Commission Implementing Regulation (EU) 2021/1280 of 2 August 2021 as regards mea... (32021R1280)
Commission Implementing Regulation (EU) 2021/1280 of 2 August 2021 as regards measures on good distribution practice for active substances used as starting materials in 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) 2021/1280
- of 2 August 2021
- as regards measures on good distribution practice for active substances used as starting materials in 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 SYSTEM
- Article 3
- Development and maintenance of a quality system
- Article 4
- Requirements for the quality system
- CHAPTER III
- PERSONNEL
- Article 5
- Persons responsible for the quality system
- Article 6
- Personnel involved in the distribution of active substances used as starting materials in veterinary medicinal products
- Article 7
- Training of personnel
- Article 8
- Hygiene
- CHAPTER IV
- PREMISES AND EQUIPMENT
- Article 9
- Requirements for premises and equipment
- Article 10
- Access to premises
- CHAPTER V
- DOCUMENTATION, PROCEDURES AND RECORD KEEPING
- Article 11
- Documentation
- Article 12
- Procedures
- Article 13
- Records
- CHAPTER VI
- OPERATIONS
- Article 14
- Verification of eligibility and approval of suppliers
- Article 15
- Receipt of active substances used as starting materials
- Article 16
- Storage
- Article 17
- Outsourced activities
- Article 18
- Deliveries to customers
- Article 19
- Transfer of information
- CHAPTER VII
- COMPLAINTS, RETURNS AND RECALLS
- Article 20
- Complaints
- Article 21
- Returns
- Article 22
- Recalls
- CHAPTER VIII
- SELF-INSPECTIONS AND FINAL PROVISIONS
- Article 23
- Self-inspections
- Article 24
- Entry into force
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