EudraVigilance fees

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

–         Country

–         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.

XEVMPD – Frequently Asked Questions

Which medicinal products fall within the scope of Article 57 (2) and need to be reported in xEVMPD ?

All medicine products authorized in the EU (national authorizations, MRP, DCP, CP) must be reported via an Extended EudraVigilance Product Report Message (xEVPRM). Registrations in EEA countries not belonging to the EU (Iceland, Liechtenstein and Norway) must also be reported.

 

Which medicinal products are not covered by Article 57 (2) and must not be reported in xEVMPD?

  • Drugs without valid registration
  • Traditional herbal medicines
  • Homeopathics
  • Drugs that are sold on named-patient basis
  • Parallel import drugs
  • Drug registrations outside the EEA

 

Do Drugs that are registered, but not marketed, need to be reported in xEVMPD?

Yes. Regardless of the marketing status, valid registrations must be submitted to xEVMPD.

 

According to Article 57 (2), do veterinary products (veterinary medicinal products) have to be reported to the xEVMPD?

No. The obligation only applies to human medicinal products.

 

Do German “Standardzulassungen” have to be reported according to the xEVMPD Guideline?

Yes. Standardzulassungen are evaluated in the same way as other national registrations and have to be included in xEVMPD.

 

In Germany, there are so-called “fictitious authorizations”, for which there is no registration date. Must these be included in xEVMPD?

No. “Fictitious authorizations” under EU law are not valid registrations and are not subject to the xEVMPD-duty.

 

How often do I have to update the xEVMPD database?

Information on any amendments to the terms of marketing authorisations following variation, transfer, renewal, suspension, revocation or withdrawal must be notified to the EMA no later than 30 calendar days from the date on which the amendments have been authorised.

 

Questions and answers drawn from: EMA/159776/2013 “Electronic submission of Article 57(2) data – Questions & Answers (Q&As)”, 08.07.2014