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 . In addition, a document called Practical user guide for electronic application Forms (eAF) for human and veterinary products in the EU has been prepared to provide practical and technical support to use the eAF.

described in the Standard terms published in the European Pharmacopoeia that provides standardised nomenclatures and quality standards for medicinal substances and products ... provide the date of the Commission Decision refusing the designation and its reference; if an application for designation has at any time been submitted and subsequently ...

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  Form, Information, Applications, Commission, Administrative, Module, Pharmacopoeia, Module 1 administrative information application form

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