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Document 32017R1569
Commission Delegated Regulation on GMP for IMPs
Komission delegoitu asetus (EU) 2017/1569, annettu 23 päivänä toukokuuta 2017, Euroopan parlamentin ja neuvoston asetuksen (EU) N:o 536/2014 täydentämisestä täsmentämällä ihmisille tarkoitettujen tutkimuslääkkeiden hyvän tuotantotavan periaatteet ja ohjeet sekä tarkastuksia koskevat järjestelyt (ETA:n kannalta merkityksellinen teksti. )
- Legal basis:
- 32014R0536 - A63P1
- EuroVoc thesaurus:
- lääketieteellinen tutkimus; testaus; myyntilupa; lääke; terveystarkastus; ihmisillä suoritettavat kokeet; bioetiikka
- 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