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Showing 9381–9390 of 18228 articles for “Art. 5° ter”
…y out its duties as defined in article 66 of the aforementioned law of 6 January 1978, refer the matter to the Comité d'expertise pour les recherches, les études et l'évaluation dans le domaine de la…
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…
…of expenses incurred and, where applicable, compensation for constraints suffered paid by the promoter. The total amount of compensation that a person may receive in any one year is limited to a maxi…
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…
…are governed by the provisions of the aforementioned Regulation (EU) and the provisions of this chapter. II-The competent authority for carrying out the scientific examination as part of the assessmen…
…in which all procedures are carried out and products are used on a routine basis, require the promoter to take out prior insurance covering its civil liability as set out in this article and that of…
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…
…National Agency for the Safety of Medicines and Health Products or, where appropriate, ask the Minister responsible for health to submit the project for a second review to another personal protection…
…sual way, the dossier submitted to the Data Protection Committee and the competent authority must determine whether it is necessary for the person not to be able to participate simultaneously in anoth…
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