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Showing 5160 of 1215 articles for Art. s. 1123

French Public Health CodeIn force
Chapter IIIa: Research, clinical investigations and performance studies covered by national defence secrets

Article L1123-18

…ence and National Security Committee for the Protection of Individuals mentioned in I of Article L. 1123-16 and, in the case of research mentioned in 1° of article L. 1121-1, clinical investigations m…

AI translation · Updated 8 Nov 2023Open Article
French Public Health CodeIn force
Chapter VII: Special provisions for certain types of research

Article L1127-1

…relating to organs, tissues or cells of human origin. The authorisation provided for in article L. 1123-8 is equivalent, where applicable for the duration of the research and for the products in ques…

AI translation · Updated 8 Nov 2023Open Article
French General Code of Local AuthoritiesIn force
Annex I

Article Sommaire

…and Expenditure (EPRD) is a decision (decision of the Director for PHEs) that the Director implements. The Director is bound only by the appropriations for permanent staff included in the EPRD, or by…

AI translation · Updated 3 Nov 2023Open Article
French Public Health CodeIn force
Chapter IV: Special provisions applicable to clinical trials on medicinal products

Article L1124-1

…n Article 6 of this Regulation is the National Agency for the Safety of Medicines and Health Products. The assessment of Part II provided for in Article 7 of this Regulation is the responsibility of t…

AI translation · Updated 8 Nov 2023Open Article
French Public Health CodeIn force
Subsection 1: Vigilance.

Article R1123-57

…n concerning the serious adverse reactions, serious incidents and new facts mentioned in Article L. 1123-10 shall be sent to the National Agency for the Safety of Medicines and Health Products without…

AI translation · Updated 6 Nov 2023Open Article
French Public Health CodeIn force
Subsection 1: Vigilance.

Article R1123-54

…lving the human person, the sponsor must report the events or effects mentioned in 7° of Article R. 1123-46 to the Agence nationale de sécurité du médicament et des produits de santé without delay.The…

AI translation · Updated 6 Nov 2023Open Article
French Public Health CodeIn force
Chapter VIII: Criminal provisions

Article L1128-5

…ose performance has been prohibited or suspended by the competent authority mentioned in article L. 1123-12. Any investigator who carries out such research in breach of the provisions of article L. 11…

AI translation · Updated 8 Nov 2023Open Article
French Public Health CodeIn force
Subsection 4: Rules applicable to authorised establishments and organisations

Article R4211-42-1

…information provided by the sponsor in the application for authorisation referred to in article L. 1123-8 and accepted by the Agence nationale de sécurité du médicament et des produits de santé. II.-…

AI translation · Updated 3 Nov 2023Open Article
French Public Health CodeIn force
Section 7: Information provided by the promoter

Article R1123-70

…ional medicinal product; 3° Where applicable, the investigator's brochure referred to in article R. 1123-20 ; 4° Where applicable, the elements of the research protocol relevant to the possession, pre…

AI translation · Updated 6 Nov 2023Open Article
French Public Health CodeIn force
Subsection 2: Manufacture and import of investigational medicinal products.

Article R5124-57-4

…f the medicinal product are provided in the application for authorisation referred to in article L. 1123-8. The importing pharmaceutical establishment shall ensure that each batch of these medicinal p…

AI translation · Updated 2 Nov 2023Open Article
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Mariela Petrova

Mariela Petrova

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