{ "article": { "LEGIARTI000023730282": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "2", "TYPE": "ENTIEREMENT_MODIF", "DATE_FIN": "2999-01-01", "DATE_DEBUT": "2999-01-01" } }, "META_COMMUN": { "ID": "LEGIARTI000023730282", "URL": "article/LEGI/ARTI/00/00/23/73/02/LEGIARTI000023730282.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "LIENS": { "LIEN": [ { "@id": "LEGISCTA000006190782", "#text": "Code de la santé publique - Section unique. (Ab)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "ABROGE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000023731987", "@num": "R5461-1", "#text": "Code de la santé publique - art. R5461-1 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000023731981", "@num": "R5461-2", "#text": "Code de la santé publique - art. R5461-2 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000023731976", "@num": "R5461-3", "#text": "Code de la santé publique - art. R5461-3 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000023731969", "@num": "R5461-4", "#text": "Code de la santé publique - art. R5461-4 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "@cid": "JORFTEXT000023728573", "@nor": "ETSP1026991D", "@num": "2011-287", "@nature": "DECRET", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Décret n° 2011-287 du 18 mars 2011 portant dispositions pénales applicables aux infractions relatives à certains produits de santé", "@debut": "2999-01-01", "@id_txt": "JORFTEXT000023728573", "@c_titre_court": "Décret n°2011-287 du 18 mars 2011" }, { "@fin": "2999-01-01", "#text": "Décret n° 2011-287 du 18 mars 2011 portant dispositions pénales applicables aux infractions relatives à certains produits de santé", "@debut": "2011-03-21", "@id_txt": "LEGITEXT000023730277", "@c_titre_court": "Décret n°2011-287 du 18 mars 2011" } ], "@ministere": "Ministère du travail, de l'emploi et de la santé", "@date_publi": "2011-03-20", "@date_signature": "2011-03-18" } }, "VERSIONS": { "VERSION": [ { "LIEN_ART": { "@id": "LEGIARTI000023730282", "@fin": "2999-01-01", "@num": "2", "@debut": "2999-01-01", "@origine": "LEGI" } }, { "LIEN_ART": { "@id": "JORFARTI000023728578", "@fin": "2999-01-01", "@num": "2", "@debut": "2999-01-01", "@origine": "JORF" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
A modifié les dispositions suivantes :

- Code de la santé publique
Art. R5461-1, Art. R5461-2, Art. R5461-3, Art. R5461-4
\n

\n
\n
A abrogé les dispositions suivantes :

- Code de la santé publique
\n Sct. Section unique.\n
\n

\n
" } }, "LEGIARTI000023731969": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R5461-4", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2011-08-19", "DATE_DEBUT": "2011-03-21" } }, "META_COMMUN": { "ID": "LEGIARTI000023731969", "URL": "article/LEGI/ARTI/00/00/23/73/19/LEGIARTI000023731969.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "LIENS": { "LIEN": [ { "@id": "JORFTEXT000000787339", "#text": "Décret n°2004-802 du 29 juillet 2004", "@sens": "source", "@cidtexte": "JORFTEXT000000787339", "@nortexte": "SANP0422530D", "@numtexte": "2004-802", "@typelien": "CODIFICATION", "@naturetexte": "DECRET", "@datesignatexte": "2004-07-29" }, { "@id": "LEGIARTI000023730282", "@num": "2", "#text": "Décret n°2011-287\n du 18 mars 2011 - art. 2", "@sens": "cible", "@cidtexte": "JORFTEXT000023728573", "@nortexte": "ETSP1026991D", "@numtexte": "2011-287", "@typelien": "MODIFIE", "@naturetexte": "DECRET", "@datesignatexte": "2011-03-18" }, { "@id": "LEGIARTI000006417368", "@num": "132-11", "#text": "Code pénal - art. 132-11", "@sens": "source", "@cidtexte": "LEGITEXT000006070719", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006417377", "@num": "132-15", "#text": "Code pénal - art. 132-15", "@sens": "source", "@cidtexte": "LEGITEXT000006070719", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006916483", "@num": "R5461-1", "#text": "Code de la santé publique - art. R5461-1", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006916488", "@num": "R5461-5", "#text": "Code de la santé publique - art. R5461-5 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000028541445", "@num": "R5471-1", "#text": "Code de la santé publique - art. R5471-1 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006801803", "@num": "R665-64-45", "#text": "Code de la santé publique - art. R665-64-45 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006178684", "@fin": "2999-01-01", "#text": "Chapitre Ier : Dispositifs médicaux", "@debut": "2004-08-08" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006161023", "@fin": "2999-01-01", "#text": "Titre VI : Dispositifs médicaux, dispositifs médicaux de diagnostic in vitro et autres produits et objets réglementés dans l'intérêt de la santé publique", "@debut": "2004-08-08" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006145492", "@fin": "2014-02-01", "#text": "Livre IV : Dispositions pénales", "@debut": "2004-08-08" }, { "@id": "LEGISCTA000028542295", "@fin": "2999-01-01", "#text": "Livre IV : Sanctions pénales et financières", "@debut": "2014-02-01" } ] }, "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": "LEGIARTI000006916487", "@fin": "2011-03-21", "@num": "R5461-4", "@etat": "MODIFIE", "@debut": "2004-08-08", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000023731969", "@fin": "2011-08-19", "@num": "R5461-4", "@etat": "MODIFIE", "@debut": "2011-03-21", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000024479547", "@fin": "2014-02-01", "@num": "R5461-4", "@etat": "MODIFIE", "@debut": "2011-08-19", "@origine": "LEGI" } }, { "@etat": "VIGUEUR", "LIEN_ART": { "@id": "LEGIARTI000028542299", "@fin": "2999-01-01", "@num": "R5461-4", "@etat": "VIGUEUR", "@debut": "2014-02-01", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "

La récidive des contraventions prévues aux articles R. 5461-1 et R. 5461-2 est réprimée conformément aux articles 132-11 et 132-15 du code pénal.

" } }, "LEGIARTI000023731976": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R5461-3", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2014-02-01", "DATE_DEBUT": "2011-03-21" } }, "META_COMMUN": { "ID": "LEGIARTI000023731976", "URL": "article/LEGI/ARTI/00/00/23/73/19/LEGIARTI000023731976.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "LIENS": { "LIEN": [ { "@id": "JORFTEXT000000787339", "#text": "Décret n°2004-802 du 29 juillet 2004", "@sens": "source", "@cidtexte": "JORFTEXT000000787339", "@nortexte": "SANP0422530D", "@numtexte": "2004-802", "@typelien": "CODIFICATION", "@naturetexte": "DECRET", "@datesignatexte": "2004-07-29" }, { "@id": "LEGIARTI000023730282", "@num": "2", "#text": "Décret n°2011-287\n du 18 mars 2011 - art. 2", "@sens": "cible", "@cidtexte": "JORFTEXT000023728573", "@nortexte": "ETSP1026991D", "@numtexte": "2011-287", "@typelien": "MODIFIE", "@naturetexte": "DECRET", "@datesignatexte": "2011-03-18" }, { "@id": "LEGIARTI000006916199", "@num": "R5211-12", "#text": "Code de la santé publique - art. R5211-12 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006916204", "@num": "R5211-17", "#text": "Code de la santé publique - art. R5211-17 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006801686", "@num": "R665-43", "#text": "Code de la santé publique - art. R665-43 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006801688", "@num": "R665-43-1", "#text": "Code de la santé publique - art. R665-43-1 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006178684", "@fin": "2999-01-01", "#text": "Chapitre Ier : Dispositifs médicaux", "@debut": "2004-08-08" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006161023", "@fin": "2999-01-01", "#text": "Titre VI : Dispositifs médicaux, dispositifs médicaux de diagnostic in vitro et autres produits et objets réglementés dans l'intérêt de la santé publique", "@debut": "2004-08-08" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006145492", "@fin": "2014-02-01", "#text": "Livre IV : Dispositions pénales", "@debut": "2004-08-08" }, { "@id": "LEGISCTA000028542295", "@fin": "2999-01-01", "#text": "Livre IV : Sanctions pénales et financières", "@debut": "2014-02-01" } ] }, "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": "LEGIARTI000006916485", "@fin": "2011-03-21", "@num": "R5461-3", "@etat": "MODIFIE", "@debut": "2004-08-08", "@origine": "LEGI" } }, { "@etat": "VIGUEUR", "LIEN_ART": { "@id": "LEGIARTI000028542318", "@fin": "2999-01-01", "@num": "R5461-3", "@etat": "VIGUEUR", "@debut": "2014-02-01", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000023731976", "@fin": "2014-02-01", "@num": "R5461-3", "@etat": "MODIFIE", "@debut": "2011-03-21", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "

Est puni de l'amende prévue pour les contraventions de troisième classe le fait de présenter, lors de réunions scientifiques ou techniques, d'expositions ou de démonstrations, des dispositifs médicaux non conformes aux dispositions des articles R. 5211-12 et R. 5211-17 sans accompagner cette présentation d'un panneau qui indique clairement que ces dispositifs ne peuvent être ni mis sur le marché ni mis en service avant leur mise en conformité.

\n
" } }, "LEGIARTI000023731981": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R5461-2", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2012-05-01", "DATE_DEBUT": "2011-03-21" } }, "META_COMMUN": { "ID": "LEGIARTI000023731981", "URL": "article/LEGI/ARTI/00/00/23/73/19/LEGIARTI000023731981.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "LIENS": { "LIEN": [ { "@id": "JORFTEXT000000787339", "#text": "Décret n°2004-802 du 29 juillet 2004", "@sens": "source", "@cidtexte": "JORFTEXT000000787339", "@nortexte": "SANP0422530D", "@numtexte": "2004-802", "@typelien": "CODIFICATION", "@naturetexte": "DECRET", "@datesignatexte": "2004-07-29" }, { "@id": "LEGIARTI000023730282", "@num": "2", "#text": "Décret n°2011-287\n du 18 mars 2011 - art. 2", "@sens": "cible", "@cidtexte": "JORFTEXT000023728573", "@nortexte": "ETSP1026991D", "@numtexte": "2011-287", "@typelien": "MODIFIE", "@naturetexte": "DECRET", "@datesignatexte": "2011-03-18" }, { "@id": "LEGIARTI000006690308", "@num": "L5212-2", "#text": "Code de la santé publique - art. L5212-2", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006916283", "@num": "R5212-12", "#text": "Code de la santé publique - art. R5212-12", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006916285", "@num": "R5212-13", "#text": "Code de la santé publique - art. R5212-13", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006801686", "@num": "R665-43", "#text": "Code de la santé publique - art. R665-43 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006801688", "@num": "R665-43-1", "#text": "Code de la santé publique - art. R665-43-1 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006178684", "@fin": "2999-01-01", "#text": "Chapitre Ier : Dispositifs médicaux", "@debut": "2004-08-08" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006161023", "@fin": "2999-01-01", "#text": "Titre VI : Dispositifs médicaux, dispositifs médicaux de diagnostic in vitro et autres produits et objets réglementés dans l'intérêt de la santé publique", "@debut": "2004-08-08" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006145492", "@fin": "2014-02-01", "#text": "Livre IV : Dispositions pénales", "@debut": "2004-08-08" }, { "@id": "LEGISCTA000028542295", "@fin": "2999-01-01", "#text": "Livre IV : Sanctions pénales et financières", "@debut": "2014-02-01" } ] }, "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": "ABROGE", "LIEN_ART": { "@id": "LEGIARTI000006916484", "@fin": "2010-06-21", "@num": "R5461-2", "@etat": "ABROGE", "@debut": "2004-08-08", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000023731981", "@fin": "2012-05-01", "@num": "R5461-2", "@etat": "MODIFIE", "@debut": "2011-03-21", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000025787008", "@fin": "2012-12-30", "@num": "R5461-2", "@etat": "MODIFIE", "@debut": "2012-05-01", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000026886401", "@fin": "2014-02-01", "@num": "R5461-2", "@etat": "MODIFIE", "@debut": "2012-12-30", "@origine": "LEGI" } }, { "@etat": "VIGUEUR", "LIEN_ART": { "@id": "LEGIARTI000028542309", "@fin": "2999-01-01", "@num": "R5461-2", "@etat": "VIGUEUR", "@debut": "2014-02-01", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "

Est puni de l'amende prévue pour les contraventions de cinquième classe le fait :

1° Pour un fabricant ou son mandataire, de ne pas informer l'Agence française de sécurité sanitaire des produits de santé de tout rappel d'un dispositif médical auquel il procède dans les conditions mentionnées à l'article L. 5212-2 ;

2° Pour un établissement, un syndicat, un groupement ou une association mentionnés à l'article R. 5212-12 ou pour un fabricant ou son mandataire mentionnés à l'article R. 5212-13, de ne pas désigner un correspondant de matériovigilance et de ne pas communiquer le nom de ce correspondant au directeur général de l'Agence française de sécurité sanitaire des produits de santé.

\n
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Est puni de l'amende prévue pour les contraventions de cinquième classe le fait :

1° Pour le fabricant d'un dispositif médical ou son mandataire, de ne pas tenir à la disposition du directeur général de l'Agence française de sécurité sanitaire des produits de santé les déclarations de conformité et les documentations techniques établies dans le cadre des procédures de certification, ainsi que les décisions et rapports des organismes habilités ayant participé à ces procédures, tels que mentionnés à l'article R. 5211-26 ;

2° Pour le fabricant d'un dispositif médical ou son mandataire, de ne pas présenter, sur demande des agents mentionnés à l'article L. 5431-1, les déclarations de conformité et les documentations techniques établies dans le cadre des procédures de certification, ainsi que les décisions et rapports des organismes habilités ayant participé à ces procédures, tels que mentionnés à l'article R. 5211-27.

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Article 2 ENTIEREMENT_MODIF (Décret n° 2011-287 du 18 mars 2011 portant dispositions pénales applicables aux infractions relatives à certains produits de santé)