In accordance to section 20 (b) of the Blood and Products Regulation of Bhutan 2016, Drug Regulatory Authority will commence registration of Transfusion Transmissible Infections (TTIs) test kits with effect from 15 January 2018.

Dossiers for Test kits shall be accepted either from Technical Authorization holders for sale and distribution of medicinal products or the test kits manufacturers as per the requirements stated under the Guidelines for registering of Invitro diagnostic test kits (transfusion transmissible infections test kits).

Therefore, DRA hereby notifies all interested eligible applicants to submit TTI test kits dossiers for registration commencing above date.

For further information and clarification, please log in to our website www.dra.gov.bt for the guidelines on registration contact the Registration Division, Drug Regulatory Authority at+975-2-337074/337075

Please click on the link below to view the notification and the draft guideline :

• Notification on commencement and acceptance of TTI test kits dossiers for registration
• Guideline for TTI test kits registration