Document ID: 32023R1766
Language: ENG

<table><col/><col/><col/><col/><tbody><tr><td><p>14.9.2023&#160;&#160;&#160;</p></td><td><p>EN</p></td><td><p>Official Journal of the European Union</p></td><td><p>L 226/102</p></td></tr></tbody></table>
COMMISSION DELEGATED REGULATION (EU) 2023/1766
of 29 June 2023
amending Regulation (EU) No 658/2014 of the European Parliament and of the Council as regards the adjustment to the inflation rate of the amounts of the fees payable to the European Medicines Agency for the conduct of pharmacovigilance activities in respect of medicinal products for human use
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EU) No 658/2014 of the European Parliament and of the Council of 15 May 2014 on fees payable to the European Medicines Agency for the conduct of pharmacovigilance activities in respect of medicinal products for human use ( 1 ) , and in particular Article 15(6) thereof,
Whereas:
<table><col/><col/><tbody><tr><td><p>(1)</p></td><td><p>In accordance with Article&#160;67(3), point (c), of Regulation (EC) No&#160;726/2004 of the European Parliament and of the Council&#160;<a>(<span>2</span>)</a>, the revenue of the European Medicines Agency includes fees paid by undertakings for obtaining and maintaining Union marketing authorisations and for other services provided by the Agency, and for services provided by the coordination group as regards the fulfilment of its tasks in accordance with Articles 107c, 107e, 107g, 107k and&#160;107q of Directive&#160;2001/83/EC of the European Parliament and of the Council&#160;<a>(<span>3</span>)</a>.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(2)</p></td><td><p>The last adjustment of the fees and remuneration amounts laid down in Regulation (EU) No&#160;658/2014 was carried out in&#160;2022 based on the cumulative inflation rate of 2020 and&#160;2021. The inflation rate of the Union for 2022, as published by the Statistical Office of the European Union, was 10,4&#160;%. Taking into consideration the level of the inflation rate for 2022, it is considered justified to adjust, in accordance with Article&#160;15(6) of Regulation (EU) No&#160;658/2014, the amounts of the fees and the amounts of the remuneration for rapporteurs and co-rapporteurs referred to in Parts I to IV of the Annex to that Regulation.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(3)</p></td><td><p>For the sake of simplicity, the adjusted amounts should be rounded to the nearest EUR&#160;10, with the exception of the annual fee for information technology systems and literature monitoring where the adjusted level should be rounded to the nearest EUR&#160;1.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(4)</p></td><td><p>Fees laid down in Regulation (EU) No&#160;658/2014 are due either at the date of the start of the respective procedure or, in the case of the annual fee for information technology systems and literature monitoring, on 1 July of every year. Consequently, the applicable amount will be determined by the due date of the fee.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(5)</p></td><td><p>Regulation (EU) No&#160;658/2014 should therefore be amended accordingly,</p></td></tr></tbody></table>
HAS ADOPTED THIS REGULATION:
Article 1
The Annex to Regulation (EU) No 658/2014 is amended as follows:
<table><col/><col/><tbody><tr><td><p>(1)</p></td><td><p>in Part I, point 1 is amended as follows:</p><table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>&#8216;EUR&#160;21&#160;940&#8217; is replaced by &#8216;EUR&#160;24&#160;220&#8217;;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>&#8216;EUR&#160;14&#160;750&#8217; is replaced by &#8216;EUR&#160;16&#160;280&#8217;;</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(2)</p></td><td><p>in Part II, point 1 is amended as follows:</p><table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>in the introductory sentence, &#8216;EUR&#160;48&#160;370&#8217; is replaced by &#8216;EUR&#160;53&#160;400&#8217;;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>point (a) is amended as follows:</p><table><col/><col/><tbody><tr><td><p>(i)</p></td><td><p>&#8216;EUR&#160;19&#160;350&#8217; is replaced by &#8216;EUR&#160;21&#160;360&#8217;;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(ii)</p></td><td><p>&#8216;EUR&#160;8&#160;190&#8217; is replaced by &#8216;EUR&#160;9&#160;040&#8217;;</p></td></tr></tbody></table></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(c)</p></td><td><p>point (b) is amended as follows:</p><table><col/><col/><tbody><tr><td><p>(i)</p></td><td><p>&#8216;EUR&#160;29&#160;020&#8217; is replaced by &#8216;EUR&#160;32&#160;040&#8217;;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(ii)</p></td><td><p>&#8216;EUR&#160;12&#160;280&#8217; is replaced by &#8216;EUR&#160;13&#160;560&#8217;;</p></td></tr></tbody></table></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(3)</p></td><td><p>in Part III, point 1 is amended as follows:</p><table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>the first subparagraph is amended as follows:</p><table><col/><col/><tbody><tr><td><p>(i)</p></td><td><p>&#8216;EUR&#160;201&#160;450&#8217; is replaced by &#8216;EUR&#160;222&#160;400&#8217;;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(ii)</p></td><td><p>&#8216;EUR&#160;43&#160;670&#8217; is replaced by &#8216;EUR&#160;48&#160;210&#8217;;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(iii)</p></td><td><p>&#8216;EUR&#160;332&#160;460&#8217; is replaced by &#8216;EUR&#160;367&#160;030&#8217;;</p></td></tr></tbody></table></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>the second subparagraph is amended as follows:</p><table><col/><col/><tbody><tr><td><p>(i)</p></td><td><p>in point (a), &#8216;EUR&#160;134&#160;290&#8217; is replaced by &#8216;EUR&#160;148&#160;260&#8217;;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(ii)</p></td><td><p>in point (b), &#8216;EUR&#160;163&#160;420&#8217; is replaced by &#8216;EUR&#160;180&#160;420&#8217;;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(iii)</p></td><td><p>in point (c), &#8216;EUR&#160;192&#160;530&#8217; is replaced by &#8216;EUR&#160;212&#160;550&#8217;;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(iv)</p></td><td><p>in point (d), &#8216;EUR&#160;221&#160;620&#8217; is replaced by &#8216;EUR&#160;244&#160;670&#8217;;</p></td></tr></tbody></table></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(c)</p></td><td><p>in the fourth subparagraph, point (b) is amended as follows:</p><table><col/><col/><tbody><tr><td><p>(i)</p></td><td><p>&#8216;EUR&#160;1&#160;130&#8217; is replaced by &#8216;EUR&#160;1&#160;250&#8217;;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(ii)</p></td><td><p>&#8216;EUR&#160;2&#160;230&#8217; is replaced by &#8216;EUR&#160;2&#160;460&#8217;;</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(iii)</p></td><td><p>&#8216;EUR&#160;3&#160;380&#8217; is replaced by &#8216;EUR&#160;3&#160;730&#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 Part IV, in point 1, &#8216;EUR&#160;75&#8217; is replaced by &#8216;EUR&#160;83&#8217;.</p></td></tr></tbody></table>
Article 2
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union . It shall apply from 4 October 2023.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 29 June 2023.
For the Commission
The President
Ursula VON DER LEYEN
<note>
( 1 ) OJ L 189, 27.6.2014, p. 112 .
( 2 ) Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Union procedures for the authorisation and supervision of medicinal products for human use and establishing a European Medicines Agency ( OJ L 136, 30.4.2004, p. 1 ).
( 3 ) Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use ( OJ L 311, 28.11.2001, p. 67 ).
</note>