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FDAnews Drug Daily Bulletin

MHRA Releases Eighth Edition of the Orange Guide

Jan. 6, 2014

The UK’s Medicines and Healthcare products Regulatory Agency announced Friday the release of the eighth edition of its Orange Guide rules for pharmaceutical manufacturers and distributors. Last published in 2007, the guide helps supply chain participants comply with best practices.

The updated edition includes:

  • Changes to the European Community Good Manufacturing Practices (GMP) guidelines;

  • Amendments to the community code for medicinal products for human use;

  • Changes to the EU Guide on GMP, including Part III;

  • Revised EU Guide distribution practices;

  • EU Directive revisions on medicines for human use;

  • New chapters, the results of the Falsified Medicines Directive 2011/62/EU, for brokers of medicines, importers, distributors and manufacturers of active substances;

  • Excerpts from the UK’s consolidated human medicines law; and

  • An appendix of contact information for EU medicines regulators.

The new guide is available at www.pharmpress.com/orange. — Lena Freund

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