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Medicines and Healthcare products Regulatory Agency (MHRA)

MHRA

The Medicines and Healthcare products Regulatory Agency (MHRA) is an executive agency of the Department for Health and is the government agency responsible for ensuring that medicines and medical devices work, and are acceptably safe.

A key objective of the MHRA is to encourage and facilitate development of products that will benefit public health. The MHRA aims to do this by communicating regulatory requirements in ways which are accessible to a variety of organisations and individuals.

Much of the day-to-day information and guidance on legislation produced by the MHRA is available directly on their website www.mhra.gov.uk. However, various must-have reference titles and guides relating to specific areas of the MHRA's work are published by and available to purchase from TSO:



Good Clinical Practice Guide

Good Clinical Practice Guide
This title is aimed at any individual and/or organisation involved in conducting clinical trials with medicines in the UK, including both commercial and non-commercial sponsors and hosts of clinical trials, as well as contract research organisations, clinical research consultants and other niche providers.

The guide references European legislation and guidance as well as international standards, so will also be relevant to organisations conducting trials across Europe and beyond.

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British Pharmacopoeia

British Pharmacopoeia
UK Pharmacopoeial activity is carried out within the Inspection, Enforcement and Standards Division of MHRA by the British Pharmacopoeia Commission Secretariat and the British Pharmacopoeia Laboratory. They are responsible for producing:

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British Approved Names (BAN)

British Approved Names
The official dictionary of names for UK medicinal substances.

The BAN is an essential reference for all individuals and organisations working within pharmaceutical research, manufacture and regulatory affairs.

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Rules and Guidance for Pharmaceutical Manufacturers and Distributors 2015 (Orange Guide)

The Orange Guide
This is the ninth edition of Rules and Guidance for pharmaceutical manufacturers and distributors, compiled by the MHRA. Commonly known as 'The Orange Guide', it remains an essential reference for all manufacturers and distributors of medicines in Europe.

The 2015 edition incorporates the revised EU guidelines on good distribution practice.
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Rules and Guidance for Pharmaceutical Distributors (Green Guide)

The Green guide
This new edition of Rules and Guidance for Pharmaceutical Distributors (the Green Guide), provides you with a single source of guidance to, and legislation for, the distribution of medicines in Europe and UK.

If you're involved in the wholesale supply, distribution and brokering of medicines for human use and the distribution of active substances, this is the one-stop guide you need.
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