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Regulatory Focus™ > News Articles > European Commission Adopts Proposal for Pharmacovigilance Fees Payable to EMA

European Commission Adopts Proposal for Pharmacovigilance Fees Payable to EMA

Posted 28 June 2013 | By Louise Zornoza

The European Commission has today adopted a proposed regulation which would see pharmaceutical companies pay specific fees for EU-wide pharmacovigilance activities.  This is due to the recent legislation on pharmacovigilance applicable in the EU since July 2012, which significantly broadens the tasks of the European Medicines Agency (EMA), reinforcing its role as a hub for the coordination of the scientific resources made available by the Member States. Since the revised pharmacovigilance legislation only concerns medicinal products for human use, this proposal on fees for pharmacovigilance only covers these medicinal products.

The proposal foresees two types of fees:

  • Fees for procedures for the assessment of periodic safety update reports, post-authorization safety studies and pharmacovigilance referrals
  • An annual flat fee to be charged to marketing authorization holders having at least one medicinal product that is authorized in the EU and registered in the database Proposed in the regulation. This annual flat fee would cover the costs of the EMA's newly assigned pharmacovigilance activities that include "the monitoring of literature cases, the improved use of information technology tools and the provision of more information to the general public."

Circumstances are provided for reduction or waiver of the fees, e.g. for small and medium size companies. The proposal will now be discussed by the European Parliament and the Council.


EC: Pharmacovigilance Fees Regulation

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