INHALT

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