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LATEST NEWS
November 20,2015
Electronic Application Forms
From January 2016, an electronic application form (eAF) will become mandatory for all EU procedures (human and veterinary).
From January 2015, Word based application forms (AF) are being replaced by electronic application forms (eAF), with new possibilities like electronic data import/export, data population within the form, online access to standardised catalogue terms, built in business rule validation and support for validation of form, etc.
The transition to mandatory use of electronic application forms was announced by the European Medicines Agency (EMA) earlier this year.
Additional information is available at the eSubmission website.
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