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. For practical reason, the content of the regulatory guidance should be read in the context with the technical document referenced ( ).

For repeat-use of decentralised procedure, please complete section 1.1.2. 1.1.4. A National Procedure In the case of a national application, the application number is allocated by some member states prior to the official application and therefore should be indicated. No specific format can be given for this application number. 1.2.

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  Form, Information, Applications, Procedures, Administrative, Module, Module 1 administrative information application form

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