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Module 1 - Administrative information application form

July 2018 CMDh/332/2017 Module 1: Administrative information application form User guide for the electronic application form for a Marketing Authorisation Purpose and general rules This User guide has been prepared in order to facilitate the work of applicants when completing the Electronic application Forms (eAF) as part of an application for a marketing authorisation of a medicinal product for human use / registration of a traditional herbal medicinal products. For traditional herbal medicinal products, marketing authorisation should be understood as registration of traditional herbal medicinal products and as registration holder for marketing authorisation holder.

Module 1: Administrative information Application form Page 2/24 application form for all strengths and pharmaceutical forms should be used and the relevant sections should be replicated as necessary. Fields relevant for certain types of applications or related to legal basis do only appear after ticking the concerned box.

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