Medicines and Healthcare products Regulatory Agency (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 from
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
Covers the legislation, guidance and good practice that relates to the conduct of clinical trials of medicinal products for human use in the UK.
Available formats:
Rules and Guidance for Pharmaceutical Manufacturers and Distributors
Commonly known as the Orange Guide, it remains an essential reference for all manufacturers and distributors of medicines in Europe.
Available formats:
Rules and Guidance for Pharmaceutical Distributors
Provides a single source of guidance to, and legislation for, the distribution of medicines in Europe and the UK.
Available formats:
British Pharmacopoeia 2021
All monographs and requirements of the European Pharmacopoeia (Ph. Eur.) are reproduced in the BP, making the BP a convenient and fully comprehensive set of standards that can be used across Europe and beyond.
Available formats:
British Approved Names (BAN) 2017
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