@debut": "2012-05-01", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "

Tout dossier technique accompagnant la demande d'autorisation doit comporter les éléments suivants :

1° La liste des personnes que le demandeur se propose d'habiliter pour contribuer, sous son autorité, aux opérations faisant l'objet de l'autorisation ;

2° La justification que le demandeur et les personnes qu'il se propose d'habiliter possèdent les titres de formation et l'expérience professionnelle nécessaires ;

4° L'engagement du demandeur selon lequel la ou les opérations portant sur les micro-organismes ou toxines seront réalisées dans le respect des bonnes pratiques applicables à ces activités ;

5° L'analyse des risques induits par les opérations pour lesquelles l'autorisation est demandée et les éléments nécessaires à cette analyse.

Le contenu du dossier technique ainsi défini est précisé par décision du directeur général de l'Agence nationale de sécurité du médicament et des produits de santé, après avis du directeur général de l'Agence nationale de sécurité sanitaire de l'alimentation, de l'environnement et du travail.

En outre, lorsque la nature des opérations envisagées l'exige, le directeur général de l'Agence nationale de sécurité du médicament et des produits de santé, après avis du directeur général de l'Agence nationale de sécurité sanitaire de l'alimentation, de l'environnement et du travail peut fixer par décision les autres éléments d'information nécessaires.

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Article R5139-12 AUTONOME VIGUEUR, en vigueur depuis le 01/05/2012 (Code de la santé publique)