Rules and Guidance for Pharmaceutical Manufacturers and Distributors


Medicines and Healthcare products Regulatory Agency (MHRA)


Pharmaceutical Press


4th Edition




Pharmaceutical,medicines, legislation, healthcare


Since its first publication in 1971 this text, commonly known as the "Orange Guide", has been an essential reference for all involved in the manufacture or distribution of medicines in Europe. Although much of the text is available elsewhere, the Orange Guide collates in one convenient and authoritative source European and UK guidance documents and information on legislation relating to the manufacture and distribution of medicines for human use. Compliance with Good Manufacturing Practice and Good Distribution Practice requirement is essential in the production and distribution of medicine for human use to safeguard public health and comply with legislation.

Changes to this edition include:
• Detailed changes to the EU guide to good manufacturing practice.
• Detailed revisions to the EU Directive on medical products for human use.
• The new Directive on The Principles and Guidelines on Good Manufacturing Practice of Medicinal Products for Human use
• Restructured contents and clearer text design.
• Addition of a subject index.

Compiled by the inspection and Standards Division, Medicines and Healthcare products Regulatory Agency (MHRA), London, and UK.