P9_TA(2023)0446 – Fees and charges payable to the European Medicines Agency – European Parliament legislative resolution of 12 December 2023 on the proposal for a regulation of the European Parliament and of the Council on 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 (COM(2022)0721 – C9-0426/2022 – 2022/0417(COD)) (Ordinary legislative procedure: first reading)
Date: 2023-12-12
Institutions: Committee on Budgets, Committee on the Environment, Climate and Food Safety, European Parliament
Subjects: European Medicines Agency, drug surveillance, drugs classification, market approval, medicinal product, operation of the Institutions, provision of services, veterinary medicinal product




C_202404191EN.000101.fmx.xml












Official Journal of the European Union


EN
C series













C/2024/4191


2.8.2024






P9_TA(2023)0446

Fees and charges payable to the European Medicines Agency


European Parliament legislative resolution of 12 December 2023 on the proposal for a regulation of the European Parliament and of the Council on 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 (COM(2022)0721 – C9-0426/2022 – 2022/0417(COD))


(Ordinary legislative procedure: first reading)

(C/2024/4191)



The European Parliament,







—


having regard to the Commission proposal to Parliament and the Council (COM(2022)0721),










—


having regard to Article 294(2) and Articles 114, 168(4), points (b) and (c), of the Treaty on the Functioning of the European Union, pursuant to which the Commission submitted the proposal to Parliament (C9-0426/2022),










—


having regard to Article 294(3) of the Treaty on the Functioning of the European Union,










—


having regard to the opinion of the European Economic and Social Committee of 24 January 2023
                   (1),










—


after consulting the Committee of the Regions,










—


having regard to the provisional agreement approved by the committee responsible under Rule 74(4) of its Rules of Procedure and the undertaking given by the Council representative by letter of 18 October 2023 to approve Parliament’s position, in accordance with Article 294(4) of the Treaty on the Functioning of the European Union,










—


having regard to Rule 59 of its Rules of Procedure,










—


having regard to the letter from the Committee on Budgets,










—


having regard to the report of the Committee on the Environment, Public Health and Food Safety (A9-0224/2023),













1.


Adopts its position at first reading hereinafter set out (2);












2.


Calls on the Commission to refer the matter to Parliament again if it replaces, substantially amends or intends to substantially amend its proposal;












3.


Instructs its President to forward its position to the Council, the Commission and the national parliaments.






(1)  
            OJ C 140, 21.4.2023, p. 85.

(2)  This position replaces the amendments adopted on 12 July 2023 (Texts adopted, P9_TA(2023)0273).






P9_TC1-COD(2022)0417


Position of the European Parliament adopted at first reading on 12 December 2023 with a view to the adoption of Regulation (EU) 2024/… of the European Parliament and of the Council on fees and charges payable to the European Medicines Agency, amending Regulations (EU) 2017/745 and (EU) 2022/123 of the European Parliament and of the Council and repealing Regulation (EU) No 658/2014 of the European Parliament and of the Council and Council Regulation (EC) No 297/95



(As an agreement was reached between Parliament and Council, Parliament's position corresponds to the final legislative act, Regulation (EU) 2024/568)




ELI: http://data.europa.eu/eli/C/2024/4191/oj
ISSN 1977-091X (electronic edition)