Subsection 3: Monitoring of post-authorisation safety studies

This sub-section applies to post-authorisation safety studies of a non-interventional nature within the meaning of Article R. 1121-2, which give rise to the collection of safety information from patients or healthcare professionals. These studies are carried out under the responsibility of the marketing authorisation holder referred to in article L. 5121-8, who is responsible for their management and checks that they are properly funded. These studies may also be carried…

This article applies to the post-authorisation safety studies referred to in Article R. 5121-178 which are carried out either voluntarily by the holder of the marketing authorisation referred to in Article L. 5121-8, or at the request of the competent national authorities, or in order to comply with an obligation imposed pursuant to Articles R. 5121-36-1 and R. 5121-37-3. The Director General of the Agence nationale de sécurité du médicament…

I.-This article applies to the post-authorisation studies referred to in article R. 5121-178 which are carried out by the holder of the authorisation referred to in article L. 5121-8 in order to comply with an obligation imposed pursuant to articles R. 5121-36-1 and R. 5121-37-3. II – Before conducting a study, the holder of the authorisation provided for in Article L. 5121-8 submits a draft protocol to the Pharmacovigilance Risk…