{ "article": { "LEGIARTI000043886129": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "35", "TYPE": "ENTIEREMENT_MODIF", "DATE_FIN": "2999-01-01", "DATE_DEBUT": "2999-01-01" } }, "META_COMMUN": { "ID": "LEGIARTI000043886129", "URL": "article/LEGI/ARTI/00/00/43/88/61/LEGIARTI000043886129.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "LIENS": { "LIEN": [ { "@id": "LEGISCTA000043890183", "#text": "Code de la santé publique - Chapitre XI : Recueil de selles d'origine humai... (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CREE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000043896297", "@num": "L1211-8", "#text": "Code de la santé publique - art. L1211-8 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000043890185", "@num": "L513-11-1", "#text": "Code de la santé publique - art. L513-11-1 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CREE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000043890187", "@num": "L513-11-2", "#text": "Code de la santé publique - art. L513-11-2 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CREE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000043890189", "@num": "L513-11-3", "#text": "Code de la santé publique - art. L513-11-3 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CREE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000043890191", "@num": "L513-11-4", "#text": "Code de la santé publique - art. L513-11-4 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CREE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000043890193", "@num": "L513-11-5", "#text": "Code de la santé publique - art. L513-11-5 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CREE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000043896283", "@num": "L5311-1", "#text": "Code de la santé publique - art. L5311-1 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000043886045", "@fin": "2999-01-01", "#text": "Chapitre II : Optimiser l'organisation des soins", "@debut": "2021-08-04" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000043886050", "@fin": "2999-01-01", "#text": "Titre V : POURSUIVRE L'AMÉLIORATION DE LA QUALITÉ ET DE LA SÉCURITÉ DES PRATIQUES DU DOMAINE BIOÉTHIQUE", "@debut": "2021-08-04" } ] }, "@cid": "JORFTEXT000043884384", "@nor": "SSAX1917211L", "@num": "2021-1017", "@nature": "LOI", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "LOI n° 2021-1017 du 2 août 2021 relative à la bioéthique (1)", "@debut": "2999-01-01", "@id_txt": "JORFTEXT000043884384", "@c_titre_court": "LOI n°2021-1017 du 2 août 2021" }, { "@fin": "2999-01-01", "#text": "LOI n° 2021-1017 du 2 août 2021 relative à la bioéthique (1)", "@debut": "2021-08-04", "@id_txt": "LEGITEXT000043886035", "@c_titre_court": "LOI n°2021-1017 du 2 août 2021" } ], "@date_publi": "2021-08-03", "@date_signature": "2021-08-02", "@num_parution_jo": "0178" } }, "VERSIONS": { "VERSION": [ { "LIEN_ART": { "@id": "LEGIARTI000043886129", "@fin": "2999-01-01", "@num": "35", "@debut": "2999-01-01", "@origine": "LEGI" } }, { "LIEN_ART": { "@id": "JORFARTI000043884442", "@fin": "2999-01-01", "@num": "35", "@debut": "2999-01-01", "@origine": "JORF" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
A modifié les dispositions suivantes :

- Code de la santé publique
\n Art. L1211-8, Art. L5311-1\n
\n

\n
\n
A créé les dispositions suivantes :

- Code de la santé publique
\n Sct. Chapitre XI : Recueil de selles d'origine humaine destinées à une utilisation thérapeutique., Art. L513-11-1, Art. L513-11-2, Art. L513-11-3, Art. L513-11-4, Art. L513-11-5\n
\n

