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Showing 201–210 of 52251 articles for “Art. L112-1”
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…
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…
I.-The performance reviews 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…
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…
In the context of the research mentioned in 1° of Article L. 1121-1 and Article L. 1124-1, failure by the sponsor to provide investigators free of charge for the duration of the research with the inve…
Any substantial modification at the initiative of the sponsor of a research project, clinical investigation or performance study covered by national defence confidentiality must obtain, prior to its i…
I.- Clinical trials of medicinal products are governed by the provisions of Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014. The competent authority for carr…
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…
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