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 ( ).

The name of the applicant should be included in the field ‘Applicant’, and its address in the field ‘Address’. Person signing the application form should have a letter of authorisation for communication/signing on behalf of the applicant (to be attached in annex 5.4). 1. Type of application 1.1. This application concerns 1.1.1.

Loading..

Tags:

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

Information

Related search queries