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Showing 7931–7940 of 61689 articles for “Art. s. L 313-3 to L 313-5”
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.
Performance studies may 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 per…
…a deceased person in a state of brain death without his or her consent expressed during his or her lifetime or through the testimony of his or her family. However, where the deceased person is a mino…
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…
…on a person without his or her free and informed consent, obtained in writing under the conditions laid down in paragraph 1 of Article 59 of Regulation (EU) 2017/746 of the European Parliament and of…
Failure to comply with Article 73(1) and Article 76(2) of Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on the communication of information intended to be made…
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…
Article L. 542-1, in the version resulting fromOrder no. 2019-1067 of 21 October 2019, is applicable in the Wallis and Futuna Islands.
Within two months of the date on which the dossier is deemed to be complete, the Minister for Research and, where applicable, the Director General of the Regional Health Agency may, in the cases provi…
When the inspection reveals that the manufacture or repackaging and relabelling carried out in the context of the distribution of a raw material for pharmaceutical use does not comply with the good pr…
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