Thursday, 20 February 2014

New edition of the ‘Green guide’ (GDP)


A new edition of the ‘Green Guide’ is now available:  Rules and Guidance for Pharmaceutical Distributors, MHRA (Medicines and Healthcare products Regulatory Agency), 2014.

This new edition of Rules and Guidance for Pharmaceutical Distributors (the Green Guide), provides you with a single source of guidance to, and legislation for, the distribution of medicines in Europe and UK.

The Green Guide reproduces all the elements of the new Rules and Guidance for Pharmaceutical Manufacturers and Distributors 2014 (the Orange Guide) that are relevant to distributors. So if you’re involved in the wholesale supply, distribution and brokering of medicines for human use and the distribution of active substances, this is the one-stop guide you need.

Since the last edition in 2007, there have been significant changes and additions to the detailed European Community guidelines on Good Distribution Practice (GDP). The Community code relating to medicinal products for human use has also been substantially amended.

This new edition of Rules and Guidance for Pharmaceutical Distributors brings together information that you need to know about these important changes, and includes:
  • A 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 the Falsified Medicines Directive 2011/62/EU
  • Updated chapters on the work of the MHRA
  • Extracts from the UK's consolidated human medicines legislation
  • A new appendix of names and addresses of other EU medicines regulators.

With its restructured contents and index and a fresh design, it’s easier than ever to find the answers you need.

For details see: Green Guide

Posted by Tim Sandle