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EU Electronic Application Forms

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Web eSubmission
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The Electronic Application Forms Website contains links to four different electronic application forms, including supporting documentation. The electronic forms mirror as close as possible the paper-based application forms, which are published on the Website of the European Commission. The application forms for medicinal products for human use are published in Eudralex Volume 2 ( http://ec.europa.eu/health/documents/eudralex/vol-2/ ) and the application forms for medicinal products for veterinary use are published in Volume 6 ( http://ec.europa.eu/health/documents/eudralex/vol-6/ ). The paper-based application forms as published in Euralex Volume 2 and 6 are the basis for the electronic application forms.

User guide

 

Electronic forms

 

DES

 

Supplement functional specifications

 

The implementation of the electronic application forms is currently in the pilot phase. After the successful completion of the pilot phase, this site will become fully operational, and the most recent versions of electronic application forms and related documentation will be available.

 
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© 1995-2012 European Medicines Agency
Last update: 31-01-2012
Contact: esubmission@ema.europa.eu