A
new edition of the ‘Green Guide’ is now available: Rules and Guidance for Pharmaceutical
Distributors, MHRA (Medicines and Healthcare products Regulatory Agency), 2014.
This
new edition of Rules and Guidance for Pharmaceutical Distributors (the Green
Guide), provides you with a single source of guidance to, and legislation for,
the distribution of medicines in Europe and UK.
The
Green Guide reproduces all the elements of the new Rules and Guidance for
Pharmaceutical Manufacturers and Distributors 2014 (the Orange Guide) that are
relevant to distributors. So if you’re involved in the wholesale supply,
distribution and brokering of medicines for human use and the distribution of
active substances, this is the one-stop guide you need.
Since
the last edition in 2007, there have been significant changes and additions to
the detailed European Community guidelines on Good Distribution Practice (GDP).
The Community code relating to medicinal products for human use has also been
substantially amended.
This
new edition of Rules and Guidance for Pharmaceutical Distributors brings
together information that you need to know about these important changes, and
includes:
- A 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 the Falsified Medicines Directive 2011/62/EU
- Updated chapters on the work of the MHRA
- Extracts from the UK's consolidated human medicines legislation
- A new appendix of names and addresses of other EU medicines regulators.
With
its restructured contents and index and a fresh design, it’s easier than ever
to find the answers you need.
Posted by Tim Sandle
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