OBJECTIVES: Non-interventional (NI) studies are an essential part of outcomes researchers’ toolset. While the thresholds between NI and interventional studies are often discussed, NI studies typically refer to prospective or retrospective studies, which may assess pharmaceutical products in their real life and authorised uses. In France, NI studies are regulated by the Jardé law since 2012. However, in the absence of an application decree, the Jardé law remained theoretical and could not be implemented until recently. This poster examines the new requirements associated with NI research in France since the application of the Jardé Law, using our experience of a qualitative research project in dermatology. METHODS: The project aimed at understanding patient experience using an acne treatment using qualitative interviews. Ethical requirements for the NI study in France were identified by reviewing official guidelines on research, communicating with institutions and publications reviews. Other relevant documents were identified using an ad-hoc search on official websites. RESULTS: To obtain validation, we registered our study to the Agence Nationale de Sécurité du Médicament (ANSM), French Agency for the Safety of Health Products). The study protocol was then randomly assigned to a CPP, which verified compliance with research ethical guidelines and patient safety. Conformity to the Commission Nationale de l’Informatique et des Libertés (CNIL, independent French regulatory body on privacy) must also be ensured by complying to the methodological guidelines. Considering the different actors and steps involved in the process for establishing a NI study, a good understanding of requirements early on is necessary to prevent delays. CONCLUSIONS: The Jardé law establishes a legal framework facilitating NI studies while protecting patients’ rights. Legal and ethical considerations must be taken into account for timely progress.