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Showing 9161–9170 of 17962 articles for “Art. 5 avr. 2011”
…to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC, shall also apply to clinical investigations.
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…
…s under the following conditions: 1° Medical devices included on the list mentioned in article L. 165-1 of the Social Security Code or covered by the hospitalisation benefits mentioned in article L. 1…
…s for clinical investigations not covered by the second and third paragraphs of II of article L. 1125-1 ; -the appropriateness of the objectives pursued and the resources deployed; -the qualifications…
…ivil 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.
…al investigations falling into one of the categories mentioned in the first paragraph of article L. 5126-7 is punishable by a fine of 30,000 euros.
…plication of Chapters II to IV of Title I of Book II of Part Three of this Code or of Article 706-135 of the Code of Criminal Procedure and persons admitted to a health and social establishment for pu…
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…
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