The World Health Organisation (WHO) has accepted Bharat Biotech's Expression of Interest (EoI) for the latter's COVID-19 vaccine Covaxin and scheduled a pre-submission meeting on June 23.
Although the meeting will not be a thorough review of the inoculation, the Hyderabad-based vaccine maker will have a chance to submit a summary on overall quality of its coronavirus jab, according to the WHO.
The details regarding this were provided on the UN health body's website in the 'Status of COVID-19 vaccines' within WHO EUL-PQ evaluation process document.
Bharat Biotech stated last month that it expects the WHO's approval for Covaxin for EUL (Emergency Use Listing) during July-September.
As per the UN health body's guidelines, EUL is a procedure to streamline the process by which new or unlicensed products can be used during public health emergencies.
According to the WHO, pre-submission meetings provide an opportunity for advice and guidance before submission of a medicines dossier, as well as an opportunity for the applicant to meet WHO medicine assessors who will be involved in assessing their product.
"The pre-submission meeting does not include a detailed review of data or full study reports. However, an essential aspect of the meeting is the submission (at least two weeks in advance of the pre-submission meeting) of a completed QOS-PD (Quality overall summary product dossiers)," the WHO said, explaining the process of the pre-submission meeting.
Sources had earlier indicated that Bharat Biotech International Limited (BBIL) has conveyed to the Centre that it has already submitted 90 per cent of documents to the WHO for obtaining EUL for Covaxin.
The remaining documents are expected to be submitted by June; the city-based vaccine maker had told the central government during a discussion last month on obtaining the WHO's authorisation for Covaxin's EUL.