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Showing 2471–2480 of 50210 articles for “Art. L. 2315-82 to L. 2315-96”
Pursuant to Articles 58,66 and 70 of Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017, before carrying out a performance study, the sponsor shall submit the proje…
…ll the procedures are carried out and the products are used in the usual way, the dossier submitted to the Committee for the Protection of Individuals and to the competent authority shall determine wh…
…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 performance study, to any documents relating to the perform…
…e for the protection of individuals and, in the case of performance studies mentioned in the second to fifth paragraphs of II of Article L. 1126-1, the authorisation of the competent authority; 2° Und…
…sponsor must obtain a favourable opinion from the Committee for the Protection of Individuals prior to its implementation and, in the case of performance studies mentioned in the second to fifth parag…
Any promoter whose civil liability is not covered by the insurance provided for in article L. 1126-8 shall be punished by one year's imprisonment and a fine of 15,000 euros.
…ay only be carried out in a place which has the human, material and technical resources appropriate to the performance study and compatible with the safety requirements of the persons undergoing it. T…
…this consent shall be expressed by each of the holders of parental authority. If it is not possible to consult one of the holders of parental authority, the performance study may be carried out provid…
…/746 of the European Parliament and of the Council of 5 April 2017 or provided for in IV of Article L. 1126-1, refusal of authorisation or unfavourable opinion of a performance study provided for in p…
…ouncil of 5 April 2017, after he or she has been given the information provided for in paragraphs 2 to 6 of Article 59 of that Regulation (EU). Where it is impossible for the data subject to express h…
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