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.
February 3rd, 2021
January 23rd, 2021
January 17th, 2021
January 9th, 2021
December 30th, 2020
December 16th, 2020