Commission Implementing Regulation (EU) 2021/1248 of 29 July 2021 as regards meas... (32021R1248)
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)
- 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)
- 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
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