Skip to content

Visit tso.co.uk

Quick Search

Search by:

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

The Good Clinical Practice Guide is a brand new publication covering legislation, guidance and good practice that relates to the conduct of clinical trials of medicinal products for human use in the UK.
Click here to find out more and to order



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:

British Pharmacopoeia
The British Pharmacopoeia - the official, authoritative collection of standards for UK medicinal substances for human and veterinary use.
Click here to find out more and to order



BAN
British Approved Names (BAN) - the official dictionary of names for UK medicinal substances.
Click here to find out more and to order




The Orange Guide

Rules and Guidance for Pharmaceutical Manufacturers and Distributors 2013 (Orange Guide)
Familiarly known as the 'Orange Guide', Rules and Guidance for Pharmaceutical Manufacturers and Distributors 2013 is an essential publication for anyone subject to an MHRA inspection.
Click here to find out more and to order


The Green Guide

Rules and Guidance for Pharmaceutical Distributors (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.
Click here to find out more and to order