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European Medicines Agency   - New Guideline on Active Substance Master File Procedure

The corrections introduced to this guideline aim to improve the ASMF procedure across the European Regulatory Network. The long term objective of these administrative amendments is to have a unique version of an ASMF for one active substance valid for the whole EU/EEA, and consequently one AR of  the ASMF recognized by all Competent Authorities. 

To this end, the annexes to the guideline have been revised, and one new annex introduced, so that assessment reports of an ASMF may be shared between the EEA National Competent Authorities, the EMA including all CHMP and CVMP Members and their experts, and the Certification of Substances Division of the European Directorate for the Quality of Medicines & Healthcare. 

Some minor textual changes in the main part of the guideline have been introduced as a consequence of the revised annexes.  

Further information:Guideline on Active Substance Master File Procedure