\n
" } }, "LEGIARTI000043890185": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "L513-11-1", "ETAT": "VIGUEUR", "TYPE": "AUTONOME", "DATE_FIN": "2999-01-01", "DATE_DEBUT": "2021-08-04" } }, "META_COMMUN": { "ID": "LEGIARTI000043890185", "URL": "article/LEGI/ARTI/00/00/43/89/01/LEGIARTI000043890185.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "LIENS": { "LIEN": [ { "@id": "LEGIARTI000043886129", "@num": "35", "#text": "LOI n°2021-1017 du 2 août 2021 - art. 35", "@sens": "cible", "@cidtexte": "JORFTEXT000043884384", "@nortexte": "SSAX1917211L", "@numtexte": "2021-1017", "@typelien": "CREE", "@naturetexte": "LOI", "@datesignatexte": "2021-08-02" }, { "@id": "LEGIARTI000047983060", "@num": "1", "#text": "Arrêté du 1er août 2023 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000047980256", "@nortexte": "SPRP2321617A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2023-08-01" }, { "@id": "LEGIARTI000006685825", "@num": "L1121-1", "#text": "Code de la santé publique - art. L1121-1", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000043890187", "@num": "L513-11-2", "#text": "Code de la santé publique - art. L513-11-2 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000043890189", "@num": "L513-11-3", "#text": "Code de la santé publique - art. L513-11-3 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000043896283", "@num": "L5311-1", "#text": "Code de la santé publique - art. L5311-1 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000043890183", "@fin": "2999-01-01", "#text": "Chapitre XI : Recueil de selles d'origine humaine destinées à une utilisation thérapeutique", "@debut": "2021-08-04" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006155086", "@fin": "2999-01-01", "#text": "Titre III : Autres produits et substances pharmaceutiques réglementés", "@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": "VIGUEUR", "LIEN_ART": { "@id": "LEGIARTI000043890185", "@fin": "2999-01-01", "@num": "L513-11-1", "@etat": "VIGUEUR", "@debut": "2021-08-04", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "

Toute activité de collecte de selles destinées à la préparation de microbiote fécal utilisé à des fins thérapeutiques est assurée par des établissements ou organismes qui sont autorisés par l'Agence nationale de sécurité du médicament et des produits de santé, à l'exception de la collecte réalisée dans le cadre de recherches impliquant la personne humaine mentionnées au 1° de l'article L. 1121-1.

" } }, "LEGIARTI000043890187": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "L513-11-2", "ETAT": "VIGUEUR", "TYPE": "AUTONOME", "DATE_FIN": "2999-01-01", "DATE_DEBUT": "2021-08-04" } }, "META_COMMUN": { "ID": "LEGIARTI000043890187", "URL": "article/LEGI/ARTI/00/00/43/89/01/LEGIARTI000043890187.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "LIENS": { "LIEN": [ { "@id": "LEGIARTI000043886129", "@num": "35", "#text": "LOI n°2021-1017 du 2 août 2021 - art. 35", "@sens": "cible", "@cidtexte": "JORFTEXT000043884384", "@nortexte": "SSAX1917211L", "@numtexte": "2021-1017", "@typelien": "CREE", "@naturetexte": "LOI", "@datesignatexte": "2021-08-02" }, { "@id": "LEGIARTI000043890185", "@num": "L513-11-1", "#text": "Code de la santé publique - art. L513-11-1", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000043890189", "@num": "L513-11-3", "#text": "Code de la santé publique - art. L513-11-3 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000043890183", "@fin": "2999-01-01", "#text": "Chapitre XI : Recueil de selles d'origine humaine destinées à une utilisation thérapeutique", "@debut": "2021-08-04" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006155086", "@fin": "2999-01-01", "#text": "Titre III : Autres produits et substances pharmaceutiques réglementés", "@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": "VIGUEUR", "LIEN_ART": { "@id": "LEGIARTI000043890187", "@fin": "2999-01-01", "@num": "L513-11-2", "@etat": "VIGUEUR", "@debut": "2021-08-04", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "

La collecte, le contrôle, la conservation, la traçabilité et le transport des selles effectués par les établissements ou organismes mentionnés à l'article L. 513-11-1, y compris dans le cadre de recherches impliquant la personne humaine, sont réalisés en conformité avec les règles de bonnes pratiques définies par décision du directeur général de l'Agence nationale de sécurité du médicament et des produits de santé. Ces règles de bonnes pratiques comprennent notamment les règles de sélection clinique et biologique applicables à la collecte de selles.
\n
L'importation de selles destinées à la préparation de microbiote fécal à des fins thérapeutiques ainsi que l'importation de préparations de microbiote fécal sont subordonnées à une autorisation délivrée par l'Agence nationale de sécurité du médicament et des produits de santé.

" } }, "LEGIARTI000043890189": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "L513-11-3", "ETAT": "VIGUEUR", "TYPE": "AUTONOME", "DATE_FIN": "2999-01-01", "DATE_DEBUT": "2021-08-04" } }, "META_COMMUN": { "ID": "LEGIARTI000043890189", "URL": "article/LEGI/ARTI/00/00/43/89/01/LEGIARTI000043890189.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "LIENS": { "LIEN": [ { "@id": "LEGIARTI000043886129", "@num": "35", "#text": "LOI n°2021-1017 du 2 août 2021 - art. 35", "@sens": "cible", "@cidtexte": "JORFTEXT000043884384", "@nortexte": "SSAX1917211L", "@numtexte": "2021-1017", "@typelien": "CREE", "@naturetexte": "LOI", "@datesignatexte": "2021-08-02" }, { "@id": "LEGIARTI000043890185", "@num": "L513-11-1", "#text": "Code de la santé publique - art. L513-11-1", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000043890187", "@num": "L513-11-2", "#text": "Code de la santé publique - art. L513-11-2", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000043890183", "@fin": "2999-01-01", "#text": "Chapitre XI : Recueil de selles d'origine humaine destinées à une utilisation thérapeutique", "@debut": "2021-08-04" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006155086", "@fin": "2999-01-01", "#text": "Titre III : Autres produits et substances pharmaceutiques réglementés", "@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": "VIGUEUR", "LIEN_ART": { "@id": "LEGIARTI000043890189", "@fin": "2999-01-01", "@num": "L513-11-3", "@etat": "VIGUEUR", "@debut": "2021-08-04", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "

En cas de méconnaissance des dispositions des articles L. 513-11-1 et L. 513-11-2 par un établissement ou organisme mentionné à l'article L. 513-11-1 ou en cas de risque pour la santé publique, l'Agence nationale de sécurité du médicament et des produits de santé peut suspendre ou interdire les activités mentionnées à l'article L. 513-11-2.
\n
Sauf en cas de risque imminent, une décision de suspension ou d'interdiction ne peut intervenir qu'après que l'établissement ou l'organisme a été mis à même de présenter ses observations.

" } }, "LEGIARTI000043890191": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "L513-11-4", "ETAT": "VIGUEUR", "TYPE": "AUTONOME", "DATE_FIN": "2999-01-01", "DATE_DEBUT": "2021-08-04" } }, "META_COMMUN": { "ID": "LEGIARTI000043890191", "URL": "article/LEGI/ARTI/00/00/43/89/01/LEGIARTI000043890191.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "LIENS": { "LIEN": [ { "@id": "LEGIARTI000043886129", "@num": "35", "#text": "LOI n°2021-1017 du 2 août 2021 - art. 35", "@sens": "cible", "@cidtexte": "JORFTEXT000043884384", "@nortexte": "SSAX1917211L", "@numtexte": "2021-1017", "@typelien": "CREE", "@naturetexte": "LOI", "@datesignatexte": "2021-08-02" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000043890183", "@fin": "2999-01-01", "#text": "Chapitre XI : Recueil de selles d'origine humaine destinées à une utilisation thérapeutique", "@debut": "2021-08-04" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006155086", "@fin": "2999-01-01", "#text": "Titre III : Autres produits et substances pharmaceutiques réglementés", "@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": "VIGUEUR", "LIEN_ART": { "@id": "LEGIARTI000043890191", "@fin": "2999-01-01", "@num": "L513-11-4", "@etat": "VIGUEUR", "@debut": "2021-08-04", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "

La transplantation de microbiote fécal s'effectue dans l'intérêt du receveur et est soumise aux principes de consentement du donneur et d'anonymat du don. Les règles d'anonymat du don ne sont pas applicables en cas de don intrafamilial.

