1. Do I need to register medicinal products if I want to import into Bhutan?
If you are importing medicinal products for large-scale sale & distribution in the country, you will have to register. However, registration is not required in following cases:
- If you are bringing medicinal products for personal use accompanied by a valid medical prescription.
- Non-prescription medicines for personal use (the list is published on DRA website at www.dra.gov.bt) the quantity of which is less than one month dose.
2. How do I register medicinal products with the DRA?
To register medicinal products, first a local dealer (called Market Authorization Holder) or manufacturer should apply for Technical Authorization for Sale and Distribution from the DRA based on which Trade License will be issued by the Department of Trade, Ministry of Economic Affairs. After obtaining the Trade License and Technical Authorization for sale and distribution, a local dealer can submit documents related to medicine to the DRA for registration. If a manufacturer outside Bhutan wishes to register medicines directly, they may do so. The documents required for registration of medicines can be viewed at www.dra.gov.bt
3. How long does it usually take to get a medicinal product registered?
If all the required documents are submitted during the time of application, a medicinal product can be registered within 1-3 months.
4. What is the fee for registration of medicinal product?
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.
5. What is validity of one-time registration of a medicinal product?
Once registered, the registration status of product 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.
6. What is meant by a Competent Person?
A Competent Person is a person who is registered with the DRA based on:
- qualification and practical experience (as per the Bhutan Medicines Rules and Regulation 2012); and
- successful passing of the competency exam conducted by the DRA.
The Competent Person will supervise sale and distribution of medicinal products.
7. Who can get registered as a Competent Person?
If you are a Pharmacist/Pharmacy Technician/Medical Doctor/Veterinary Doctor Drungtsho (Traditional Medicine Physician) or if you possess Diploma in gSso-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.
8. I am a Health Assistant/Nurse/Technician who has recently retired from service. 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 someone who has been certified as a Competent Person.
9. Where can I obtain further information on registration of medicines?
You can access this web-link for more information http://dra.gov.bt/wp-content/uploads/2015/07/Guideline-for-Application-for-Registration-of-medical-product-2013.pdf
10. What is an Import Authorization and what is the validity of a one-time Import Authorization?
Import Authorization is a permit to import medicines in the country issued by the Drug Regulatory Authority. A one-time authorization is valid for a period of 6 months.
11. I want to open a Pharmacy. How should I proceed?
To open a pharmacy, you should fulfill following requirements:
- Competent Person certified by the DRA
- Have a suitable location separated from meat shops/living rooms etc.
- Apply to the DRA for Technical Authorization for Sale & Distribution of Medicinal Products.
- DRA will visit & inspect your location and you will be issued a Technical Authorization.
- Proceed to obtain Trade License.
- You are ready to stock/sale medicines.
12. Which organization in Bhutan should I contact if I want to participate in the tender for supply of medical goods in Bhutan?
All medical supplies for public health services in Bhutan are centrally procured and distributed through the Department of Medical Supplies and Health Infrastructure (DMSHI) under the Ministry of Health. You should contact this office at +975-2-325955/56.