Main description:

Familiarly known as the "Orange Guide," this title is an essential reference work for all those involved in the manufacture or distribution of medicines in or for Europe. It is compiled by the UK drug regulatory body, the MHRA, and brings together the European and UK guidance documents and information on legislation relating to the manufacture and distribution of medicines for human use. It therefore contains EU guidance on good manufacturing and good distribution practice along with relevant information on EU and UK legislation.

Contents:

Section 1: Medicines and Healthcare Products Regulatory Agency (MHRA); Section 2: Guidance on Good Manufacturing Practice (GMP); Section 3: Legislation on Manufacture; Section 4: Guidance on Wholesale Distribution Practice; Section 5: Legislation on Wholesale Distribution; Section 6: Glossary of Legislation