COVID Support

Bharat Biotech’s Expression Of Interest For Covaxin Accepted By WHO, Pre-Submission Meeting To Be Held On June 23

• ByStartupStory     |    June 19, 2021

Bharat Biotech’s expression of interest for Covaxin accepted by WHO and scheduled a pre-submission meeting on June 23, a step that will take the vaccine maker closer to a WHO’s emergency use listing (EUL). The meeting will give them an opportunity to submit a summary on the overall quality of Covaxin and not a detailed review of the product.

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, as per WHO. The guidelines determine  EUL a procedure to streamline the process, where new or unlicensed products can be used during public health emergencies.

Bharat Biotech International Limited (BBIL) has conveyed to the government that it has already submitted 90 percent of documents to WHO for obtaining EUL for Covaxin according to sources.

 

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