Ministry of Health, royal Government of Bhutan
Drug Regulatory Authority (DRA), Bhutan
Yes
Yes
2-3 months.
3 Years
Nu. 1500.00
A local dealer (referred to as a Market Authorization Holder) or producer must first apply to the DRA for Technical Authorization for Sale and Distribution before registering medical items. The Department of Trade, Ministry of Economic Affairs, will then grant a Trade License based on this authorization.
A local dealer can register their business by submitting medicine-related paperwork to the DRA once they have obtained the Trade License and Technical Authorization for sale and distribution. Manufacturers from other countries are free to register medications directly if they so want.
The Bhutan Medicines Board, in the exercise of the authority granted to it by Chapter II, Section 5.2 of the Medicines Act of the Kingdom of Bhutan 2003, thus sets the following rules on medicines to carry out the requirements of the Act:
All additional pharmaceuticals that do not come within the above-mentioned clause must be registered using the following requirements:
1.1 Company profile
1.2 cGMP certificate
1.3 Manufacturing license
1.4 WHO Model Certificate of Pharmaceutical Product
1.5 Free Sale Certificate
1.7 Letter of authorization from the manufacturer for registration (in case of registration by a dealer)
1.8 Dealership certificate (in case of registration by a dealer)
1.9 Credentials of the dealer
1.10Product sample
1.11 Price structure
2.1 Name of drug, its composition, physico-chemical properties of active and inactive ingredients.
2.2 Analytical method for identification of active substance and excipients
2.3 Manufacturing process for the product.
2.4 List of raw material and specifications
2.5 QC procedure and report on raw materials
2.6 Finished product specifications
2.7 Disintegration and dissolution profile
2.8 Analytical method for the finished product
2.9 Certificate of analysis
2.10 Stability test report for Zone IV
2.11 Packaging specifications
2.12 Specimen of package, label and package insert
2.13 QC procedure and report on label and package
3.1 Data on basic pharmacological and microbiological studies
3.2 Toxicity data *
3.3 Teratogenicity data *
3.4 Mutagenicity data *
3.5 General pharmacology
3.6 Pharmaco-kinetics data
3.7 Data on clinical studies Phase I, Phase II, Phase III & Phase IV *
3.8 Clinical pharmaco-kinetics *
3.9 Bioavailability and bio-equivalence data (in case of generic drugs)
Temporary registration for medications specifically needed in an emergency, during a disease outbreak, or for individuals with particular needs will be approved upon request from the appropriate government agencies.
The following documents must be submitted with the Form VI application for such registration:
The registration shall be approved in Form IA and authorized seal shall be used to attest to this.
Note: The temporary registration shall be granted for duration of three months at a time with a maximum of six months.
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