Accelerated registration of vaccines against COVID-19 is now available in Ukraine



February 1, 2021

On January 29, 2021 there was adopted by the Ukrainian Parliament and signed by the President the Law No. 1159 introducing amendments to the existing Ukrainian Law on Medicinal Products by providing for the possibility of accelerated registration of vaccines or other immunobiological medicinal products at the applicant`s obligations.

Specifically, to ensure the possibility of emergency use of the above-mentioned products during an emergency situation the registration of vaccines or other immunobiological medicinal products shall be available at the applicant`s obligations in case the applicant can prove the impossibility to provide complete data on the effectiveness and safety of the product under normal conditions of use for objective reasons and in case of:

- availability of data on the successful preclinical studies, separate phases of clinical studies suggesting the effectiveness of the product;

- Emergency authorization has been granted by the competent authority of the United States of America, the United Kingdom, the Swiss Confederation, Japan, Australia, Canada, China, India or a centralized procedure by the competent authority of the European Union or the product has been prequalified by WHO;

- known and potential benefits exceed the known and potential risks of using the vaccine or another immunobiological medicinal product.

If the vaccines or other medical immunobiological medicinal products are registered at the applicant`s obligations the applicant is then obliged to complete the clinical studies within a period agreed with the authorized body. Besides, the registered products are allowed at the applicant`s obligations can be dispensed by health care institutions only by prescription and, in certain cases, used only under strict control, including in a hospital, etc.

The registration certificate issued at the applicant`s obligations has to determine the deadlines for fulfilling such obligations. The registration certificate is issued for one year with the possibility of renewal for one more year. The renewal of the marketing authorization is possible only upon annual assessment of fulfilment of the obligations. Upon fulfilment of all obligations provided by the applicant within the prescribed period, the validity of the registration certificate can be extended up to 5 years.