News
Government updates guidelines on emergency use authorization of drugs
On September 29, the Cabinet of Ministers greenlighted amendments to the draft law ‘On medicines’ changing emergency use authorization rules.
Wednesday, 29 September 2021, 18:28

Ukraine’s Health Ministry says  it has updated emergency authorization use to accelarate approval of drugs and vaccines  listed in the international COVID-19 treatment protocols.

 

Health officials emphasize that such authorization will be granted only if:

  • there is succeful pre-clinical and key clinical trial drug efficacy data;
  • clinical trials were conducted with the permission and/or under the supervision of the relevant competent authorities of the countries;
  • there is evidences of benefits of a drug, which outweigh the known and potential risks of the vaccine;
  • there is no adequate, approved and available alternative to a drug.

 

Last week, the Ukrainian government updated the Criminal Code to  make fake vaccination certificates a criminal offense in response to a growing number of such incidents.

Tags: Cabimet of Ministers, Covid, Covid vaccines, emergency use authorization