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Showing 16411650 of 6655 articles for Art. EU Regulation 2368/2002

French Public Health CodeIn force
Chapter II: Industrial preparation and wholesale.

Article L5142-1-4

The local or regional representative referred to in paragraph 3 of Article 77 of Regulation (EU) 2019/6 of 11 December 2018 shall carry out his duties in professional premises located on national terr…

AI translation · Updated 6 Nov 2023Open Article
French Public Health CodeIn force
Chapter I: General provisions.

Article L5141-5-1

By way of derogation from the provisions of paragraph 1 of Article 5 of Regulation (EU) 2019/6 of 11 December 2018, the veterinary medicinal products referred to in paragraph 6 of the same Article sha…

AI translation · Updated 6 Nov 2023Open Article
French Public Health CodeIn force
Chapter I: Industrial preparation and wholesale.

Article L5441-5

…defined in Article L. 5142-1, without the authorisation required pursuant to Articles 88 and 99 of Regulation (EU) 2019/6 of 11 December 2018 or without this having been renewed in the event of a cha…

AI translation · Updated 6 Nov 2023Open Article
French Public Health CodeIn force
Chapter VI: Special provisions applicable to studies of the performance of devices referred to in Article 1 of Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017

Article L1126-17

The investigator may ask the person taking part in a performance study, at the time he or she gives informed consent, to agree to his or her data being used in subsequent research exclusively for scie…

AI translation · Updated 8 Nov 2023Open Article
French Public Health CodeIn force
Chapter VI: Special provisions applicable to studies of the performance of devices referred to in Article 1 of Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017

Article L1126-24

Notwithstanding article 13 of the law of 16 and 24 August 1790 on the organisation of the judiciary, the judicial court has sole jurisdiction to rule on any action for compensation for damage resultin…

AI translation · Updated 8 Nov 2023Open Article
French Public Health CodeIn force
Chapter VI: Special provisions applicable to studies of the performance of devices referred to in Article 1 of Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017

Article L1126-8

The promoter is responsible for compensating for the harmful consequences of the performance study for the person taking part in it and their dependants, unless it can prove that the damage is not att…

AI translation · Updated 8 Nov 2023Open Article
French Public Health CodeIn force
Chapter VI: Special provisions applicable to studies of the performance of devices referred to in Article 1 of Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017

Article L1126-18

…the Protection of Individuals. The Committee shall issue a reasoned opinion within a period set by regulation. The State shall be held liable in the event of any fault on the part of the Committee in…

AI translation · Updated 8 Nov 2023Open Article
French Public Health CodeIn force
Chapter VI: Special provisions applicable to studies of the performance of devices referred to in Article 1 of Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017

Article L1126-26

…categories mentioned in the first paragraph of article L. 5126-7 is punishable by a fine of 30,000 euros.

AI translation · Updated 8 Nov 2023Open Article
French Public Health CodeIn force
Chapter VI: Special provisions applicable to studies of the performance of devices referred to in Article 1 of Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017

Article L1126-9

The performance study does not give rise to any direct or indirect financial compensation for the persons taking part, apart from the reimbursement of expenses incurred and, where applicable, compensa…

AI translation · Updated 8 Nov 2023Open Article
French Public Health CodeIn force
Chapter VI: Special provisions applicable to studies of the performance of devices referred to in Article 1 of Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017

Article L1126-29

…ar: 1° The procedures applicable to the coordinated assessment procedure described in Article 74 of Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017; 2° The condi…

AI translation · Updated 8 Nov 2023Open Article
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Mariela Petrova

Mariela Petrova

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