Important changes

The last edition of the Orange Guide 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

Win a free copy

The ‘Rules and Guidance for Pharmaceutical Manufacturers and Distributors’ is a must for manufacturers and distributors of medicines who do business within the EU or intend to do so in the future. This handy and unique reference book will be published in January 2014 and CurTec is giving away three copies.

Would you like to enter the competition for a free copy? Simply tell us how this publication will assist you in your daily work! The winners will be contacted personally and will be announced in the March Newsletter.

Click here to win the new Orange Guide.