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EMA Postpones User Testing Of New e-Application Forms For Variations

 
• By Ian Schofield

A new web-based form is being introduced by the European Medicines Agency to improve the filing and processing of applications for variations to medicines authorized under the EU's centralized procedure. The form will later be extended to nationally approved drugs.

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Web-based forms are to be used for product variation applications in the EU • Source: Shutterstock

The European Medicines Agency has announced that user acceptance testing of the new web-based electronic application form (eAF) for submitting variations to EU centralized drug approvals has been postponed to allow further improvements to be made and to give stakeholders more time to plan for the new system.

User acceptance testing (UAT) for the variations eAF was originally scheduled to begin this month, but is now expected to...

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