To finance the cost of pharmacovigilance activities of the European Medicines Agency (EMA), the Fee Regulation (EU) no. 658/2014 has been introduced. In her “Explanatory Note” published on March 11th 2015 the EMA defines different fees such as process-based and annual fees. This is based on “chargable units” for MAHs, which in future can be determined with the help of the XEVMPD database. They fall into the category of annual fees which are intended to cover EMA’s costs for the care of the XEVMPD database.
The “chargeable unit” is a unit defined by a specific combination of information from the XEVMPD records. These are:
– Name of the Medicinal Product
– MAH – Marketing Authorisation Holder
– Active ingredient or combination of active ingredients
– Pharmaceutical form
In particular, the number of variants of the same medicinal product authorized (e.g. marketing duplicates with name additions such as “pediatric” or “migraine”) and the number of countries in which a product is approved, determine the total amount of units subject to charges. In contrast, it does not affect the annual fee if multiple records are created in XEVMPD due to multilingual texts (e.g. in Belgium).
An annual fee of 67 Euros will be charged per countable unit. Certain types of medicinal products as well as small and medium-sized pharmaceutical companies (SMEs) receive discounts. Exemption from charges is offered to micro-enterprises. For this, the SME status of the company at the EMA must previously have been clarified.
Every year the QPPV is informed by EMA about the currently registered data in XEVMPD and has to review the integrity of the list. Some weeks later EMA sends their invoice on basis of this list to the Marketing Authorisation Holder.
Process-based fees apply for Safety Studies after approval (PASS), the examination of individual periodic safety reports (PSURs) and for the assessment of pharmacovigilance referrals.