Rules and Guidance for Pharmaceutical Distributors (Green Guide) 2014 - Softcover

Medicines And Healthcare Products Regulatory Agency

Softcover

ISBN 10: 0857111035 ISBN 13: 9780857111036

Publisher: Pharmaceutical Press, 2014

Synopsis

An essential 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 (commonly known as the "Orange Guide") specific to wholesale supply and distribution of medicines for human use. It is compiled by the UK drug regulatory body, the MHRA, and contains official EU guidance on good distribution practice and wholesale distribution along with relevant information on EU and UK legislation. It brings together the main pharmaceutical regulations, directives and guidance which manufacturers and wholesalers are expected to follow when distributing medicinal products within Europe.

About this title

From the Back Cover

This new edition will provide you with a single source of guidance to, and legislation for, the distribution of medicines. 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. The new edition 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. The Green Guide is compiled by the Inspection, Enforcement and Standards Division, MHRA, London, UK.Available online as part of the Orange Guide at www.medicinescomplete.com

Edition details

• Publisher: Pharmaceutical Press
• Publication date: 2014
• ISBN 10: 0857111035
• ISBN 13: 9780857111036
• Binding: Paperback
• Language: English
• Number of pages: 176