" } }, "LEGIARTI000043890193": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "L513-11-5", "ETAT": "VIGUEUR", "TYPE": "AUTONOME", "DATE_FIN": "2999-01-01", "DATE_DEBUT": "2021-08-04" } }, "META_COMMUN": { "ID": "LEGIARTI000043890193", "URL": "article/LEGI/ARTI/00/00/43/89/01/LEGIARTI000043890193.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "LIENS": { "LIEN": [ { "@id": "LEGIARTI000043886129", "@num": "35", "#text": "LOI n°2021-1017 du 2 août 2021 - art. 35", "@sens": "cible", "@cidtexte": "JORFTEXT000043884384", "@nortexte": "SSAX1917211L", "@numtexte": "2021-1017", "@typelien": "CREE", "@naturetexte": "LOI", "@datesignatexte": "2021-08-02" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000043890183", "@fin": "2999-01-01", "#text": "Chapitre XI : Recueil de selles d'origine humaine destinées à une utilisation thérapeutique", "@debut": "2021-08-04" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006155086", "@fin": "2999-01-01", "#text": "Titre III : Autres produits et substances pharmaceutiques réglementés", "@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": "VIGUEUR", "LIEN_ART": { "@id": "LEGIARTI000043890193", "@fin": "2999-01-01", "@num": "L513-11-5", "@etat": "VIGUEUR", "@debut": "2021-08-04", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "

Les modalités d'application du présent chapitre sont déterminées par décret.

