Pharmacovigilance fees payable to the European Medicines Agency

The basis of calculation of pharmacovigilance fees for PSURs, pharmacovigilance referrals and the annual fee is the chargeable unit. This is defined in Article 2 of Regulation (EC) 658/2014.

The chargeable unit is a unique combination of the following dataset derived from information on all medicines authorised in the European Union held by the Agency:

• Name of the medicinal product, as defined in point 20 of Article 1 of Directive 2001/83/EC;
• marketing authorisation holder;
• the Member State in which the marketing authorisation is valid;
• active substance or a combination of active substances;
• pharmaceutical form.

This is consistent with the obligation of marketing-authorisation holders referred to in points (b) and (c) of Article 57(2) of Regulation (EC) No 726/2004 to submit such information to the database referred to in point (l) of the second subparagraph of Article 57(1) of that regulation.

For guidance on how 'chargeable units' are derived from medicinal product information held within the Article 57 database, refer to:

Please note that, for PASS procedures, a flat amount to be paid in two instalments is applied.

Fee reductions and exemptions are available for micro-, small- and medium-sized-enterprises (SMEs) and for certain categories of medicines such as generics, well-established use, homeopathic and herbal products.

For full details, see: