2012/0192(COD)COM(2012)369

Clinical Trials Regulation

Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC

Stage: In force, reached 27 May 2014
In force: In force since 16 Jun 2014 · CELEX 32014R0536
Procedure: Regulation · Ordinary legislative procedure
Last activity: 16 Jun 2014

4 acts

Delegated and implementing acts beneath it

By status: 4 published.

Act	Kind	Status	Adoption
Commission Delegated Regulation (EU) 2022/2239	Delegated · Regulation	Published	Q2 2022
Commission Implementing Regulation (EU) 2022/20	Implementing · Regulation	Published	Q4 2021
Commission Delegated Regulation (EU) 2017/1569	Delegated · Regulation	Published	23/05/2017
Commission Implementing Regulation (EU) 2017/556	Implementing · Regulation	Published

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

17 documents

Documents

Newest first. Each opens at its source.

Report · A7-0208/2013Parliament
Text adopted · Corrigendum to final act 32014R0536R(04)Commission
OJ C 253 03.09.2013, p. 0010Commission
Text adopted · OJ L 158 27.05.2014, p. 0001Commission
Text adopted · OJ L 311 17.11.2016, p. 0025Commission
Committee opinion · PE500.727Parliament
Committee opinion · PE504.167Parliament
Report · PE504.236Parliament
Amendments · PE506.158Parliament
Amendments · PE506.159Parliament
Amendments · PE506.160Parliament
Amendments · PE506.161Parliament
Amendments · PE506.162Parliament
Committee opinion · PE506.211Parliament
Text adopted · Regulation 2014/0536Commission
Text adopted · SP(2014)471Parliament
Text adopted · T7-0273/2014Parliament

Summary

Generated

Regulation (EU) 536/2014 governs all clinical trials on medicinal products in the EU, replacing Directive 2001/20/EC. It introduces a single application through an EU portal with a coordinated assessment by a reporting Member State. Applies from six months after the Commission's functionality notice, but no earlier than 28 May 2016. In force now.

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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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