As per the recommendation of Blood Technical Advisory Committee, Drug Regulatory Authority (DRA) hereby notifies all the potential importers (Market Authorization Holders) that Import Authorization from Drug Regulatory Authority is required for importation of any Transfusion Transmissible Infection (TTI: HIV, Hepatitis B, Hepatitis C, Syphilis, Malaria) Test kits irrespective of their registration status with DRA.

The application for Import Authorization should be accompanied by pro-forma invoice, letter of authorization from the manufacturer and one batch Certificate of Analysis.

Further, Authority would also like to notify that adequate TTI test kit samples should be submitted to the DRA for preliminary assessment by Royal Centre for Disease Control (RCDC) prior to their distribution in Bhutan.

This regulatory notification is issued for immediate compliance.

Please Click here to view the notification:Regulatory Notification on Importation of TTI Test kits

For further information and clarification, contact Registration Division, Drug Regulatory Authority at +975-2-337074/337075