Article L1126-20
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.…
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Showing 7341–7350 of 17465 articles for “Art. Form 2044 spéciale”
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.…
…l court 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…
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…
I.-The Data Protection Committee will give its opinion on the conditions for the validity of the performance study, in particular with regard to : the protection of individuals, in particular the prot…
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…
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…
…4° The conditions for coverage of in vitro diagnostic medical devices subject to non-commercial performance studies provided for in Article L. 1126-14; 5° the conditions applicable to performance stu…
Performance studies relating to dentistry may only be carried out under the direction and supervision of a dental surgeon or a doctor with appropriate experience. Performance studies relating to midwi…
…nal file shall be kept of persons who are free from any disease and who voluntarily take part in performance studies, as well as of sick persons when the purpose of the performance study is unrelated…
I.-For the duration of the performance study involving an intervention on the patient which is not justified by the patient's usual care and which exposes the patient to risks and constraints which ar…
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