Glossary of MHRA terms

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ABHI
Association of British Healthcare Industries - represents manufacturers and suppliers of medical devices

ABPI
Association of the British Pharmaceutical Industry - represents manufacturers mainly producing POM medicines

Abridged application
An application for a marketing authorisation in which the applicant is not required to provide full results of tests and trials because the product is essentially similar to one already licensed in the UK (or the constituents of the product have a well established medicinal use).

ADR
Adverse Drug Reaction - a reaction which is harmful and unintended and which occurs at a dose normally used for the prophylaxis, diagnosis or treatment of disease or the modification of physiological function.

ADROIT
Adverse Drug Reactions On line Information Tracking - the MHRA computer system for storage and analysis of UK and foreign adverse reaction data.

AEGIS
Electronically Generated Information Service - an automated link between the MHRA and the pharmaceutical industry for exchange of information on adverse drug reactions. A subscription service. Available to regulatory authorities free of charge.

AI
Adverse incident - an event that produces, or has the potential to produce, unwanted effects involving the safety of patients, users or other persons.

AIMDD
Active Implantable Medical Devices Directive

AITS
Adverse Incident Tracking System

API
Association of Pharmaceutical Importers

ARGOS
See: SCOP

ARM
Application to reclassify a medicines. A consultative letter issued when an application is made for a change in legal status of a product.

ASPPs
Anonymised Single Patient Print Outs

ATC
Anatomical, Therapeutic, Chemical. This is a World Health Organisation classification of drug substances

AXREM
Association of X-ray Equipment Manufacturers