European Medicines Agency welcomes publication of pharmacovigilance fee Regulation in Official Journal of the EU

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27/06/2014

European Medicines Agency welcomes publication of pharmacovigilance fee Regulation in Official Journal of the EU

The European Medicines Agency (EMA) welcomes the publication of the Regulation on pharmacovigilance fees in the Official Journal of the European Union (EU) today.

The pharmacovigilance legislation foresees that pharmacovigilance activities conducted at EU level for medicinal products for human use should be financed by fees paid by marketing-authorisation holders. The Regulation will allow the EMA to collect these fees.

The income will be used to remunerate national competent authorities (NCAs) of the EU for the scientific assessment carried out by the rapporteurs of the EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) and to cover the pharmacovigilance-related costs of the Agency.

The pharmacovigilance legislation underwent a major review that led to the adoption of new laws in 2010 and 2012 to strengthen and rationalise the system for monitoring the safety of medicines on the EU market. It assigned new pharmacovigilance activities to the European medicines regulatory network, including new EU-level procedures for the review of safety of medicines.

Over the first two years of implementation, the legislation has had a major impact on improving the safety monitoring of medicines in Europe in a proactive and transparent way and by involving patients and healthcare professionals in the decision-making process, enhancing public-health protection. Until now, all of these activities had to be absorbed by the existing resources of the national regulatory authorities and the EMA.

The key principles of the new pharmacovigilance fee Regulation provide for transparency and proportionality between fee level and assessment workload. Fee reductions and exemptions are foreseen for micro-, small and medium-sized enterprises (SMEs) and for certain categories of medicines such as generics and herbal medicinal products.

Two types of fees will be charged:

  • a procedure-based fee for the single assessment of periodic safety update reports (PSURs) and the assessment of post-authorisation-safety-study (PASS) protocols and study results, and for pharmacovigilance-related referrals. This fee is split among the marketing-authorisation holders concerned by the procedure and will be charged for procedures starting from 26 August 2014;
  • an annual fee that applies to nationally authorised products only. This fee will be applicable from January 2015 and will be charged as of 1 July 2015. Fees related to centrally authorised products are covered by the existing fee Regulation.

The EMA will use the annual pharmacovigilance fees to support the implementation and maintenance of specific measures from the pharmacovigilance legislation, such as literature monitoring, the European medicines web portal, enhanced functionalities for EudraVigilance and a repository of PSURs. These activities will directly benefit marketing-authorisation holders by reducing administrative burden, simplifying reporting and streamlining processes.

Until July 2015, only companies involved in PSURs, PASSs and pharmacovigilance-related referral procedures will be concerned by the new pharmacovigilance fees. The EMA will contact each concerned company individually to provide specific guidance and explanation with regards to the applicable fee.

The EMA will also release new guidance over the next few weeks on how the pharmacovigilance fees will be calculated and collected.

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