The
eighth edition of EU GMP guidance is now available:
‘Rules
and Guidance for Pharmaceutical Manufacturers and Distributors’ (The Orange
Guide), MHRA (Medicines and Healthcare products Regulatory Agency), 2014
This
is the eighth edition of Rules and Guidance for Pharmaceutical Manufacturers
and Distributors, compiled by the MHRA. Commonly known as The Orange Guide, it
remains an essential reference for all manufacturers and distributors of
medicines in Europe. It provides a single authoritative source of European and
UK guidance, information and legislation relating to the manufacture and
distribution of human medicines.
Since
the 2007 edition there have been significant changes and additions to the
detailed European Community guidelines on Good Manufacturing Practice (GMP), as
well as substantial amendments to the Community code relating to medicinal
products for human use.
This
new edition covers these important changes as well as featuring
- Changes to the EU Guide on GMP, including the addition of Part III
- Revised EU Guide for good distribution practice
- Revisions to the EU Directive on medicines for human use
- New chapters for brokers of finished medicines and manufacturers, importers and distributors of active substances as a result of Falsified Medicines Directive 2011/62/EU
- Updated chapters on the work of the MHRA
- Extracts from the UK's consolidated human medicines legislation
- New appendix of names and addresses of other EU medicines regulators.
With
restructured contents and index and a fresh design, the new edition of The
Orange Guide offers easy navigation of these important changes.
Posted by Tim Sandle
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