Maintenance
- Maintain pharmacovigilance system master file and notify Agency of changes
Retained EU Law
2012
United Kingdom
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)
At a glance
What's here
18 compliance obligations
What this Act requires
Sections that create concrete duties on businesses or carry penalties. Procedural and definitional sections are folded into the “Browse other sections” expander at the bottom of each group. Click any section title to read the source text on legislation.gov.uk.
Form of the documents contained in the pharmacovigilance system master file
- Maintain pharmacovigilance system master file and logbook of alterations
Subcontracting
- Draw up a list of subcontracts for pharmacovigilance activities
Availability and location of the pharmacovigilance system master file
- Keep pharmacovigilance system master file accessible and available for inspection
Quality system
- Establish a quality system for pharmacovigilance activities
Management of human resources
- Have sufficient qualified staff and trained personnel for pharmacovigilance
Compliance management
- Set up a quality system to monitor medicine safety and report side effects
Record management and data retention
- Record and retain pharmacovigilance information for all authorised medicines
Methodology for determining the evidentiary value of a signal
- Use recognised methodology to evaluate safety signals
Signal management process
- Validate and report new signals from Eudravigilance monitoring
Use of internationally agreed terminology
- Use MedDRA and other internationally agreed terminology for pharmacovigilance
Use of internationally agreed formats and standards
- Use specified electronic formats for pharmacovigilance reporting
Content of the individual case safety report
- Report suspected adverse drug reactions accurately and completely
Format of electronic transmission of suspected adverse reactions
- Use specified formats and terminology for electronic adverse reaction reports
Content of the risk management plan
- Establish a risk management plan with safety and risk-minimisation details
Updates of the risk management plan
- Submit updated risk management plan to authorities
Content of periodic safety update reports
- Prepare periodic safety update reports covering all available safety data
Scope
- Submit study documents and maintain records for post-authorisation safety studies
Browse 28 other sections — procedural / definitional / commencement
uri:annex/iii/division/1
uri:annex/iii/division/3/division/10
uri:annex/iii/division/3/division/5
uri:annex/iii/division/3/division/8
The periodic safety update report shall consist of the following...
Structure of the pharmacovigilance system master file
Content of the pharmacovigilance system master file
Content of the Annex to the pharmacovigilance system master file
Performance indicators
Audit
Management of human resources
Compliance management
Record management and data retention
Audit
General requirements
Identification of changed risks and new risks
Worksharing for signal management
Signal detection support
Signal detection audit trail
Individual case safety reports
Summary of the risk management plan
Format of the risk management plan
Format of periodic safety update reports
Definitions
Format of post-authorisation safety studies
Data protection
Transitional provisions
Entry into force and application
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