Article L1123-7-2
…r the Protection of Individuals for an opinion, it shall give the opinion referred to in Article L. 1123-7 solely with regard to the requirements mentioned in the third paragraph of Article L. 1124-1.
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Showing 41–50 of 1215 articles for “Art. s. 1123”
…r the Protection of Individuals for an opinion, it shall give the opinion referred to in Article L. 1123-7 solely with regard to the requirements mentioned in the third paragraph of Article L. 1124-1.
…icle L. 1451-1. These declarations are also attached to the activity report mentioned in article R. 1123-19-1.
…The newly appointed committee will examine the request under the conditions laid down in article R. 1123-23. A member of the committee which issued the unfavourable opinion may not sit on the committe…
The substantial modifications referred to in Article L. 1123-9 are those which occur after the authorisation of the research by the competent authority and the favourable opinion of the Committee for…
…the Regional Health Agency, a call for candidates for each of the categories mentioned inArticle R. 1123-4 is circulated by any appropriate means.The same person may be a member of one or more other c…
…he Committee for the Protection of Individuals receives the safety report referred to in Article R. 1123-53.
…s and no therapeutic alternative. By way of derogation from the first paragraph of II of article R. 1123-20-1, the Committee for the Protection of Individuals responsible for giving an opinion on the…
…human person enables: 1° Exchanges between sponsors and committees for the protection of individuals. To this end, it receives requests for advice from sponsors, informs them of additional documents…
…rticle L. 1121-1 or on request, the sponsor must send the competent authority defined in Article L. 1123-12 and the relevant Data Protection Committee a safety report taking into account all available…
…formation concerning the adverse reactions, serious incidents and new facts mentioned in Article L. 1123-10 shall be sent to the National Agency for the Safety of Medicines and Health Products without…
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