india Regulatory Framework for Bhutan

Acts, Policy and Regulations

S.no Title Download Pdf
1. Medicines Act of Kingdom of Bhutan 2003   View File
2. National Drug Policy   View File
3. National Blood Policy   View File
4. Bhutan Medicines Rules and Regulation 2012   View File
5. Blood and Blood Products Regulation of Bhutan 2016    View File

Guidelines Documents

S.no Title Download Pdf
1. Guideline for Application for Registration of medical product 2013   View File
2. Guideline for registration of Biotechnology Products for Human use   View File
3. Guideline for Registration of Biotechnology Products for Veterinary Use   View File
4. Guideline for Registration of Human Vaccines, 1st Edition, 2018   View File
5. Guideline for Registration of API    View File
6. Conditions & Documents for Expedited Registration of Medicinal products   View File
7. Guideline for Regulating Health Supplements, 1st Edition, 2018   View File
8. Guideline for Registration of Transfusion Transmissible Infections(TTI) test kits   View File
9. Inspection Guidelines   View File
10. Guideline for filling in the ADR form 2014    View File
11. Pharmacovigilance Guide for Adverse Drug Reaction Monitoring and Causality Assessment 2017   View File
12. Guideline for Obtaining Technical Authorization for Pharmaceutical Manufacturing Plant   View File
13. Guideline on Pharmacoviglance for Traditional Medicines-Dzongkha version   View File
14. Guideline on Pharmacoviglance for Traditional English-version   View File
15. Guideline on Pharmacoviglance for Veterinary centres    View File
16. Bhutan National Formulary 2013, BNF 2013   View File
17. Bhutan National Formulary 2013, Addendum 2016   View File
18. National Standards for Blood Transfusion Services   View File
19. Guideline for disposal of Pharmaceutical Waste   View File
20. Medical Device Control Strategy 2018-2023    View File

Regulatory Notifications

S.no Title View Link
1. Procedure for Import Authorization   View More
2. Commencement and acceptance of registration for TTI test kits   View More
3. Importation of TTI test kits   View More
4. Notification on Fixed Dose Combinations(FDCs)   View More