This is the eighth 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.
It provides a single authoritative source of European and UK guidance, information and legislation relating to the manufacture and distribution of human medicines.
With restructured contents and index and a fresh design, the new edition of The Orange Guide offers easy navigation of these important changes.
The Orange Guide was published on 2 January 2014. Order your Orange Guide (external link)
'Rules and Guidance for Pharmaceutical Manufacturers and Distributors 2014' is published by and available from Pharmaceutical Press. (external link)
The Orange Guide is updated online and also available via MedicinesComplete.