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L'exportation d'un médicament sans se conformer aux dispositions de l'article L. 5124-11 est punie de deux ans d'emprisonnement et de 30 000 euros d'amende.

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" } }, "LEGIARTI000006689992": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "L5124-11", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2004-08-07", "DATE_DEBUT": "2000-06-22" } }, "META_COMMUN": { "ID": "LEGIARTI000006689992", "URL": "article/LEGI/ARTI/00/00/06/68/99/LEGIARTI000006689992.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SPANXXXXXXX1X5124L11XXAA" } }, "LIENS": { "LIEN": [ { "@id": "JORFTEXT000000217229", "#text": "Ordonnance 2000-548 2000-06-15", "@sens": "source", "@cidtexte": "JORFTEXT000000217229", "@nortexte": "MESX0000036P", "@typelien": "CODIFICATION", "@naturetexte": "RAPPORT", "@datesignatexte": "2999-01-01" }, { "@id": "JORFTEXT000000227015", "#text": "Loi 2002-303 2002-03-04 art. 92 JORF 5 mars 2002", "@sens": "source", "@cidtexte": "JORFTEXT000000227015", "@nortexte": "MESX0100092L", "@numtexte": "2002-303", "@typelien": "CODIFICATION", "@naturetexte": "LOI", "@datesignatexte": "2002-03-04" }, { "@id": "LEGIARTI000025788527", "@num": "D1221-66", "#text": "Code de la santé publique - art. 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L1261-2 (Ab)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000032411395", "@num": "L1413-4", "#text": "Code de la santé publique - art. L1413-4 (VD)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000024462696", "@num": "L3135-1", "#text": "Code de la santé publique - art. L3135-1 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006689889", "@num": "L5121-8", "#text": "Code de la santé publique - art. L5121-8 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006689995", "@num": "L5124-12", "#text": "Code de la santé publique - art. L5124-12 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000048703322", "@num": "L5124-18", "#text": "Code de la santé publique - art. L5124-18 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006689977", "@num": "L5124-3", "#text": "Code de la santé publique - art. L5124-3 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000023753770", "@num": "L5124-9-1", "#text": "Code de la santé publique - art. 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Un établissement pharmaceutique exportant un médicament doit demander à l'Agence française de sécurité sanitaire des produits de santé de certifier qu'il possède l'autorisation mentionnée à l'article L. 5124-3 ou, pour les établissements ou organismes fabriquant des produits mentionnés à l'article L. 1261-1, l'autorisation prévue à l'article L. 1261-2. Un Etat non membre de la Communauté européenne important un médicament peut effectuer les mêmes demandes.
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L'Agence française de sécurité sanitaire des produits de santé peut, pour des raisons de santé publique, interdire l'exportation de médicaments qui ne bénéficient pas d'une autorisation de mise sur le marché telle que définie à l'article L. 5121-8 ou qui sont susceptibles de faire courir aux patients concernés des risques non proportionnés aux bénéfices escomptés.
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L'Agence française de sécurité sanitaire des produits de santé interdit l'exportation de médicaments dont l'autorisation de mise sur le marché a été suspendue ou retirée pour des raisons de santé publique.
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Lorsque le médicament exporté ne bénéficie pas d'une autorisation de mise sur le marché, l'établissement pharmaceutique qui l'exporte fournit à l'Agence française de sécurité sanitaire des produits de santé une déclaration expliquant les raisons pour lesquelles cette autorisation n'est pas disponible. L'Agence française de sécurité sanitaire des produits de santé communique ces raisons au ministre chargé de la santé du pays importateur.
