Regulatory Focus™ > News Articles > European Commission Proposes User Fees to Support Pharmacovigilance Program

European Commission Proposes User Fees to Support Pharmacovigilance Program

Posted 19 June 2012 | By Alexander Gaffney, RAC 

The European Commission has released a concept paper laying out the case for the collection of user fees under pharmacovigilance legislation set to go into effect in July 2012.

The concept paper directs the European Medicines Agency (EMA) to collect fees as the result of its increased role in the postmarketing oversight of medicinal products. "Given that the new pharmacovigilance legislation provides a significantly greater role for EMA in the area of pharmacovigilance … it is justified that EMA will charge fees also where nationally authorized products are involved," wrote the Commission. This new role is a "service to the industry," it added.

Among the largest expansions of EMA's duties will be the constitution and maintenance of a new EMA scientific advisory committee and the Pharmacovigilance Risk Assessment Committee (PRAC), and strengthening the existing EudraVigilance database to handle a larger volume of data.

The Commission is proposing four separate fees under the pharmacovigilance legislation:

  • a yearly service fee (maximum of €1,000 per medical product)
  • a fee for the assessment of Periodic Safety Update Reports (maximum of €80,300)
  • a fee for the assessment of Post-Authorisation Safety Studies (maximum of €80,300)
  • a fee for the assessment of pharmacovigilance referrals (maximum of €267,400)

As with the majority of fees, reductions will be available to small- and medium-sized enterprises (SMEs). Under the Commission's plan, micro-enterprises would be exempt from any pharmacovigilance fees.

Comments on the concept paper are due by 15 September 2012.

Read more:

European Commission - Introduction of Fees to be Charges by the EMA for Pharmacovigilance

Regulatory Focus newsletters

All the biggest regulatory news and happenings.