On Thursday evening (28 January 2021) a new Government Decree (Nr. 19/2021) was published in the Official Journal of Hungary amending the Government Decree (Nr. 488/2020) and providing legal basis for emergency use authorization of vaccines prior to EMA authorization.
By way of Government Decree Nr. 19/2021 the procurement and supply of any vaccine has become possible, provided that it has been made available to patients or authorized for use, in any three countries including at least one EU member state or EU member state candidate.
Another significant change in the regulations is that where the aforementioned conditions (i.e. that the vaccine has been used in 3 countries for at least 1 million people) are met, the Hungarian Regulatory Agency (RA) must – without any further investigation – issue the emergency use authorization upon request of the Government.
Previously, the emergency use authorization meant that only vaccines already in use in an EEA member state or in the UK and which had undergone the RA examination process could be granted authorization. Such prior regulation provided the basis for the granting of emergency use authorization to the vaccine currently being used in Hungary.
In light of the new regulation the Government has announced that 5,000,000 doses of Chinese vaccines will arrive in Hungary, starting in February.