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Showing 781–790 of 2837 articles for “Art. 26 janv. 2017”
I.-For the duration of the performance study involving an intervention on the patient which is not justified by the patient's usual care and which exposes the patient to risks and constraints which ar…
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…
…icles L. 3212-1 and L. 3213-1 who do not fall under the provisions 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 hea…
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…
The provisions of Section 3 of Chapter III of Title II of Law No. 78-17 of 6 January 1978, as amended, relating to information technology, files and freedoms, as well as the provisions of Regulation (…
…rmation 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 the performance study…
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…
…eloper. Where the competent authority considers that the requirements 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…
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