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The Orange Guide

Rules and Guidance for Pharmaceutical Manufacturers and Distributors (commonly known as the Orange Guide) brings together all the main European and UK directives, regulations and legislation relating to the manufacture and distribution of medicines.

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

How the Orange Guide will help you

  • Practical guidance on Good Manufacturing Practice (GMP) will help you ensure quality compliance
  • Gives you the information you need to implement new policies and systems
  • Provides an essential reference when training staff or preparing for an inspection


Content is revised on a regular basis to take into account changes to European and national legislation and guidance documents.

Who should use this resource?

  • Holders of pharmaceutical manufacturer's licences
  • Holders of pharmaceutical wholesale dealer's licences
  • Qualified Persons
  • Responsible Persons
  • Brokers of medicines
  • Manufacturers, importers and distributors of active substances
  • Anyone subject to MHRA inspection or interested in this area

Key coverage includes:

  • Detailed EU guidance on Good Manufacturing Practice (GMP)
  • Guidance and legislation on manufacture and importation
  • Guidance and legislation on wholesale distribution practice and brokering medicines
  • Includes the latest changes to the EU guide on GMP, including the addition of Part III
  • A revised EU Guide for good distribution practice
  • Revisions to the EU Directive on medicines for human use
  • Updated information for brokers of finished medicines and manufacturers, importers and distributors of active substances as a result of Falsified Medicines Directive 2011/62/EU
  • Extracts from the UK's consolidated human medicines legislation
  • Appendix of names and addresses of other EU medicines regulators

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