The Drug Regulatory Authority hereby notifies all the Market Authorization Holders (Pharmacy Licensees) that for ease of application and regulatory processes, the Bhutan Medicines Board has approved for one time Import Authorization with effect from 1 April 2018. This provision applies to the products with minimum registration validity of one year and requires the applicants to submit a six monthly data of imported medicines.

The prescribed formats for import application (From No. 11) and import data (From No. 24) can be downloaded from the Drug Applications form on the right side or you can click on the link here

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

Please click here to view the notification on New Procedure for Import Authorization