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Document 32017R1569
Commission Delegated Regulation on GMP for IMPs
Commission Delegated Regulation (EU) 2017/1569 of 23 May 2017 supplementing Regulation (EU) No 536/2014 of the European Parliament and of the Council by specifying principles of and guidelines for good manufacturing practice for investigational medicinal products for human use and arrangements for inspections (Text with EEA relevance. )
- Legal basis:
- 32014R0536 - A63P1
- EuroVoc thesaurus:
- medical research; experiment on humans; health control; medicinal product; market approval; bio-ethics; testing
- See the lifecycle of this act on the Interinstitutional register of delegated acts
-
- Documents:
- Ares(2017)203309 (Draft delegated regulation)Ares(2017)203309 (Draft delegated regulation)
- Legal basis:
- 32014R0536 - A63P1
- Leading service:
- Directorate-General for Health and Food Safety
- Expert group:
- Expert Group 'Delegated act on safety features for medicinal products for human use'
- Consultation type:
- Stakeholder feedback
- Consultation duration (weeks):
- 4
- Check the status of this initiative on the Better Regulation Portal
-
- Documents:
- C/2017/3368 final (Delegated regulation)
- Leading service:
- Directorate-General for Health and Food Safety
-
- Documents:
- 32017R1569 (Delegated regulation)
- Date of publication:
- 16/09/2017