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Showing 4631–4640 of 51271 articles for “Art. L. 2312-22 to L. 2312-26”
…opinion on the conditions for the validity of the clinical investigation, particularly with regard to :the protection of individuals, in particular the protection of participants; -the adequacy, comp…
…hose 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.
…des or in a health establishment or army hospital with an in-house pharmacy, failure by the sponsor to communicate in advance to the pharmacist managing this pharmacy the data relating to clinical inv…
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…
…of the assessment of the clinical investigation request provided for in Article 62(3) and referred to in Articles 70, 74, 75, 78 and 82 of this Regulation is the National Agency for the Safety of Med…
…part in it and for that of his successors, unless he can prove that the damage is not attributable to his fault or to the fault of any other party involved, without it being possible to invoke the ac…
…and 24 August 1790 on the organisation of the judiciary, the judicial court alone has jurisdiction to rule on any action for compensation for damage resulting from a clinical investigation; this acti…
…4 of Article 71 of the aforementioned Regulation (EU), the sponsor may submit a request for review to the National Agency for the Safety of Medicines and Health Products or, where appropriate, ask th…
…ll the procedures are carried out and the products are used in the usual way, the dossier submitted to the Data Protection Committee and the competent authority must determine whether it is necessary…
…minor, this consent is expressed by each of the holders of parental authority. If it is impossible to consult one of the holders of parental authority, the clinical investigation may be carried out p…
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