O/E Rules and Guidance for Pharmaceutical Manufacturers and Distributors (The Orange Guide) 2014

Compiled by the Inspection, Enforcement and Standards Division, Medicines and Healthcare products Regulatory Agency (MHRA), London, UK. MHRA (Medicines and Healthcare products Regulatory Agency) This is the eighth edition of Rules and Guidance for Pharmaceutical Manufacturers and Distributors, compiled by the MHRA. Commonly known as "The Orange Guide", it remains an essential reference for all manufacturers and distributors of medicines in Europe. It provides a single authoritative source of European and UK guidance, information and legislation relating to the manufacture and distribution of human medicines. Since the 2007 edition there have been significant changes and additions to the detailed European Community guidelines on Good Manufacturing Practice (GMP), as well as substantial amendments to the Community code relating to medicinal products for human use. This new edition covers these important changes as well as featuring: Changes to the EU Guide on GMP, including the addition of Part III Revised EU Guide for good distribution practice Revisions to the EU Directive on medicines for human use New chapters for brokers of finished medicines and manufacturers, importers and distributors of active substances as a result of Falsified Medicines Directive 2011/62/EU Updated chapters on the work of the MHRA Extracts from the UK's consolidated human medicines legislation New appendix of names and addresses of other EU medicines regulators. With restructured contents and index and a fresh design, the new edition of The Orange Guide offers easy navigation of these important changes.