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Commission Directive (EU) 2017/1572 of 15 September 2017
Supplementing Directive 2001/83/EC of the European Parliament and of the Council as regards the principles and guidelines of good manufacturing practice for medicinal products for human use
(Text with EEA relevance)- Recitals
- Article 1 — Subject-matter
- Article 2 — Definitions
- Article 3 — Inspections
- Article 4 — Conformity with good manufacturing practice
- Article 5 — Compliance with marketing authorisation
- Article 6 — Pharmaceutical quality system
- Article 7 — Personnel
- Article 8 — Premises and equipment
- Article 9 — Documentation
- Article 10 — Production
- Article 11 — Quality control
- Article 12 — Outsourced operations
- Article 13 — Complaints and product recall
- Article 14 — Self-inspection
- Article 15 — Repeal of Directive 2003/94/EC
- Article 16 — Transposition
- Article 17 — Entry into force
- Article 18 — Addressees
- Final
- ANNEX — Correlation table