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Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC Text with EEA relevance
In force
- CELEX number:
- 32014R0536
- Form:
- Regulation
- Author:
- European Parliament, Council of the European Union
- Date of document:
- 16/04/2014
- Number of pages:
- 76
Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use
In force
- CELEX number:
- 32001L0020
- Form:
- Directive
- Author:
- European Parliament, Council of the European Union
- Date of document:
- 04/04/2001
- Number of pages:
- 11
Decision of the EEA joint Committee No 237/2021 of 24 September 2021 amending Annex II (Technical regulations, standards, testing and certification) to the EEA Agreement [2024/517]
Date of entry into force unknown (pending notification) or not yet in force.
- CELEX number:
- 22024D0517
- Form:
- Decision adopted by bodies created by international agreements
- Author:
- EEA Joint Committee
- Date of document:
- 24/09/2021; Date of adoption
Decision of the EEA Joint Committee No 7/2023 of 3 February 2023 amending Annex II (Technical regulations, standards, testing and certification) to the EEA Agreement [2023/2315]
Date of entry into force unknown (pending notification) or not yet in force.
- CELEX number:
- 22023D2315
- Form:
- Decision adopted by bodies created by international agreements
- Author:
- EEA Joint Committee
- Date of document:
- 03/02/2023; Date of adoption
Commission Delegated Regulation (EU) 2022/2239 of 6 September 2022 amending Regulation (EU) No 536/2014 of the European Parliament and of the Council as regards labelling requirements for unauthorised investigational and unauthorised auxiliary medicinal products for human use (Text with EEA relevance)
C/2022/6240
In force
- CELEX number:
- 32022R2239
- Form:
- Delegated regulation
- Author:
- European Commission, Directorate-General for Health and Food Safety
- Date of document:
- 06/09/2022; Date of adoption
- Number of pages:
- 3
Decision of the EEA Joint Committee No 63/2022 of 18 March 2022 amending Annex II (Technical regulations, standards, testing and certification) to the EEA Agreement [2022/1131]
Date of entry into force unknown (pending notification) or not yet in force.
- CELEX number:
- 22022D1131
- Form:
- Decision adopted by bodies created by international agreements
- Author:
- EEA Joint Committee
- Date of document:
- 18/03/2022; Date of adoption
- Number of pages:
- 1
Commission Implementing Regulation (EU) 2022/20 of 7 January 2022 laying down rules for the application of Regulation (EU) No 536/2014 of the European Parliament and of the Council as regards setting up the rules and procedures for the cooperation of the Member States in safety assessment of clinical trials (Text with EEA relevance)
C/2022/30
In force
- CELEX number:
- 32022R0020
- Form:
- Implementing regulation
- Author:
- European Commission, Directorate-General for Health and Food Safety
- Date of document:
- 07/01/2022; Date of adoption
- Number of pages:
- 12
Decision of the EEA Joint Committee No 88/2018 of 27 April 2018 amending Annex II (Technical regulations, standards, testing and certification) to the EEA Agreement [2020/1448]
Date of entry into force unknown (pending notification) or not yet in force.
- CELEX number:
- 22020D1448
- Form:
- Decision adopted by bodies created by international agreements
- Author:
- EEA Joint Committee
- Date of document:
- 27/04/2018; Date of adoption
- Number of pages:
- 1
P7_TA(2014)0366 European and Developing Countries Clinical Trials Partnership Programme ***I European Parliament legislative resolution of 15 April 2014 on the proposal for a decision of the European Parliament and of the Council on the participation of the Union in a second European and Developing Countries Clinical Trials Partnership Programme jointly undertaken by several Member States (COM(2013)0498 — C7-0222/2013 — 2013/0243(COD)) P7_TC1-COD(2013)0243 Position of the European Parliament adopted at first reading on 15 April 2014 with a view to the adoption of Decision No …/2014/EU of the European Parliament and of the Council on the participation of the Union in a second European and Developing Countries Clinical Trials Partnership Programme (EDCTP2) jointly undertaken by several Member States
- CELEX number:
- 52014AP0366
- Form:
- Legislative resolution
- Author:
- European Parliament, Committee on Budgets, Committee on Development, Committee on Industry, Research and Energy, Committee on the Environment, Public Health and Food Safety
- Date of document:
- 15/04/2014; Date of vote
- Number of pages:
- 1
P7_TA(2014)0273 Clinical trials on medicinal products for human use ***I European Parliament legislative resolution of 2 April 2014 on the 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 (COM(2012)0369 — C7-0194/2012 — 2012/0192(COD)) P7_TC1-COD(2012)0192 Position of the European Parliament adopted at first reading on 2 April 2014 with a view to the adoption of Regulation (EU) No …/2014 of the European Parliament and of the Council on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC
- CELEX number:
- 52014AP0273
- Form:
- Legislative resolution
- Author:
- European Parliament, Committee on Civil Liberties, Justice and Home Affairs, Committee on Industry, Research and Energy, Committee on the Environment, Public Health and Food Safety, Committee on the Internal Market and Consumer Protection
- Date of document:
- 02/04/2014; Date of vote
- Number of pages:
- 1
Domain: All, EUROVOC descriptor: experiment on humans, Search language: English