European Commission 29 July 2021, Commission Implementing Regulation (EU) 2021/1248 of 29 July 2021 as regards measures on good distribution practice for veterinary medicinal products in accordance with Regulation (EU) 2019/6 of the European Parliament and of the Council (Text with EEA relevance)

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European Union · · · Cited by 31 · 30-07-2021

CHAPTER I. GENERAL PROVISIONS
Article 1. Subject matter and scope
Article 2. Definitions
CHAPTER II. QUALITY MANAGEMENT
Article 3. Development and maintenance of a quality system
Article 4. Requirements for the quality system
Article 5. Management of outsourced activities
Article 6. Management review and monitoring
Article 7. Quality risk management
CHAPTER III. PERSONNEL REQUIREMENTS
Article 8. Obligations of persons responsible for wholesale distribution
Article 9. Other personnel
Article 10. Training of personnel
Article 11. Hygiene
CHAPTER IV. PREMISES AND EQUIPMENT
Article 12. Premises
Article 13. Temperature and environmental control
Article 14. Equipment
Article 15. Computerised systems
Article 16. Qualification and validation
CHAPTER V. DOCUMENTATION, PROCEDURES AND RECORD-KEEPING
Article 17. Documentation requirements
Article 18. Procedures
Article 19. Records
CHAPTER VI. OPERATIONS
Article 20. Requirements for operations
Article 21. Verification of eligibility and approval of suppliers
Article 22. Verification of eligibility and approval of customers
Article 23. Receipt of veterinary medicinal products
Article 24. Storage
Article 25. Destruction of obsolete veterinary medicinal products
Article 26. Picking
Article 27. Supply
Article 28. Export
CHAPTER VII. COMPLAINTS, RETURNS, SUSPECTED FALSIFIED VETERINARY MEDICINAL PRODUCTS AND RECALLS
Article 29. Complaints
Article 30. Returns
Article 31. Falsified veterinary medicinal products
Article 32. Recalls
CHAPTER VIII. OUTSOURCED ACTIVITIES
Article 33. Obligations of contract giver
Article 34. Obligations of contract acceptor
CHAPTER IX. SELF-INSPECTIONS
Article 35. Self-inspection programme
Article 36. Conduct and recording of self-inspections
CHAPTER X. TRANSPORT
Article 37. Transport requirements
Article 38. Containers, packaging and labelling
Article 39. Products requiring special conditions
CHAPTER XI. FINAL PROVISIONS
Article 40. Entry into force and application

30.7.2021

Official Journal of the European Union

L 272/46

COMMISSION IMPLEMENTING REGULATION (EU) 2021/1248

of 29 July 2021

as regards measures on good distribution 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 to the Treaty

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