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Showing 3161–3170 of 13796 articles for “Art. European Commission report COM”
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…
…procedures are carried out and the products are used in the usual way, the dossier submitted to the Committee for the Protection of Individuals and to the competent authority shall determine whether i…
The competent authority may, at any time, request additional information on the performance study from the developer. Where the competent authority considers that the requirements set out in Regulatio…
…r'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 of performance studies mentioned in the…
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…
Any promoter whose civil liability is not covered by the insurance provided for in article L. 1126-8 shall be punished by one year's imprisonment and a fine of 15,000 euros.
…lace which has the human, material and technical resources appropriate to the performance study and compatible with the safety requirements of the persons undergoing it. This place must be authorised…
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…
…refusal of validation provided for in paragraph 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, r…
…ting 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 he or she has been given the informati…
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