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Gergely Gulyás The minister occupying the prime minister’s office made several interesting statements in the government briefing on Thursday, and the new government decrees on the authorization of vaccines just appeared in the Hungarian Gazette. As of 19/2021. In practice, a government decree stipulates that both drugs and vaccines must be authorized by the government at home without the need for an approval from the OGYÉI (National Institute of Pharmacy and Food Health).
The latest version of the Regulation on “certain measures necessary for the safe supply of emergency medicines” is in fact Regulation 488/2020. According to Telex, paragraph 6 / A allowed the National Institute of Pharmacy and Food Safety (OGYÉI) to authorize AstraZeneca without any kind of testing, on the basis that it had already been tested and approved by the local UK pharmaceutical authority. The decree was issued due to the coronavirus epidemic and is valid until February 8.
However, the current decree goes further, Gergely Gulyás reported this morning on government information: the government can now authorize any medicine and vaccine that
- in the countries of the European Economic Area,
- or authorized in the UK,
- can already be used in at least three countries, and at least one of these three member states or candidates for accession to the European Union,
- and the drug has already been used by at least a million people.
In this way, the Hungarian government not only avoids the EMA (European Medicines Agency) licensing process, but also practically OGYÉI, as there is no need for a separate national control of production and vaccine.
With the government decree, practically both the already authorized Sputnik V and the Chinese Sinopharm vaccine could be authorized out of turn, since more than a million Chinese citizens were vaccinated with the latter in November.
Definitely concerning that last week Viktor Orban he gently lobbied OGYÉI by stating that he hoped the “Chinese vaccine” would be approved as soon as possible (this would cover the Sinopharm vaccine), but with this government decree he would no longer have to wait for the opinion of the professional organization. Questions were also raised regarding the Sputnik V license, but we were unable to confirm or refute the press reports as we did not receive answers to our questions from OGYÉI.
Officially, the member states of the European Union can authorize a vaccine that is not produced by biotechnological methods without the EMA. These include Sinopharm and Sputnik V, as well as the AstraZeneca vaccine.
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