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Showing 9241–9250 of 17987 articles for “Art. 5 avr. 1978”
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…
…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…
For each study of performance, with the exception of that which does not involve any risk or constraint and in which all the procedures are carried out and the products are used in the usual way, the…
…equirements set out in Regulation (EU) No 2017/746 of the European Parliament and of the Council of 5 April 2017 are not being met, it may, at any time, request that changes be made to the arrangement…
The following is punishable by one year's imprisonment and a fine of 15,000 euros: 1° Without having obtained the favourable opinion of a committee for the protection of individuals and, in the case o…
Once the Committee for the Protection of Individuals has issued a favourable opinion and the performance study has been authorised, where applicable, by the Agence nationale de sécurité du médicament…
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