Document ID: 32019R0480
Language: ENG

<table><col/><col/><col/><col/><tbody><tr><td><p>25.3.2019&#160;&#160;&#160;</p></td><td><p>EN</p></td><td><p>Official Journal of the European Union</p></td><td><p>L 82/15</p></td></tr></tbody></table>
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 ( 1 ) , and in particular the fifth paragraph of Article 12 thereof,
Whereas:
<table><col/><col/><tbody><tr><td><p>(1)</p></td><td><p>In accordance with Article 67(3) of Regulation (EC) No 726/2004 of the European Parliament and of the Council&#160;<a>(<span>2</span>)</a>, 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.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(2)</p></td><td><p>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&#160;<a>(<span>3</span>)</a>, was 1,7&#160;% in 2018.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(3)</p></td><td><p>For the sake of simplicity, the adjusted levels of the fees should be rounded to the nearest EUR 100.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(4)</p></td><td><p>Regulation (EC) No 297/95 should therefore be amended accordingly.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(5)</p></td><td><p>For reasons of legal certainty, this Regulation should not apply to valid applications which are pending on 1&#160;April 2019.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(6)</p></td><td><p>In accordance with Article 12 of Regulation (EC) No 297/95, the update is to be made with effect from 1&#160;April 2019. It is therefore appropriate that this Regulation enters into force as a matter of urgency and applies from that date,</p></td></tr></tbody></table>
HAS ADOPTED THIS REGULATION:
Article 1
Regulation (EC) No 297/95 is amended as follows:
<table><col/><col/><tbody><tr><td><p>(1)</p></td><td><p>Article 3 is amended as follows:</p><table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>paragraph 1 is amended as follows:</p><table><col/><col/><tbody><tr><td><p>(i)</p></td><td><p>point (a) is amended as follows:</p><table><col/><col/><tbody><tr><td><p>&#8212;</p></td><td><p>in the first subparagraph, &#8216;EUR 286&#160;900                                                         &#8217; is replaced by &#8216;EUR 291&#160;800                                                         &#8217;;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>&#8212;</p></td><td><p>in the second subparagraph, &#8216;EUR 28&#160;800                                                         &#8217; is replaced by &#8216;EUR 29&#160;300                                                         &#8217;;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>&#8212;</p></td><td><p>in the third subparagraph, &#8216;EUR 7&#160;200                                                         &#8217; is replaced by &#8216;EUR 7&#160;300                                                         &#8217;;</p></td></tr></tbody></table></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(ii)</p></td><td><p>point (b) is amended as follows:</p><table><col/><col/><tbody><tr><td><p>&#8212;</p></td><td><p>in the first subparagraph, &#8216;EUR 111&#160;400                                                         &#8217; is replaced by &#8216;EUR 113&#160;300                                                         &#8217;;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>&#8212;</p></td><td><p>in the second subparagraph, &#8216;EUR 185&#160;500                                                         &#8217; is replaced by &#8216;EUR 188&#160;700                                                         &#8217;;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>&#8212;</p></td><td><p>in the third subparagraph, &#8216;EUR 11&#160;100                                                         &#8217; is replaced by &#8216;EUR 11&#160;300                                                         &#8217;;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>&#8212;</p></td><td><p>in the fourth subparagraph, &#8216;EUR 7&#160;200                                                         &#8217; is replaced by &#8216;EUR 7&#160;300                                                         &#8217;;</p></td></tr></tbody></table></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(iii)</p></td><td><p>point (c) is amended as follows:</p><table><col/><col/><tbody><tr><td><p>&#8212;</p></td><td><p>in the first subparagraph, &#8216;EUR 86&#160;100                                                         &#8217; is replaced by &#8216;EUR 87&#160;600                                                         &#8217;;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>&#8212;</p></td><td><p>in the second subparagraph, &#8216;EUR 21&#160;600 to EUR 64&#160;600                                                         &#8217; is replaced by &#8216;EUR 