Rules and Guidance for Pharmaceutical Manufacturers and Distributors 2007
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Author(s): MHRA
Publisher: Pharmaceutical Press
ISBN: 9780853697190
Format: softback
430pp
Price: £40.00
Review Date: 04 April 2007
Review: This ‘Orange Guide’ brings together in one volume the main pharmaceutical regulations, directives and guidance that manufacturers are expected to follow when making and distributing medicinal products in the European Union and European Economic Area. The new edition includes, amongst others, the detailed changes to the EU guide to Good Manufacturing Practice, detailed revisions to the EU Directive on medicinal products for human use, and the new Directive on the Principles and guidelines on Good Manufacturing Practice of Medicinal Products for Human Use