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Showing 2361–2370 of 67437 articles for “Art. I-5° bis and Art. 35 bis”
The sponsor shall inform the competent authority and the Committee for the Protection of Individuals without delay of the new facts defined in 12° of Article R. 1123-46 and, where appropriate, of the…
For the research referred to in 1° of Article L. 1121-1 concerning medical devices and in vitro diagnostic medical devices, the sponsor must report to the Agence nationale de sécurité du médicament et…
…cament et des produits de santé any adverse reaction occurring in a person undergoing such research and any serious incident occurring in France and outside national territory without delay from the d…
…he Agence nationale de sécurité du médicament et des produits de santé any serious adverse reaction and any serious incident occurring in France and outside national territory in the research it is co…
For the research mentioned in 1° of Article L. 1121-1 concerning the products mentioned in I of Article R. 1211-29, with the exception of cell therapy preparations, the investigator who has knowledge…
…rt to the competent authority any suspected serious unexpected adverse reaction occurring in France and outside national territory, within the following time limits: 1° In the case of a serious unexpe…
…médicament et des produits de santé any suspicion of a serious adverse reaction occurring in France and outside national territory. The notification must be made without delay and at the latest within…
The guardian may not, even with authorisation: 1° Perform acts which involve a gratuitous alienation of the property or rights of the protected person except as stated in relation to gifts, such as th…
…ct points established on the basis of Article 14 of Directive 2011/24/EU of the European Parliament and of the Council of 9 March 2011 on the application of patients' rights in cross-border healthcare…
…national health identifier of the patient concerned as well as his/her surname, first name, gender and date of birth. If the request is incomplete, the national contact point for eHealth shall inform…
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