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.

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.

Changes to this edition include:

• Detailed changes to the EU guide to good manufacturing practice
• Detailed revisions to the EU Directive on medicinal products for human use
• The new Directive on the Principles and Guidelines on Good Manufacturing Practice of Medicinal Products for Human Use