" } }, "LEGIARTI000043896283": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "L5311-1", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2022-04-22", "DATE_DEBUT": "2021-08-04" } }, "META_COMMUN": { "ID": "LEGIARTI000043896283", "URL": "article/LEGI/ARTI/00/00/43/89/62/LEGIARTI000043896283.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "LIENS": { "LIEN": [ { "@id": "LEGIARTI000006630983", "@num": "1", "#text": "Décret n°81-278 du 25 mars 1981 - art. 1 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000503017", "@numtexte": "81-278", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1981-03-25" }, { "@id": "LEGIARTI000006631025", "@num": "Annexe I", "#text": "Décret n°81-278 du 25 mars 1981 - art. Annexe I (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000503017", "@numtexte": "81-278", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1981-03-25" }, { "@id": "LEGIARTI000035606736", "@num": "2-1", "#text": "Décret n°90-975 du 30 octobre 1990 - art. 2-1 (VD)", "@sens": "cible", "@cidtexte": "JORFTEXT000000160314", "@nortexte": "SPSG9001546D", "@numtexte": "90-975", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1990-10-30" }, { "@id": "LEGIARTI000006712582", "@num": "2", "#text": "Décret n°92-1432 du 30 décembre 1992 - art. 2 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000726011", "@nortexte": "SPSG9202710D", "@numtexte": "92-1432", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1992-12-30" }, { "@id": "LEGIARTI000006355280", "@num": "87", "#text": "Loi n°93-122 du 29 janvier 1993 - art. 87 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000711604", "@nortexte": "PRMX9200148L", "@numtexte": "93-122", "@typelien": "CITATION", "@naturetexte": "LOI", "@datesignatexte": "1993-01-29" }, { "@id": "LEGIARTI000006865783", "@num": "Annexe", "#text": "Décret n°96-850 du 20 septembre 1996 - art. Annexe (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000195660", "@nortexte": "ENVP9640024D", "@numtexte": "96-850", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1996-09-20" }, { "@id": "LEGIARTI000006506987", "@num": "3", "#text": "Décret n°98-385 du 18 mai 1998 - art. 3 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000571865", "@nortexte": "MESG9820693D", "@numtexte": "98-385", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1998-05-18" }, { "@id": "LEGIARTI000006724441", "@num": "5", "#text": "Décret n°2001-35 du 11 janvier 2001 - art. 5 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000388987", "@nortexte": "MJSK0070147D", "@numtexte": "2001-35", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2001-01-11" }, { "@id": "LEGIARTI000006254318", "@num": "1", "#text": "Arrêté du 16 août 2006 - art. 1 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000459554", "@nortexte": "SANP0623381A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000006254325", "@num": "1", "#text": "Arrêté du 16 août 2006 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000639980", "@nortexte": "SANP0623382A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000006254307", "@num": "1", "#text": "Arrêté du 16 août 2006 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000270592", "@nortexte": "SANP0623380A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000006254319", "@num": "2", "#text": "Arrêté du 16 août 2006 - art. 2 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000459554", "@nortexte": "SANP0623381A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000020326653", "@num": "2", "#text": "Arrêté du 16 août 2006 - art. 2 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000270592", "@nortexte": "SANP0623380A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000020320295", "@num": "3", "#text": "Arrêté du 16 août 2006 - art. 3 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000459554", "@nortexte": "SANP0623381A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000020326611", "@num": "3", "#text": "Arrêté du 16 août 2006 - art. 3 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000270592", "@nortexte": "SANP0623380A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000006254321", "@num": "4", "#text": "Arrêté du 16 août 2006 - art. 4 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000459554", "@nortexte": "SANP0623381A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000006254313", "@num": "7", "#text": "Arrêté du 16 août 2006 - art. 7 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000270592", "@nortexte": "SANP0623380A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000006734099", "@num": "ANNEXE", "#text": "Arrêté du 16 août 2006 - art. ANNEXE (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000639975", "@nortexte": "SANP0623370A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000006255223", "@num": "1", "#text": "Arrêté du 11 septembre 2006 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000271992", "@nortexte": "SANP0623792A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-09-11" }, { "@id": "LEGIARTI000020322856", "@num": "3", "#text": "Arrêté du 11 septembre 2006 - art. 3 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000271992", "@nortexte": "SANP0623792A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-09-11" }, { "@id": "LEGIARTI000006697048", "@num": "39", "#text": "Loi n°2007-248 du 26 février 2007 - art. 39 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000613381", "@nortexte": "SANX0600004L", "@numtexte": "2007-248", "@typelien": "CITATION", "@naturetexte": "LOI", "@datesignatexte": "2007-02-26" }, { "@id": "LEGIARTI000006868630", "@num": "29", "#text": "Décret n° 2007-358 du 19 mars 2007 - art. 29 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000821090", "@nortexte": "AGRG0700644D", "@numtexte": "2007-358", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2007-03-19" }, { "@id": "LEGIARTI000006726837", "@num": "5", "#text": "Décret n°2007-462 du 25 mars 2007 - art. 5 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000466314", "@nortexte": "MJSK0770075D", "@numtexte": "2007-462", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2007-03-25" }, { "@id": "LEGIARTI000018361459", "@num": "Annexe", "#text": "Arrêté du 5 mars 2008 - art. Annexe (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000018360158", "@nortexte": "SJSP0805973A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2008-03-05" }, { "@id": "LEGIARTI000019382668", "@num": "2", "#text": "Arrêté du 11 août 2008 - art. 2 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000019381783", "@nortexte": "SJSP0820319A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2008-08-11" }, { "@id": "LEGIARTI000034448482", "@num": "7", "#text": "Arrêté du 6 février 2009 - art. 7 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000020234297", "@nortexte": "SJSG0824493A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2009-02-06" }, { "@id": "LEGITEXT000020319418", "#text": "Arrêté du 19 février 2009 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000020318429", "@nortexte": "SASP0904387A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2009-02-19" }, { "@id": "LEGITEXT000020319427", "#text": "Arrêté du 19 février 2009 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000020318439", "@nortexte": "SASP0904427A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2009-02-19" }, { "@id": "LEGITEXT000020319436", "#text": "Arrêté du 19 février 2009 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000020318449", "@nortexte": "SASP0904394A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2009-02-19" }, { "@id": "LEGIARTI000021782780", "@num": "Annexe au règlement intérieur", "#text": "Arrêté du 13 janvier 2010 - art. Annexe au règlement intérieur (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000021782073", "@nortexte": "SASP1001133A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2010-01-13" }, { "@id": "LEGITEXT000022416787", "#text": "Arrêté du 30 juin 2010 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000022415149", "@nortexte": "SASP1017123A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2010-06-30" }, { "@id": "LEGITEXT000022416463", "#text": "Arrêté