Regulation (EU) 2024/5682022/0417(COD)COM(2022)721ENVI

Fees and charges payable to the European Medicines Agency

Fees and charges payable to the European Medicines Agency, amending Regulation (EU) 2017/745 of the European Parliament and of the Council and repealing Council Regulation (EC) No 297/95 and Regulation (EU) 658/2014 of the European Parliament and of the Council

Stage: In force, reached 14 Feb 2024
In force: In force since 15 Feb 2024 · CELEX 32024R0568
Procedure: Ordinary legislative procedure
Rapporteur: Cristian-Silviu BUŞOI (EPP)
Last activity: 14 Feb 2024

38 entries · record as of 14 Sept 2026

Where it stands

Latest: Published in the Official Journal, 14 Feb 2024.

Show the earlier record: 25 dates, 16 Oct 2019 to 11 Oct 2023

16 Oct 2019
- Inception impact assessment closed: Revision of EMA fees, 12 responses · Commission
13 Dec 2022
- Adoption by Commission
14 Dec 2022
- Discussions within the Council or its preparatory bodies
15 Dec 2022
- Discussions within the Council or its preparatory bodies
- Referred to committee
7 Feb 2023
- Feedback on adopted proposal closed: Revision of EMA fees, 10 responses · Commission
16 Feb 2023
- Discussions within the Council or its preparatory bodies
23 Feb 2023
- Discussions within the Council or its preparatory bodies
6 Mar 2023
- Discussions within the Council or its preparatory bodies
16 Mar 2023
- Discussions within the Council or its preparatory bodies
22 Mar 2023
- Discussions within the Council or its preparatory bodies
23 Mar 2023
- Discussions within the Council or its preparatory bodies
27 Mar 2023
- Committee report tabled
8 May 2023
- Discussions within the Council or its preparatory bodies
11 May 2023
- Discussions within the Council or its preparatory bodies
23 May 2023
- Committee opinion adopted
2 Jun 2023
- Discussions within the Council or its preparatory bodies
8 Jun 2023
- Discussions within the Council or its preparatory bodies
15 Jun 2023
- Discussions within the Council or its preparatory bodies
27 Jun 2023
- Committee report adopted
30 Jun 2023
- Tabled for plenary
3 Jul 2023
- Discussions within the Council or its preparatory bodies
7 Jul 2023
- Discussions within the Council or its preparatory bodies
12 Jul 2023
- EP decision on amendments to the legislative proposal
- Plenary vote
- Plenary amended the proposal
- Referred back to committee for interinstitutional negotiations
7 Sept 2023
- Discussions within the Council or its preparatory bodies
11 Oct 2023
- Discussions within the Council or its preparatory bodies

24 Oct 2023
- Committee approved the provisional agreement
12 Dec 2023
- Plenary adopted first-reading position
- Plenary vote
15 Dec 2023
- Discussions within the Council or its preparatory bodies
10 Jan 2024
- Discussions within the Council or its preparatory bodies
12 Jan 2024
- Discussions within the Council or its preparatory bodies
23 Jan 2024
- Approval of the EP's first reading position by the Council (adoption of the legislative act)
7 Feb 2024
- Signed
14 Feb 2024
- Published in the Official Journal

7 people

Who is on it

The Parliament's rapporteurs, shadow rapporteurs and opinion rapporteurs currently on this file.

Role	Name	Group	Country	Committee
Rapporteur	Cristian-Silviu BUŞOI	EPP	RO	ENVI
Shadow rapporteur	Joanna Kopcińska	ECR	PL	ENVI
Shadow rapporteur	Kateřina Konečná	The Left	CZ	ENVI
Shadow rapporteur	Michèle Rivasi	Greens/EFA	FR	ENVI
Shadow rapporteur	Susana Solís Pérez	Renew	ES	ENVI
Shadow rapporteur	Tudor Ciuhodaru	S&D	RO	ENVI
Rapporteur for opinion	Johan Van Overtveldt	ECR	BE	BUDG

1 amendment

Amendments

Tabled on 6 Dec 2023. The texts are in the amendment documents below.

By author

Pascal Canfin1

Amendments each member tabled or co-signed.

By article

–1

13 documents

Documents

Newest first. Each opens at its source.

Report · A9-0224/2023Parliament
Text adopted · Corrigendum to final act 32024R0568R(01)Commission
Text adopted · Corrigendum to final act 32024R0568R(02)Commission
Text adopted · OJ L 000 14.02.2024, p. 0000Commission
Text adopted · OJ L 14.03.2025Commission
Text adopted · OJ L 23.04.2024Commission
Report · PE742.478Parliament
Committee opinion · PE746.962Parliament
Amendments · PE747.008Parliament
Text adopted · Regulation 2024/0568Commission
Text adopted · SP(2024)56Parliament
Text adopted · T9-0273/2023Parliament
Text adopted · T9-0446/2023Parliament

1 consultation

Consultations on it

The Commission's Have Your Say consultations linked to this file. Where we publish the positions filed, the title opens them here.

Consultation	Feedback deadline	Feedback received
Revision of EMA fees Who filed what · Follow the consultation	7 Feb 2023	22

Summary

Generated

This regulation updates the fee structure for the European Medicines Agency (EMA) to reflect its expanded responsibilities under the Medical Devices Regulation. It primarily affects pharmaceutical and medical device companies that submit applications for regulatory evaluation. The legislation was signed in February 2024 and is now in force.

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Sources: EP Legislative Observatory · EUR-Lex. Record as of 14 Sept 2026. Something wrong on this page? Report an error.

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