Good Pharmacovigilance Practice Guide

First edition

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...

Practical Guide to Licensing Herbal Medicinal Products (A)

First edition

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...

Principles of Good Clinical Practice

First edition

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...

Rules and Guidance for Pharmaceutical Distributors

2007

MHRA

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...

Rules and Guidance for Pharmaceutical Manufacturers and Distributors

"The Orange Guide"

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...