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Document 32017R1569
Commission Delegated Regulation on GMP for IMPs
Regolamento delegato (UE) 2017/1569 della Commissione, del 23 maggio 2017, che integra il regolamento (UE) n. 536/2014 del Parlamento europeo e del Consiglio precisando i principi e le linee guida relativi alle buone prassi di fabbricazione dei medicinali sperimentali per uso umano nonché le modalità di ispezione (Testo rilevante ai fini del SEE. )
- Legal basis:
- 32014R0536 - A63P1
- EuroVoc thesaurus:
- ricerca medica; collaudo; autorizzazione di vendita; medicinale; ispezione sanitaria; esperimento sull'uomo; bioetica
- 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