French Business Law - French Legislation

Article R1121-1-1 of the French Public Health Code

November 6, 2023

Research involving the human person relating to a medicinal product is understood to mean any research relating to one or more medicinal products not falling within the scope of Article 1 of Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use and repealing Directive 2001/20/ EC. They are intended to identify or verify the…

Article R1121-2 of the French Public Health Code

November 6, 2023

The research referred to in 3° of Article L. 1121-1 involving products referred to in Article L. 5311-1 is understood to mean any research in the context of which the product or products are prescribed or used on a regular basis and which complies with : 1° For research involving medical devices and in vitro diagnostic medical devices, with the intended use in the context of CE marking as mentioned,…

Article R1121-3 of the French Public Health Code

November 6, 2023

For the application of 2° of III of Article L. 1121-16-1, the sponsor may, provided that he has a favourable opinion from the Committee for the Protection of Individuals, ask the Ministers responsible for health and social security to waive the reimbursement by the health insurance funds of experimental medicinal products or authorised auxiliaries or products which are the subject of the research, when they are not used under conditions…

Article R1121-3-1 of the French Public Health Code

November 6, 2023

I.-When the research mentioned in 1° and 2° of Article L. 1121-1 for commercial purposes is carried out in health establishments, or health centres, it is the subject of the agreement provided for in the second paragraph of IV of Article L. 1121-16-1, between the legal representative of the research site and the legal representative of the research sponsor. This agreement is referred to as a single agreement. It is…

Article R1121-4 of the French Public Health Code

November 6, 2023

Insurance contracts for the research referred to in 1° and 2° of Article L. 1121-1 guaranteeing, under the conditions provided for in Article L. 1121-10, the pecuniary consequences of the civil liability of the sponsor and that of any intervening party may not derogate from the provisions defined in this section, except in a way that is more favourable to the interests of the victims or their beneficiaries.

Article R1121-5 of the French Public Health Code

November 6, 2023

The contracts mentioned in article R. 1121-4 may only include clauses excluding cover for damage suffered by victims or their dependants in the following cases: 1° The research does not take place under the conditions set out in the second and third paragraphs of article L. 1121-3, as approved by the Committee for the Protection of Individuals pursuant to article L. 1123-7 and, where applicable, by the French National Agency…

Article R1121-6 of the French Public Health Code

November 6, 2023

The contracts referred to in article R. 1121-4 may not provide cover for less than : 1° 1,000,000 euros per victim ; 2° 6,000,000 euros per research protocol; 3° 10,000,000 euros for all claims made during one insurance year in respect of several research protocols.

Article R1121-7 of the French Public Health Code

November 6, 2023

The contracts mentioned in article R. 1121-4 may provide for an excess per victim.

Article R1121-8 of the French Public Health Code

November 6, 2023

The insurer may not invoke against the victim or his successors : 1° The fact that the research was carried out even though consent had not been given under the conditions provided for in articles L. 1122-1-1, L. 1122-1-3 or L. 1122-2 or had been withdrawn; 2° The excess provided for in article R. 1121-7 ; 3° The proportional reduction in compensation provided for in article L. 113-9 of the…

Article R1121-9 of the French Public Health Code

November 6, 2023

Subscription to the contracts mentioned in article R. 1121-4 is justified by the production of a certificate issued by the insurer, which constitutes a presumption of cover. This certificate includes the following information 1° References to the applicable legislative and regulatory provisions ; 2° The name of the insurance company; 3° The number of the insurance contract; 4° The name and address of the policyholder; 5° The precise name of…

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Article R1121-1-1 of the French Public Health Code

Article R1121-2 of the French Public Health Code

Article R1121-3 of the French Public Health Code

Article R1121-3-1 of the French Public Health Code

Article R1121-4 of the French Public Health Code

Article R1121-5 of the French Public Health Code

Article R1121-6 of the French Public Health Code

Article R1121-7 of the French Public Health Code

Article R1121-8 of the French Public Health Code

Article R1121-9 of the French Public Health Code

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