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Showing 6901–6910 of 49555 articles for “Art. L. 125-5 V + jurisprudence”
I.-The Data Protection Committee gives its opinion on the conditions for the validity of the clinical investigation, particularly with regard to :the protection of individuals, in particular the prote…
Any promoter whose civil liability is not covered by the insurance provided for in the third paragraph of article L. 1125-9 shall be punished by one year's imprisonment and a fine of 15,000 euros.
Where a clinical investigation is carried out at the Institution nationale des invalides or in a health establishment or army hospital with an in-house pharmacy, failure by the sponsor to communicate…
The clinical investigation does not give rise to any direct or indirect financial compensation for the persons who take part in it, apart from the reimbursement of expenses incurred and, where applica…
I.-Natural persons guilty of the offence referred to in article L. 1125-21 shall also be liable to the following penalties: 1° disqualification from civic, civil and family rights, in accordance with…
I.-The clinical investigations of the devices mentioned in Article 1 of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 are governed by the provisions of the afo…
The sponsor is responsible for compensating for the harmful consequences of the clinical investigation for the person who takes part in it and for that of his successors, unless he can prove that the…
…lone has jurisdiction to rule on any action for compensation for damage resulting from a clinical investigation; this action is time-barred under the conditions set out in article 2226 of the Civil Co…
In the event of a refusal of validation provided for in paragraph 3 of Article 70 of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017, a refusal of authorisation…
For each clinical investigation with the exception of that which does not involve any risk or constraint and in which all the procedures are carried out and the products are used in the usual way, the…
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