- Department of Health and Medicines and Healthcare products Regulatory Agency
- 2 August 2013
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The Department of Health and the MHRA are seeking views on this proposal by the European Commission.
This consultation ran from
The European Commission has published a legal proposal for fees for pharmacovigilance payable to the European Medicines Agency (EMA). The new pharmacovigilance legislation that came into force in July 2012 strengthened the system for safety monitoring of medicines in Europe and introduced a number of EU-wide procedures and widened the pharmacovigilance tasks of the EMA. To finance these new activities the new legislation provided for fees to be charged to marketing authorisation holders by the EMA. The Commission’s current proposal specifies these fees.
The proposal foresees two types of fees:
- fees for procedures for the assessment of periodic safety update reports, post authorisation safety studies and pharmacovigilance referrals
- an annual flat fee to be charged to marketing authorisation holders having at least one medicinal product that is authorised in the EU and registered in the database provided for in Article 57(1)(l) of the Regulation. This annual flat fee would cover only the costs of the pharmacovigilance activities of the EMA other than those related to the above-mentioned procedures. Therefore, it is foreseen that the fee revenue from the annual flat fee be retained by the MHRA. The Commission foresees some fee reductions and fee waivers in respect of the above fees for small and medium sized or micro enterprises.
The proposal can be found at Adoption of a legal proposal for fees for pharmacovigilance payable to the European Medicines Agency
Published: 2 August 2013