GMP: Additional Guidance Document on Active Substance Master File (ASMF) published by EMA

The European Medicines Agency (EMA) has published an additional Guidance document relating to Active substance Master Files (formerly known as European Drug Master File). The new document will complement the revised Guideline on Active Substance Master File Procedure which was published on 21 June 2012 and which came into force on 1 October 2012.