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.

The applicant should note whether an application for orphan designation, for the medicinal product concerned, has ever been submitted to the EMA for the condition that is the subject of the application for marketing authorisation, and if ‘yes’, the EMA procedure number (EMEA/OD/XXX/year or

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  Form, Information, Applications, Marketing, Administrative, Module, Authorisation, Module 1 administrative information application form, Application for marketing authorisation

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