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Law on emergency use of coronavirus pills comes into force in Ukraine

Source : 112 Ukraine

These drugs are still in the final stages of clinical trials but have already received permission for emergency use in medical practice in countries with strict regulatory systems
11:54, 13 November 2021

Merck

Today, November 13, the law on state registration of medicinal products under the obligation, which the parliament adopted on November 2, came into force in Ukraine.

These drugs are still in the final stages of clinical trials but have already received permission for emergency use in medical practice in countries with strict regulatory systems. However, according to the current legislation, they cannot be registered in Ukraine today. Therefore, this document introduces a mechanism for simplified registration of drugs for emergency medical use for the prevention and treatment of coronavirus disease.

Related: 23,572 new Covid-19 cases observed in Ukraine

The Emergency Authorization (EUA) is a mechanism that facilitates the availability and use of medicines, vaccines or other medical immunobiological during emergencies and/or health quarantine.

According to the document, the possibility of emergency registration of such pills or other drugs is possible if:

  • data on successful preclinical and clinical trials is available, such drugs must have an emergency use permit issued by a regulator of a country with a strict regulatory system (USA, UK, Swiss Confederation, Japan, Australia, Canada, Israel, EU countries), or a drug retrained for WHO emergency use;
  • clinical trials were conducted with the permission and/or under the supervision (control) of the relevant competent authorities of the countries;
  • the known and potential benefits of the medicinal product, when used for the diagnosis, prevention or treatment of identified serious or life-threatening diseases or conditions, outweigh the known and potential risks of the medicinal product;
  • there is no adequate, approved and available alternative to a drug for the diagnosis, prevention or treatment of a disease or condition.

As it was reported earlier, the American pharmaceutical company Merck & Co together with Ridgeback Biotherapeutics announced the successful development of the first coronavirus pill, which halves the risk of death. The drug was named after the hammer of Thor, Mjölnir - Molnupiravir. According to the plan, the drug should become a “hammer from SARS-CoV-2” and new aggressive mutations.

Related: WHO condemns widespread use of vaccine booster doses

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