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Showing 131140 of 151 articles for Art. 1123

French Public Health CodeIn force
Subsection 1: Vigilance.

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…

AI translation · Updated 6 Nov 2023Open Article
French Public Health CodeIn force
Subsection 1: Vigilance.

Article R1123-46

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…

AI translation · Updated 6 Nov 2023Open Article
French Public Health CodeIn force
Subsection 2: Manufacture and import of investigational medicinal products.

Article R5124-57-4

…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…

AI translation · Updated 2 Nov 2023Open Article
French Public Health CodeIn force
Subsection 3: Application for substantial modification

Article R1124-12

…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…

AI translation · Updated 6 Nov 2023Open Article
French Public Health CodeIn force
Chapter II: Informing and obtaining the consent of the person undergoing research involving the human person

Article L1122-1

…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…

AI translation · Updated 8 Nov 2023Open Article
French Public Health CodeIn force
Subsection 2: Vigilance

Article R1125-22

…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…

AI translation · Updated 6 Nov 2023Open Article
French Public Health CodeIn force
Chapter II: Informing and obtaining the consent of the person undergoing research involving the human person

Article L1122-1-3

…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…

AI translation · Updated 8 Nov 2023Open Article
French Public Health CodeIn force
Chapter II: Informing and obtaining the consent of the person undergoing research involving the human person

Article L1122-2

…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…

AI translation · Updated 8 Nov 2023Open Article
French Public Health CodeIn force
Chapter VII: Special provisions for certain types of research

Article L1127-3

…y be carried out after express authorisation from the competent authority referred to in article L. 1123-12.

AI translation · Updated 8 Nov 2023Open Article
French Public Health CodeIn force
Subsection 1: Reporting healthcare-associated infections

Article R1413-79

…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…

AI translation · Updated 4 Nov 2023Open Article
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