Section 4: Experimentation

Testing of medicinal products, within the meaning of 9° of article L. 5121-20, means all chemical, pharmaceutical and biological tests, non-clinical tests and clinical trials. Without prejudice to the provisions of Title II of Book I of Part I of this Code, these trials are carried out under the conditions laid down in this section.

The standards and methods applicable to the testing of medicinal products are set, on a proposal from the Director General of the Agence nationale de sécurité du médicament et des produits de santé, by order of the Minister for Health.

The people who direct and supervise the performance of chemical, pharmaceutical, biological, pharmacological or toxicological tests are known as experimenters.

Subject to the provisions of articles L. 1123-6 to L. 1123-8 and L. 1123-13 and those adopted for their application, the investigators and persons called upon to collaborate in the trials are bound by professional secrecy concerning in particular the nature of the products studied, the trials, the persons taking part in them and the results obtained. Without the agreement of the sponsor, they may only give information relating to…

The sponsor shall provide the investigators of chemical, pharmaceutical, biological, pharmacological or toxicological tests with: 1° The title and objective of the test requested ; 2° Identification of the medicinal product to be tested: a) Its special or scientific name or its code name ; b) Its pharmaceutical form ; c) Its qualitative and quantitative composition, using the international non-proprietary names where they exist or, failing this, the names of…

The sponsor provides clinical trial investigators with : 1° The title and objective of the trial requested; 2° The pharmaceutical form, batch number(s) and expiry date of the investigational medicinal product; 3° For the investigational medicinal product or the medicinal product used as a reference, its special or scientific name or its code name, its qualitative and quantitative composition in terms of active substances and excipient constituents, knowledge of which…

Investigational medicinal products are prepared in accordance with the good practices mentioned in article L. 5121-5. The information appearing on the labelling must be written at least in French. The labelling must guarantee the protection of the person undergoing the research and traceability, enable the product and the trial to be identified and facilitate the appropriate use of the investigational medicinal product. The content of the labelling of these medicinal…

The investigational medicinal products and, where applicable, the devices used to administer them are supplied free of charge by the sponsor, except where the law provides otherwise.

Each chemical, pharmaceutical, biological and non-clinical trial gives rise to a report drawn up by the investigator who carried out the trial. This report, dated and signed, states in particular: 1° The identity of the investigator(s), their qualifications, experience and duties ; 2° The dates and places where the trial was conducted; 3° The information mentioned in 2° and 3° of article R. 5121-14.