" } }, "LEGIARTI000006689993": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "L5124-11", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2010-02-26", "DATE_DEBUT": "2004-08-07" } }, "META_COMMUN": { "ID": "LEGIARTI000006689993", "URL": "article/LEGI/ARTI/00/00/06/68/99/LEGIARTI000006689993.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SPANXXXXXXX1X5124L11XXAB" } }, "LIENS": { "LIEN": [ { "@id": "JORFTEXT000000217229", "#text": "Ordonnance 2000-548 2000-06-15", "@sens": "source", "@cidtexte": "JORFTEXT000000217229", "@nortexte": "MESX0000036P", "@typelien": "CODIFICATION", "@naturetexte": "RAPPORT", "@datesignatexte": "2999-01-01" }, { "@id": "JORFTEXT000000227015", "#text": "Loi 2002-303 2002-03-04 art. 92 JORF 5 mars 2002", "@sens": "source", "@cidtexte": "JORFTEXT000000227015", "@nortexte": "MESX0100092L", "@numtexte": "2002-303", "@typelien": "CODIFICATION", "@naturetexte": "LOI", "@datesignatexte": "2002-03-04" }, { "@id": "LEGIARTI000006697582", "@num": "14", "#text": "Loi n°2004-800 du 6 août 2004 - art. 14 () JORF 7 août 2004", "@sens": "source", "@cidtexte": "JORFTEXT000000441469", "@nortexte": "SANX0100053L", "@numtexte": "2004-800", "@typelien": "MODIFICATION", "@naturetexte": "LOI", "@datesignatexte": "2004-08-06" }, { "@id": "LEGIARTI000025788527", "@num": "D1221-66", "#text": "Code de la santé publique - art. 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L5124-3 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000023753770", "@num": "L5124-9-1", "#text": "Code de la santé publique - art. L5124-9-1 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000019227485", "@num": "L5423-4", "#text": "Code de la santé publique - art. L5423-4 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000041397671", "@num": "L5423-8", "#text": "Code de la santé publique - art. L5423-8 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693737", "@num": "L603", "#text": "Code de la santé publique - art. L603 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693731", "@num": "L603", "#text": "Code de la santé publique - art. L603 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000025787909", "@num": "R5121-133", "#text": "Code de la santé publique - art. R5121-133 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000025787905", "@num": "R5121-134", "#text": "Code de la santé publique - art. R5121-134 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000032105981", "@num": "R5121-135", "#text": "Code de la santé publique - art. R5121-135 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006171369", "@fin": "2999-01-01", "#text": "Chapitre IV : Fabrication et distribution en gros.", "@debut": "2000-06-22" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006155085", "@fin": "2999-01-01", "#text": "Titre II : Médicaments à usage humain", "@debut": "2000-06-22" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006140630", "@fin": "2999-01-01", "#text": "Livre Ier : Produits pharmaceutiques", "@debut": "2000-06-22" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006125349", "@fin": "2999-01-01", "#text": "Cinquième partie : Produits de santé", "@debut": "2000-06-22" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006103419", "@fin": "2999-01-01", "#text": "Partie législative", "@debut": "2000-06-22" } ] }, "@cid": "LEGITEXT000006072665", "@nature": "CODE", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Code de la santé publique", "@debut": "1953-10-07", "@id_txt": "LEGITEXT000006072665", "@c_titre_court": "Code de la santé publique" } ], "@date_publi": "2999-01-01", "@date_signature": "2999-01-01" } }, "VERSIONS": { "VERSION": [ { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006689992", "@fin": "2004-08-07", "@num": "L5124-11", "@etat": "MODIFIE", "@debut": "2000-06-22", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006689993", "@fin": "2010-02-26", "@num": "L5124-11", "@etat": "MODIFIE", "@debut": "2004-08-07", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000021941960", "@fin": "2012-05-01", "@num": "L5124-11", "@etat": "MODIFIE", "@debut": "2010-02-26", "@origine": "LEGI" } }, { "@etat": "VIGUEUR", "LIEN_ART": { "@id": "LEGIARTI000025104488", "@fin": "2999-01-01", "@num": "L5124-11", "@etat": "VIGUEUR", "@debut": "2012-05-01", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
