Pharmacovigilance

Pharmacovigilance is the obligation placed on owners of market authorised products to ensure the safety of the products after they have been approved. The most important element of Pharmacovigilance is the obligation to report any adverse events related to the products to the authorities.

Pronova BioPharma's Pharmacovigilance system has recently been upgraded with the acquisition and implementation of Argus Safety, an electronic reporting and exchange system that enables reception and reporting of adverse events within required timelines. As a holder of marketing authorisations, we are also required to develop and submit periodic safety update reports (PSURs) to registration authorities in all relevant markets. Detailed pharmacovigilance agreements are concluded with all of our licensees.