Glossary of MHRA terms - A

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Click on a different letter in the list above for terms beginning with that letter.

A


ABHI
Association of British Healthcare Industries. This is the trade association representing medical device technology manufacturers and distributors in the UK.

ABPI
Association of the British Pharmaceutical Industry. This is the trade association representing the manufacturers of prescription only medicines in the UK.

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 harmful and unintended reaction that occurs at a dose normally used for the prophylaxis, diagnosis or treatment of disease or the modification of physiological function.

ADROIT
Obsolete term. Replaced by the Sentinel PV Case Folder.

AEGIS
Obsolete term. Replaced by secure internet portal.

AI
Adverse incident. This is 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. This is the the MHRA internal database for processing and monitoring medical adverse incident reports from health professionals and members of the public.

API
Association of Pharmaceutical Importers.

ARGOS
See: PEAG

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

ASPRs
Anonymised Single Patient Reports. [Formerly 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.

 

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Page last modified: 23 September 2008