4 Oct 2021 12:26

Documents needed for Sputnik V's approval to be submitted to WHO within 7-10 days - Murashko

MOSCOW. Oct 4 (Interfax) - The documents needed to continue the process for the approval of the Russian coronavirus vaccine Sputnik V by the World Health Organization (WHO) will be submitted within seven or ten days, Russian Health Minister Mikhail Murashko said.

"It was necessary to prepare a certain package of documents consistent with certain rules. The documents have been fully prepared, and all differences have been settled. So, the manufacturing plants and the registering company are due to submit the entire package of documents within a week or a week and a half, and the further process will begin," Murashko said at a plenary session of the Biotechmed Forum.

The documents enclosed with the application for the vaccine's approval were the only thing criticized by the WHO, he said.

"There are no complaints about the product, but there have been some questions about the dossier. A package of documents is prepared for every pharmaceutical product. It is assessed by experts who prepare conclusions, in particular, by monitoring the process of clinical trials, production, quality control, etc. Every country has its own dossier form, and Russia and the five EAEU countries have their approaches to registration. The product has passed quality control here, the question is about forming [a package of documents]," Murashko said.