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Announcements & Notifications

Regulatory Notification on Revised/New Guidelines

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Regulatory Notification on Requirement of Import Authorization for medical syringes

Drug Regulatory Authority (DRA) hereby notifies all potential importers (Market Authorization Holders) that Import Authorization from DRA is required for importation of any medical syringes.Following documents shall be furnished at the time of Import Application: i. Manufacturer and packaging details (in the absence of products samples);ii. Description of the intended use(s) of the syringe. If […]

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DRA Foundation Day, 14 June 2021

The Drug Regulatory Authority was established in 2004 to enforce the Medicines Act of the Kingdom of Bhutan 2003. The first Bhutan Medicines Board meeting was held on 14 June, 2004. Since its establishment, the regulation of medicinal products in Bhutan has progressed with expansion of roles and functions such as regulation of Blood and […]

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