Retained EU Law SI 2012/520 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)

Read it on legislation.gov.uk (opens in a new tab)
Status
In Force
Penalty ceiling
Regulated

Does it bind you?

Business-side roles with duties under this instrument.

Manufacturer14 Any Person4

Other Acts binding the same actors

If a role above is yours, these are the other instruments that most often bind it.

Manufacturer — also bound by 502 other Acts
Any Person — also bound by 2340 other Acts

What it requires

Regulations creating concrete business duties or carrying penalties, grouped as the instrument is structured. Titles link to the source text — blue means you’re leaving for legislation.gov.uk.

s.art004 Maintenance Regulated
  • Maintain pharmacovigilance system master file and notify Agency of changesManufacturer
s.art005 Form of the documents contained in the pharmacovigilance system master file Regulated
  • Maintain pharmacovigilance system master file and logbook of alterationsManufacturer
s.art006 Subcontracting Regulated
  • Draw up a list of subcontracts for pharmacovigilance activitiesAny Person
s.art007 Availability and location of the pharmacovigilance system master file Regulated
  • Keep pharmacovigilance system master file accessible and available for inspectionManufacturer
s.art008 Quality system Regulated
  • Establish a quality system for pharmacovigilance activitiesManufacturer
s.art010 Management of human resources Regulated
  • Have sufficient qualified staff and trained personnel for pharmacovigilanceManufacturer
s.art011 Compliance management Regulated
  • Set up a quality system to monitor medicine safety and report side effectsManufacturer
s.art012 Record management and data retention Regulated
  • Record and retain pharmacovigilance information for all authorised medicinesManufacturer
s.art020 Methodology for determining the evidentiary value of a signal Regulated
  • Use recognised methodology to evaluate safety signalsAny Person
s.art021 Signal management process Regulated
  • Validate and report new signals from Eudravigilance monitoringManufacturer
s.art025 Use of internationally agreed terminology Regulated
  • Use MedDRA and other internationally agreed terminology for pharmacovigilanceAny Person
s.art026 Use of internationally agreed formats and standards Regulated
  • Use specified electronic formats for pharmacovigilance reportingManufacturer
s.art028 Content of the individual case safety report Regulated
  • Report suspected adverse drug reactions accurately and completelyManufacturer
s.art029 Format of electronic transmission of suspected adverse reactions Regulated
  • Use specified formats and terminology for electronic adverse reaction reportsAny Person
s.art030 Content of the risk management plan Regulated
  • Establish a risk management plan with safety and risk-minimisation detailsManufacturer
s.art032 Updates of the risk management plan Regulated
  • Submit updated risk management plan to authoritiesManufacturer
s.art034 Content of periodic safety update reports Regulated
  • Prepare periodic safety update reports covering all available safety dataManufacturer
s.art036 Scope Regulated
  • Submit study documents and maintain records for post-authorisation safety studiesManufacturer
28 other provisions — procedural and definitional
uri:annex/iii/division/1 uri:annex/iii/division/1
uri:annex/iii/division/3/division/10 uri:annex/iii/division/3/division/10
uri:annex/iii/division/3/division/5 uri:annex/iii/division/3/division/5
uri:annex/iii/division/3/division/8 uri:annex/iii/division/3/division/8
s.annex ii para.1 The periodic safety update report shall consist of the following...
s.art001 Structure of the pharmacovigilance system master file
s.art002 Content of the pharmacovigilance system master file
s.art003 Content of the Annex to the pharmacovigilance system master file
s.art009 Performance indicators
s.art013 Audit
s.art014 Management of human resources
s.art015 Compliance management
s.art016 Record management and data retention
s.art017 Audit
s.art018 General requirements
s.art019 Identification of changed risks and new risks
s.art022 Worksharing for signal management
s.art023 Signal detection support
s.art024 Signal detection audit trail
s.art027 Individual case safety reports
s.art031 Summary of the risk management plan
s.art033 Format of the risk management plan
s.art035 Format of periodic safety update reports
s.art037 Definitions
s.art038 Format of post-authorisation safety studies
s.art039 Data protection
s.art040 Transitional provisions
s.art041 Entry into force and application

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