du 30 juin 2010 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000022415125", "@nortexte": "SASP1017105A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2010-06-30" }, { "@id": "LEGITEXT000022416472", "#text": "Arrêté du 30 juin 2010 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000022415141", "@nortexte": "SASP1017114A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2010-06-30" }, { "@id": "LEGIARTI000023430029", "@num": "6", "#text": "Décret n°2011-57\n du 13 janvier 2011 - art. 6", "@sens": "cible", "@cidtexte": "JORFTEXT000023428330", "@nortexte": "SPOV1017553D", "@numtexte": "2011-57", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2011-01-13" }, { "@id": "LEGITEXT000023778069", "#text": "Arrêté du 17 mars 2011 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000023776935", "@nortexte": "ETSP1108041A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2011-03-17" }, { "@id": "LEGIARTI000025071143", "@num": "38", "#text": "LOI n°2011-2012\n du 29 décembre 2011 - art. 38 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000025053440", "@nortexte": "ETSX1119227L", "@numtexte": "2011-2012", "@typelien": "CITATION", "@naturetexte": "LOI", "@datesignatexte": "2011-12-29" }, { "@id": "LEGIARTI000025071141", "@num": "39", "#text": "LOI n°2011-2012\n du 29 décembre 2011 - art. 39 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000025053440", "@nortexte": "ETSX1119227L", "@numtexte": "2011-2012", "@typelien": "CITATION", "@naturetexte": "LOI", "@datesignatexte": "2011-12-29" }, { "@id": "LEGIARTI000026480621", "@num": "4", "#text": "Arrêté du 10 octobre 2012 - art. 4 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000026479723", "@nortexte": "AFSP1221372A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2012-10-10" }, { "@id": "LEGIARTI000027648252", "#text": "Arrêté du 23 janvier 2013 - art. (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000027047902", "@nortexte": "AFSP1228322A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2013-01-23" }, { "@id": "LEGITEXT000027434552", "#text": "Décret n°2013-414\n du 21 mai 2013 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000027434029", "@nortexte": "AFSP1304115D", "@numtexte": "2013-414", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2013-05-21" }, { "@id": "LEGIARTI000027594512", "#text": "Arrêté du 20 juin 2013 - art. (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000027592947", "@nortexte": "AFSP1313848A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2013-06-20" }, { "@id": "LEGIARTI000027699119", "@num": "1", "#text": "Arrêté du 17 juin 2013 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000027697076", "@nortexte": "AFSP1301854A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2013-06-17" }, { "@id": "LEGIARTI000033202304", "#text": "Arrêté du 29 août 2013 - art. (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000027910341", "@nortexte": "PROI1311061A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2013-08-29" }, { "@id": "LEGIARTI000035971526", "#text": "DÉCRET n°2014-1286 du 23 octobre 2014 - art. (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000029675991", "@nortexte": "AFSX1419046D", "@numtexte": "2014-1286", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2014-10-23" }, { "@id": "LEGIARTI000036393921", "@num": "166", "#text": "LOI n°2016-41 du 26 janvier 2016 - art. 166 (VD)", "@sens": "cible", "@cidtexte": "JORFTEXT000031912641", "@nortexte": "AFSX1418355L", "@numtexte": "2016-41", "@typelien": "CITATION", "@naturetexte": "LOI", "@datesignatexte": "2016-01-26" }, { "@id": "LEGIARTI000031916570", "@num": "169", "#text": "LOI n°2016-41 du 26 janvier 2016 - art. 169 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000031912641", "@nortexte": "AFSX1418355L", "@numtexte": "2016-41", "@typelien": "CITATION", "@naturetexte": "LOI", "@datesignatexte": "2016-01-26" }, { "@id": "LEGIARTI000043508038", "#text": "Arrêté du 28 novembre 2016 - art. (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000033507693", "@nortexte": "AFSP1633477A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2016-11-28" }, { "@id": "LEGIARTI000033554483", "@num": "3", "#text": "Arrêté du 2 décembre 2016 - art. 3 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000033553349", "@nortexte": "AFSP1635656A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2016-12-02" }, { "@id": "LEGIARTI000038887172", "@num": "2", "#text": "LOI n°2017-220 du 23 février 2017 - art. 2 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000034078423", "@nortexte": "AFSP1622342L", "@numtexte": "2017-220", "@typelien": "CITATION", "@naturetexte": "LOI", "@datesignatexte": "2017-02-23" }, { "@id": "LEGIARTI000034152829", "@num": "1", "#text": "Arrêté du 27 février 2017 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000034150863", "@nortexte": "AFSP1706243A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2017-02-27" }, { "@id": "LEGIARTI000035988048", "@num": "3", "#text": "Arrêté du 27 février 2017 - art. 3 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000034150842", "@nortexte": "AFSP1706241A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2017-02-27" }, { "@id": "LEGIARTI000035269375", "@num": "1", "#text": "Arrêté du 17 juillet 2017 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000035268202", "@nortexte": "SSAE1720859A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2017-07-17" }, { "@id": "LEGITEXT000036406189", "#text": "Décret n°2017-1781 du 27 décembre 2017 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000036299141", "@nortexte": "SSAP1728401D", "@numtexte": "2017-1781", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2017-12-27" }, { "@id": "LEGIARTI000038432466", "@num": "1", "#text": "Décret n°2019-389 du 30 avril 2019 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000038431240", "@nortexte": "SSAS1906324D", "@numtexte": "2019-389", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2019-04-30" }, { "@id": "LEGITEXT000039664011", "#text": "Arrêté du 20 décembre 2019 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000039663324", "@nortexte": "SSAP1936730A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2019-12-20" }, { "@id": "LEGIARTI000041898595", "@num": "10-3-1", "#text": "Arrêté du 23 mars 2020 - art. 10-3-1 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000041746744", "@nortexte": "SSAX2007864A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-03-23" }, { "@id": "LEGIARTI000042645749", "@num": "17", "#text": "Ordonnance n°2020-460 du 22 avril 2020 - art. 17 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000041814597", "@nortexte": "ECOX2009794R", "@numtexte": "2020-460", "@typelien": "CITATION", "@naturetexte": "ORDONNANCE", "@datesignatexte": "2020-04-22" }, { "@id": "LEGIARTI000041890409", "@num": "1", "#text": "Arrêté du 18 mai 2020 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000041889362", "@nortexte": "SSAZ2011564A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-05-18" }, { "@id": "LEGIARTI000041898504", "@num": "1", "#text": "Arrêté du 20 mai 2020 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000041897919", "@nortexte": "SSAZ2012596A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-05-20" }, { "@id": "LEGIARTI000043298218", "@num": "25", "#text": "Arrêté du 10 juillet 2020 - art. 25 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000042106233", "@nortexte": "SSAZ2018110A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-07-10" }, { "@id": "LEGIARTI000042609739", "@num": "26", "#text": "Arrêté du 10 juillet 2020 - art. 26 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000042106233", "@nortexte": "SSAZ2018110A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-07-10" }, { "@id": "LEGIARTI000043103458", "#text": "Arrêté du 5 février 2021 - art. 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I.-L'Agence nationale de sécurité du médicament et des produits de santé est un établissement public de l'Etat, placé sous la tutelle du ministre chargé de la santé.

