Rada passes a draft law to speed up registration of COVID vaccines
The Verkhovna Rada approved a draft law on launching coronavirus vaccination in Ukraine. It's a draft №4613.
318 people's deputies voted for the decision.
The draft law proposes to speed up the registration of medicines, including COVID vaccines. To this end, it is designed to amend the Law on Medicinal Products, namely, to supplement Section II with Article 92 "State Registration of Medicinal Products under Obligations for Emergency Medical Use of Medicinal Products."
As Mykhailo Radutskyi, Chairperson of the Verkhovna Rada Committee on Nation Health, Medical Care, and Medical Insurance, explained on his Facebook page, thanks to the draft law, Ukraine would be able to use vaccines of Pfizer\BioNTech, Sinovac Biotech, Moderna, Sinopharm, AstraZeneca.
"To date, no COVID-19 vaccine has been fully tested. Vaccinations in the EU, the US, and other countries have started in emergency use. Ukrainian legislation doesn't provide for such a mode. Therefore, we need legislative changes for the registration of vaccines in our country," the parliamentarian explained.
Radutskyi added that emergency registration took place under the following conditions:
- available data on the successful conduct of preclinical trials;
- clinical trials have been conducted with the permission of the relevant competent authorities of the United States, the United Kingdom, the Swiss Confederation, Japan, Australia, Canada, China, Israel, India, Mexico, Brazil or the European Union;
- known potential benefits of the drug;
- there's no adequate, approved, and available alternative.
