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Showing 2391–2400 of 50210 articles for “Art. L. 2315-82 to L. 2315-96”
…and 24 August 1790 on the organisation of the judiciary, the judicial court alone has jurisdiction to rule on any action for compensation for damage resulting from a clinical investigation; this acti…
…4 of Article 71 of the aforementioned Regulation (EU), the sponsor may submit a request for review to the National Agency for the Safety of Medicines and Health Products or, where appropriate, ask th…
…ll the procedures are carried out and the products are used in the usual way, the dossier submitted to the Data Protection Committee and the competent authority must determine whether it is necessary…
…minor, this consent is expressed by each of the holders of parental authority. If it is impossible to consult one of the holders of parental authority, the clinical investigation may be carried out p…
…t's usual care and that involves risks and constraints that are not minimal, failure by the sponsor to provide the investigators, free of charge for the duration of the clinical investigation, with th…
With a view to the application of the provisions of the first paragraph of article L. 1125-6 and article L. 1125-7, a national register shall be kept of persons who are free of any disease and who vol…
…d of the Council of 5 April 2017 are not being met, it may at any time request that changes be made to the arrangements for carrying out the clinical investigation, to any documents relating to the cl…
Failure to comply with paragraph 1 of Article 77 and paragraph 2 of Article 80 of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017, on the communication of inform…
…heir liberty by a judicial or administrative decision, persons undergoing psychiatric care pursuant to Articles L. 3212-1 and L. 3213-1 who do not come under the provisions of Article 64 of Regulation…
…n the case of clinical investigations mentioned in the second and third paragraphs of II of Article L. 1125-1, the authorisation of the competent authority; 2° Under conditions contrary to the provisi…
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