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Guidelines

Name of The Guideline
Guideline for Registration of Medicinal Products 2020
Addendum 2021: Guideline for Registration of Medicinal Products 2020
Guideline for Registration of Medical Devices 2022
Guideline for Importation of Medicinal Products and Health Supplements
Guideline for Regulating Human Vaccines
Pharmacovigilance Guide for Adverse Drug Reaction Monitoring And Causality Assessment, 2017
Guideline for Regulating Health Supplements
Interim Guideline for Regulating Face mask
Guideline for Import, Sale, Distribution and Use of COVID-19 Self-Test Kits 2022
Inspection Guideline, 2018
Guideline for Registration of Biotechnology Products for Human Use
Interim Guideline for Import of Hand Sanitizers
Guideline on Pharmacovigilance for Traditional Medicines Dzongkha Version
Guideline on Pharmacovigilance for Traditional Medicines English Version
Guideline for Advertisement of Medicinal Products
Guideline on Pharmacovigilance for Veterinary Centers
Guideline for Disposal of Pharmaceutical waste
Guideline for Registration of Biotechnology Products for Veterinary Use
Guideline for Registration of API
Guidance document on Technical Authorization for Manufacture and Regulatory Certifications
Guideline for Management and Handling of Defective Medical Products, 2019
Sampling Guideline for Pharmaceutical Products and Related Materials, 2019
Guidelines for Good Manufacturing Practices of Medical Gases
  • Information on Products, Manufacturers & Distributors
  • Internal Services
  • Summary Product Information of Covid-19 Vaccines
  • List of Registered Medicinal Products
  • Listed Health Supplements
  • Regulatory Notifications
  • COVID-19 Self Test Kits with EUA
  • List of Hand Sanitizers
  • Download
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  • Download
    Administrative Forms
  • Application Forms
  • ADR Human Allopathic Medicines
  • ADR form for Traditional Medicines (Dzo version)
  • Defective Medicinal Product Complaint Form
  • Information on Products, Manufacturers & Distributors
  • List of Wholesalers and Retailers
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  • DRA ICT Help Desk Form

Important Links

  • Ministry of Health
  • Drukmed
  • SFPRS & MPQMS
  • Bhutan Narcotics Control Authority
  • World Health Organization
  • Bhutan Web Portal

Contact Information

  • PHONE: +975-02-337074/337075
  • FAX: +975-2-335803
  • Drug Controller: +975-2-334271

Contact E-mail Adresss

  • Registration Division: registration@dra.gov.bt
  • Policy and Planning Services: pps@dra.gov.bt
  • Post Marketing Control Division: pmcd@dra.gov.bt
  • Administration & Finance Section: afs@dra.gov.bt
  • Webmaster: tdorji@dra.gov.bt
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