II.-L'agence procède à l'évaluation des bénéfices et des risques liés à l'utilisation des produits à finalité sanitaire destinés à l'homme et des produits à finalité cosmétique. Elle surveille le risque lié à ces produits et effectue des réévaluations des bénéfices et des risques.

L'agence peut demander que les essais cliniques portant sur des médicaments soient effectués sous forme d'essais contre comparateurs actifs et contre placebo. Si la personne produisant ou exploitant un médicament s'oppose aux essais contre comparateurs actifs, elle doit le justifier.

L'agence participe à l'application des lois et règlements et prend, dans les cas prévus par des dispositions particulières, des décisions relatives à l'évaluation, aux essais, à la fabrication, à la préparation, à l'importation, à l'exportation, à la distribution en gros, au courtage, au conditionnement, à la conservation, à l'exploitation, à la mise sur le marché, à la publicité, à la mise en service ou à l'utilisation des produits à finalité sanitaire destinés à l'homme et des produits à finalité cosmétique, et notamment :

1° Les médicaments, y compris les insecticides, acaricides et antiparasitaires à usage humain, les préparations magistrales, hospitalières et officinales, les substances stupéfiantes, psychotropes ou autres substances vénéneuses, les huiles essentielles et plantes médicinales, les matières premières à usage pharmaceutique ;

2° Les produits contraceptifs et contragestifs ;

3° Les biomatériaux et les dispositifs médicaux ;

4° Les dispositifs médicaux de diagnostic in vitro ;

5° Les produits sanguins labiles ;

