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Public Health

Public consultation on the concept paper on the Introduction of Fees for Pharmacovigilance to be charged by the European Medicines Agency

Period of consultation

From 19 June 2012 to 15 September 2012.

Contributions to and results of the consultation

A summary of the responses is available here.

The following submitting parties requested their submission not to be published: C. Brady (Austria), Combe International Ltd., Dallas Burston Ashbourne Ltd., Derma UK, Four Pharmaceuticals Ltd. (UK), Greek National Agency Organization (EOF), Romastru Trading SRL, S.A. MITHRA Pharmaceuticals NV and SpePharm Holding BV, Pharma Schwoerer GmbH.

Below are the public responses to the above-mentioned public consultation:

Objective of the consultation

The new pharmacovigilance legislation Regulation (EU) No 1235/2010 of 15.12.2010 and Directive 2010/84/EU of 15.12.2010 (OJ 31.12.2010, L348) enables the European Medicines Agency to charge fees for its new pharmacovigilance activities. With this public consultation, Directorate General for Health and Consumers intends to consult all stakeholders on the proposed structure and levels of fees for pharmacovigilance.

The consultation document

The consultation document can be downloaded here.

Protection of personal data

The policy on "protection of individuals with regard to the processing of personal data by the Community institutions" is based on Regulation (EC) N° 45/2001 of the European Parliament and of the Council of 18 December 2000. More information is available here.

Additional information: