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Showing 4150 of 151 articles for Art. 1123

French Public Health CodeIn force
Subsection 4: Notification procedure.

Article R1123-20-1

…application of Article R. 1121-15 and provides them with the information provided for in Article R. 1123-41; 2° Exchanges between the personal data protection committees and the Agence nationale de sé…

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

Article R1123-61

…rticle L. 1121-1 or on request, the sponsor must send the competent authority defined in Article L. 1123-12 and the relevant Data Protection Committee a safety report taking into account all available…

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

Article R1123-58

…formation concerning the 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
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
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 2: Composition and appointment

Article R1123-10

…e members of the Committee.If the Chairman is a member of the first college mentioned in article R. 1123-4, the Vice-Chairman is elected from among the members of the second college and vice versa. Th…

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 IIIa: Research, clinical investigations and performance studies covered by national defence secrets

Article L1123-16

…onal Security Committee for the Protection of Individuals if the conditions laid down in article L. 1123-5 are no longer met.II - The composition of the Protection of Individuals - Defence and Nationa…

AI translation · Updated 8 Nov 2023Open Article
French Public Health CodeIn force
Section 6: Suspension, prohibition and termination of research.

Article R1123-63

If the competent authority defined in article L. 1123-12 considers that the sponsor, the investigator or any other person involved in the conduct of the research is no longer fulfilling its obligation…

AI translation · Updated 6 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
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Mariela Petrova

Mariela Petrova

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