Article L1126-10
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…
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Showing 9281–9290 of 17962 articles for “Art. 5 avr. 2011”
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…
…rance provided for in article L. 1126-8 shall be punished by one year's imprisonment and a fine of 15,000 euros.
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…
…mance study may be carried out provided that the other holder consents. The provisions of article 225-17 of the Criminal Code do not apply to these performance reviews.
…agraph 3 of Article 66 of Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 or provided for in IV of Article L. 1126-1, refusal of authorisation or unfavourable op…
…and informed consent, obtained in writing under the conditions laid down in paragraph 1 of Article 59 of Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017, after…
…3(1) and Article 76(2) of Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on the communication of information intended to be made available to the public in the…
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