- Guideline for filling in the ADR form 2014
- Guideline for Registration of Transfusion Transmissible Infections(TTI) test kits
- Pharmacovigilance Guide for Adverse Drug Reaction Monitoring and Causality Assessment 2017
- Guideline for registration of Biotechnology Products for Human use
- Guideline for Application for Registration of medical product 2013
- Guideline on Pharmacoviglance for Traditional Medicines-Dzongkha version
- Medical Device Strategy
- Guideline on Pharmacoviglance for Traditional English-version
- Guideline on Pharmacoviglance for Veterinary centres
- Bhutan National Formulary 2013
- BNF 2013 Addendum 2016
- Blood and Blood Products Regulation of Bhutan 2016
- National Standards for Blood Transfusion Services
- Guideline for disposal of Pharmaceutical Waste
- Guideline for Regulating Health Supplements, 1st Edition, 2018
- Guideline for Registration of Human Vaccines, 1st Edition, 2018
- Guideline for Registration of Biotechnology Products for Veterinary Use
- Guideline for Registration of API
- Inspection Guideline
- Application, Registration fees and Renewal fees
- Conditions & Documents for ER Registration of Medicinal products
- Guidance document on Technical Authorization for Manufacture and Regulatory Certifications
- Home
- About Us
- Division
- Announcements & Notifications
- News & Events
- Publications
- Medicines Act 2003 Dzongkha Version
- Medicines Act 2003 English Version
- Bhutan Medicines Rules and Regulation 2019
- Guide for Import of Hand Sanitizer and Issuance of Import clearance
- National Drug Policy 2007
- Blood and Blood Products Regulation of Bhutan 2016
- Newsletter
- Annual Reports
- Service Delivery Standards
- Service Delivery for DRA G2C Services
- Other Guidelines and Publications
- eReport
- FAQ
- Contact Us