Good Pharmacovigilance Practice Guide
(MHRA Purple Guide)
essential reference guide relates to pharmacovigilance of medicinal
products for human use. It complements currently available EU
legislation and guidance and provides practical advice to key
stakeholders in particular Marketing Authorisdation Holders, about
achieving an appropriate system of pharmacovigilance.
This Guide is the result of collaboration between different groups
within the MHRA, including the GPvP Inspectorate, the Pharmacovigilance
Group and the Clinical Trials Unit. By highlighting the areas in which
inspection findings are commonly found and providing specific examples
of god or poor practice, the guide can assist organisation in developing
effective pharmacovigilance systems.
ISBN 978 0 85369 834 0 2009 / 2010