Regulatory Framework for Bhutan

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

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

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