Regulatory information – User testing of electronic application forms underway

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Regulatory information – User testing of electronic application forms underway

Electronic application forms mandatory for human and veterinary centralised procedure applications from 1 July 2015

The European Medicines Agency (EMA) has launched user-acceptance testing of updated electronic application forms (eAF) for centralised procedures of initial marketing authorisations, variations and renewals for human and veterinary medicines. Companies are invited to take part in the exercise and provide feedback on user experience with the updated forms.

Electronic application forms offer a convenient, online version of the paper versions currently used, which are published and maintained on the European Commission’s EudraLex website. These electronic forms are designed to reflect and capture the same content as the paper-based application forms.

Since the initial release of eAF, the forms have been significantly amended following feedback received. A new version will be made available following the current user testing exercise.

In order to take part in user testing and receive the test package, companies should send an email to Companies that are part of a trade association are encouraged to send their feedback to their trade association so that consolidated feedback can be sent to EMA by 8 June at the latest. National competent authorities (NCAs) can provide their comments before 12 June.

From 1 July 2015 it will be mandatory for companies to use electronic application forms for applications in the centralised procedure. The transition is expected to reduce the administrative burden for regulatory authorities and industry, while at the same time improving data quality and consistency during data entry. The forms are available from the eAF webpage on the eSubmission website and can be used for any centralised procedure application.

Further information on the requirements can be found on the eSubmission website where an information leaflet on the mandatory use of the forms has been published.

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