List of Abbreviations used in Regulatory Affairs.

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 - Decentralized 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 DrugI

NN - 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 LeafletPL (PI) - Product Licence (Parallel Import)

PLR - Product Licence of Righ

tPLUS - 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 Pharmacopeiav

AIC - Virtual Adverse Incident Centre

VAMF - Vaccine Antigen Master File

VMD - Veterinary Medicines Directorate

VTE - Venous ThromboEmbolism

WL - Wholesale Dealer's Licence