Document ID: 32018R0471
Language: ENG

<table><col/><col/><col/><col/><tbody><tr><td><p>22.3.2018&#160;&#160;&#160;</p></td><td><p>EN</p></td><td><p>Official Journal of the European Union</p></td><td><p>L 79/19</p></td></tr></tbody></table>
COMMISSION REGULATION (EU) 2018/471
of 21 March 2018
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 2018
(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 the 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 2017. The inflation rate in the Union, as made available by the Statistical Office of the European Union, was 1,7&#160;% in 2017.</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 2018.</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 2018. 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 282&#160;100                                                         &#8217; is replaced by &#8216;EUR 286&#160;900                                                         &#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;300                                                         &#8217; is replaced by &#8216;EUR 28&#160;800                                                         &#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;100                                                         &#8217; is replaced by &#8216;EUR 7&#160;200                                                         &#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 109&#160;500                                                         &#8217; is replaced by &#8216;EUR 111&#160;400                                                         &#8217;,</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>&#8212;</p></td><td><p>in the second subparagraph, &#8216;EUR 182&#160;400                                                         &#8217; is replaced by &#8216;EUR 185&#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 10&#160;900                                                         &#8217; is replaced by &#8216;EUR 11&#160;100                                                         &#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;100                                                         &#8217; is replaced by &#8216;EUR 7&#160;200                                                         &#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 84&#160;700                                                         &#8217; is replaced by &#8216;EUR 86&#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 21&#160;200 to EUR 63&#160;500                                                         &#8217; is replaced by &#8216;EUR 21&#160;600 to EUR 64&#160;600                                                         &#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;100                                                         &#8217; is replaced by &#8216;EUR 7&#160;200                                                         &#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>in the first subparagraph of point (a), &#8216;EUR 3&#160;000&#8217; is replaced by &#8216;EUR 3&#160;100&#8217;</p><p>and &#8216;EUR 7&#160;100                                                &#8217; is replaced by &#8216;EUR 7&#160;200                                                &#8217;;</p></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 84&#160;700                                                         &#8217; is replaced by &#8216;EUR 86&#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 21&#160;200 to EUR 63&#160;500                                                         &#8217; is replaced by &#8216;EUR 21&#160;600 to EUR 64&#160;600                                                         &#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;000&#8217; is replaced by &#8216;EUR 14&#160;200&#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;200&#8217; is replaced by &#8216;EUR 21&#160;600&#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;100&#8217; is replaced by &#8216;EUR 7&#160;200&#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 101&#160;200&#8217; is replaced by &#8216;EUR 102&#160;900&#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;200 to EUR 75&#160;800&#8217; is replaced by &#8216;EUR 25&#160;600 to EUR 77&#160;100&#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 70&#160;200&#8217; is replaced by &#8216;EUR 71&#160;400&#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 141&#160;300                                                         &#8217; is replaced by &#8216;EUR 143&#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 14&#160;000                                                         &#8217; is replaced by &#8216;EUR 14&#160;200                                                         &#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;100                                                         &#8217; is replaced by &#8216;EUR 7&#160;200                                                         &#8217;,</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>&#8212;</p></td><td><p>in the fourth subparagraph, &#8216;EUR 70&#160;200                                                         &#8217; is replaced by &#8216;EUR 71&#160;400                                                         &#8217; and &#8216;EUR 7&#160;100                                                         &#8217; is replaced by &#8216;EUR 7&#160;200                                                         &#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 70&#160;200                                                         &#8217; is replaced by &#8216;EUR 71&#160;400                                                         &#8217;,</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>&#8212;</p></td><td><p>in the second subparagraph, &#8216;EUR 119&#160;200                                                         &#8217; is replaced by &#8216;EUR 121&#160;200                                                         &#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;000                                                         &#8217; is replaced by &#8216;EUR 14&#160;200                                                         &#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;100                                                         &#8217; is replaced by &#8216;EUR 7&#160;200                                                         &#8217;,</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>&#8212;</p></td><td><p>in the fifth subparagraph, &#8216;EUR 35&#160;300                                                         &#8217; is replaced by &#8216;EUR 35&#160;900                                                         &#8217; and &#8216;EUR 7&#160;100                                                         &#8217; is replaced by &#8216;EUR 7&#160;200                                                         &#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 35&#160;300                                                         &#8217; is replaced by &#8216;EUR 35&#160;900                                                         &#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;800 to EUR 26&#160;500                                                         &#8217; is replaced by &#8216;EUR 8&#160;900 to EUR 27&#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;100                                                         &#8217; is replaced by &#8216;EUR 7&#160;200                                                         &#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>in the first subparagraph of point (a), &#8216;EUR 3&#160;000&#8217; is replaced by &#8216;EUR 3&#160;100&#8217; and &#8216;EUR 7&#160;100&#8217; is replaced by &#8216;EUR 7&#160;200&#8217;;</p></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 42&#160;300                                                         &#8217; is replaced by &#8216;EUR 43&#160;000                                                         &#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;600 to EUR 31&#160;900                                                         &#8217; is replaced by &#8216;EUR 10&#160;800 to EUR 32&#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;100                                                         &#8217; is replaced by &#8216;EUR 7&#160;200                                                         &#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;100&#8217; is replaced by &#8216;EUR 7&#160;200&#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;200&#8217; is replaced by &#8216;EUR 21&#160;600&#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;100&#8217; is replaced by &#8216;EUR 7&#160;200&#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 33&#160;800&#8217; is replaced by &#8216;EUR 34&#160;400&#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;400 to EUR 25&#160;200&#8217; is replaced by &#8216;EUR 8&#160;500 to EUR 25&#160;600&#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 42&#160;300&#8217; is replaced by &#8216;EUR 43&#160;000&#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 70&#160;200&#8217; is replaced by &#8216;EUR 71&#160;400&#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;200&#8217; is replaced by &#8216;EUR 21&#160;600&#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 84&#160;700&#8217; is replaced by &#8216;EUR 86&#160;100&#8217;;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(ii)</p></td><td><p>in the third subparagraph, &#8216;EUR 42&#160;300&#8217; is replaced by &#8216;EUR 43&#160;000&#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;200 to EUR 63&#160;500&#8217; is replaced by &#8216;EUR 21&#160;600 to EUR 64&#160;600&#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;600 to EUR 31&#160;900&#8217; is replaced by &#8216;EUR 10&#160;800 to EUR 32&#160;400&#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 282&#160;100&#8217; is replaced by &#8216;EUR 286&#160;900&#8217;;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(ii)</p></td><td><p>in the third subparagraph, &#8216;EUR 141&#160;300&#8217; is replaced by &#8216;EUR 143&#160;700&#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;000 to EUR 243&#160;200&#8217; is replaced by &#8216;EUR 3&#160;100 to EUR 247&#160;300&#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;000 to EUR 121&#160;700&#8217; is replaced by &#8216;EUR 3&#160;100 to EUR 123&#160;800&#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;100&#8217; is replaced by &#8216;EUR 7&#160;200&#8217;.</p></td></tr></tbody></table></td></tr></tbody></table>
Article 2
This Regulation shall not apply to valid applications pending on 1 April 2018.
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 2018.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 21 March 2018.
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 ).
</note>