Article R5121-13
Subject to the provisions of articles L. 1123-6 to L. 1123-8 and L. 1123-13 and those adopted for their application, the investigators and persons called upon to collaborate in the trials are bound by…
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Showing 61–70 of 151 articles for “Art. 1123”
Subject to the provisions of articles L. 1123-6 to L. 1123-8 and L. 1123-13 and those adopted for their application, the investigators and persons called upon to collaborate in the trials are bound by…
…le L. 1121-3, as approved by the Committee for the Protection of Individuals pursuant to article L. 1123-7 and, where applicable, by the French National Agency for the Safety of Medicines and Health P…
…the manufacturer shall draw up a declaration containing the information referred to in Articles R. 1123-37 to R. 1123-41 and certifying that the medical device concerned complies with the essential r…
…sent to the Minister responsible for health using the information system provided for in Article R. 1123-20-1. A committee for the protection of individuals shall be appointed in accordance with the p…
…ng the necessary competence to examine the project, under the conditions provided for in Article L. 1123-14 or Article L. 1123-16. It may only request one opinion per clinical investigation project. I…
…sent to the Minister responsible for health using the information system provided for in Article R. 1123-20-1. A committee for the protection of individuals shall be appointed in accordance with the p…
…ng the necessary competence to examine the project, under the conditions provided for in Article L. 1123-14 or Article L. 1123-16. It may only request one opinion per performance study project. In the…
…u médicament et des produits de santé of its intention under the conditions laid down in Article L. 1123-8 and Articles R. 1123-37 to R. 1123-41. Investigations may only be undertaken under the condit…
…Agence nationale de sécurité du médicament et des produits de santé as provided for in articles L. 1123-8 and R. 1123-30 ; however, where the implementation of the research is of an urgent nature, th…
…committee may, in accordance with the procedures laid down by the decree provided for in article L. 1123-14, refer the matter to the expert committee for research, studies and assessments in the healt…
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