Date: 2022-09-13Category: Not ApplicableState: Union GovernmentCountry: Europe
Commission Delegated Regulation (EU) 2022/1520 of 17 June 2022 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
Issued by European Commission
· Directorate-General for Health and Food Safety
Executive Summary:
This Commission Delegated Regulation (EU) 2022/1520 adjusts the fees payable to the European Medicines Agency (EMA) for pharmacovigilance activities related to medicinal products for human use, in accordance with Regulation (EU) No 658/2014. The adjustment reflects the inflation rates of 2020 and 2021. The regulation amends the Annex to Regulation (EU) No 658/2014. It enters into force on the twentieth day following its publication in the Official Journal of the European Union and applies from 3 October 2022.
Key Points / Main Content:
Fee Adjustments:
* The amounts of fees and remuneration for rapporteurs and co-rapporteurs in Parts I to IV of the Annex to Regulation (EU) No 658/2014 are adjusted to account for inflation.
* Adjusted amounts are rounded to the nearest EUR 10, except for the annual fee for information technology systems and literature monitoring, which is rounded to the nearest EUR 1.
Specific Amendments to Annex:
* Part I, point 1:
* EUR 20 780 is replaced by EUR 21 940.
* EUR 13 970 is replaced by EUR 14 750.
* Part II, point 1:
* Introductory sentence: EUR 45 810 is replaced by EUR 48 370.
* Point a: EUR 18 330 replaced by EUR 19 350; EUR 7 760 replaced by EUR 8 190.
* Point b: EUR 27 480 replaced by EUR 29 020; EUR 11 630 replaced by EUR 12 280.
* Part III, point 1:
* First subparagraph: EUR 190 740 replaced by EUR 201 450; EUR 41 350 replaced by EUR 43 670; EUR 314 790 replaced by EUR 332 460.
* Second subparagraph: EUR 127 150 replaced by EUR 134 290; EUR 154 730 replaced by EUR 163 420; EUR 182 290 replaced by EUR 192 530; EUR 209 840 replaced by EUR 221 620.
* Fourth subparagraph, point b: EUR 1 070 replaced by EUR 1 130; EUR 2 110 replaced by EUR 2 230; EUR 3 200 replaced by EUR 3 380.
* Part IV, point 1: EUR 71 is replaced by EUR 75.
Entry into Force and Application:
* The Regulation enters into force on the twentieth day following its publication in the Official Journal of the European Union.
* It applies from 3 October 2022.
Impact Analysis:
European Medicines Agency (EMA):
* Impact: Receives adjusted fees for pharmacovigilance activities.
* Action Required: Implement the new fee structure for relevant services.
Undertakings Holding Marketing Authorisations:
* Impact: Required to pay adjusted fees for obtaining and maintaining Union marketing authorisations and related services.
* Action Required: Budget for and pay the adjusted fees as of the application date.
Rapporteurs and Co-Rapporteurs:
* Impact: Receive adjusted remuneration amounts.
* Action Required: N/A
European Commission:
* Impact: Oversees the implementation of the regulation and ensures its application across Member States.
* Action Required: Monitor the effectiveness of the adjusted fees and their impact on the EMA's operations.
Key Entities Referenced
European Union: A political and economic union of member states located primarily in Europe.
European Commission: An institution of the European Union, responsible for proposing legislation, implementing decisions, upholding the EU treaties and managing the day-to-day business of the EU.
European Medicines Agency: A European Union agency responsible for the scientific evaluation, supervision and safety monitoring of medicines in the EU.
Regulation EU No 658/2014: A regulation of the European Parliament and of the Council on fees payable to the European Medicines Agency for the conduct of pharmacovigilance activities in respect of medicinal products for human use.
Regulation EC No 726/2004: A regulation of the European Parliament and of the Council laying down Union procedures for the authorisation and supervision of medicinal products for human use and establishing a European Medicines Agency.
Directive 2001/83/EC: A directive of the European Parliament and of the Council on the Community code relating to medicinal products for human use.
Ursula VON DER LEYEN: The President of the European Commission.
Brussels: The location where the regulation was adopted.
