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Showing 251–260 of 14565 articles for “Art. L112-6”
With a view to the application of the provisions of the first paragraph of article L. 1121-11 and article L. 1121-12 and for the research mentioned in 1° of article L. 1121-1 concerning the products m…
Once the Data Protection Committee has issued a favourable opinion and the investigation has been authorised by the Agence nationale de sécurité du médicament et des produits de santé, where applicabl…
The provisions of Articles 72, 75, 76, 77, 80, 87, 88, 89 and 90 of the aforementioned Regulation (EU) shall apply to the clinical investigations provided for in paragraph 1 of Article 82 of Regulatio…
Minors may be asked to take part in the research referred to in 1° or 2° of Article L. 1121-1 only if research of comparable effectiveness cannot be carried out on adults and under the following condi…
Pursuant to Articles 62,70,74,75 and 82 of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017, before carrying out a clinical investigation, the sponsor shall submi…
At the time of giving informed consent, the investigator may ask the person undergoing clinical investigation to agree to his/her data being used in subsequent research for scientific purposes only. T…
The research referred to in 1° of Article L. 1121-1 may only be carried out after a favourable opinion has been obtained from the Committee for the Protection of Individuals referred to in Article L.…
No research may be carried out on a deceased person in a state of brain death without their consent expressed during their lifetime or through the testimony of their family. However, if the deceased p…
The procedures for applying the provisions of this chapter are determined by decree in the Conseil d'Etat, and in particular : 1° The minimum guarantees for the insurance provided for in the third par…
I.-The competent authority for the research involving the human person provided for in article L. 1121-1 is the Agence nationale de sécurité du médicament et des produits de santé (French National Age…
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