Article R1413-68
…The first paragraph is without prejudice to the compulsory declarations provided for in articles L. 1123-10, L. 1211-7-1, L. 1221-13, L. 1333-3, L. 1340-4, L. 5121-25, L. 5212-2, L. 5222-3 and R. 1413…
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Showing 141–150 of 151 articles for “Art. 1123”
…The first paragraph is without prejudice to the compulsory declarations provided for in articles L. 1123-10, L. 1211-7-1, L. 1221-13, L. 1333-3, L. 1340-4, L. 5121-25, L. 5212-2, L. 5222-3 and R. 1413…
…s the responsibility of the committees for the protection of individuals referred to in Articles L. 1123-1 and L. 1123-16. With the exception of clinical investigations covered by national defence sec…
…ng the human person which has been the subject of an authorisation within the meaning of Article L. 1123-8 is subject, prior to its importation into the customs territory, to an import authorisation i…
…in the competence and responsibility of the personal protection committees mentioned in Articles L. 1123-1 and L. 1123-16. With the exception of performance studies covered by national defence secrecy…
…ned, or if one of the advisory committees for the protection of individuals mentioned in article L. 1123-1, consulted by the person responsible for the research, does not consider this information to…
…isations within the meaning of the previous paragraph. The authorisation provided for in article L. 1123-8 is equivalent to an import authorisation for any medicinal product required to carry out the…
…uthorisation from the competent authority, in accordance with the procedures set out in articles L. 1123-7 and L. 1123-12, when they are not used under conditions giving entitlement to reimbursement,…
…to other investigators. It is mentioned in the elements of the protocol provided for in article R. 1123-20 and is carried out in agreement with the sponsor and in compliance with the good clinical pr…
…es, commissions, working groups and councils of the authorities and bodies mentioned in articles L. 1123-1, L. 1142-5, L. 1142-22, L. 1222-1, L. 1313-1, L. 1413-1, L. 1415-2, L. 1418-1, L. 1431-1, L.…
…from the previous paragraph, Chapters I to IIIa, with the exception of the provisions of Article L. 1123-10, and Chapter VIII of this Title cover research involving the human person relating to device…
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