19 Sep News from Hungary
Jan 2016 – CESP submission is accepted for HU in the case of new marketing authorisation applications for human medicinal products (in either eCTD or NeeS) for MRP/DCP and national applications only.
Jan 2016 – eAF is mandatory in case of registration, variation and renewal. In addition a paper copy is still required if eAF does not contain e-signature
13 June 2016 – Use of the PSUR Repository (developed and maintained by the European Medicines Agency) becomes mandatory on 13 June 2016, which leads to the amendment of PSUR submission requirements.
For more information and contact details, please visit: http://www.propharma.hu/