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This is the ninth edition of Rules and Guidance for Pharmaceutical Manufacturers and Distributors compiled by 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.
The new 2015 edition incorporates all the significant updates and additions to the detailed European Community guidelines on GMP since the last edition, including the revised EU Guidelines on Good Distribution Practice.
In addition, it contains new sections on:-