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…
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Showing 41–50 of 151 articles for “Art. 1123”
…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…
…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…
…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…
…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…
…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…
…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…
…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…
…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…
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…
…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…
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