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Document 32017R1569
Commission Delegated Regulation on GMP for IMPs
Delegirana uredba Komisije (EU) 2017/1569 z dne 23. maja 2017 o dopolnitvi Uredbe (EU) št. 536/2014 Evropskega parlamenta in Sveta z določitvijo načel in smernic dobre proizvodne prakse za zdravila za uporabo v humani medicini v preskušanju ter ureditvijo poteka pregledov (Besedilo velja za EGP. )
- Legal basis:
- 32014R0536 - A63P1
- EuroVoc thesaurus:
- medicinske raziskave; preizkušanje; dovoljenje za prodajo; zdravilo; zdravstveni inšpekcijski pregled; poskusi na ljudeh; bioetika
- See the lifecycle of this act on the Interinstitutional register of delegated acts
-
- Documents:
- Ares(2017)203309 (Draft delegated regulation)
- Legal basis:
- 32014R0536 - A63P1
- Leading service:
- Directorate-General for Health and Food Safety
- Expert group:
- E02719
- 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