European Commission 17 October 2025, Commission Implementing Regulation (EU) 2025/2091 of 17 October 2025 laying down good manufacturing practice for veterinary medicinal products in accordance with Regulation (EU) 2019/6 of the European Parliament and of the Council

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European Union · · · Cited by 2 · 17-10-2025

CHAPTER I. GENERAL PROVISIONS
Article 1. Subject matter and scope
Article 2. Definitions
Article 3. Role of the marketing authorisation holder regarding good manufacturing practice
CHAPTER II. PHARMACEUTICAL QUALITY SYSTEM
Article 4. Implementation of a pharmaceutical quality system
Article 5. Requirements of the pharmaceutical quality system
Article 6. Product quality reviews
Article 7. Self-inspection
Article 8. Management review
CHAPTER III. PERSONNEL
Article 9. General requirements for personnel
Article 10. Training
Article 11. Hygiene
CHAPTER IV. PREMISES AND EQUIPMENT
Article 12. General requirements for premises
Article 13. Production areas
Article 14. Quality control areas
Article 15. Storage areas
Article 16. Ancillary areas
Article 17. Temperature and environmental controls
Article 18. Equipment
Article 19. Qualification of premises and equipment
CHAPTER V. DOCUMENTATION
Article 20. Documentation system
Article 21. Specifications and instructions
Article 22. Records
Article 23. Other documentation
Article 24. Retention periods
Article 25. Data integrity
CHAPTER VI. PRODUCTION
Article 26. General requirements for production
Article 27. Handling of materials and products
Article 28. Qualification of suppliers and compliance with specifications
Article 29. Prevention of cross-contamination
Article 30. Packaging operations
Article 31. Rejected, recovered and returned materials
Article 32. Use of ionising radiation
CHAPTER VII. QUALITY CONTROL
Article 33. General requirements for quality control
Article 34. Sampling
Article 35. Testing
Article 36. On-going stability programme
Article 37. Technical transfer of testing methods
CHAPTER VIII. CERTIFICATION AND BATCH RELEASE
Article 38. Qualified person
Article 39. Certification and batch release
Article 40. Additional considerations for imports of veterinary medicinal products
Article 41. Repackaging operations
Article 42. Handling of unplanned deviations
CHAPTER IX. OUTSOURCED ACTIVITIES
Article 43. Requirements for outsourced activities
CHAPTER X. QUALITY DEFECTS AND RECALL OF PRODUCTS
Article 44. Quality defects
Article 45. Product recalls
CHAPTER XI. FINAL PROVISIONS
Article 46. Entry into force and application
ANNEX I. STERILE PRODUCTS AND ASEPTIC MANUFACTURING

Official Journal
of the European Union

L series

2025/2091

27.10.2025

COMMISSION IMPLEMENTING REGULATION (EU) 2025/2091

of 17 October 2025

laying down good manufacturing practice for veterinary medicinal products in accordance with Regulation (EU) 2019/6 of the European Parliament and of the Council

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

Having regard

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