Electronic Application Forms Mandatory for EU Centralized Procedure

Posted 01 July 2015 | By Michael Mezher

Electronic Application Forms Mandatory for EU Centralized Procedure

Beginning today, the European Medicines Agency (EMA) will require companies to use new electronic application forms (eAF) for all medicines applying to the centralized procedure.

Background

In March 2012, EMA piloted the use of electronic application forms as part of its efforts to modernize the marketing authorization process. Since then, EMA has allowed companies to submit their initial marketing authorization applications in either electronic or paper format.

Then in February 2015, following the adoption of the Heads of Medicines Agencies' eSubmission Roadmap the previous year, EMA announced it would no longer accept paper application forms for products applying to the centralized procedure beginning 1 July 2015.

Following the announcement, EMA held an initial round of user testing that concluded on 5 March 2015. However, due to the significant amount of feedback the agency received, the electronic forms were "significantly amended," and a final round of user testing was held during June 2015.

Benefits of Going Digital

EMA says transitioning to the new PDF-based applications will provide a number of benefits to both it and the pharmaceutical industry.

By moving to electronic application forms, EMA says it will be able to significantly reduce the administrative burden surrounding data extraction and importation into databases. The agency also says the new forms will be easier to complete and will result in better data quality.

Going Forward

As of today, EMA will no longer accept paper applications for the centralized procedure, as well as for variations and renewals on centrally authorized products. Companies can view and download the new electronic forms from the eSubmission website.

Beginning in January 2016, the new forms will also be mandatory for all other EU authorization procedures, including the decentralized, mutual recognition and national authorization procedures.

 

EMA Press Release


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