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Showing 7461–7470 of 49555 articles for “Art. L. 125-5 V + jurisprudence”
…the opinion of a personal data protection committee appointed at random from among the committees available and having the necessary competence to examine the project, under the conditions provided f…
For each study of performance, with the exception of that which does not involve any risk or constraint and in which all the procedures are carried out and the products are used in the usual way, the…
…tent authority may, at any time, request additional information on the performance study from the developer. Where the competent authority considers that the requirements set out in Regulation (EU) No…
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 committee for the protection of individuals and, in the case o…
Once the Committee for the Protection of Individuals has issued a favourable opinion and the performance study has been authorised, where applicable, by the Agence nationale de sécurité du médicament…
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.
…e must be authorised for this purpose, for a specified period, in the case of performance studies involving an intervention on a person which is not justified by their usual care and which exposes the…
…her consent expressed during his or her lifetime or through the testimony of his or her family. However, where the deceased person is a minor, this consent shall be expressed by each of the holders of…
In the event of a refusal of validation provided for in paragraph 3 of Article 66 of Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 or provided for in IV of Art…
…2017/746 of the European Parliament and of the Council 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 i…
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