Un établissement pharmaceutique exportant un médicament doit demander à l'Agence française de sécurité sanitaire des produits de santé de certifier qu'il possède l'autorisation mentionnée à l'article L. 5124-3 ou, pour les établissements ou organismes fabriquant des produits mentionnés à l'article L. 1243-1 et aux 12° et 13° de l'article L. 5121-1, l'autorisation prévue aux articles L. 1243-2, L. 4211-8 et L. 4211-9. Un Etat non membre de la Communauté européenne important un médicament peut effectuer les mêmes demandes.
\n
L'Agence française de sécurité sanitaire des produits de santé peut, pour des raisons de santé publique, interdire l'exportation de médicaments qui ne bénéficient pas d'une autorisation de mise sur le marché telle que définie à l'article L. 5121-8 ou qui sont susceptibles de faire courir aux patients concernés des risques non proportionnés aux bénéfices escomptés.
\n
L'Agence française de sécurité sanitaire des produits de santé interdit l'exportation de médicaments dont l'autorisation de mise sur le marché a été suspendue ou retirée pour des raisons de santé publique.
\n
Lorsque le médicament exporté ne bénéficie pas d'une autorisation de mise sur le marché, l'établissement pharmaceutique qui l'exporte fournit à l'Agence française de sécurité sanitaire des produits de santé une déclaration expliquant les raisons pour lesquelles cette autorisation n'est pas disponible. L'Agence française de sécurité sanitaire des produits de santé communique ces raisons au ministre chargé de la santé du pays importateur.
" } }, "LEGIARTI000019216410": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "6", "TYPE": "ENTIEREMENT_MODIF", "DATE_FIN": "2999-01-01", "DATE_DEBUT": "2999-01-01" } }, "META_COMMUN": { "ID": "LEGIARTI000019216410", "URL": "article/LEGI/ARTI/00/00/19/21/64/LEGIARTI000019216410.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "LIENS": { "LIEN": [ { "@id": "LEGIARTI000019227492", "@num": "L5423-1", "#text": "Code de la santé publique - art. L5423-1 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000019227479", "@num": "L5423-2", "#text": "Code de la santé publique - art. L5423-2 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000019227488", "@num": "L5423-3", "#text": "Code de la santé publique - art. L5423-3 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000019227485", "@num": "L5423-4", "#text": "Code de la santé publique - art. L5423-4 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000019227482", "@num": "L5423-5", "#text": "Code de la santé publique - art. L5423-5 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000019227476", "@num": "L5423-6", "#text": "Code de la santé publique - art. L5423-6 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000019227473", "@num": "L5423-7", "#text": "Code de la santé publique - art. L5423-7 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000019216396", "@fin": "2999-01-01", "#text": "CHAPITRE IER : MEDICAMENTS A USAGE HUMAIN", "@debut": "2008-07-20" } ] }, "@cid": "JORFTEXT000019215060", "@nor": "SJSX0814719R", "@num": "2008-717", "@nature": "ORDONNANCE", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Ordonnance n° 2008-717 du 17 juillet 2008 portant sur les dispositions pénales relatives à certains produits de santé", "@debut": "2999-01-01", "@id_txt": "JORFTEXT000019215060", "@c_titre_court": "Ordonnance n° 2008-717 du 17 juillet 2008" }, { "@fin": "2999-01-01", "#text": "Ordonnance n° 2008-717 du 17 juillet 2008 portant sur les dispositions pénales relatives à certains produits de santé", "@debut": "2008-07-20", "@id_txt": "LEGITEXT000019216390", "@c_titre_court": "Ordonnance n° 2008-717 du 17 juillet 2008" } ], "@ministere": "Ministère de la santé, de la jeunesse, des sports et de la vie associative", "@date_publi": "2008-07-19", "@date_signature": "2008-07-17" } }, "VERSIONS": { "VERSION": [ { "LIEN_ART": { "@id": "LEGIARTI000019216410", "@fin": "2999-01-01", "@num": "6", "@debut": "2999-01-01", "@origine": "LEGI" } }, { "LIEN_ART": { "@id": "JORFARTI000019215091", "@fin": "2999-01-01", "@num": "6", "@debut": "2999-01-01", "@origine": "JORF" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
\n
A modifié les dispositions suivantes :

