Regulatory information - Transitioning to mandatory use of electronic application forms

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25/02/2015

Regulatory information - Transitioning to mandatory use of electronic application forms

Electronic application forms to be used for all human and veterinary centralised procedure applications from July 2015 and for all other human and veterinary EU procedures from January 2016

The European Medicines Agency (EMA) is announcing the transition to the mandatory use of electronic application forms for initial marketing authorisations, variations and renewals for human and veterinary medicines.

As of 1 July 2015 it will be mandatory for companies submitting applications for centralised procedures to use the electronic application form.

From 1 January 2016 the application forms in Word format published by the European Commission will no longer be available and only the latest version of the electronic application form will be used for all EU procedures, including national procedures.

The electronic application forms offer a convenient, online version of the currently used paper versions, 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. EMA first made these forms available to companies in July 2012, following a successful pilot phase. Since the initial release, the forms have been significantly improved and a further release based on change requests will be made available this Spring.

The mandatory use of these forms is expected to reduce the administrative burden for both the regulatory authorities and the industry, while at the same time improving data quality and consistency during data entry.

A user acceptance testing (UAT) period is now open until 5 March 2015. EMA encourages all interested parties to take part in the exercise.

In order to receive the test package and to provide feedback, companies wishing to participate should send an email to gareth.wilson@ext.ema.europa.eu. Companies that are part of a trade association are encouraged to send their feedback on the test results to their trade association so that consolidated feedback can be sent to EMA by 5 March at the latest.

Further information on the new 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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