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Showing 7801–7810 of 53863 articles for “Art. Rép. Cherki: AN 24-1-2017 n° 94515”
…e L. 1125-21 shall also be liable to the following penalties: 1° disqualification from civic, civil and family rights, in accordance with the provisions ofarticle 131-26 of the French Penal Code; 2° d…
…ting for the harmful consequences of the clinical investigation for the person who takes part in it and for that of his successors, unless he can prove that the damage is not attributable to his fault…
Notwithstanding article 13 of the law of 16 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 resulti…
…al of validation provided for in paragraph 3 of Article 70 of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017, a refusal of authorisation or an unfavourable opin…
In the context of a clinical investigation involving an intervention that is not justified by the patient's usual care and that involves risks and constraints that are not minimal, failure by the spon…
The competent authority may, at any time, request additional information on the clinical investigation from the sponsor. Where the competent authority considers that the requirements set out in Regula…
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…
…of their 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 Regula…
The following is punishable by one year's imprisonment and a fine of 15,000 euros: 1° Without having obtained the favourable opinion of a personal protection committee and, in the case of clinical inv…
…pter apply to clinical investigations which are classified as national defence secrets within the meaning of article 413-9 of the French Criminal Code.
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