EMA GVP Annex V

EMA Guideline on good pharmacovigilance practices (GVP) Annex V – Abbreviations (Rev 1*)

* Revision 1 includes a revision to the abbreviation SDR and the following additional abbreviations: Add, ADME, aRMM, BSA, CAT, DCP, EDI, EMA, Enpr-EMA, eRMR, EudraCT, EU-POG, EV EWP, GPG, HLGT, ID, ME, MRP, No, PDCO, PEM, PhV, PIP, PUMA, RCT, RMM, SCOPE and US FDA.

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

EMA GVP Annex V: