How do I register medicine with DRA?

Drug Regulatory Authority (DRA) is responsible for regulation all the medicinal products including human and veterinary medicines in Bhutan. To register medicines, a local dealer (called Market Authorization Holder) needs to apply for Technical Authorization for Sale and Distribution from DRA based on which Trade License will be issued by the Department of Trade, Ministry of Economic Affairs. After obtaining Trade License and Technical Authorization for sale and distribution, a local dealer can submit documents related to medicine to DRA for registration. If a manufacturer outside Bhutan wishes to register medicines directly, they may do so.

Please click on the link ⇒ Guideline for Registration of Medicinal Products to get more information and to know what documents are required.

How long does it typically take to get a medicine registered?

If all the documents are complete during the time of application, a medicine can be registered within 1-3 months.

What is the fee for registration of medicine?

An initial application fee of BTN 150/- per product is levied. Once the assessment of the document is completed, a registration fee of BTN 1500/- per product will be charged. The fees may be however revised from time to time.

What is validity of one-time registration of a medicine?

Once registered, the registration status of a medicine is valid for a period of three years. After the expiry of validity of three years, you can apply for renewal of registration. Fees and charges remains same as initial registration.

Do we need to register medicines if we want to import into the country?

If you are importing medicine for large-scale sale & distribution in the country, you will have to register. However, registration of medicine is not required in following cases:

  • If you are bringing medicine for personal use accompanied by a valid prescription, you need not register.
  • Non-prescription medicines for personal use (the list is published on DRA website List of Non-prescription Medicines ) the quantity of which is less than one-month dose.
What are the advantages of registering medicines?

By registering medicines, you can assure its quality, safety and effectiveness. Risk of fake medicines coming into the country and consumption by patients is reduced.

What do you mean by Competent Person?

A Competent Person is one who is registered with DRA based on:

  • the qualification and practical experience (as per the Bhutan Medicines Rules and Regulation 2012); and
  • passed the competency exam conducted by DRA.

The Competent Person will supervise sale and distribution of medicinal products.

Can I register as a Competent Person?

If you are a pharmacist/Pharmacy Technician/medical Doctor/Vet. / or if you possess diploma in so-ba-rig-pa medicine, you can apply for registration as a Competent Person. You will be asked to pay a fee of BTN 300/- as application fee and will be assigned a date for Examination. If you pass the theory and practical exams, you will be issued a certificate of Competent Person.

I am recently retired as a Health Assistant/Nurse/Technician, can I sit for Competent Person Examination?

No. You are not eligible for the Competent Person Examination for Sale & Distribution of Medicinal products. But you can still open a Pharmacy by employing a Competent Person.

Where can I obtain further information on registration of medicines?

You can access this web-link for more information Guideline for Registration of Medicinal Products.

I want to open a Pharmacy. How should I proceed?

To open a pharmacy, you should fulfill following requirements:

  • Competent Person certified by DRA
  • A suitable location separates from meat shops/living rooms etc.
  • Apply to DRA for Technical Authorization for Sale & Distribution of Medicinal Products.
  • DRA will visit & inspect your location.
  • You will get Technical Authorization.
  • Proceed to obtain Trade License.
  • You are ready to stock/ sale medicines.