eCTD submission

Electronic application forms mandatory for human and veterinary centralised procedure applications from 1 July 2015

The European Medicines Agency (EMA) has launched user-acceptance testing of updated electronic application forms (eAF) for centralised procedures of initial marketing authorisations, variations and renewals for human and veterinary medicines. Companies are invited to take part in the exercise and provide feedback on user experience with the updated forms.

http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2015/06/news_detail_002340.jsp&mid=WC0b01ac058004d5c1

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KnetAdmin

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