French Business Law - French Legislation

Article R1124-12 of the French Public Health Code

November 6, 2023

Applications for substantial amendments are subject to a simplified assessment procedure. These applications are examined by 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 epidemiology, and the Chairman or, in his absence, the Vice-Chairman. The Select Committee shall meet, including by means of a telephone or…

Article R1124-13 of the French Public Health Code

November 6, 2023

When the Committee for the Protection of Individuals examines an application for a substantial amendment, the Committee may provide the competent authority with ethically-related comments on elements falling under Part I provided for in Article 6 of the aforementioned Regulation of 16 April 2014 within 15 days of the date of validation of the application referred to in Article 17(5) of this Regulation. If the competent authority has sent a…

Article R1124-14 of the French Public Health Code

November 6, 2023

For requests for substantial changes to the list of investigation sites or principal investigators, the Chairman issues the opinion on behalf of the Committee on the proposal of a single rapporteur.

Article R1124-15 of the French Public Health Code

November 6, 2023

The request for re-examination relating to elements covered by Part II of the initial applications provided for in Article 7 of the aforementioned European Regulation of 16 April 2014 shall be sent to the Minister responsible for health using the information system provided for in Article R. 1123-20-1. A committee for the protection of individuals shall be appointed in accordance with the procedures defined in the first paragraph of II…

Article R1124-16 of the French Public Health Code

November 6, 2023

The request for re-examination relating to elements covered by Part II of the requests for substantial changes provided for in Article 20 of the aforementioned European Regulation of 16 April 2014 shall be sent to the Minister responsible for health using the information system provided for in Article R. 1123-20-1. A committee for the protection of individuals shall be appointed in accordance with the procedures defined in the first paragraph…

Article R1124-17 of the French Public Health Code

November 6, 2023

An accelerated assessment procedure may be set up under conditions defined by order of the Minister for Health when the clinical trial of medicinal products takes place in the context of an emergency situation or a serious health threat, or when it concerns the assessment of a promising compound in an indication with a severe prognosis and no therapeutic alternative. By way of derogation from the first paragraph of II…

Article R1125-7 of the French Public Health Code

November 6, 2023

Research involving the following products is subject to express authorisation from the Director General of the Agence nationale de sécurité du médicament et des produits de santé: 1° Organs and tissues of human origin and labile blood products ; 2° Cells of human origin and the cell therapy preparations referred to in Article L. 1243-1 ; 3° Xenogenic cell therapy preparations mentioned in 13° of Article L. 5121-1; 4° Medical…

Article R1125-8 of the French Public Health Code

November 6, 2023

The application for authorisation relating to the research mentioned in 1° of Article L. 1121-1 concerning the products mentioned in Article R. 1125-7 is sent to the Director General of the Agence nationale de sécurité du médicament et des produits de santé, who decides on the admissibility of the application, ensuring that the application contains all the information. He will acknowledge receipt to the sponsor and notify him of the…

Article R1125-9 of the French Public Health Code

November 6, 2023

When the application concerns the organs and tissues of human or animal origin mentioned in 1° and 6° of Article R. 1125-7, and the cell therapy preparations mentioned in 2° of Article R. 1125-7 as well as the xenogenic cell therapy preparations mentioned in 3° of Article R. 1125-7, the Director General of the Agence nationale de sécurité du médicament et des produits de santé sends a copy of the…

Article R1125-10 of the French Public Health Code

November 6, 2023

The time limits within which the Director General of the Agence nationale de sécurité du médicament et des produits de santé must notify the applicant of his response are set as follows: 1° Sixty days from the date of receipt of the complete dossier for research involving the products mentioned in 4° and 5° of Article R. 1125-7; 2° Ninety days from the date of receipt of the complete dossier…

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French Public Health Code

Article R1124-12 of the French Public Health Code

Article R1124-13 of the French Public Health Code

Article R1124-14 of the French Public Health Code

Article R1124-15 of the French Public Health Code

Article R1124-16 of the French Public Health Code

Article R1124-17 of the French Public Health Code

Article R1125-7 of the French Public Health Code

Article R1125-8 of the French Public Health Code

Article R1125-9 of the French Public Health Code

Article R1125-10 of the French Public Health Code

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French Public Health Code

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