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Showing 151–160 of 187 articles for “Art. 1121”
…sponsor to the competent authority, in the application for authorisation referred to in Article L. 1121-4; 4° The procedures for consulting the committees for the protection of individuals with regar…
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 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…
…by the Committee for the Protection of Individuals in application of the provisions of Articles L. 1121-1 et seq. and, where applicable, a copy of the authorisation issued in application of the same…
…5121-1 which are not used in the context of research mentioned in the first paragraph of article L. 1121-1. Exports by these companies or organisations, as well as by wholesale export distributors, to…
…e research are no longer met as they stand.When they concern research mentioned in 1° of Article L. 1121-1, requests for additional information or modifications issued by the Committee are forwarded b…
…elements or products are intended to be used in the context of the research mentioned in article L. 1121-1. These same establishments may, for the same purposes, supply tissues, their derivatives or c…
…py of the insurance certificate;7° Where applicable, the exclusion period referred to in article L. 1121-12 ; 8° The opinion of the personal protection committee consulted on the project in applicatio…
…re carried out by the manufacturer, under the responsibility of the sponsor mentioned in article L. 1121-1 ; 2° Importer, the company or organisation engaged, with a view to their wholesale, free tran…
…transferred, where applicable. IV.-Except in the context of the research referred to in article L. 1121-1, an advanced therapy medicinal product prepared on an ad hoc basis is distributed to the reci…
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