Mandatory use of electronic application forms for human and veterinary procedures in EU
By William Chin, PhD, Scientific Coordinator, EUCRAF
The European Medicines Agency (EMA) has published that from 1 January 2016, the application forms in Word format for initial marketing authorisations, variations and renewals published by the European Commission will no longer be available. Paper based application will be phased out and replaced with the electronic application format. This electronic forms will be used for all EU procedures, including national procedures.
It is expected that the electronic submission will reduce administrative burden for both the regulatory authorities and the industry. It will also ensure data quality and consistency during the process of data entry.
- Until 5 March 2015 - User Acceptance Testing (UAT) period is open.
- From 1 July 2015 - mandatory use of electronic application form for centralised procedure.
- From 1 January 2016 - mandatory use of electronic application form for all EU procedures.
More information can be found at the Information leaflet: Transitioning to a compulsory usage of the eAFs for Human and Veterinary procedures, published by EMA.
1. EMA, News and Press Release Archive, 25 February 2015, Regulatory information - Transitioning to mandatory use of electronic application forms.