Commission Regulation (EU) 2019/480 of 22 March 2019 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 2019Text with EEA relevance.

Commission Regulation (EU) 2019/480 of 22 March 2019 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 2019 (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 Products OJ L 35, 15.2.1995, p. 1. , 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 Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (OJ L 136, 30.4.2004, p. 1). , the revenue of the European Medicines Agency consists of a contribution from the Union and fees paid by undertakings to that Agency. 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 2018. The inflation rate in the Union, as published by the Statistical Office of the European Union https://ec.europa.eu/eurostat/documents/2995521/9499950/2-17012019-AP-EN.pdf/4ea467c3-8ff2-4723-bc6e-b0c85fb991e4 , was 1,7 % in 2018. (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 2019. (6) In accordance with Article 12 of Regulation (EC) No 297/95, the update is to be made with effect from 1 April 2019. 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 286900 is replaced by EUR 291800; in the second subparagraph, EUR 28800 is replaced by EUR 29300; in the third subparagraph, EUR 7200 is replaced by EUR 7300; (ii) point (b) is amended as follows: in the first subparagraph, EUR 111400 is replaced by EUR 113300; in the second subparagraph, EUR 185500 is replaced by EUR 188700; in the third subparagraph, EUR 11100 is replaced by EUR 11300; in the fourth subparagraph, EUR 7200 is replaced by EUR 7300; (iii) point (c) is amended as follows: in the first subparagraph, EUR 86100 is replaced by EUR 87600; in the second subparagraph, EUR 21600 to EUR 64600 is replaced by EUR 22000 to EUR 65700; in the third subparagraph, EUR 7200 is replaced by EUR 7300; (b) paragraph 2 is amended as follows:

(i) the first subparagraph of point (a) is amended as follows: EUR 3100 is replaced by EUR 3200; EUR 7200 is replaced by EUR 7300; (ii) point (b) is amended as follows: in the first subparagraph, EUR 86100 is replaced by EUR 87600; in the second subparagraph, EUR 21600 to EUR 64600 is replaced by EUR 22000 to EUR 65700; (c) in paragraph 3, EUR 14200 is replaced by EUR 14400; (d) in the first subparagraph of paragraph 4, EUR 21600 is replaced by EUR 22000; (e) in paragraph 5, EUR 7200 is replaced by EUR 7300; (f) paragraph 6 is amended as follows: (i) in the first subparagraph, EUR 102900 is replaced by EUR 104600; (ii) in the second subparagraph, EUR 25600 to EUR 77100 is replaced by EUR 26000 to EUR 78400; (2) in the first paragraph of Article 4, EUR 71400 is replaced by EUR 72600; (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 143700 is replaced by EUR 146100; in the second subparagraph, EUR 14200 is replaced by EUR 14400; in the third subparagraph, EUR 7200 is replaced by EUR 7300; the fourth subparagraph is amended as follows: EUR 71400 is replaced by EUR 72600; EUR 7200 is replaced by EUR 7300; (ii) point (b) is amended as follows: in the first subparagraph, EUR 71400 is replaced by EUR 72600; in the second subparagraph, EUR 121200 is replaced by EUR 123300; in the third subparagraph, EUR 14200 is replaced by EUR 14400; in the fourth subparagraph, EUR 7200 is replaced by EUR 7300; the fifth subparagraph is amended as follows: EUR 35900 is replaced by EUR 36500; EUR 7200 is replaced by EUR 7300; (iii) point (c) is amended as follows: in the first subparagraph, EUR 35900 is replaced by EUR 36500; in the second subparagraph, EUR 8900 to EUR 27000 is replaced by EUR 9100 to EUR 27500; in the third subparagraph, EUR 7200 is replaced by EUR 7300; (b) paragraph 2 is amended as follows: (i) the first subparagraph of point (a) is amended as follows: EUR 3100 is replaced by EUR 3200; EUR 7200 is replaced by EUR 7300; (ii) point (b) is amended as follows: in the first subparagraph, EUR 43000 is replaced by EUR 43700; in the second subparagraph, EUR 10800 to EUR 32400 is replaced by EUR 11000 to EUR 33000; in the third subparagraph, EUR 7200 is replaced by EUR 7300; (c) in paragraph 3, EUR 7200 is replaced by EUR 7300; (d) in the first subparagraph of paragraph 4, EUR 21600 is replaced by EUR 22000; (e) in paragraph 5, EUR 7200 is replaced by EUR 7300; (f) paragraph 6 is amended as follows: (i) in the first subparagraph, EUR 34400 is replaced by EUR 35000; (ii) in the second subparagraph, EUR 8500 to EUR 25600 is replaced by EUR 8600 to EUR 26000; (4) in the first paragraph of Article 6, EUR 43000 is replaced by EUR 43700; (5) Article 7 is amended as follows: (a) in the first paragraph, EUR 71400 is replaced by EUR 72600; (b) in the second paragraph, EUR 21600 is replaced by EUR 22000; (6) Article 8 is amended as follows: (a) paragraph 1 is amended as follows:

(i) in the second subparagraph, EUR 86100 is replaced by EUR 87600; (ii) in the third subparagraph, EUR 43000 is replaced by EUR 43700; (iii) in the fourth subparagraph, EUR 21600 to EUR 64600 is replaced by EUR 22000 to EUR 65700; (iv) in the fifth subparagraph, EUR 10800 to EUR 32400 is replaced by EUR 11000 to EUR 33000; (b) paragraph 2 is amended as follows: (i) in the second subparagraph, EUR 286900 is replaced by EUR 291800; (ii) in the third subparagraph, EUR 143700 is replaced by EUR 146100; (iii) in the fifth subparagraph, EUR 3100 to EUR 247300 is replaced by EUR 3200 to EUR 251500; (iv) in the sixth subparagraph, EUR 3100 to EUR 123800 is replaced by EUR 3200 to EUR 125900; (c) in the first subparagraph of paragraph 3, EUR 7200 is replaced by EUR 7300.

Article 2

This Regulation shall not apply to valid applications pending on 1 April 2019.

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 2019. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 22 March 2019. For the Commission The President Jean-Claude Juncker