use of the electronic Application Form (eAF) is going to be mandatory fornew registrations, renewals and variations,
both for human and veterinary medicines, approved throughDecentralized /
Mutual Recognition andNationalprocedures. From 1 January 2016,
filling out the electronic form RAEFAR will be replaced by the eAF, using
PDF technology to capture and transfer information through XML format.
content of the Application Form will not change, nevertheless it will only be
available in English. There will be also some new features, such as import /
export data and online access to the standard terms.
more info: http://www.aemps.gob.es/informa/notasInformativas/industria/2015/NI-SG_02-2015-electronic-application-form.htm