Guidelines and Publications

  1. Guideline for filling in the ADR form 2014
  2. Guideline for Registration of Transfusion Transmissible Infections(TTI) test kits
  3. Pharmacovigilance Guide for Adverse Drug Reaction Monitoring and Causality Assessment 2017
  4. Guideline for registration of Biotechnology Products for Human use 
  5. Guideline for Application for Registration of medical product 2013
  6. Guideline on Pharmacoviglance for Traditional Medicines-Dzongkha version
  7. Medical Device Strategy
  8. Guideline on Pharmacoviglance for Traditional English-version
  9. Guideline on Pharmacoviglance for Veterinary centres
  10. Bhutan National Formulary 2013
  11. BNF 2013 Addendum 2016
  12. Blood and Blood Products Regulation of Bhutan 2016
  13. National Standards for Blood Transfusion Services
  14. Guideline for disposal of Pharmaceutical Waste
  15. Guideline for Regulating Health Supplements, 1st Edition, 2018
  16. Guideline for Registration of Human Vaccines, 1st Edition, 2018
  17. Guideline for Registration of Biotechnology Products for Veterinary Use
  18. Guideline for Registration of API
  19. Inspection Guideline
  20. Application, Registration fees and Renewal fees
  21. Conditions & Documents for ER Registration of Medicinal products
  22. Guidance document on Technical Authorization for Manufacture and Regulatory Certifications
  23. Bhutan National Formulary for Traditional Medicines 2019
  24. Bhutan National Formulary 2019
  25. Guideline for Management and Handling of Defective Medical Products, 2019
  26. Sampling Guideline for Pharmaceutical Products and Related Materials, 2019