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Showing 2351–2360 of 6074 articles for “Art. 12 janv. 2017”
…ponsor. Where the competent authority considers that the requirements set out in Regulation (EU) No 2017/745 of the European Parliament and of the Council of 5 April 2017 are not being met, it may at…
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…
…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) 2017/745 of…
…e 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 provisions…
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…
Persons who are not affiliated to a social security scheme or who are beneficiaries of such a scheme may be asked to take part in clinical investigations which do not involve any risk or constraint. B…
Clinical investigations in the field of dentistry may only be carried out under the direction and supervision of a dental surgeon or a doctor with appropriate experience. Clinical investigations in th…
…g or having performed a clinical investigation in breach of Articles 63 to 66 of Regulation (EU) No 2017/745 of the European Parliament and of the Council of 5 April 2017 and Article L. 1121-6, is pun…
…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 II.…
…l apply to the clinical investigations provided for in paragraph 1 of Article 82 of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017.
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