Drug Regulatory Authority (DRA) is pleased to issue a guidance document on Emergency Use Authorization procedure and conditions for Deployment of COVID-19 Vaccines. This procedure is effective from 10 January 2021.
The decision to grant the Emergency Use Authorization (EUA) of COVID-19 vaccines is contingent to fulfilling the following:
In case of the technology transfer or ‘contract manufacturing” of the Stringent Regulatory Authority approved vaccine by another country’s manufacturer (whose National Regulatory Authority is not listed as SRA); following documentation (in addition to what has been prescribed under EUA procedure) would apply;
This notification has reference to the approval accorded vide note no. DRA/D4B/06-NS/20-21 dated 10 January 2021 from Hon’ble Chairperson, Bhutan Medicines Board.
Please click here to view and download the Notification
Please click here to view and download the guidance document on Emergency Use Authorization procedure and conditions for Deployment of COVID-19 Vaccines
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