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IPEC Europe

Supporting the interests of pharmaceutical excipient developers, producers, distributors and users.

Excipient Master File

 

 

IPEC Europe strongly believes in the necessity of an EMF in Europe. The current Active Substance Master File (ASMF) should be used as a basis for a master file that would encompass excipients and novel excipients.

 

For more information, please download:

- IPEC Europe follow up paper on the need for extending the European ASMF system to novel excipients - 18 November 2013

- IPEC Europe approach to the lack of a Master File system for excipients in Europe

- IPEC Europe proposed outline for an Excipient Master File system in Europe

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