Address https://gelex.eu/eli/EU/regulation/2016/461@2016-03-30/en

Contents

1. Preamble
2. 1. Article 1
   2. Article 2
   3. Article 3

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 Products, 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 Council, 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:

Article 1

Regulation (EC) No 297/95 is amended as follows:

(1) Article 3 is amended as follows:

(a) paragraph 1 is amended as follows:

(i) point (a) is amended as follows:

in the first subparagraph, EUR 278200 is replaced by EUR 278800,

in the second subparagraph, EUR 27900 is replaced by EUR 28000;

(ii) point (b) is amended as follows:

in the first subparagraph, EUR 108000 is replaced by EUR 108200,

in the second subparagraph, EUR 179800 is replaced by EUR 180200;

(iii) point (c) is amended as follows:

in the first subparagraph, EUR 83500 is replaced by EUR 83700,

in the second subparagraph, EUR 20900 to EUR 62600 is replaced by EUR 20900 to EUR 62700;

(b) in paragraph 2, point (b) is amended as follows:

(i) in the first subparagraph, EUR 83500 is replaced by EUR 83700;

(ii) in the second subparagraph, EUR 20900 to EUR 62600 is replaced by EUR 20900 to EUR 62700;

(c) paragraph 6 is amended as follows:

(i) in the first subparagraph, EUR 99800 is replaced by EUR 100000;

(ii) in the second subparagraph, EUR 24900 to EUR 74800 is replaced by EUR 24900 to EUR 74900;

(2) in Article 4, in the first paragraph, EUR 69300 is replaced by EUR 69400;

(3) Article 5 is amended as follows:

(a) paragraph 1 is amended as follows:

(i) point (a) is amended as follows:

in the first subparagraph, EUR 139300 is replaced by EUR 139600,

in the fourth subparagraph EUR 69300 is replaced by EUR 69400;

(ii) point (b) is amended as follows:

in the first subparagraph, EUR 69300 is replaced by EUR 69400,

in the second subparagraph, EUR 117600 is replaced by EUR 117800,

in the fifth subparagraph EUR 34800 is replaced by EUR 34900;

(iii) point (c) is amended as follows:

in the first subparagraph, EUR 34800 is replaced by EUR 34900,

in the second subparagraph, EUR 8700 to EUR 26100 is replaced by EUR 8700 to EUR 26200;

(b) in paragraph 2, point (b) is amended as follows:

(i) in the first subparagraph, EUR 41700 is replaced by EUR 41800;

(ii) in the second subparagraph, EUR 10500 to EUR 31400 is replaced by EUR 10500 to EUR 31500;

(c) in the first subparagraph of paragraph 6, EUR 33300 is replaced by EUR 33400;

(4) in Article 6, in the first paragraph, EUR 41700 is replaced by EUR 41800;

(5) in Article 7, in the first paragraph, EUR 69300 is replaced by EUR 69400;

(6) Article 8 is amended as follows:

(a) paragraph 1 is amended as follows:

(i) in the second subparagraph, EUR 83500 is replaced by EUR 83700;

(ii) in the third subparagraph, EUR 41700 is replaced by EUR 41800;

(iii) in the fourth subparagraph, EUR 20900 to EUR 62600 is replaced by EUR 20900 to EUR 62700;

(iv) in the fifth subparagraph, EUR 10500 to EUR 31400 is replaced by EUR 10500 to EUR 31500;

(b) paragraph 2 is amended as follows:

(i) in the second subparagraph, EUR 278200 is replaced by EUR 278800;

(ii) in the third subparagraph, EUR 139300 is replaced by EUR 139600;

(iii) in the fifth subparagraph, EUR 3000 to EUR 239800 is replaced by EUR 3000 to EUR 240300;

(iv) in the sixth subparagraph, EUR 3000 to EUR 120100 is replaced by EUR 3000 to EUR 120300.

Article 2

This Regulation shall not apply to valid applications pending on 1 April 2016.

Article 3

This Regulation shall enter into force on the day following that of its publication in the Official Journal of the European Union. It shall apply from 1 April 2016.

This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 30 March 2016. For the Commission The President Jean-Claude Juncker

Versions

1. 2016-03-30