On March 30, 2020, the Ukrainian parliament adopted a law amending certain legislative acts regarding the provision of treatment for coronavirus disease (COVID-19).
The law allows the import and use in Ukraine of unregistered medicines officially recommended for the treatment of COVID-19 by the authorities of the USA, EU member states, Australia, Great Britain, Israel, Canada, China, Switzerland, and Japan.
It is also allowed to use registered medicines for indications for treatment that are not determined by the instructions for use, provided that there is proven effective in treating coronavirus disease and/or if these medicines are recommended by an official body in one of the above-mentioned countries.
The Cabinet of Ministers is instructed to provide:
– examination of registration materials and materials on amendments to the registration materials of medicines for the treatment of COVID-19, in case of providing materials in Ukrainian or English, up to 5 calendar days, as well as decision-making on state registration or on refusal of registration of such medicines, decisions to amend registration materials or to refuse within a period not exceeding two business days from the date of receipt of conclusions by the Ministry of Health;
– examination of materials of clinical trials of drugs for the treatment of COVID-19, and significant amendments to them, in case of providing materials in Ukrainian or English, up to five calendar days;
– the implementation by the Ministry of Health of an urgent and continuous update of medical protocols for the treatment of COVID-19;
– implementation by the Ministry of Health of Ukraine of monitoring the safety and efficacy of drugs for the treatment of COVID-19 in the manner prescribed by it.
The law will be valid for three months after its publication.