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Showing 21–30 of 87 articles for “Art. 1125”
…line for the Director General to decide on the application for authorisation pursuant to Article R. 1125-10. This amendment procedure may only be applied once to each research project. Any sponsor who…
…o the research mentioned in 1° of Article L. 1121-1 concerning the products mentioned in Article R. 1125-7 is sent to the Director General of the Agence nationale de sécurité du médicament et des prod…
I.-Natural persons guilty of the offence referred to in article L. 1125-21 shall also be liable to the following penalties: 1° disqualification from civic, civil and family rights, in accordance with…
…l modification requires a new authorisation to be issued under the conditions set out in Article R. 1125-8. If the Director General of the Agence française de sécurité sanitaire does not respond to an…
…r to its implementation and, in the case of clinical investigations referred to in II of Article L. 1125-1, authorisation from the competent authority in accordance with the provisions of this same II…
…ions for clinical investigations not covered by the second and third paragraphs of II of article L. 1125-1 ; -the appropriateness of the objectives pursued and the resources deployed; -the qualificati…
…no. 2012-300 of 5 March 2012 L. 1121-17 Law no. 2004-806 of 9 August 2004 L. 1122-1 Order no. 2018-1125 of 12 December 2018 L. 1122-1-1 Order no. 2016-800 of 16 June 2016 L. 1122-1-2 Order no. 2016-8…
…no. 2012-300 of 5 March 2012 L. 1121-17 Law no. 2004-806 of 9 August 2004 L. 1122-1 Order no. 2018-1125 of 12 December 2018 L. 1122-1-1 Order no. 2016-800 of 16 June 2016 L. 1122-1-2 Order no. 2016-8…
…es designated at random from among the competent committees available in accordance with article L. 1125-2. This ethical review and the procedures applicable to the coordinated assessment procedure de…
Research involving the following products is subject to express authorisation from the Director General of the Agence nationale de sécurité du médicament et des produits de santé: 1° Organs and tissue…
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