Section 2: Experimentation.

Experiments on veterinary medicinal products within the meaning of article L. 5141-16 are any tests, research or experiments, hereinafter referred to as trials, which are carried out with a view to obtaining a marketing authorisation or a marketing authorisation variation. These trials include : a) For non-immunological medicinal products : -pharmaceutical tests, i.e. physico-chemical, biological or microbiological tests ; non-clinical tests, i.e. safety tests, including tests to assess the risk…

The natural or legal person who initiates a veterinary medicinal product trial as defined in article R. 5141-2 is called the sponsor. The persons who direct and supervise the performance of pharmaceutical trials and non-clinical trials are called investigators. Those who direct and supervise the performance of clinical trials are called investigators. Depending on their activity, investigators and investigators have the qualifications and experience mentioned in article R. 5141-25. The…

The experimenters, investigators, experts and persons called upon to collaborate in the trials are bound by professional secrecy under the conditions and penalties laid down inarticle 226-13 of the French Penal Code with regard to the nature of the products studied, the protocols and the results obtained. Without the agreement of the sponsor, they may only provide information relating to the trials to the Ministers of Agriculture and Health, the…

The sponsor provides the investigators within the meaning of Article R. 5141-3 with the following information: 1° The title and objective of the trial requested ; 2° Identification of the medicinal product to be tested: a) Its name or code name ; b) Its pharmaceutical form; c) Its qualitative and quantitative composition in active substances using the common names; for immunological medicinal products, the composition is expressed in units of…

The sponsor provides the investigators conducting the clinical trials with the following information: 1° The title and objective of the trial requested; 2° For the medicinal product to be tested : a) Its name or code name ; b) Its pharmaceutical form; c) Its qualitative and quantitative composition in active substances expressed per unit of administration or, depending on the pharmaceutical form, for a given volume or weight, using the…

Medicinal products subject to clinical trials, on the one hand, and any reference medicinal products and placebos, on the other, are prepared in accordance with good manufacturing practice, defined in accordance with the procedures set out in article L. 5142-3. The labelling of these medicinal products includes : 1° The name and address of the sponsor ; 2° The reference of the trial in progress; 3° A reference showing their…

Within a period of two months prior to the clinical trial of a veterinary medicinal product, the sponsor shall inform the Director General of the Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail of his intention by sending him, by registered post with acknowledgement of receipt, a dossier containing the following information: 1° The identity of the sponsor ; 2° The framework of the trial: a)…

Any substantial amendment to the trial must be the subject of a prior additional declaration by the sponsor sent by registered post with acknowledgement of receipt to the Director General of the Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail. The Director General may, within one month of receipt of the aforementioned declaration, object to this amendment by means of a reasoned decision.

Each trial gives rise to a report drawn up by the investigator who carried it out. This report is dated and signed and includes : 1° The identity of the investigator(s) or investigator(s), their qualifications, experience and duties ; 2° The dates and places where the trial was conducted; 3° For the medicinal product undergoing the trial, the information mentioned in 4° of Article R. 5141-8 ; 4° For a…

As stated in article R. 234-4 of the French Rural and Maritime Fishing Code, which reads as follows: “I. – Foodstuffs derived from an animal that has undergone a clinical trial on veterinary medicinal products mentioned in V of article L. 234-2 may only be placed on the market if this trial has not been opposed by the Director General of the Agence nationale de sécurité sanitaire de l’alimentation, de…