http://www.legislation.gov.uk/id/eur/2016/461

Commission Regulation (EU) 2016/461

of 30 March 2016

amending Council Regulation (EC) No 297/95 as regards the adjustment of the fees of the European Medicines Agency to the inflation rate with effect from 1 April 2016

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Council Regulation (EC) No 297/95 of 10 February 1995 on fees payable to the European Agency for the Evaluation of Medicinal Products1, and in particular the fifth paragraph of Article 12 thereof,

Whereas:

(1)

In accordance with Article 67(3) of Regulation (EC) No 726/2004 of the European Parliament and of the Council2, the revenue of the European Medicines Agency consists of a contribution from the Union and fees paid to it by undertakings. Regulation (EC) No 297/95 lays down the categories and levels of such fees.

(2)

Those fees should be updated by reference to the inflation rate of 2015. The inflation rate in the Union, as published by the Statistical Office of the European Union, was 0,2 % in 2015.

(3)

For the sake of simplicity, the adjusted levels of the fees should be rounded to the nearest EUR 100.

(4)

Regulation (EC) No 297/95 should therefore be amended accordingly.

(5)

For reasons of legal certainty, this Regulation should not apply to valid applications which are pending on 1 April 2016.

(6)

In accordance with Article 12 of Regulation (EC) No 297/95, the update is to be made with effect from 1 April 2016. It is therefore appropriate that this Regulation enters into force as a matter of urgency and applies from that date,

HAS ADOPTED THIS REGULATION: