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.

development of medicinal products for rare diseases (orphan medicinal products) including market exclusivity, protocol assistance, eligibility for initiatives which support research and development, access to the centralised procedure and the …

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  Form, Information, Applications, Product, Disease, Rear, Administrative, Module, Medicinal, Medicinal products, Module 1 administrative information application form, Of medicinal products for rare diseases

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