- Code de la santé publique
\n Art. L5423-1, Art. L5423-3, Art. L5423-4, Art. L5423-5, Art. L5423-2, Art. L5423-6, Art. L5423-7\n
\n

\n
" } }, "LEGIARTI000021941960": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "L5124-11", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2012-05-01", "DATE_DEBUT": "2010-02-26" } }, "META_COMMUN": { "ID": "LEGIARTI000021941960", "URL": "article/LEGI/ARTI/00/00/21/94/19/LEGIARTI000021941960.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "LIENS": { "LIEN": [ { "@id": "LEGIARTI000021869972", "@num": "26", "#text": "Ordonnance n°2010-177\n du 23 février 2010 - art. 26", "@sens": "cible", "@cidtexte": "JORFTEXT000021868310", "@nortexte": "SASX0930688R", "@numtexte": "2010-177", "@typelien": "MODIFIE", "@naturetexte": "ORDONNANCE", "@datesignatexte": "2010-02-23" }, { "@id": "LEGIARTI000025788527", "@num": "D1221-66", "#text": "Code de la santé publique - art. D1221-66 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000036511334", "@num": "L1222-1-1", "#text": "Code de la santé publique - art. L1222-1-1 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006686213", "@num": "L1243-1", "#text": "Code de la santé publique - art. L1243-1", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006686215", "@num": "L1243-2", "#text": "Code de la santé publique - art. L1243-2", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000032411395", "@num": "L1413-4", "#text": "Code de la santé publique - art. L1413-4 (VD)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000024462696", "@num": "L3135-1", "#text": "Code de la santé publique - art. L3135-1 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006689015", "@num": "L4211-8", "#text": "Code de la santé publique - art. L4211-8", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006689017", "@num": "L4211-9", "#text": "Code de la santé publique - art. L4211-9", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006689870", "@num": "L5121-1", "#text": "Code de la santé publique - art. L5121-1", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006689889", "@num": "L5121-8", "#text": "Code de la santé publique - art. L5121-8", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006689995", "@num": "L5124-12", "#text": "Code de la santé publique - art. L5124-12 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000048703322", "@num": "L5124-18", "#text": "Code de la santé publique - art. L5124-18 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006689977", "@num": "L5124-3", "#text": "Code de la santé publique - art. L5124-3", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000023753770", "@num": "L5124-9-1", "#text": "Code de la santé publique - art. L5124-9-1 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000019227485", "@num": "L5423-4", "#text": "Code de la santé publique - art. L5423-4 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000041397671", "@num": "L5423-8", "#text": "Code de la santé publique - art. L5423-8 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693737", "@num": "L603", "#text": "Code de la santé publique - art. L603 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693731", "@num": "L603", "#text": "Code de la santé publique - art. L603 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000025787909", "@num": "R5121-133", "#text": "Code de la santé publique - art. R5121-133 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000025787905", "@num": "R5121-134", "#text": "Code de la santé publique - art. R5121-134 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000032105981", "@num": "R5121-135", "#text": "Code de la santé publique - art. R5121-135 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006171369", "@fin": "2999-01-01", "#text": "Chapitre IV : Fabrication et distribution en gros.", "@debut": "2000-06-22" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006155085", "@fin": "2999-01-01", "#text": "Titre II : Médicaments à usage humain", "@debut": "2000-06-22" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006140630", "@fin": "2999-01-01", "#text": "Livre Ier : Produits pharmaceutiques", "@debut": "2000-06-22" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006125349", "@fin": "2999-01-01", "#text": "Cinquième partie : Produits de santé", "@debut": "2000-06-22" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006103419", "@fin": "2999-01-01", "#text": "Partie législative", "@debut": "2000-06-22" } ] }, "@cid": "LEGITEXT000006072665", "@nature": "CODE", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Code de la santé publique", "@debut": "1953-10-07", "@id_txt": "LEGITEXT000006072665", "@c_titre_court": "Code de la santé publique" } ], "@date_publi": "2999-01-01", "@date_signature": "2999-01-01" } }, "VERSIONS": { "VERSION": [ { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006689992", "@fin": "2004-08-07", "@num": "L5124-11", "@etat": "MODIFIE", "@debut": "2000-06-22", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006689993", "@fin": "2010-02-26", "@num": "L5124-11", "@etat": "MODIFIE", "@debut": "2004-08-07", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000021941960", "@fin": "2012-05-01", "@num": "L5124-11", "@etat": "MODIFIE", "@debut": "2010-02-26", "@origine": "LEGI" } }, { "@etat": "VIGUEUR", "LIEN_ART": { "@id": "LEGIARTI000025104488", "@fin": "2999-01-01", "@num": "L5124-11", "@etat": "VIGUEUR", "@debut": "2012-05-01", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
Un établissement pharmaceutique exportant un médicament doit demander à l'Agence française de sécurité sanitaire des produits de santé de certifier qu'il possède l'autorisation mentionnée à l'article L. 5124-3 ou, pour les établissements ou organismes fabriquant des produits mentionnés à l'article L. 1243-1 et aux 12° et 13° de l'article L. 5121-1, l'autorisation prévue aux articles L. 1243-2, L. 4211-8 et L. 4211-9. Un Etat non membre de l'Union européenne important un médicament peut effectuer les mêmes demandes.
\n
L'Agence française de sécurité sanitaire des produits de santé peut, pour des raisons de santé publique, interdire l'exportation de médicaments qui ne bénéficient pas d'une autorisation de mise sur le marché telle que définie à l'article L. 5121-8 ou qui sont susceptibles de faire courir aux patients concernés des risques non proportionnés aux bénéfices escomptés.
\n
L'Agence française de sécurité sanitaire des produits de santé interdit l'exportation de médicaments dont l'autorisation de mise sur le marché a été suspendue ou retirée pour des raisons de santé publique.
\n
Lorsque le médicament exporté ne bénéficie pas d'une autorisation de mise sur le marché, l'établissement pharmaceutique qui l'exporte fournit à l'Agence française de sécurité sanitaire des produits de santé une déclaration expliquant les raisons pour lesquelles cette autorisation n'est pas disponible.L'Agence française de sécurité sanitaire des produits de santé communique ces raisons au ministre chargé de la santé du pays importateur.
" } }, "LEGIARTI000025104488": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "L5124-11", "ETAT": "VIGUEUR", "TYPE": "AUTONOME", "DATE_FIN": "2999-01-01", "DATE_DEBUT": "2012-05-01" } }, "META_COMMUN": { "ID": "LEGIARTI000025104488", "URL": "article/LEGI/ARTI/00/00/25/10/44/LEGIARTI000025104488.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "NOTA": { "CONTENU": "

