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Document 32017R1569
Commission Delegated Regulation on GMP for IMPs
Kommissionens delegerede forordning (EU) 2017/1569 af 23. maj 2017 om supplerende regler til Europa-Parlamentets og Rådets forordning (EU) nr. 536/2014 for så vidt angår specificering af principperne og retningslinjerne for god fremstillingspraksis for forsøgslægemidler til human brug samt bestemmelserne om inspektion (EØS-relevant tekst. )
- Legal basis:
- 32014R0536 - A63P1
- EuroVoc thesaurus:
- medicinsk forskning; forsøg; salgstilladelse; lægemiddel; sundhedstilsyn; forsøg på mennesker; bioetik
- 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