EMA publishes revised dossier-submission requirements for active-substance master files

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The European Medicines Agency has updated its pre-authorisation procedural advice for users of the centralised procedure to reflect new requirements for the submission of active-substance-master-file (ASMF) dossiers as part of human or veterinary marketing-authorisation or variation applications. Go here to read more.

http://www.gmp-compliance.org/ecanl_632_0_news_3914_7935,S-WKS_n.html

 

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