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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