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Showing 1381–1390 of 3724 articles for “Art. 18 April 1961”
If the foreign court's request is granted, the Ministry of Justice shall indicate the conditions under which the investigative measure is to be carried out and, where appropriate, designate the compet…
If so requested in the letter rogatory, and provided that the investigative measure prescribes that a hearing be conducted exclusively, the Ministry of Justice may authorise its direct execution by th…
…2 to 6 of Article 63 of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017. Where the clinical investigation concerns the field of maieutics, the investigator may e…
…l as the provisions of Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of individuals with regard to the processing of personal data and on th…
Clinical investigations may only be carried out in a place that has the human, material and technical resources appropriate to the clinical investigation and compatible with the safety requirements of…
I.-For the duration of the clinical investigation 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 whi…
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…
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