As of January 1st 2016 electronic Application Forms will be mandatory for all applications for granting a marketing authorisation, renewal, or variation
12.10.2015
The Agency for Medicinal Products and Medical Devices (HALMED) would like to inform marketing authorisation holders on the beginning of use of electronic Application Forms (eAF) for applications for granting a marketing authorisation, renewal, or variation.
The use of these electronic forms for centralised procedure became mandatory on 1st July 2015, whereas for use in national and MRP/DCP procedures will be mandatory as of 1st January 2016. As of this date, the electronic Application Forms will be mandatory for all procedures with regard to applying for a marketing authorisation, renewal or variation.
Further information is accessible here.
