Report on the exercise of the delegation conferred on the Commission pursuant to Regulation (EU) No 658/2014

Summary:

Report presented on 30 September 2019 by the European Commission on the adoption of delegated acts relating to fees payable to the European Medicines Agency for the conduct of pharmacovigilance activities in respect of medicinal products for human use.

Further information:

The legal framework for the monitoring of the safety of medicinal products that have been placed on the market in the Union is provided for in Regulation (EC) No 726/2004 and in Directive 2001/83/EC. These pharmacovigilance activities cover the whole life-cycle management of medicinal products for human use in relation to safety.

To finance these activities, Regulation (EU) No 658/2014 ('the Pharmacovigilance Fee Regulation') provides for fees to be charged to marketing authorisation holders. Additionally, it sets out the amounts of remuneration for the rapporteurs and the co-rapporteurs appointed by the relevant committees for the respective assessments.

Article 16(2) of the Pharmacovigilance Fee Regulation empowers the Commission to adopt delegated acts for a period of five years from 17 July 2014. This report presents an overview of the Commission’s use of the empowerment.