The Electronic Application Form is now mandatory

Thursday, January 14, 2016

The Electronic Application Form (eAF) is now mandatory to use for all new Marketing Authorisation Applications, Renewals and Variations within all procedures regarding medicinal products.

From 1 January 2016 the electronic Application Form (eAF) is now mandatory to use for all new Marketing Authorisation Applications, Renewals and Variations within all procedures. Please, note that this also applies to all national procedures, since the European Commission will no longer publish the word/PDF form at the Notice to Applicant’s website, but only refer to the eAF. The eAF can be found  here. On the same website you can find relevant regulatory and technical guidance documents and Q&As. Recordings and presentations from training webinars provided to the industry are also published, which focus on the most common issues and workaround solutions faced by industry when filling the forms.

If any problems occur when filling in the forms, please contact the MPA or the RMS by normal means if there are regulatory based questions and the EMA by eAF@ema.europa.eu for any technical issues.

 

Please note the news item’s date of publishing. The Swedish Medical Products Agency does not update news.

 
 
 

Swedish Medical Products Agency, P.O. Box 26, SE-751 03 Uppsala, SWEDEN | +46 18 17 46 00 | registrator@lakemedelsverket.se | Contact information