25 April 2013 EMA/135814/2013

Guideline on good pharmacovigilance practices (GVP)

Annex V Abbreviations

See websites for contact details

European Medicines Agency www.ema.europa.eu Heads of Medicines Agencies www.hma.eu
The European Medicines Agency is an agency of the European Union

European Medicines Agency and Heads of Medicines Agencies, 2013. Reproduction is authorised provided the source is acknowledged.

Abbreviation A-CASI ACK ADR AE AEFI AESI AR Art ATC Audio computer-assisted self-interviewing Acknowledgement Adverse drug reaction (preferred term: Adverse reaction) Adverse event Adverse event following immunisation Adverse event of special interest Assessment report Article Anatomical- therapeutic-chemical (in Anatomical Therapeutic Chemical Classification System) ATMP CAP CCDS CCSI CHMP Advanced therapy medicinal product Centrally authorised medicinal product Company core data sheet Company core safety information Committee for Medicinal Products for Human Use (at the European Medicines Agency) CIOMS CMDh Council for International Organizations of Medical Sciences Coordination Group for Mutual Recognition and Decentralised Procedures Human (at the European Medicines Agency) COSO DB DDPS DHPC DIBD DIR Committee of Sponsoring Organizations of the Treadway Commission Database Detailed description of the pharmacovigilance system Direct healthcare professional communication Development international birth date Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use as amended DLP DP DSUR DUS Data lock point Decentralised authorisation procedure Development safety update report Drug utilisation study

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Abbreviation EC (in reference numbers of legislation) EC ECDC ECG eCTD EEA ENCePP European Commission European Centre for Disease Prevention and Control Electrocardiogram Electronic Common Technical Document European Economic Area European Network of Centres for Pharmacoepidemiology and Pharmacovigilance ENS EPAR EPITT EPPV ePSUR ERMS FG Early Notification System European public assessment report European Pharmacovigilance Issues Tracking Tool Early post-marketing phase vigilance (e.g. in Japan) Periodic safety update report in structured electronic format European Risk Management Strategy Facilitation Group (of the Heads of Medicines Agencies) ESTRI EU EURD EV EVCTM EVDAS EVMPD EVPM GCP GDP GLP GMP GPP GVP HLT ICH electronic standards for the transfer of regulatory information European Union EU reference date EudraVigilance EudraVigilance Clinical Trial Module EudraVigilance Data Analysis System EudraVigilance Medicinal Product Dictionary EudraVigilance Post-Authorisation Module Good clinical practice Good distribution practice Good laboratory practice Good manufacturing practice ISPE Guidelines for good pharmacoepidemiology practices Good pharmacovigilance practices (for the European Union) High-level term (in MedDRA) European Community

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Abbreviation HMA IBD ICH Heads of Medicines Agencies International birth date International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use ICSR IIA IME INN IR Individual case safety report Chartered Institute of Internal Auditors Important medical event International non-proprietary name Commission Implementing Regulation (EU) No 520/2012 on the Performance of Pharmacovigilance Activities Provided for in Regulation (EC) No 726/2004 and Directive 2001/83/EC ISO ISPE IT IVRS MA MAH MaxSPRT MedDRA MR MS NAP NCA NIMP O/E P. PAES PAS PASS PBRER PCG International Organization for Standardization International Society for Pharmacoepidemiology Information technology Interactive voice response systems Marketing authorisation Marketing authorisation holder Maximised sequential probability ratio test ICH Medical Dictionary for Regulatory Activities Mutual recognition authorisation procedure Member State Nationally authorised medicinal product National competent authority Non-investigational medicinal product Observed-versus-expected analysis Product- or Population-Specific Considerations (in GVP) Post-authorisation efficacy study Post-authorisation study Post-authorisation safety study Periodic benefit-risk evaluation report Project Co-ordination Group (of the governance structure set up by the European Medicines Agency and national competent authorities for the

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Abbreviation implementation of the new pharmacovigilance legislation) PhV DB PhVIWG Pharmacovigilance database Pharmacovigilance Inspectors Working Group (at the European Medicines Agency) PL PPP PRAC Package leaflet Pregnancy prevention programme Pharmacovigilance and Risk Assessment Committee (at the European Medicines Agency) PrAR PRR PSMF PSUR PT QPPV QRD REG Preliminary assessment report Proportionate reporting ratio Pharmacovigilance system master file Periodic safety update report Preferred term (in MedDRA) Qualified person responsible for pharmacovigilance in the EU Quality Review of Documents (at the European Medicines Agency) Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency as amended Rev RMP SCCS SDR SmPC SMQ SOC SUSAR TT URD WHO XEVMPD XEVPRM Revision Risk management plan Self-controlled case series design Statistic of disproportionate reporting Summary of product characteristics Standardised MedDRA query System organ class (in MedDRA) Suspected unexpected serious adverse reaction Timetable Union reference date (preferred term: EU reference date) World Health Organization eXtended EudraVigilance Medicinal Product Dictionary eXtended EudraVvigilance Product Report Message

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