Industry update – EMA transition to mandatory use of electronic application forms for all EU procedures

News Category: Regulatory news

Date: 17/11/2015

From January 2016, an electronic application form (eAF) will become mandatory for MRP/DCP and national procedures (human and veterinary). 

The transition to mandatory use of electronic application forms was announced by the European Medicines Agency (EMA) earlier this year.

Recordings and presentations of training webinars provided to NCAs in November are posted on the eAF - eSubmission website and available from the following links: 


eAF webinar with NCAs – initial MAA Multimedia webinar (10/11/2015) 

eAF webinar with NCAs – variation and renewal Multimedia webinar (25/11/2015) 

Please visit the eSubmission website for further information.
 


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