22&#160;000 to EUR 65&#160;700                                                         &#8217;;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>&#8212;</p></td><td><p>in the third subparagraph, &#8216;EUR 7&#160;200                                                         &#8217; is replaced by &#8216;EUR 7&#160;300                                                         &#8217;;</p></td></tr></tbody></table></td></tr></tbody></table></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>paragraph 2 is amended as follows:</p><table><col/><col/><tbody><tr><td><p>(i)</p></td><td><p>the first subparagraph of point (a) is amended as follows:</p><table><col/><col/><tbody><tr><td><p>&#8212;</p></td><td><p>                                                         &#8216;EUR 3&#160;100                                                         &#8217; is replaced by &#8216;EUR 3&#160;200                                                         &#8217;;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>&#8212;</p></td><td><p>                                                         &#8216;EUR 7&#160;200                                                         &#8217; is replaced by &#8216;EUR 7&#160;300                                                         &#8217;;</p></td></tr></tbody></table></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(ii)</p></td><td><p>point (b) is amended as follows:</p><table><col/><col/><tbody><tr><td><p>&#8212;</p></td><td><p>in the first subparagraph, &#8216;EUR 86&#160;100                                                         &#8217; is replaced by &#8216;EUR 87&#160;600                                                         &#8217;;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>&#8212;</p></td><td><p>in the second subparagraph, &#8216;EUR 21&#160;600 to EUR 64&#160;600                                                         &#8217; is replaced by &#8216;EUR 22&#160;000 to EUR 65&#160;700                                                         &#8217;;</p></td></tr></tbody></table></td></tr></tbody></table></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(c)</p></td><td><p>in paragraph 3, &#8216;EUR 14&#160;200&#8217; is replaced by &#8216;EUR 14&#160;400&#8217;;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(d)</p></td><td><p>in the first subparagraph of paragraph 4, &#8216;EUR 21&#160;600&#8217; is replaced by &#8216;EUR 22&#160;000&#8217;;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(e)</p></td><td><p>in paragraph 5, &#8216;EUR 7&#160;200&#8217; is replaced by &#8216;EUR 7&#160;300&#8217;;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(f)</p></td><td><p>paragraph 6 is amended as follows:</p><table><col/><col/><tbody><tr><td><p>(i)</p></td><td><p>in the first subparagraph, &#8216;EUR 102&#160;900&#8217; is replaced by &#8216;EUR 104&#160;600&#8217;;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(ii)</p></td><td><p>in the second subparagraph, &#8216;EUR 25&#160;600 to EUR 77&#160;100&#8217; is replaced by &#8216;EUR 26&#160;000 to EUR 78&#160;400&#8217;;</p></td></tr></tbody></table></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(2)</p></td><td><p>in the first paragraph of Article 4, &#8216;EUR 71&#160;400&#8217; is replaced by &#8216;EUR 72&#160;600&#8217;;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(3)</p></td><td><p>Article 5 is amended as follows:</p><table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>paragraph 1 is amended as follows:</p><table><col/><col/><tbody><tr><td><p>(i)</p></td><td><p>point (a) is amended as follows:</p><table><col/><col/><tbody><tr><td><p>&#8212;</p></td><td><p>in the first subparagraph, &#8216;EUR 143&#160;700                                                         &#8217; is replaced by &#8216;EUR 146&#160;100                                                         &#8217;;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>&#8212;</p></td><td><p>in the second subparagraph, &#8216;EUR 14&#160;200                                                         &#8217; is replaced by &#8216;EUR 14&#160;400                                                         &#8217;;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>&#8212;</p></td><td><p>in the third subparagraph, &#8216;EUR 7&#160;200                                                         &#8217; is replaced by &#8216;EUR 7&#160;300                                                         &#8217;;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>&#8212;</p></td><td><p>the fourth subparagraph is amended as follows:</p><table><col/><col/><tbody><tr><td><p>&#8212;</p></td><td><p>                                                                  &#8216;EUR 71&#160;400                                                                  &#8217; is replaced by &#8216;EUR 72&#160;600                                                                  &#8217;;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>&#8212;</p></td><td><p>                                                                  &#8216;EUR 7&#160;200                                                                  &#8217; is replaced by &#8216;EUR 7&#160;300                                                                  &#8217;;</p></td></tr></tbody></table></td></tr></tbody></table></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(ii)</p></td><td><p>point (b) is amended as follows:</p><table><col/><col/><tbody><tr><td><p>&#8212;</p></td><td><p>in the first subparagraph, &#8216;EUR 71&#160;400                                                         &#8217; is replaced by &#8216;EUR 72&#160;600                                                         &#8217;;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>&#8212;</p></td><td><p>in the second subparagraph, &#8216;EUR 121&#160;200                                                         &#8217; is replaced by &#8216;EUR 123&#160;300                                                         &#8217;;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>&#8212;</p></td><td><p>in the third subparagraph, &#8216;EUR 14&#160;200                                                         &#8217; is replaced by &#8216;EUR 14&#160;400                                                         &#8217;;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>&#8212;</p></td><td><p>in the fourth subparagraph, &#8216;EUR 7&#160;200                                                         &#8217; is replaced by &#8216;EUR 7&#160;300                                                         &#8217;;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>&#8212;</p></td><td><p>the fifth subparagraph is amended as follows:</p><table><col/><col/><tbody><tr><td><p>&#8212;</p></td><td><p>                                                                  &#8216;EUR 35&#160;900                                                                  &#8217; is replaced by &#8216;EUR 36&#160;500                                                                  &#8217;;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>&#8212;</p></td><td><p>                                                                  &#8216;EUR 7&#160;200                                                                  &#8217; is replaced by &#8216;EUR 7&#160;300                                                                  &#8217;;</p></td></tr></tbody></table></td></tr></tbody></table></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(iii)</p></td><td><p>point (c) is amended as follows:</p><table><col/><col/><tbody><tr><td><p>&#8212;</p></td><td><p>in the first subparagraph, &#8216;EUR 35&#160;900                                                         &#8217; is replaced by &#8216;EUR 36&#160;500                                                         &#8217;;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>&#8212;</p></td><td><p>in the second subparagraph, &#8216;EUR 8&#160;900 to EUR 27&#160;000                                                         &#8217; is replaced by &#8216;EUR 9&#160;100 to EUR 27&#160;500                                                         &#8217;;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>&#8212;</p></td><td><p>in the third subparagraph, &#8216;EUR 7&#160;200                                                         &#8217; is replaced by &#8216;EUR 7&#160;300                                                         &#8217;;</p></td></tr></tbody></table></td></tr></tbody></table></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>paragraph 2 is amended as follows:</p><table><col/><col/><tbody><tr><td><p>(i)</p></td><td><p>the first subparagraph of point (a) is amended as follows:</p><table><col/><col/><tbody><tr><td><p>&#8212;</p></td><td><p>                                                         &#8216;EUR 3&#160;100                                                         &#8217; is replaced by &#8216;EUR 3&#160;200                                                         &#8217;;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>&#8212;</p></td><td><p>                                                         &#8216;EUR 7&#160;200                                                         &#8217; is replaced by &#8216;EUR 7&#160;300                                                         &#8217;;</p></td></tr></tbody></table></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(ii)</p></td><td><p>point (b) is amended as follows:</p><table><col/><col/><tbody><tr><td><p>&#8212;</p></td><td><p>in the first subparagraph, &#8216;EUR 43&#160;000                                                         &#8217; is replaced by &#8216;EUR 43&#160;700                                                         &#8217;;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>&#8212;</p></td><td><p>in the second subparagraph, &#8216;EUR 10&#160;800 to EUR 32&#160;400                                                         &#8217; is replaced by &#8216;EUR 11&#160;000 to EUR 33&#160;000                                                         &#8217;;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>&#8212;</p></td><td><p>in the third subparagraph, &#8216;EUR 7&#160;200                                                         &#8217; is replaced by &#8216;EUR 7&#160;300                                                         &#8217;;</p></td></tr></tbody></table></td></tr></tbody></table></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(c)</p></td><td><p>in paragraph 3, &#8216;EUR 7&#160;200&#8217; is replaced by &#8216;EUR 7&#160;300&#8217;;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(d)</p></td><td><p>in the first subparagraph of paragraph 4, &#8216;EUR 21&#160;600&#8217; is replaced by &#8216;EUR 22&#160;000&#8217;;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(e)</p></td><td><p>in paragraph 5, &#8216;EUR 7&#160;200&#8217; is replaced by &#8216;EUR 7&#160;300&#8217;;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(f)</p></td><td><p>paragraph 6 is amended as follows:</p><table><col/><col/><tbody><tr><td><p>(i)</p></td><td><p>in the first subparagraph, &#8216;EUR 34&#160;400&#8217; is replaced by &#8216;EUR 35&#160;000&#8217;;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(ii)</p></td><td><p>in the second subparagraph, &#8216;EUR 8&#160;500 to EUR 25&#160;600&#8217; is replaced by &#8216;EUR 8&#160;600 to EUR 26&#160;000&#8217;;</p></td></tr></tbody></table></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(4)</p></td><td><p>in the first paragraph of Article 6, &#8216;EUR 43&#160;000&#8217; is replaced by &#8216;EUR 43&#160;700&#8217;;</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(5)</p></td><td><p>Article 7 is amended as follows:</p><table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>in the first paragraph, &#8216;EUR 71&#160;400&#8217; is replaced by &#8216;EUR 72&#160;600&#8217;;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>in the second paragraph, &#8216;EUR 21&#160;600&#8217; is replaced by &#8216;EUR 22&#160;000&#8217;;</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(6)</p></td><td><p>Article 8 is amended as follows:</p><table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>paragraph 1 is amended as follows:</p><table><col/><col/><tbody><tr><td><p>(i)</p></td><td><p>in the second subparagraph, &#8216;EUR 86&#160;100&#8217; is replaced by &#8216;EUR 87&#160;600&#8217;;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(ii)</p></td><td><p>in the third subparagraph, &#8216;EUR 43&#160;000&#8217; is replaced by &#8216;EUR 43&#160;700&#8217;;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(iii)</p></td><td><p>in the fourth subparagraph, &#8216;EUR 21&#160;600 to EUR 64&#160;600&#8217; is replaced by &#8216;EUR 22&#160;000 to EUR 65&#160;700&#8217;;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(iv)</p></td><td><p>in the fifth subparagraph, &#8216;EUR 10&#160;800 to EUR 32&#160;400&#8217; is replaced by &#8216;EUR 11&#160;000 to EUR 33&#160;000&#8217;;</p></td></tr></tbody></table></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>paragraph 2 is amended as follows:</p><table><col/><col/><tbody><tr><td><p>(i)</p></td><td><p>in the second subparagraph, &#8216;EUR 286&#160;900&#8217; is replaced by &#8216;EUR 291&#160;800&#8217;;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(ii)</p></td><td><p>in the third subparagraph, &#8216;EUR 143&#160;700&#8217; is replaced by &#8216;EUR 146&#160;100&#8217;;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(iii)</p></td><td><p>in the fifth subparagraph, &#8216;EUR 3&#160;100 to EUR 247&#160;300&#8217; is replaced by &#8216;EUR 3&#160;200 to EUR 251&#160;500&#8217;;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(iv)</p></td><td><p>in the sixth subparagraph, &#8216;EUR 3&#160;100 to EUR 123&#160;800&#8217; is replaced by &#8216;EUR 3&#160;200 to EUR 125&#160;900&#8217;;</p></td></tr></tbody></table></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(c)</p></td><td><p>in the first subparagraph of paragraph 3, &#8216;EUR 7&#160;200&#8217; is replaced by &#8216;EUR 7&#160;300&#8217;.</p></td></tr></tbody></table></td></tr></tbody></table>
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
<note>
( 1 ) OJ L 35, 15.2.1995, p. 1 .
( 2 ) 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 ).
( 3 ) https://ec.europa.eu/eurostat/documents/2995521/9499950/2-17012019-AP-EN.pdf/4ea467c3-8ff2-4723-bc6e-b0c85fb991e4
</note>