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Bhutan Drug Registration Process

Streamlining Pharmaceutical Registration in Argentina: A Comprehensive Guide to Navigate the Regulatory Process for Drug Approval

MoH: Ministry of Health, royal Government of Bhutan

MoH website:  https://www.moh.gov.bt/

Regulatory Authority: Drug Regulatory Authority (DRA), Bhutan

Link for Regulatory Authority: https://dra.gov.bt/

Local Authorised Representative: Yes

Free Sale Certificate: Yes

Registration Timeline: 2-3 months.

Liscense Validity: 3 Years

Renewal of registration:

  • Application must be submitted no later than 3 months after the registration expiration date.
  • A grace period will be in place for one month following the designated expiration date.
  • After the grace period expires, the defaulter will be penalized Nu. 100 each day up to one month.

Registration fees: Nu. 1500.00

Medicine Regulation & Requirements in Bhutan

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:

Application for Registration:

  • During the designated period, the product registration application must be submitted in in Form I with the necessary document and a token payment for the evaluation of the product registration dossier i.e. Nu. 150.00
  • The necessary registration paperwork must be presented in bond form on A4-sized paper and must be in either English or Zhungkha.
  • The registration paperwork must be full and meet all requirements to be approved.
  • Applications for multiple formulations of the same medical product must be submitted separately.

Clause:

  • Until the Board notifies us of a new registration criterion, the pharmaceutical ingredients utilized in gSo-ba Rig-pa (Traditional medicine in Bhutan is known as gSo-ba Rig-pa) shall be registered under the following criteria:
  1. Send in the master formulation, the gSo-ba Rig-pa text abstract, sample product packaging, label, and sample;
  2. Send in the quality control certificate issued by the Royal Government-designated authorized agency.
  • The traditional medications not included in gSo-ba Rig-pa According to the registration document created by the Board-constituted Sub-Committee for Traditional Medicines in accordance with Section 5.11 of the Act,  gSo-ba rig-pa must be registered.

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 licence

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

1.10 Product sample

1.11 Price structure

  1. 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

  1. 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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