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Showing 2951–2960 of 46416 articles for “Art. CE 10-2-2017 n° 387960”
…investigators, free of charge for the duration of the clinical investigation, with the medical devices that are the subject of the clinical investigation is punishable by a fine of 30,000 euros.
…lating to the clinical investigation, and suspend or prohibit the clinical investigation in accordance with Article 76 of the aforementioned Regulation (EU). The sponsor shall inform the relevant Data…
Failure to comply with paragraph 1 of Article 77 and paragraph 2 of Article 80 of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017, on the communication of inform…
…nt authority; 2° Under conditions contrary to the provisions of article L. 1125-11; 3° The performance of which has been prohibited or suspended by the competent authority. Any investigator who carrie…
Performing or having performed a clinical investigation in breach of Articles 63 to 66 of Regulation (EU) No 2017/745 of the European Parliament and of the Council of 5 April 2017 and Article L. 1121-…
…data protection committee appointed at random from among the committees available and having the necessary competence to examine the project, under the conditions provided for in Article L. 1123-14 o…
MEDICAL CERTIFICATEReminder of the regulations: a medical certificate issued less than three months before the date on which the application is submitted is required for anyone holding a national wate…
Carrying out or causing to be carried out a performance study in breach of Articles 59 to 62 of Regulation (EU) No 2017/746 of the European Parliament and of the Council of 5 April 2017 and Article L.…
…t has sole jurisdiction to rule on any action for compensation for damage resulting from a performance study. This action is time-barred under the conditions set out inarticle 2226 of the Civil Code.
Where a performance study is conducted at the Institution nationale des invalides or in a health establishment or army hospital with an in-house pharmacy, failure by the promoter to communicate in adv…
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