Article D1123-32 of the French Public Health Code
November 6, 2023
The Commission meets at least twice a year, either at the invitation of its Chairman or at the request of the Minister for Health.
The Commission meets at least twice a year, either at the invitation of its Chairman or at the request of the Minister for Health.
The Commission’s secretariat is provided by the Directorate-General for Health.
Members’ duties are performed free of charge and entitle them to travel and subsistence allowances under the conditions laid down in the regulations applicable to civil servants.
The Chairman sets the agenda for the meetings. The Chairman informs the Director General for Health, who may request that new items be added to the agenda. Opinions are adopted by a simple majority of the members present and, in the event of a tied vote, the Chairman has the casting vote. The provisions of article R. 133-10 of the Code des relations entre le public et l’administration are applicable…
The content, format and methods of presentation of the application for authorisation are defined by decision of the Director General of the Agence nationale de sécurité du médicament et des produits de santé.
The competent authority shall notify the sponsor of the date of receipt of the dossier and the date on which, in the absence of express authorisation, the research is deemed to have been authorised. If the dossier is not complete, the competent authority will notify the sponsor of a list of the missing documents and set a deadline for submission, after which the sponsor will be deemed to have withdrawn…
If the research involving the human person has not begun within two years of authorisation, this authorisation lapses. However, if justification is provided before the expiry of this period, it may be extended by decision of the competent authority.
The sponsor informs the competent authority and the Committee for the Protection of Individuals without delay of the effective date of commencement of the research, corresponding to the date on which the consent is signed by the first person to take part in the research in France.
The sponsor shall inform the National Commission for Research Involving the Human Person and the National Agency for the Safety of Medicines and Health Products without delay of situations in which it has terminated the participation of an investigator or any other person involved in the research because of a serious or deliberately repeated deviation from the protocol, or a serious breach of the legislative and regulatory provisions in force…
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 Protection of Individuals and have a significant impact on any aspect of the research, in particular on the protection of individuals, including with regard to their safety, on the conditions for the validity of the research, where applicable…
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is a Registered Trademark of
PETROFF LAW FIRM (SELARL LEGASTRAT)
182, rue de Rivoli
75001, Paris France
RCS Paris n°814433470
Paris Bar Registration n° (Toque) C2396
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