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Showing 9271–9280 of 17962 articles for “Art. 5 avr. 2011”
…escribed in Article 74 of Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017; 2° The conditions applicable to the appeals provided for in Article L. 1126-4; 3° The…
With a view to the application of the provisions of the first paragraph of article L. 1126-9 and article L. 1126-10, a national file shall be kept of persons who are free from any disease and who volu…
…ng conditions: 1° In vitro diagnostic medical devices included on the list mentioned inarticle L. 165-1 of the Social Security Code or covered by the list of acts and services mentioned in article L.…
In the context of a performance study involving an intervention not justified by the usual management of the participant and entailing risks and constraints that are not minimal, failure by the sponso…
…ovisions of Article 60 of Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 and persons admitted to a health or social establishment for purposes other than perfor…
Persons who are not affiliated to a social security scheme or who are beneficiaries of such a scheme may be asked to take part in performance studies which do not involve any risk or constraint and in…
…to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC, shall also apply to performance studies.
…esenting him. The information shall be communicated in accordance with paragraphs 2 to 6 of Article 59 of Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017. Where…
I.-Natural persons guilty of the offence referred to in article L. 1126-20 shall also be liable to the following penalties: 1° Disqualification from civic, civil and family rights, in accordance with…
Pursuant to Articles 58,66 and 70 of Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017, before carrying out a performance study, the sponsor shall submit the proje…
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