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Showing 6611–6620 of 61689 articles for “Art. s. L 313-3 to L 313-5”
The authorisation application or renewal file provided for in article R. 6122-32 must show whether the establishment has joined a specific regional scheme or entered into an agreement with one or more…
I.-In order to draw up the declaration relating to the employment obligation, the bodies mentioned in articles L. 213-1 and L. 752-4 of the Social Security Code or in article L. 723-2 of the Rural and…
The sponsor provides the investigators within the meaning of Article R. 5141-3 with the following information: 1° The title and objective of the trial requested ; 2° Identification of the medicinal pr…
If there is a change in the designation of the accounting officer or in the terms of settlement of the contract, the purchaser shall annotate the single copy or the certificate of transferability with…
For all research involving humans, the sponsor must pass on to the investigators concerned any information likely to affect the safety of individuals.
For the research mentioned in 1° of Article L. 1121-1 involving the cell therapy preparations defined in Article L. 1243-1, the sponsor shall report to the Agence nationale de sécurité du médicament e…
The sponsor shall inform the competent authority and the Committee for the Protection of Individuals without delay of the new facts defined in 12° of Article R. 1123-46 and, where appropriate, of the…
For the research referred to in 1° of Article L. 1121-1 concerning medical devices and in vitro diagnostic medical devices, the sponsor must report to the Agence nationale de sécurité du médicament et…
For the research referred to in 1° of Article L. 1121-1 involving labile blood products, the sponsor shall report to the Agence nationale de sécurité du médicament et des produits de santé any adverse…
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…
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