News Category: Regulatory news
The European Medicines Agency (EMA) has announced 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 EMA press release includes further information on these new requirements. In addition, an information leaflet can be found on the eSubmission website.