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Showing 3111–3120 of 70899 articles for “Art. I-1° and II”
…e 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 are not minimal, the sponsor provides t…
…ordance 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 concerns the field of maieutics, the…
…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 doss…
…y 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 any time, request that changes be m…
Performance studies may only be carried out in a place which has the human, material and technical resources appropriate to the performance study and compatible with the safety requirements of the per…
No performance study may be carried out on a deceased person in a state of brain death without his or her consent expressed during his or her lifetime or through the testimony of his or her family. Ho…
No performance study may be carried out on a person without his or her free and informed consent, obtained in writing under the conditions laid down in paragraph 1 of Article 59 of Regulation (EU) 201…
…iews of the devices referred to in Article 1 of Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 shall be governed by the provisions of the aforementioned Regulat…
…ative authority or, where applicable, have a guarantor that meets the conditions laid down by order and has such a rating. The following are exempt from this obligation 1° Credit institutions and inve…
Negotiable debt securities may be issued in euros or in any other currency. The Banque de France may suspend issues of securities denominated in a given currency for a period it determines.
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