L 236/16 EN Official Journal of the European Union 13.9.2022
COMMISSION DELEGATED REGULATION (EU) 2022/1520
of 17 June 2022
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 2014on 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:
(1) In accordance with Article 67(3) of Regulation (EC) No 726/2004 of the European Parliament and of the Council(2),
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 107q of Directive 2001/83/EC of the European Parliament and of the Council(3).
(2) The last adjustment of the fees and remuneration amounts laid down in Regulation (EU) No 658/2014 was carried
out in 2020 based on the cumulative inflation rate of 2018 and 2019. The inflation rate of the Union for the years
2020 and 2021, as published by the Statistical Office of the European Union, was respectively 0,3 % and 5,3 %(4).
Taking into consideration the level of the inflation rates for those years, it is considered justified to adjust, in
accordance with Article 15(6) of Regulation (EU) No 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. A
cumulative adjustment taking into account the inflation rates for both 2020 and 2021 should therefore be applied.
(3) For the sake of simplicity, the adjusted amounts should be rounded to the nearest EUR 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 1.
(4) Fees laid down in Regulation (EU) No 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 and there is no need to set
specific transitional provisions for pending procedures.
(5) In accordance with Article 15(6) of Regulation (EU) No 658/2014, where an act adjusting the amounts of the fees
laid down in Parts I to IV of the Annex to that Regulation enters into force before 1 July, the adjustments are to take
effect as from 1 July, whereas where it enters into force after 30 June, the adjustments are to take effect from the date
of entry into force of the act. The date of application for this Regulation should be laid down in accordance with that
provision.
(6) Regulation (EU) No 658/2014 should therefore be amended accordingly,
(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).
(4) Eurostat, euroindicators 11/2022, published on 20 January 2022.13.9.2022 EN Official Journal of the European Union L 236/17
HAS ADOPTED THIS REGULATION:
Article 1
The Annex to Regulation (EU) No 658/2014 is amended as follows:
(1) in Part I, point 1 is amended as follows:
(a) ‘EUR 20 780’ is replaced by ‘EUR 21 940’;
(b) ’EUR 13 970’ is replaced by 14 750’;
(2) in Part II, point 1 is amended as follows:
(a) in the introductory sentence, ‘EUR 45 810’ is replaced by ‘EUR 48 370’;
(b) point (a) is amended as follows:
(i) ‘EUR 18 330’ is replaced by ‘EUR 19 350’;
(ii) ‘EUR 7 760’ is replaced by ‘EUR 8 190’;
(c) point (b) is amended as follows:
(i) ‘EUR 27 480’ is replaced by ‘EUR 29 020’;
(ii) ‘EUR 11 630’ is replaced by ‘EUR 12 280’;
(3) in Part III, point 1 is amended as follows:
(a) the first subparagraph is amended as follows:
(i) ‘EUR 190 740’ is replaced by ‘EUR 201 450’;
(ii) ‘EUR 41 350’ is replaced by ‘EUR 43 670’;
(iii) ‘EUR 314 790’ is replaced by ‘EUR 332 460’;
(b) the second subparagraph is amended as follows:
(i) in point (a), ‘EUR 127 150’ is replaced by ‘EUR 134 290’;
(ii) in point (b), ‘EUR 154 730’ is replaced by ‘EUR 163 420’;
(iii) in point (c), ‘EUR 182 290’ is replaced by ‘EUR 192 530’;
(iv) in point (d), ‘EUR 209 840’ is replaced by ‘EUR 221 620’;
(c) in the fourth subparagraph, point (b) is amended as follows:
(i) ‘EUR 1 070’ is replaced by ‘EUR 1 130’;
(ii) ‘EUR 2 110’ is replaced by ‘EUR 2 230’;
(iii) ‘EUR 3 200’ is replaced by ‘EUR 3 380’;
(4) in point 1 of Part IV, ‘EUR 71’ is replaced by ‘EUR 75’.
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 3 October 2022.L 236/18 EN Official Journal of the European Union 13.9.2022
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 17 June 2022.
For the Commission
The President
Ursula VON DER LEYEN