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Showing 121–130 of 187 articles for “Art. 1121”
…als mentioned in I of Article L. 1123-16 and, in the case of research mentioned in 1° of article L. 1121-1, clinical investigations mentioned in II of article L. 1125-1, or performance studies mention…
No one may carry out any research mentioned in 1° of Article L. 1121-1 without authorisation from the competent authority issued within a period set by regulation.If the competent authority informs th…
…of sexual harassment or reported such acts, may be subject to the measures mentioned in Article L. 1121-2. The persons mentioned in the first paragraph of this article benefit from the protections pr…
…inal product to a patient. This traceability also applies to the research referred to in Article L. 1121-1. This traceability supplements the requirements relating to the traceability of tissues and c…
…rposes for others, including in the context of biomedical research within the meaning of Article L. 1121-1. The provisions of this sub-section also apply in the case of incorporation of these elements…
For the research mentioned in 1° of Article L. 1121-1 involving the products mentioned in I of Article R. 1211-29 with the exception of cell therapy preparations, the sponsor shall report to the Agenc…
…ticle L. 4211-1 and in the context of the research referred to in the first paragraph of Article L. 1121-1, the manufacture, import, export, distribution and use of advanced therapy medicinal products…
…37 to R. 1123-41. Investigations may only be undertaken under the conditions set out in articles L. 1121-3 and L. 1123-8. They must be conducted in accordance with the conditions laid down in Title II…
…ministration in the context of research involving the human person within the meaning of Article L. 1121-1 are considered to be samples taken for therapeutic purposes, without prejudice to the provisi…
…ich has issued an opinion on the research concerned. For the research mentioned in 1° of Article L. 1121-1 relating to medicinal products, the competent authority shall immediately communicate this ac…
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