Drug Regulatory Authority is coming up with 4th edition of Bhutan Medicines Rules and Regulation. The revision of the regulation is mainly carried out to incorporate new regulatory provisions based on the current scenario in the market and institutions dealing with the medicinal products. This regulation also covers the regulatory provisions of Health Supplement and Clinical Trial Oversight. 
Series of consultation meeting involving the relevant stakeholder and Market Authorization Holders were carried out. Now the draft regulation is made available to general public, the Authority solicit comments/views on the draft Bhutan Medicines Rules and Regulation 2019, if any. You may send your comments or views on the draft document latest by 7 Aug, 2019 to dra@dra.gov.bt or pmcd@dra.gov.bt or call at 337075.

Please click on the link below to view the draft BMRR 2019 and the format to send the comments.

Please click on the link below to view the draft BMRR 2019

Format for sending Comments