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Showing 2921–2930 of 31982 articles for “Art. 10 May 2017”
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…
…omply with the obligation to repay referred to in the previous paragraph, a penalty of no more than 10% of the promoter's turnover for the previous year will be applied. The procedures for applying th…
…onale de l'informatique et des libertés. The Commission nationale de l'informatique et des libertés may, in order to carry out its duties as defined in article 66 of the aforementioned law of 6 Januar…
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…
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…
…itially agreed to take part in the clinical investigation. Where the sponsor is not liable, victims may be compensated under the conditions set out in article L. 1142-3. All clinical investigations, w…
Notwithstanding article 13 of the law of 16 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 resulti…
…n 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 o…
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