To get 2014 off to a good start, CurTec has given away three copies of ‘Rules and Guidance for Pharmaceutical Manufacturers and Distributors’.
Many people entered the prize draw, which started in January, and three winners have been picked at random:
- Lucia Leoni from F.I.S. in Montecchio Maggiore (Italy)
- Roger Holmström from Bayn Europe in Stockholm (Sweden)
- David Kuchta from United Biochemicals in Sanborn (USA)
Important changes
This book, also known as the ‘Orange Guide’, is an essential reference for all manufacturers and distributors of medicines. It provides an overview of the latest changes to laws and regulations. he last edition was published in 2007. There have been a number of important changes to the European directives on Good Manufacturing Practice (GMP) since then.
In addition to these changes, the new Orange Guide covers matters such as:
- Changes to the EU Guide on GMP
- 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
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