Commonly known as the Orange Guide, this title is 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.

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
• Restructured contents and clearer text design
• A subject index

Contents

1. MHRA: Licensing, Inspection and Enforcement for Human Medicines
2. EU Guidance on Good Manufacturing Practice
3. UK Guidance on Manufacture
4. EU Legislation on Manufacture
5. UK Legislation on Manufacture
6. EU Guidance on Wholesale Distribution Practice
7. UK Guidance on Wholesale Distribution Practice
8. EU Legislation on Wholesale Distribution
9. UK Legislation on Wholesale Distribution

Glossary of Legislation
Index

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