Sweden, Spain and Hungary Post Electronic Submission Specifications

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As the EU authorities continue their progress towards welcoming eSubmissions, information continues to surface on their web sites and elsewhere.

The Swedish National Authority (MPA) has updated their web site with new eSubmission information – see Electronic submissions to the MPA. The MPA maintains a dedicated email address (eSubmissions@mpa.se) for general questions on electronic submissions. They also provide guidance on media, cover letters, handling of MS Word documents, etc. Some of the information is only in Swedish (which BabelFish unfortunately won’t translate!).

If you visit the web site of the Spanish agency La Agencia EspaƱola de Medicamentos y Productos Sanitarios, look for a Welcome link in the top toolbar to access some content in English. Click the Electronic Submission link and look for the link to Instructions for electronic submission eCTD/NEES Pilot Phase. The agency has instructions for generating electronic submissions, to take effect in January 2009. The agency requuires sponsors to register new authorizations and variations in the AEMPS Regulatory Tool: RAEFAR, and to use the Belgian tool eCTDchecker on NEES submissions. A more detailed guide is available in Spanish: Guide AEMPS v1.11 .

Finally, an interesting presentation on Electronic Submissions in Hungary, by Dr. Gergely Zajzon of National Institute of Pharmacy is available. Since 2006, the National Institute of Pharmacy (OGYI) in Hungary has been accepting full electronic eCTD applications, without any printed sections of the dossier. Dr. Zajzon’s presentation discusses status, progress, challenges, requirements for eCTD and NEES in Hungary, and the agency’s ongoing program to digitize paper submissions.

Author: GS

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