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.
British Pharmacopoeia 2024
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.
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British Pharmacopoeia 2023
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) 2022
Rules and Guidance for Pharmaceutical Manufacturers and Distributors (Orange Guide) 2022
This latest edition of the "Orange Guide", is the essential reference for all manufacturers and distributors of medicines in the UK. It has been updated to incorporate changes made after the UK’s exit from the European Union on the 31st January 2020.
Available formats:
Rules and Guidance for Pharmaceutical Distributors (Green Guide) 2022
This latest edition of the "Green Guide", is the essential reference for all distributors, brokers of human medicines, importers and distributors of active substances in the UK. It has been updated to incorporate changes made after the UK's exit from the European Union on the 31st January 2020.
Available formats:
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:
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
Supplement No. 1
Supplement No. 2
Supplement No. 3
Supplement No. 4
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