Any company or organisation exploiting a medicinal product or a product mentioned in
article L. 5121-1is required to comply with its obligations in terms of pharmacovigilance and, in particular, to implement a pharmacovigilance system and to record, report and monitor any adverse reaction suspected of being due to a medicinal product or product mentioned in the same article L. 5121-1 of which it is aware and to set up the post-authorisation studies mentioned in
article L. 5121-8-1within the time limits laid down.

