EMA Guideline on good pharmacovigilance practices (GVP) Annex V – Abbreviations (Rev 1*)
Abbreviations:
A-CASI - Audio computer-assisted
self-interviewing
ACK - Acknowledgement
Add - Addendum (in GVP reference numbers)
ADME - Absorption, distribution,
metabolism and excretion
ADR - Adverse drug reaction (preferred
term: Adverse reaction)
AE - Adverse event
AEFI - Adverse event following
immunisation
AESI - Adverse event of special interest
App - Appendix (in GVP reference numbers)
AR - Assessment report
aRMM - Additional risk minimisation
measure
Art - Article
ATC - Anatomical- therapeutic-chemical (in Anatomical Therapeutic Chemical Classification System)
ATMP - Advanced therapy medicinal product
BSA - Body surface area
CAP - Centrally authorised medicinal
product
CAT - Committee for Advanced Therapies
(at the European Medicines Agency)
CCDS - Company core data sheet
CCSI - Company core safety information
CHMP - Committee for Medicinal Products for Human Use (at the European Medicines Agency)
CIOMS - Council for International
Organizations of Medical Sciences
CMDh - Coordination Group for Mutual Recognition and Decentralised Procedures – Human (at the European Medicines Agency)
COSO - Committee of Sponsoring
Organizations of the Treadway Commission
DB - Database
DCP - Medicinal product authorised through the decentralised authorisation procedure
DDPS - Detailed description of the pharmacovigilance
system
DHPC - Direct healthcare professional
communication
DIBD - Development international birth
date
DIR - 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 - Data lock point
DP - Decentralised authorisation
procedure
DSUR - Development safety update report
DUS - Drug utilisation study
EC (in reference numbers of legislation) - European Community
EC - European Commission
ECDC - European Centre for Disease
Prevention and Control
ECG - Electrocardiogram
eCTD - Electronic common technical
document
EDI - Electronic data interchange
EEA - European Economic Area
EMA - European Medicines Agency
ENCePP - European Network of Centres for Pharmacoepidemiology and Pharmacovigilance
Enpr-EMA - European Network of Paediatric
Research at the European Medicines Agency
ENS - Early Notification System
EPAR - European public assessment report
EPITT - European Pharmacovigilance Issues
Tracking Tool
EPPV - Early post-marketing phase vigilance
(e.g. in Japan)
ePSUR - Periodic safety update report in
structured electronic format
eRMR - Electronic reaction monitoring
report
ERMS FG - European Risk Management Strategy Facilitation Group (of the Heads of Medicines Agencies)
ESTRI - ICH electronic standards for the
transfer of regulatory information
EU - European Union
EudraCT - European Clinical Trials
Database
EU-POG - EU Network Pharmacovigilance
Oversight Group
EURD - EU reference date
EV - EudraVigilance
EV EWG - EudraVigilance Expert Working
Group (at the European Medicines Agency)
EVCTM - EudraVigilance Clinical Trial
Module
EVDAS - EudraVigilance Data Analysis
System
EVMPD - EudraVigilance Medicinal Product
Dictionary
EVPM - EudraVigilance Post-Authorisation
Module
FAERS - FDA Adverse Event Reporting
System (of the US FDA)
GCP - Good clinical practice
GDP - Good distribution practice
GLP - Good laboratory practice
GMP - Good manufacturing practice
GPG - Good practice guide
GPP - ISPE Guidelines for good
pharmacoepidemiology practices
GVP - Good pharmacovigilance practices
(for the European Union)
HLGT - Higher level group term (in
MedDRA)
HLT - High-level term (in MedDRA)
HMA - Heads of Medicines Agencies
IBD - International birth date
ICH - International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use
ICSR - Individual case safety report
ID - Identifier
IIA - Chartered Institute of Internal
Auditors
IME - Important medical event
INN - International non-proprietary name
IR - 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 - International Organization for
Standardization
ISPE - International Society for
Pharmacoepidemiology
IT - Information technology
IVRS - Interactive voice response systems
MA - Marketing authorisation
MAH - Marketing authorisation holder
MaxSPRT - Maximised sequential
probability ratio test
ME - Medication error
MedDRA - ICH Medical Dictionary for
Regulatory Activities
MR - Mutual recognition authorisation
procedure
MRP - Mutually recognised medicinal product, i.e. medicinal product authorised through the mutual recognition authorisation procedure
MS - Member State
NAP - Nationally authorised medicinal
product
NCA - National competent authority
NIMP - Non-investigational medicinal
product
No - Number
O/E - Observed-versus-expected analysis
P. - Product- or Population-Specific
Considerations (in GVP)
PAES - Post-authorisation efficacy study
PAS - Post-authorisation study
PASS - Post-authorisation safety study
PBRER - Periodic benefit-risk evaluation
report
PCG - Project Co-ordination Group (of the governance structure set up by the European Medicines Agency and national competent authorities for the implementation of the new pharmacovigilance legislation)
PDCO - Paediatric Committee Committee (at
the European Medicines Agency)
PEM - Prescription event monitoring
PhV - Pharmacovigilance
PhV DB - Pharmacovigilance database
PhVIWG - Pharmacovigilance Inspectors Working Group (at the European Medicines Agency)
PIP - Paediatric investigation plan
PL - Package leaflet
PPP - Pregnancy prevention programme
PRAC - Pharmacovigilance and Risk Assessment Committee (at the European Medicines Agency)
PrAR - Preliminary assessment report
PRR - Proportional reporting ratio
PSMF - Pharmacovigilance system master
file
PSUR - Periodic safety update report
PT - Preferred term (in MedDRA)
PUMA - Paediatric use marketing
authorisation
QPPV - Qualified person responsible for
pharmacovigilance in the EU
QRD - Quality Review of Documents (at the
European Medicines Agency)
RCT - Randomised clinical trial
REG - 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 - Revision
RMM - Risk minimisation measure
RMP - Risk management plan
SCCS - Self-controlled case series design
SCOPE (short for SCOPE Joint Action) - Strengthening Collaboration for Operating Pharmacovigilance in Europe Joint Action (of EU Member States)
SDR - Signal of disproportionate
reporting
SmPC - Summary of product characteristics
SMQ - Standardised MedDRA query
SOC - System organ class (in MedDRA)
SUSAR - Suspected unexpected serious
adverse reaction
TT - Timetable
URD - Union reference date (preferred
term: EU reference date)
US FDA - United States Food & Drug
Administration
WHO - World Health Organization
XEVMPD - eXtended EudraVigilance
Medicinal Product Dictionary
XEVPRM - eXtended EudraVvigilance Product Report Message
