2001/0252(COD)COM(2002)735

European Medicines Agency (EMA) Regulation

Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products

Stage: In force, reached 30 Apr 2004
In force: In force since 20 May 2004 · CELEX 32004R0726
Procedure: Regulation · Ordinary legislative procedure
Last activity: 20 May 2004

1 entry · record as of 30 Sept 2026

Where it stands

Latest: Delegated act published: Correcting acts, 4 Aug 2026.

4 Aug 2026
- Delegated act published: Correcting acts

5 acts

Delegated and implementing acts beneath it

By status: 5 published.

Act	Kind	Status	Adoption
Commission Delegated Regulation (EU) 2026/863	Delegated · Regulation	Published
Commission Delegated Regulation (EU) 2024/1701	Delegated · Regulation	Published	Q1 2024
Commission Delegated Regulation (EU) 2021/756	Delegated · Regulation	Published	Q1 2021
Commission Implementing Regulation (EU) 2013/198	Implementing · Regulation	Published
Commission Implementing Regulation (EU) 2012/520	Implementing · Regulation	Published

Titles link to EUR-Lex where the act has been published.

16 documents

Documents

Newest first. Each opens at its source.

Text adopted · 32005R2049Commission
Text adopted · 32006R0507Commission
Report · A5-0330/2002Parliament
Report · A5-0425/2003Parliament
Proposal · COM(2016)0498Commission
Proposal · COM(2019)0591Commission
Proposal · COM(2021)0497Commission
Text adopted · Corrigendum to final act 32019R0005R(03)Commission
Text adopted · OJ L 092 30.03.2006, p. 0006-0009Commission
Text adopted · OJ L 136 30.04.2004, p. 0001-0033Commission
Text adopted · OJ L 329 16.12.2005, p. 0004-0007Commission
Text adopted · OJ L 05.08.2026Commission
Text adopted · Regulation 2004/0726Commission
SEC(2003)1082Commission
Text adopted · T5-0504/2002Parliament
Text adopted · T5-0576/2003Parliament

Summary

Generated

Regulation (EC) No 726/2004 establishes the EU centralized procedure for authorizing and supervising medicinal products for human use and creates the European Medicines Agency. It applies from 20 November 2005, with certain annex provisions from 20 May 2008. The regulation affects pharmaceutical companies seeking EU-wide marketing authorizations, national authorities, and the EMA.

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Sources: EP Legislative Observatory · EU Law Tracker · EUR-Lex. Record as of 30 Sept 2026. Something wrong on this page? Report an error.

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