Mandatory use of electroning application forms soon

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

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