Glossary of MHRA terms - M

M

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MAC
Microbiology Advisory Committee.

MA
Marketing Authorisation. This is the European licensing system for medicines that replaced the Product Licence (PL) system.

MAIL
Medicines Act Information Letter. This is a defunct journal replaced by the Medicines Regulatory News section of the MHRA website.

MAL
Medicines Act Leaflet. This is an information booklet covering particular aspects of the Medicines Act. Replaced in 1998 by the MHRA Guidance Note series.

MC
Medicines Commission. This commission is defunct. See: CHMP.

MCA
Medicines Control Agency. Merged with the Medicines Devices Agency in 2003 to become the MHRA.

MDA
Medical Devices Agency. Merged with the Medicines Control Agency in 2003 to become the MHRA.

MDA
Medical Device Alert. Issued since 2003 and replaced Hazard Notices, Safety Notices, Advice Notes and Device Alerts.

MDD
Medical Devices Directive.

MDLO
Medical Device Liaison Officer. This person's primary role is to encourage the effective reporting of adverse incidents.

MDR
Medical Device Reporting or Medical Device Regulations (SI 2002/618 and 2003/1697).

MEDDRA
Medical Dictionary for Drug Regulatory Affairs. See also: MedDRA.

MedDRA
Medical Dictionary for Regulatory Activities. This is the internationally accepted medical terminology for use in drug regulation. Developed under the auspices of the ICH and based on MEDDRA which was in turn based on the MHRA's medical dictionary.

MHRA
Medicines and Healthcare Products Regulatory Agency.

ML
Manufacturer's Licence. This is required by manufacturers of medicinal products in the UK.

MLA
Obsolete. See: European licensing system.

MLX
MLX Consultative letters sent out by the MHRA to interested organisations, companies and individuals when considering proposals to amend the Orders and Regulations made under the Medicines Act.

MORE
Manufacture's On-line Reporting Environment. This is a web based system for device manufacturers to submit reports to the MHRA.

MRA
Mutual Recognition Agreement. MRA's are agreements between the EU and third countries to recognise each others' Good Manufacturing Practices.

MRFG
Mutual Recognition Facilitation Group. Obsolete term. See: CMD(h.)

MRC
Medical Research Council.

MRI
Magnetic resonance imaging.

MT
Market Towers. MHRA headquarters in Vauxhall, London.

MTL
Medicines Testing Laboratory. This was formerly the Laboratory of the Government Chemist and is based at Teddington.

MTS
The MHRA's Medicines Testing Scheme. This exists for sampling and testing medicines, both planned market surveillance and "one-off."

Multi-state procedure
Obsolete term. See: Mutual Recognition procedure.

Mutual recognition
Part of the EC licensing system. Aimed at facilitating access to a single market using the principle of Mutual Recognition. Identical dossiers are submitted to the Reference Member State (RSM) and the Concerned Member States (CSM). The second or subsequent Member State should mutually recognise, within 90 days, the MA in the RMS.