Overview

Complied by the Medicines and Healthcare products Regulatory Agency (MHRA), this new publication provides guidance for distributors of medicines for human use in Europe. Rules and Guidance for Pharmaceutical Distributors reproduces those elements of the 2007 edition of Rules and Guidance for Pharmaceutical Manufactures and Distributors (commonly known as the Orange Guide ) specific to the wholesale supply and distribution of medicines for human use. Essential information to ensure the safe distribution of medicines and the safety of the public is provided in this new guide. Rules and Guidance for Pharmaceutical Distributors 2007 includes: EU guidelines on Good Distribution Practice; UK guidance on wholesale distribution practice; EU legislation on wholesale distribution; and, UK legislation on wholesale distribution.

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