Loi n° 2011-2012 du 29 décembre 2011 article 41 III : Les présentes dispositions entrent en vigueur à une date prévue par le décret pris pour leur application et au plus tard le 1er août 2012. Dès cette entrée en vigueur, l'Agence nationale de sécurité du médicament et des produits de santé exerce l'ensemble des droits et supporte l'ensemble des obligations de l'Agence française de sécurité sanitaire des produits de santé. Jusqu'à l'entrée en vigueur de ces dispositions, les compétences et pouvoirs que la présente loi attribue à l'Agence nationale de sécurité du médicament et des produits de santé sont exercés par l'Agence française de sécurité sanitaire des produits de santé.

Le décret n° 2012-597 du 27 avril 2012 est entré en vigueur le 1er mai 2012.

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Un établissement pharmaceutique exportant un médicament doit demander à l'Agence nationale de sécurité du médicament et des produits de santé de certifier qu'il possède l'autorisation mentionnée à l'article L. 5124-3 ou, pour les établissements ou organismes fabriquant des produits mentionnés à l'article L. 1243-1 et aux 12° et 13° de l'article L. 5121-1, l'autorisation prévue aux articles L. 1243-2, L. 4211-8 et L. 4211-9. Un Etat non membre de l'Union européenne important un médicament peut effectuer les mêmes demandes.

L'Agence nationale de sécurité du médicament et des produits de santé peut, pour des raisons de santé publique, interdire l'exportation de médicaments qui ne bénéficient pas d'une autorisation de mise sur le marché telle que définie à l'article L. 5121-8 ou qui sont susceptibles de faire courir aux patients concernés des risques non proportionnés aux bénéfices escomptés.

L'Agence nationale de sécurité du médicament et des produits de santé interdit l'exportation de médicaments dont l'autorisation de mise sur le marché a été suspendue ou retirée pour des raisons de santé publique ou dont l'autorisation de mise sur le marché n'a pas été renouvelée pour les mêmes raisons.

Lorsque le médicament exporté ne bénéficie pas d'une autorisation de mise sur le marché, l'établissement pharmaceutique qui l'exporte fournit à l'Agence nationale de sécurité du médicament et des produits de santé une déclaration expliquant les raisons pour lesquelles cette autorisation n'est pas disponible. L'Agence nationale de sécurité du médicament et des produits de santé communique ces raisons au ministre chargé de la santé du pays importateur.

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Article L5423-4 AUTONOME MODIFIE, en vigueur du 20/07/2008 au 01/02/2014 (Code de la santé publique)