Guidelines and Publications

  1. Guideline for Registration of Transfusion Transmissible Infections(TTI) test kits
  2. Guideline for registration of Biotechnology Products for Human use 
  3. Guideline on Pharmacoviglance for Traditional Medicines-Dzongkha version
  4. Medical Device Strategy
  5. Guideline for Advertisement of Medicinal Products
  6. Guideline on Pharmacoviglance for Traditional English-version
  7. Guideline on Pharmacoviglance for Veterinary centres
  8. Blood and Blood Products Regulation of Bhutan 2016
  9. National Standards for Blood Transfusion Services
  10. Guideline for disposal of Pharmaceutical Waste
  11. Guideline for Registration of Biotechnology Products for Veterinary Use
  12. Guideline for Registration of API
  13. Inspection Guideline
  14. Application, Registration fees and Renewal fees
  15. Conditions & Documents for ER Registration of Medicinal products
  16. Guidance document on Technical Authorization for Manufacture and Regulatory Certifications
  17. Bhutan National Formulary for Traditional Medicines 2019
  18. Bhutan National Formulary 2019
  19. Guideline for Management and Handling of Defective Medical Products, 2019
  20. Sampling Guideline for Pharmaceutical Products and Related Materials, 2019
  21. Guidelines for Good Manufacturing Practices of Medical Gases
  22. Guideline for Regulating Health Supplements
  23. Guidelines for Regulating Human Vaccines
  24. Addendum 2021: Guideline for Registration of Medicinal Products 2020
  25. Guideline for Import, Sale, Distribution and Use of COVID-19 Self-Test Kits 2022