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Showing 5081–5090 of 10478 articles for “Art. 150 VI”
…entioned Regulation (EU). The sponsor shall inform the relevant Committee for the Protection of Individuals and the competent authority of the start and end of the performance study, in the manner lai…
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.
…ust 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 them t…
…le to consult one of the holders of parental authority, the performance study may be carried out provided that the other holder consents. The provisions of article 225-17 of the Criminal Code do not a…
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…
…an 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 it is impossible for the…
…ommunication of information intended to be made available to the public in the electronic system provided for in Article 69 of the aforementioned Regulation (EU) shall be punishable by one year's impr…
I.-The performance reviews of the devices referred to in Article 1 of Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 shall be governed by the provisions of the…
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