Medicinal products for human use: fees payable to the European Medicines Agency for the conduct of pharmacovigilance activities

The dossier concerns fees payable to the European Medicines Agency for the conduct of pharmacovigilance activities relating to medicinal products for human use. Amendments address fees for periodic safety update reports, post-authorisation safety studies and referral procedures, the chargeable unit, remuneration of rapporteurs, avoiding double charging by Member States, and reductions or exemptions for SMEs, homeopathic and herbal medicinal products and small target groups.