Article R1123-50
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…
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Showing 131–140 of 151 articles for “Art. 1123”
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…
For the purposes of this section, the following definitions shall apply 1° Adverse event, any noxious occurrence in a person who undergoes research involving the human person, whether or not this occu…
…f the medicinal product are provided in the application for authorisation referred to in article L. 1123-8. The importing pharmaceutical establishment shall ensure that each batch of these medicinal p…
…a select committee made up of two representatives from each of the colleges mentioned in Article R. 1123-4, including at least one person qualified by virtue of their expertise in biostatistics or epi…
…the event of exclusion from the research;5° The opinion of the committee referred to in Article L. 1123-1 and the authorisation of the competent authority referred to in Article L. 1123-12 ;6° Where…
…rning unexpected serious adverse reactions, serious incidents and new facts mentioned in Article L. 1123-10 shall be sent to the Agence nationale de sécurité du médicament et des produits de santé and…
…sent is required, the protocol submitted for the opinion of the committee referred to in Article L. 1123-1 may stipulate that the consent of this person is not sought and that only the consent of the…
…sation is given by the minor's legal representative and, if the committee referred to in Article L. 1123-1 considers that the research entails a serious risk of infringing privacy or the integrity of…
…y be carried out after express authorisation from the competent authority referred to in article L. 1123-12.
…This declaration is made without prejudice to the declaration obligations mentioned in articles L. 1123-10, L. 1211-7-1, L. 1221-13, L. 1340-4, L. 5121-25, L. 5212-2, L. 5222-3, R. 1413-68, and L. 31…
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