6° Les organes, tissus, cellules et produits d'origine humaine ou animale, y compris lorsqu'ils sont prélevés à l'occasion d'une intervention chirurgicale ;

7° Les produits cellulaires à finalité thérapeutique ;

8° Le lait maternel collecté, qualifié, préparé et conservé par les lactariums ;

9° Les produits destinés à l'entretien ou à l'application des lentilles de contact ;

10° (Abrogé) ;

11° Les procédés et appareils destinés à la désinfection des locaux et des véhicules dans les cas prévus à l'article L. 3114-1 ;

12° (Abrogé) ;

13° (Abrogé) ;

14° Les lentilles oculaires non correctrices ;

15° Les produits cosmétiques ;

16° Les micro-organismes et toxines mentionnés à l'article L. 5139-1 ;

17° Les produits de tatouage ;

18° Les logiciels qui ne sont pas des dispositifs médicaux et qui sont utilisés par les laboratoires de biologie médicale, pour la gestion des examens de biologie médicale et lors de la validation, de l'interprétation, de la communication appropriée en application du 3° de l'article L. 6211-2 et de l'archivage des résultats ;

19° Les dispositifs à finalité non strictement médicale utilisés dans les laboratoires de biologie médicale pour la réalisation des examens de biologie médicale ;

20° Les logiciels d'aide à la prescription et les logiciels d'aide à la dispensation ;

21° Les selles collectées par les établissements ou organismes mentionnés à l'article L. 513-11-1 et destinées à la fabrication d'un médicament.

III.-L'agence participe à l'application des lois et règlements relatifs aux recherches impliquant la personne humaine et prend, dans les cas prévus par des dispositions particulières, des décisions relatives aux recherches impliquant la personne humaine.

Elle assure la mise en œuvre des systèmes de vigilance, portant sur les produits mentionnés au II, à l'exception de la biovigilance et du dispositif de vigilance relatif à l'assistance médicale à la procréation, et élabore la pharmacopée.

Elle rend publics un rapport de synthèse de l'évaluation effectuée pour tout nouveau médicament dans des conditions déterminées par voie réglementaire, ainsi que les décisions d'octroi, de suspension et de retrait de l'autorisation de mise sur le marché mentionnées aux articles L. 5121-8 et L. 5121-9. Elle organise des réunions régulières d'information avec des associations agréées de personnes malades et d'usagers du système de santé mentionnées à l'article L. 1114-1 sur les problèmes de sécurité sanitaire des produits de santé, notamment sur les actions entreprises dans le domaine de la prévention et de la répression de la falsification des médicaments.

Elle contrôle la publicité en faveur de tous les produits, objets, appareils et méthodes revendiquant une finalité sanitaire.

Elle prend ou demande aux autorités compétentes de prendre les mesures de police sanitaire nécessaires lorsque la santé de la population est menacée, dans les conditions prévues au présent code ou par toute autre disposition législative ou réglementaire visant à préserver la santé humaine.

Elle établit un rapport annuel d'activité adressé au Gouvernement et au Parlement. Ce rapport est rendu public. Le rapport comporte le bilan annuel de la réévaluation du rapport entre les bénéfices et les risques des médicaments à usage humain mentionnés à l'article L. 5121-8.

Elle organise des auditions publiques sur des thèmes de santé publique.

L'agence est également chargée du contrôle du respect des dispositions des autorisations délivrées en application de l'article L. 1161-5.

\n
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Ne sont soumis aux dispositions du présent livre ni les produits du corps humain pour lesquels il est d'usage de ne pas appliquer l'ensemble des principes qu'énoncent les articles L. 1211-1 à L. 1211-7, ni les éléments et produits du corps humain prélevés et utilisés à des fins thérapeutiques autologues dans le cadre d'une seule et même intervention médicale, sans être conservés ou préparés à aucun moment au sein d'un organisme ou d'un établissement autorisé en application de l'article L. 1243-2.

Ne sont pas non plus soumises aux dispositions du présent livre les selles collectées en application des articles L. 513-11-1 à L. 513-11-5 pour une utilisation à des fins thérapeutiques.

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Article 35 ENTIEREMENT_MODIF (LOI n° 2021-1017 du 2 août 2021 relative à la bioéthique (1))