Announcements & Notifications

Production of Animation Video

The Office of the Drug Controller, Drug Regulatory Authority would like to invite eligible consultants/firms with valid Bhutanese trade license for the production of animation video for medicines regulation in Bhutan. The deadline for receipt of quotation(s) by the purchaser is 24 April 2018 at 11:00 AM and will open on the same day at […]

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Regulatory Notification on Fixed Dose Combinations (FDCs)

As per the recommendations of 32nd Drug Technical Advisory Committee (DTAC) meeting on the 344 fixed dose combinations (FDCs) banned by Central Drugs Standard Control Organization, India: No new applications from this list of banned category shall be accepted for registration until further notice; For banned FDCs registered earlier than 31 March 2018, Import Authorizations […]

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New Procedure for Import Authorization

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 […]

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