Annexure to Bhutan Medicines Rules and Regulation 2012

Application, Registration fees and Renewal fees

  1. Application fee for product registration dossier assessment per product- Nu. 150.00 (One hundred fifty
  2. Registration fee for product registration per product- Nu. 1500.00 (One thousand five hundred
  3. Application fee for registration of Competent Persons- Nu.300.00 (One hundred)
  4. Examination fees for registration of competent person-Nu. 300 (Three hundred
  5. Fee for Re-examination for competent person- Nu. 500 (Five hundred
  6. Application fee for renewal of registration certificate of Competent Persons- Nu. 300.00 (three hundred
  7. Penalty for late renewal of registration of competent person – Nu. 100.00 per day (One hundred per day

Authorisation for Sale, and export

  1. Application fee for technical authorization for sale- Nu. 300.00 (three hundred
  2. Late renewal of Technical Authorization for sale and distribution per day- Nu. 100.00 per day (One hundred per day
  3. Application fee for renewal of technical authorization for sale- Nu. 300.00 (one hundred fifty
  4. Application fee change of ownership of Technical Authorization, location of Pharmacy, name of Pharmacy, Competent Person- Nu. 300.00 (three hundred

Technical Authorization for Manufacture

  1. Application fee for provisional manufacturing authorization per application – Nu. 5000.00 (five thousand)
  2. Application fee for final approval for manufacturing- Nu. 5000 (Five Thousand)
  3. Fee for renewal of approval for manufacturing- Nu. 500.00(Five hundred)