Commission Implementing Regulation (EU) 2021/1281 of 2 August 2021 laying down ru... (32021R1281)
Commission Implementing Regulation (EU) 2021/1281 of 2 August 2021 laying down rules for the application of Regulation (EU) 2019/6 of the European Parliament and of the Council as regards good pharmacovigilance practice and on the format, content and summary of the pharmacovigilance system master file for veterinary medicinal products (Text with EEA relevance)
- COMMISSION IMPLEMENTING REGULATION (EU) 2021/1281
- of 2 August 2021
- laying down rules for the application of Regulation (EU) 2019/6 of the European Parliament and of the Council as regards good pharmacovigilance practice and on the format, content and summary of the pharmacovigilance system master file for veterinary medicinal products
- (Text with EEA relevance)
- CHAPTER 1
- GENERAL PROVISIONS AND PHARMACOVIGILANCE SYSTEM
- Article 1
- Definitions
- Article 2
- Pharmacovigilance system
- Article 3
- Qualified person responsible for pharmacovigilance
- CHAPTER 2
- QUALITY MANAGEMENT SYSTEM
- Article 4
- Quality management system for pharmacovigilance
- Article 5
- Document management system
- Article 6
- Training
- Article 7
- Performance indicators
- Article 8
- Audits
- Article 9
- Corrective and preventive action and change management
- CHAPTER 3
- RECORD MANAGEMENT SYSTEM, DATA COLLECTION AND MONITORING
- Article 10
- Record management system
- Article 11
- Suspected adverse events
- Article 12
- Recording of adverse events
- Article 13
- Adverse event recording in the Union pharmacovigilance database
- Article 14
- Provision of additional data
- Article 15
- Post-marketing surveillance studies
- Article 16
- Risk management system
- Article 17
- Signal management process
- Article 18
- Monitoring benefit-risk balance
- Article 19
- Conclusion on the benefit-risk balance
- Article 20
- Communication
- CHAPTER 4
- THE PHARMACOVIGILANCE SYSTEM MASTER FILE
- Article 21
- General requirements for the pharmacovigilance system master file
- Article 22
- Content and structure of the pharmacovigilance system master file
- Article 23
- Summary
- Article 24
- Maintenance
- Article 25
- Location and availability
- CHAPTER 5
- CONTROLS AND INSPECTIONS BY COMPETENT AUTHORITIES
- Article 26
- Controls
- Article 27
- Pharmacovigilance inspections
- Article 28
- Entry into force
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