Commission Implementing Regulation (EU) No 520/2012 of 19 June 2012 on the perfor... (32012R0520)
Commission Implementing Regulation (EU) No 520/2012 of 19 June 2012 on the performance of pharmacovigilance activities provided for in Regulation (EC) No 726/2004 of the European Parliament and of the Council and Directive 2001/83/EC of the European Parliament and of the Council Text with EEA relevance
- COMMISSION IMPLEMENTING REGULATION (EU) No 520/2012
- of 19 June 2012
- on the performance of pharmacovigilance activities provided for in Regulation (EC) No 726/2004 of the European Parliament and of the Council and Directive 2001/83/EC of the European Parliament and of the Council
- (Text with EEA relevance)
- CHAPTER I
- Pharmacovigilance system master file
- Article 1
- Structure of the pharmacovigilance system master file
- Article 2
- Content of the pharmacovigilance system master file
- Article 3
- Content of the Annex to the pharmacovigilance system master file
- Article 4
- Maintenance
- Article 5
- Form of the documents contained in the pharmacovigilance system master file
- Article 6
- Subcontracting
- Article 7
- Availability and location of the pharmacovigilance system master file
- CHAPTER II
- Minimum requirements for the quality systems for the performance of pharmacovigilance activities
- Section 1
- General provisions
- Article 8
- Quality system
- Article 9
- Performance indicators
- Section 2
- Minimum requirements for the quality systems for the performance of pharmacovigilance activities by marketing authorisation holders
- Article 10
- Management of human resources
- Article 11
- Compliance management
- Article 12
- Record management and data retention
- Article 13
- Audit
- Section 3
- Minimum requirements for the quality systems for the performance of pharmacovigilance activities by national competent authorities and the Agency
- Article 14
- Management of human resources
- Article 15
- Compliance management
- Article 16
- Record management and data retention
- Article 17
- Audit
- CHAPTER III
- Minimum requirements for the monitoring of data in the Eudravigilance database
- Article 18
- General requirements
- Article 19
- Identification of changed risks and new risks
- Article 20
- Methodology for determining the evidentiary value of a signal
- Article 21
- Signal management process
- Article 22
- Worksharing for signal management
- Article 23
- Signal detection support
- Article 24
- Signal detection audit trail
- CHAPTER IV
- Use of terminology, formats and standards
- Article 25
- Use of internationally agreed terminology
- Article 26
- Use of internationally agreed formats and standards
- CHAPTER V
- Transmission of reports of suspected adverse reactions
- Article 27
- Individual case safety reports
- Article 28
- Content of the individual case safety report
- Article 29
- Format of electronic transmission of suspected adverse reactions
- CHAPTER VI
- Risk management plans
- Article 30
- Content of the risk management plan
- Article 31
- Summary of the risk management plan
- Article 32
- Updates of the risk management plan
- Article 33
- Format of the risk management plan
- CHAPTER VII
- Periodic safety update reports
- Article 34
- Content of periodic safety update reports
- Article 35
- Format of periodic safety update reports
- CHAPTER VIII
- Post-authorisation safety studies
- Article 36
- Scope
- Article 37
- Definitions
- Article 38
- Format of post-authorisation safety studies
- CHAPTER IX
- Final provisions
- Article 39
- Data protection
- Article 40
- Transitional provisions
- Article 41
- Entry into force and application
- ANNEX I
- Risk management plans
- Format of the risk management plan
- ANNEX II
- Format of the electronic periodic safety update reports
- ANNEX III
- Protocols, abstracts and final study reports for post-authorisation safety studies
- 1.
- Format of the study protocol
- 2.
- Format of the abstract of the final study report
- 3.
- Format of the final study report
- 9. Research methods
- 11. Discussion
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