Asset Publisher

null Transfering marketing authorisation

Transfering marketing authorisation

As stated in the administrative regulation 4/2019, the packages of the old holder and the new one can be simultaneously released for distribution for a maximum of six months if the responsibilities and liability relating to the packages of the old holder are included in to the transfer agreement contract of the old and the new marketing authorisation holder. Can this section of the administrative regulation be applied to marketing authorisation holder transfer applications that have been submitted to Fimea before the administrative regulation 4/2019 entered into force (9.2.2019)?

Yes, this section of the administrative regulation 4/2019 can be applied to marketing auhorisation transfer applications that have been submitted to Fimea before the administrative regulation 4/2019 entered into force (9.2.2019).

2 Sep 2019