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Document 32017R1569
Commission Delegated Regulation on GMP for IMPs
Komisijas Deleģētā regula (ES) 2017/1569 (2017. gada 23. maijs), ar ko papildina Eiropas Parlamenta un Padomes Regulu (ES) Nr. 536/2014, sīkāk norādot pētāmo cilvēkiem paredzēto zāļu labas ražošanas prakses principus un pamatnostādnes un inspekciju kārtību (Dokuments attiecas uz EEZ. )
- Legal basis:
- 32014R0536 - A63P1
- EuroVoc thesaurus:
- medicīnas pētniecība; testēšana; tirgus atļauja; zāles; veselības pārbaude; eksperiments ar cilvēkiem; bioētika
- See the lifecycle of this act on the Interinstitutional register of delegated acts
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- 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
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- Documents:
- C/2017/3368 final (Delegated regulation)
- Leading service:
- Directorate-General for Health and Food Safety
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- Documents:
- 32017R1569 (Delegated regulation)
- Date of publication:
- 16/09/2017