- Publisher: Pharmaceutical Press
- Copyright: 2014
- Language: English
- ISBN13 : 9780857111036
- Number Of Pages: 176 pages
- Author: Medicines and Healthcare products Regulatory Agency (MHRA)
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.