Subsection 4: Post-authorisation studies

Studies on veterinary medicinal products that already have a marketing authorisation” within the meaning of 6° of article L. 5141-16, hereinafter referred to as “post-authorisation studies”, means studies carried out under the responsibility of the marketing authorisation holder, as referred to in article L. 5141-5, who manages them, or under the responsibility of the operator, as defined in article R. 5142-1, and falling into one of the following categories 5141-5,…

Post-authorisation studies may be carried out, on behalf of this licence holder and under its responsibility, by another company or organisation. Any study must be the subject of a protocol validated by the person responsible, describing in particular the objective and methodology of the study. At the end of the study, the person responsible validates a report analysing, in particular, the impact on the risk-benefit ratio of the medicinal product,…

The marketing authorisation holder responsible for the study referred to in Article R. 5141-30 shall make the study protocol and report available to the Director General of the Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail.