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Showing 6691–6700 of 43982 articles for “Art. L. 125-5”
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…
…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 (EU) 2017/7…
…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…
Subject to the provisions of articles L. 1123-15 to L. 1123-20, the provisions of this chapter apply to clinical investigations which are classified as national defence secrets within the meaning of a…
…case, the foreseeable risk and the constraints involved in the clinical investigation must be minimal.
…tion from the duly informed data subjects, to the individual data strictly necessary for this control. They are subject to professional secrecy under the conditions defined by articles 226-13 and 226-…
…gulation (EU) No 2017/745 of the European Parliament and of the Council of 5 April 2017 and Article L. 1121-6, is punishable by three years' imprisonment and a fine of €45,000.
…rior to its implementation and, in the case of clinical investigations referred to in II of Article L. 1125-1, authorisation from the competent authority in accordance with the provisions of this same…
No clinical investigation may be carried out on a person without his free and informed consent, obtained in writing under the conditions laid down in paragraph 1 of Article 63 of Regulation (EU) 2017/…
…aving 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…
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