Bhutan Drug Registration Process

Documents Required for Registration of Medicinal Products

All additional pharmaceuticals that do not come within the above-mentioned clause must be registered using the following requirements:

1.  General Documents

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. 6 Summary of product information sheet

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. Pharmaceutical Documents

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. Pharmacological Documents

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)

• The pharmacological papers that have an asterisk (*) next to them can only be used for the registration of newly created compounds, reformulated versions of previously existing molecules, or molecules with minimal post-marketing experience.
• All the documents listed shall be submitted either in original or in copies attested by the relevant control authorities.
• Notwithstanding the conditions stated above, some products may be registered with some exceptions considering the national needs.
• When registering a product, suitable considerations may be considered if there is confirmation that the product has already been registered in a developed nation.
• With prior consent from the Board, any anyone wishing to import any product for research purposes at a pharmacy school, research or training facility, or to collect samples for registration purposes, may be excluded from the requirements of Section 16.2.1 of the Act

Temporary Registration of 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:

1.   Details of the therapeutic indication
2.  Free product sale certificates;
3.  A certificate of product registration issued in the nation of origin;
4.  Specifications of the package;
5.  Final product details

     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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