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Showing posts with the label Drug license certificate for importers

Government Approves US FDA Approved Covid Vaccines For Emergency Use

  The National Expert Group on Vaccine Administration for the Covid 19, on April 15, 2021, offered authorization for emergency use of the Covid 19 vaccine, which has already been approved for restricted use by the US FDA, MHRA, or those listed for emergency use in WHO. But certain conditions are satisfying which the applicant will get permission for making use of vaccines for restricted use like The vaccine must follow all guidelines as per the National Covid 19 vaccination program. For the first seven days after administration, the first 100 persons will be closely monitored. Within 30 days of vaccine approval, the applicant should start post-approval bridging clinical trials. Steps for processing the application. All manufacturers of vaccines outside India can apply for getting approval through the Indian Subsidiary or any authorized agent in India according to the rules under the Drugs and Cosmetics Act, 1940. The applicants can apply through the SUGAM online portal with a