10 February 2021, Wednesday, 18:17 152

Cabinet Approves Procedure For Registration Of Coronavirus Vaccines For Emergency Use

Редактор: Daria Zubkova

The Cabinet of Ministers has approved the procedure for registering vaccines against the coronavirus for emergency use.

This is stated in government decree No. 95 of February 8, Ukrainian News Agency reports.

It is noted that the registration of vaccines or other medical immunobiological preparations for the specific prevention of the COVID-19 acute respiratory disease under the obligation for emergency medical use, the development and/or production of which was carried out in a state recognized by the parliament as an aggressor state, is prohibited.

Registration of drugs that will be supplied under the global COVAX initiative will be free of charge to manufacturers and companies applying for registration.

The applicant will be required to provide comprehensive data on the drugs to the State Expert Center of the Ministry of Health after completing the clinical trials of vaccines.

Prior to this, registration will be carried out after assessing the benefit/risk ratio and checking the registration materials for their authenticity.

The applicant must submit, together with other documents, a written commitment from the manufacturer to produce a vaccine registered in Ukraine for emergency use for delivery to Ukraine at the same production facilities used in the production of this drug for use in the respective country of registration (the United States, the United Kingdom, Switzerland, Japan , Australia, Canada, China, India).

The application for registration goes to the Ministry of Health, which within one working day must submit it to the State Expert Center.

The State Expert Center within five days evaluates the benefit/risk ratio and checks the documents, after which the Ministry of Health, within a period of no more than three days, must decide on the registration of the vaccine or on the refusal to register.

The registration certificate is issued for a period of one year.

The validity period of the marketing authorization can be extended every year for one more year, provided there is no information on the revealed negative benefit/risk ratio and pharmacovigilance data indicating the identified harmful properties of the drug.

The total period of validity of a marketing authorization for a vaccine cannot exceed the period of validity of an emergency use authorization granted by the competent authority of the United States, the United Kingdom, Switzerland, Japan, Australia, Canada, China, India or under a centralized procedure by the competent authority of the European Union.

As Ukrainian News Agency earlier reported, Deputy Minister of Health and Chief State Sanitary Doctor Viktor Liashko said that Pfizer intends to apply for registration of its coronavirus vaccine in Ukraine on February 11.

Health Minister Maksym Stepanov expects coronavirus vaccination to begin on February 15.

At the same time, Liashko says that the exact date of the start of vaccination against the coronavirus depends on the schedule of vaccine supplies, which is still unknown.