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Rules and Guidance for Pharmaceutical Distributors (Green Guide) 2017

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Description

This title is an very important reference work for all those involved in the distribution of medicines in Europe. It reproduces relevant parts of Rules and Guidance for Pharmaceutical Manufacturers and Distributors (regularly referred to as the Orange Guide) specific to wholesale supply and distribution of medicines for human use.
It is compiled by the United Kingdom drug regulatory body, MHRA, and accommodates official EU guidance on good distribution practice and wholesale distribution in conjunction with relevant information on EU and UK legislation. It brings together the primary pharmaceutical regulations, directives and guidance which manufacturers and wholesalers are expected to follow when distributing medicinal products within Europe.
Changes to this new edition:

There have been significant changes and additions to the detailed European Community guidelines on Good Distribution Practice (GDP) in addition to substantial amendments to the Community code in terms of medicinal products for human use. This new edition covers these vital changes in addition to featuring the addition of the Guidelines on principles of Good Distribution Practice of active substances for medicinal products for human use (2015/C 95/01).

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