Medicines and Healthcare products Regulatory Agency
This essential reference guide covers pharmacovigilance of medicinal products for human use. By highlighting the areas in which inspection findings are commonly found and providing specific examples of good or poor...
ISBN 978 0 85369 834 0
Published Nov 2008
Brendler, Thomas; Phillips, L Denzil; Spiess, Stefan
Answers all questions most frequently asked by manufacturers and provides full guidance on license applications. The procedure for licensing herbal products in the UK and European Union is changing. The Traditional...
ISBN 978 0 85369 784 8
Published Apr 2009
McGraw, Michael J; George, Adam N; Shearn, Shawn P; Hall, Rigel L; Haws, Jr, Thomas F
This text aims to be a one-stop source for guidance and checking the rules for proper conduct of clinical trials, as well as providing a historical perspective of the clinical research...
ISBN 978 0 85369 790 9
Published Jul 2010
Compiled by the Medicines and Healthcare products Regulatory Agency (MHRA), this new publication provides guidance for distributors of medicines for human use in Europe. First published in 2007, Rules and Guidance...
ISBN 978 0 85369 758 9
Published Jun 2007
MHRA (Medicines and Healthcare products Regulatory Agency)
Commonly known as the Orange Guide, this title is an essential reference for all involved in the manufacture or distribution of medicines in Europe. Compiled by the MHRA. The Orange Guide...
ISBN 978 0 85369 719 0
Published Feb 2007