Regulatory information - Electronic application becomes mandatory today

News 01/07/2015

EMA application forms should be used for all human and veterinary centralised procedure applications as of 1 July 2015

As of today, 1 July 2015, companies are obliged to use electronic application forms provided by the European Medicines Agency (EMA) for all centralised marketing authorisation applications for human and veterinary medicines. Forms are available for initial marketing authorisations, variations and renewals and can be downloaded from the electronic Application Forms (eAF) website.

The electronic application forms reflect and capture the same content as the previous paper-based versions, but offer a more structured application process for users. Their use is expected to reduce the administrative burden for both the regulatory authorities and pharmaceutical companies.

Since their initial release in 2012, the forms have been significantly improved following feedback received. Further testing exercises will be conducted prior to new releases of the next versions in the coming months to collect user comments and further improve user experience.

From January 2016, the use of electronic application forms will also be mandatory for all other EU marketing authorisation procedures for human and veterinary medicines, i.e. the decentralised (DCP), mutual recognition (MRP) procedures and for national submissions.

Further information on the new requirements can be found on the eSubmission website and in a new information leaflet.

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