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Regulatory Affairs: List of Abbreviations

ADR
Adverse Drug Reaction

 

ADME
Absorption, Distribution, Metabolism and Excretion

 

ADROIT
Adverse Drug Reactions On line Information Tracking

 

AI
Adverse Incident

 

AIMDD
Active Implantable Medical Devices Directive

 

AITS
Adverse Incident Tracking System

 

ARM
Application to Reclassify a Medicine

 

ASPPs
Anonymised Single Patient Print Outs

 

ASR
Annual Safety Report

 

ATC
Anatomical, Therapeutic, Chemical

BAN
British Approved Names

 

BLA
Biological License Application

 

BNF
British National Formulary

 

BP
British Pharmacopoeia

 

BSE
Bovine Spongiform Encephalopathy

CA

Competent Authority

 

CAPLA
Computer Assisted Product Licence Application

 

CANDA
Computer Assisted New Drug Application

 

CD
Controlled Drug

 

CEP
Central Enquiry Point
Certificate of European Pharmacopeia (certificate of suitability)

 

CFC
Chlorofluorocarbons

 

CJD
Creutzfeldt-Jakob Disease

 

CMC
Chemical, Manufacture and Control

 

CMS
Concerned Member State

 

CP
Centralised Procedure

 

CPP
Certificate of Pharmaceutical Product

 

CR
Computed radiology

 

CRO
Contract Research Organisation

 

CT
Computed tomography

 

CTA
Clinical Trial Application

 

CTC
Clinical Trials Certificate

 

CTD
Clinical Trials Directive
Common Technical Document

 

CTX
Clinical Trials Exemption scheme

DB
Device Bulletin

 

DCP
Decentralised Procedure

 

DDX
Doctors and Dentist Exemptions

 

DIR
Diagnostic Imaging Review

 

DMF
Drug Master File

 

DMRC
Defective Medicines Report Centre

 

DR
Digital radiology

EC
European Community

 

ECTD
Electronic Common Technical Document

 

EEA
European Economic Area

 

EEC
European Economic Community

 

EP
European Pharmacoepia

 

EPAR
European Public Assessment Report

 

EPID
Extended Public Information Document

 

EQA
European Quality Award

 

ERA
Environmental Risk Assessment

 

EU
European Union

 

EUDRA
European Union Drug Regulatory Authorities

FOI
Freedom Of Information

GCP
Good Clinical Practice

 

GDP
Good Distribution Practice

 

GHTF
Global Harmonisation Task Force

 

GLP
Good Laboratory Practice

 

GLPMA
Good Laboratory Practice Monitoring Authority

 

GMDN
Global Medical Device Nomenclature

 

GMO
Genetically Modified Organism

 

GMP
Good Manufacturing Practice

 

GMPLA
Good Manufacturing Practice Licensing Authority

 

GP
General Practitioner

 

GPRD
General Practice Research Database

 

GPvP
Good Pharmacovigilance Practice

 

GSI
Government Secure Intranet

 

GSL
General Sale List

I&AC
Imaging and Acute Care

 

IC
Information Centre

 

ICES
Integrating Community Equipment Services

 

IM
Intramuscular

 

IM(ER)R
Ionising Radiation (Medical Exposure) Regulations

 

ImPACT
Imaging Performance Assessment of CT scanners

 

IMPD
Investigational Medicinal Product Dossier

 

IMS
Information Management Strategy

 

IMP
Investigational Medicinal Products

 

IND
Investigational New Drug

 

INN
International Non-proprietary Names

 

IRR
Ionising Radiation Regulations

 

IVDD
In Vitro Diagnostic Directive

 

ISBN
International Standard Book Number

 

IUCD
IntraUterine Contraceptive Device

 

IUD
IntraUterine Device

 

IVDs
In Vitro Diagnostic Medical Devices

 

IT
Information Technology

 

IV
Intravenous

MA
Marketing Authorisation

 

MAA
Marketing Authorisation Application

 

MAIL
Medicines ACT Information Letter

 

MAL
Medicines Act Leaflet

 

MDA
Medical Device Alert

 

MDD
Medical Devices Directive

 

MDR
Medical Device Reporting
Medical Device Regulation

 

MDLO
Medical Device Liaison Officer

 

MEDDRA (MedDRA)
Medical Dictionary for Drug Regulatory Affairs

 

ML
Manufacturer's Licence

 

MORE
Manufacturer's On-line Reporting Environment

 

MP
Member of Parliament

 

MRA
Mutual Recognition Agreement

 

MRI
Magnetic Resonance Imaging

 

MRP
Mutual Recognition Procedure

 

MTL
Medicines Testing Laboratory

 

MTS
Medicines Testing Scheme

NAS
New Active Substance

 

NB
Notified Body

 

NCE
New Chemical Entity

 

NDA
New Drug Application

 

NOP
Non-Orthodox Practitioner

ODD
Orphan Drug Designation

 

OTC
Over-The-Counter products

P (medicine)
Pharmacy medicines

 

PAPs
Product Analysis Prints

 

PCT
Primary Care Trust

 

PD
Pharmacodynamy

 

PET
Positron Emission Tomography

 

PET/CT
Positron Emission Tomography and Computerised Tomography

 

PIL
Patient Information Leaflet

 

PIP
Paediatric Investigation Plan

 

PK
Pharmacokinetic

 

PL
Product Licence
Package Leaflet

 

PL(PI)
Product Licence (Parallel Import)

 

PLR
Product Licence of Right

 

PLUS
Product Licence User System

 

PMS
Post Marketing Surveillance

 

POM
Prescription Only Medicines

 

PPI
Patient Pack Initiative

 

PRRs
Proportioned Reporting Ratios

 

PSURs
Periodic Safety Update Reports

 

PUMA
Paediatric Use Marketing Authorisation

QA
Quality Assurance

 

QC
Quality Control

 

QOS
Quality Overall Summary

 

QP
Qualified Person

 

QRD
Quality Review of Documents

RAMA
Remote Access for Marketing Authorisations

 

R&D
Research & Development

 

rINN
Recommended International Non-proprietary Name

 

RMP
Risk Management Plan

 

RMS
Reference Member State

 

RP
Responsible Person

SABS
Safety Alert Broadcast System

 

SAMM
Safety Assessment of Marketed Medicines

 

SI
Statutory Instrument

 

SMF
Site Master File

 

SOP
Standard Operating Procedure

 

SPC or SmPC
Summary of Product Characteristics

 

SPECT
Single photon emission computed tomography

 

SSRIs
Selective Serotonin Reuptake Inhibitors

TCM
Traditional Chinese Medicine

 

THMPD
Traditional Herbal Medicinal Products Directive

 

THMRS
Traditional Herbal Medicines Registration Scheme

 

THR
Traditional Herbal Registration

 

TSE
Transmissible Spongiform Encephalopathy

USAN
United States Adopted Names

 

USP
United States Pharmacopeia

VAIC
Virtual Adverse Incident Centre

 

VAMF
Vaccine Antigen Master File

 

VMD
Veterinary Medicines Directorate

 

VTE
Venous ThromboEmbolism

WL
Wholesale Dealer's Licence