Latest news from eAF

Latest news from eAF

The
use of the electronic Application Form (eAF) is going to be mandatory for
new 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.

The
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.

For
more info:
http://www.aemps.gob.es/informa/notasInformativas/industria/2015/NI-SG_02-2015-electronic-application-form.htm

OPEN SEMINAR 2016: FDA Road to Success
Changes with the report to the art 57 database

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