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Registration of Food Supplement in Bhutan

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Registration of Food Supplement in Bhutan

Regulatory Authority

Drug regulatory Authority (DRA)

License Validity

3 years

Fees

Nu. 150 (one hundred fifty only) may be revised from time to time along withthe documents.

Registration Requirements and Regulation for Health Supplement

Procedure for Application for Registration

Application for Registration

  • Using application form VI-FPR of the Bhutan Medicines Rules and Regulation 2012, one may apply to the Drug Regulatory Authority to register a health supplement or special dietary product.
  • A separate application is needed for each Health Supplement or Special
  • Dietary Product, i.e. Health Supplement or Special Dietary Product containing different ingredients or manufactured at different manufacturing sites or Health Supplement or Special Dietary Product and Special Dietary Product containing the same nutritional composition but differing in forms.

General Requirements of the Dossiers

The registration dossier should be:

  1.  In English or Dzongkha language or both. If original certificates are in another language, copies shall be presented together with certified English translation.
  2.  Properly bonded
  3.  In A4 size paper
  4.  Contain the price structure of the Health Supplement or Special Dietary Product and Special Dietary Product.
  5. Pages of the dossier shall be sequentially numbered.
  6. Be complete as per the specifications detailed in this guideline.
  7. Contain certificates or testimonies obtained from other agencies or authorities in original or in case of duplicate or electronic submission, attested by the Public Notary or a Court of Justice.

Mandatory Data Requirements

  1. Company profile:
  • Brief summary on history of company
  • Address with phone and fax number.
  • List of the product category manufactured
  • Name and qualification of the key personnel (Head of Quality Assurance Quality Control. Store and production) with the signatures of the personnel against name.
  1.  Current Good Manufacturing Practices (cGMP) certificate.
  2.  Evidence of free sale:
    It should include-
  • Name of the Health Supplement or Special Dietary Product and Special Dietary Product.
  • Dosage form and strength.
  • Complete name and address of manufacturer
  1. Manufacturing license.
  2. Letter of Authorization from the manufacturer.
  3. Price Structure
  4. Sample of Health Supplement or Special Dietary Product.
  5. Specimen of Package and Label.
  6. List of raw materials used in production.
  7. Batch Manufacturing Formula.
  8. Certificate of analysis for the finished Health Supplement or Special Dietary Product.
  9. Clinical evidence.

Processing of Applications

  1.  Applications will only be processed and approved if they are complete.
  2. The Authority may ask the applicant for clarification, further information, or samples while evaluating the health supplement or special dietary product. The application’s processing will be suspended until such time as this data is received.
  3. The certificate will be issued within 30 working days except for the period when the application is kept on hold pending clarification or submission of additional information. In such case, the party will be informed.
  4. After their application has been processed, applicants will receive notification. The health supplement or special dietary product will be registered if the application is approved.

Regulatory Decision

1. Decisions of the Drug Regulatory Authority

The Registration Committee for Registration of the Medical Product evaluates the dossier and makes a regulatory judgment based on its results. The applicant will be informed of the decision as appropriate.

2. Issuance of the Registration Certificate

After payment of the registration fee, Nu. 1500 (one thousand five hundred only), the certificate for a registered health supplement or special dietary product will be delivered in the format required.

3. Appeal against Regulatory Decisions

Any applicant aggrieved by the Regulatory Decisions may submit a written petition to the Bhutan Medicines Board within thirty (30) days from the date of issue of the decision as per chapter XVII of the Bhutan Medicines Rules and Regulation.

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