Method of submitting applications for marketing authorization, variations, renewals and ASMF

Please note that AIFA adheres to the eSmissionMap of the Roadmap from the HMA and that, in accordance with Annex 2 of the HMA eSubmission Roadmap, starting from 1 January 2019, the obligation to use the Common Technical Document electronics (eCTD) extends to all regulatory activities concerning the marketing authorization issued by national procedure.

For more information on the timing of the mandatory use of eCTD, electronic application forms (eAF), please consult the eSmission portal.

The annex the document:

How to apply for AIC applications, variations, renewals and ASMF

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