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Showing 81–90 of 151 articles for “Art. 1123”
…relating to organs, tissues or cells of human origin. The authorisation provided for in article L. 1123-8 is equivalent, where applicable for the duration of the research and for the products in ques…
…is the responsibility of the Committees for the Protection of Individuals mentioned in Articles L. 1123-1 and L. 1123-16. The Agence nationale de sécurité du médicament et des produits de santé notif…
…ose performance has been prohibited or suspended by the competent authority mentioned in article L. 1123-12. Any investigator who carries out such research in breach of the provisions of article L. 11…
…information provided by the sponsor in the application for authorisation referred to in article L. 1123-8 and accepted by the Agence nationale de sécurité du médicament et des produits de santé. II.-…
No one may carry out any research mentioned in 1° of Article L. 1121-1 without authorisation from the competent authority issued within a period set by regulation.If the competent authority informs th…
If the research is to be carried out in one or more public or private establishments, the sponsor must inform the director(s) of these establishments before the research is carried out.
For research, clinical investigations or performance studies covered by national defence confidentiality, the sponsor must notify the competent authority of all relevant information relating to the sa…
The Minister for Health approves one or, as required, several personal protection committees for a fixed period. Their members are appointed by the Director General of the Regional Health Agency for t…
The members of the Committees, the persons called upon to collaborate in their work, and the agents covered by the general statute of civil servants or the general statute of military personnel who ar…
Subject to the provisions of this chapter, the provisions of chapters III, V and VI of this title apply respectively to research involving the human person, clinical investigations and performance stu…
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