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Rules and Guidance for Pharmaceutical Distributors (The Green Guide)

Rules and Guidance for Pharmaceutical Distributors (commonly known as the Green Guide) provides you with a useful, single source of guidance and legislation on the distribution of medicines. The content is taken from the distributors' section of the Orange Guide.

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

How the Green Guide will help you

  • It brings together the main pharmaceutical regulations, directive and guidance you need to follow when distributing medicinal products in the EU and European Economic area
  • Incorporates the revised EU Guidelines on Good Distribution Practice – keeping you up to date with best practice
  • Gives you the guidance and help you need to pass inspection by the MHRA

Who should use this resource?

  • Holders of pharmaceutical wholesale dealer's licenses
  • Qualified Persons
  • Responsible Persons
  • Brokers of medicines
  • Manufacturers, importers and distributors of active substances
  • Anyone subject to MHRA inspection

Key coverage includes:

  • UK Guidance on the manufacture, importation and distribution of active substances
  • Legislation on manufacture and importation
  • Guidance and legislation on wholesale distribution practice and brokering medicines
  • GDP quality systems
  • The Gold Standard for Responsible Persons
  • EU Commission Q&A on GDP guidelines
  • Controls on certain medicinal products
  • A flow chart on registration requirements for UK companies involved in the sourcing and supply of active substances (ASs) to be used in the manufacture of licensed human medicines

Updates

Content is updated on a regular basis to keep up to date with changes to European and national legislation and guidance documents.

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