Background

The Plant and Animal Biosecurity Division is mandated to protect the health of plants, animals and humans including the environment from harmful pests, diseases, and invasive species. Biosecurity practices involve the prevention, early detection, and rapid response to biological threats. For plant biosecurity & Plant Germplasm and Quality Control section, this includes import regulations, plant quarantine, phytosanitary certifications and trade facilitation in compliance with international requirements. For the Animal Biosecurity & Veterinary Public health section, it includes regulation of import and export, management of notifiable pests and diseases that can affect livestock and its products and also ensuring farm biosecurity including the quality and safety of the products derived from animals.

Who is Who

Name Designation Email ID
Dr. Chendu Dorji Chief Regulatory and Quarantine Officer cdorji@bfda.gov.bt
Sonam Dorji N Dy. Chief Regulatory and Quarantine Officer sdorjin@bfda.gov.bt
Suraj Tamang Senior Regulatory Quarantine officer surajtamang@bfda.gov.bt
Sherab Zangpo Senior Regulatory Quarantine Inspector szangpo@bfda.gov.bt
Dr. Sherub Phuntsho Dy. Chief Regulatory and Quarantine Officer sherubp@bfda.gov.bt
Prakash Tamang Senior Regulatory Quarantine Inspector ptamang@bfda.gov.bt
Sonam Choki Senior Regulatory Quarantine Inspector schoki@bfda.gov.bt

Mandates

  1. Ensure quality and safety of food and feed
  2. Protect biodiversity, environment and agricultural system from pests and diseases, invasive species and genetically modified organisms

Services

Plant Section

  1. Import of agrochemical (pesticides, fertilisers and bio inputs)
    1. The import application must be submitted at least one week in advance with the required documents (valid trade license, supply order & technical clearance) to the officiating Chief Regulatory or Quarantine Officer or Officer in Charge of the respective BFDA field office.
    2. BFDA-IS-FM-54 Application form for import of agrochemicals
    3. Import permit is issued after fulfillment of requirement with validity of one month and Nu 300/- permit.
  2. Import of plants and plant products
    1. The import application must be submitted at least one week in advance with the required documents (valid trade license for commercial and CID copy for individual) to the officiating Chief Regulatory and Quarantine Officer or Officer in Charge of the respective BFDA field office.
    2. BFDA-IS-FM-47 Application for import of seed, plants, plant products
    3. Import permit issued after fulfillment of requirements with validity of three months:
      Nu 300 per permit for commercial and Nu 100 per permit for individual.
  3. Import of Soil
    1. The import application must be submitted at least one week in advance with the required documents (letter of recommendation from head of the agency – MoAL) to the officiating Chief Regulatory and Quarantine Officer or Officer in Charge of the respective BFDA field office.
    2. BFDA-IS-FM-201 Application for import of soil
    3. Import permit issued after fulfillment of requirements with validity of three months and Nu 300 per permit.
  1. Export of plants and plant products (Phytosanitary Certification)
    1. The application for a phytosanitary certificate must be submitted to the officiating Chief Regulatory and Quarantine Officer or Officer in Charge of the respective BFDA field office.
    2. BFDA-IS-FM-52 Application for issuance of Phytosanitary Certificate

Export of Ophiocordyceps

  1. Application shall be submitted to the nearest BFDA office for registration and issuance of Cordyceps Export Certificate (EC) with the following documents:
  2. Copy of valid Trade License.
  3. Original copy of Royal Government Receipt issued by the DoFPS as a royalty for the purchase of Cordyceps (the validity of the document shall be one year from the date of issue).
  4. Original copy of Business Transaction Document signed by the Gup, representatives from DAMC and BFDA.
  5. Letter to the Officer-In-Command, BFDA, MoH requesting for registration (Both for direct export and Retail Export).
  6. BFDA-IS-FM-53 Application for issuance of export certificate for OphioCorydyceps
  7. Export certificate will be issued after completion of the inspection process with a fee of Nu 300/- per certificate.

Fumigation (Kiln/Heat Treatment of Wood/WPM for Issuance of treatment Certificate

  1. The clients requesting fumigation (heat/kiln) treatment services shall apply to the Head, Plant Biosecurity Section (PBS) or Officer-In-Charge (OIC) of the nearest BFDA field office.
  2. BFDA-IS-FM-52 Application for issuance of Phytosanitary Certificate
  3. The Head, PBS/OIC will assign a technical officer and treatment team for review and treatment based on the application.
  4. Clients must apply to the nearest BFDA office after consultation and confirmation of the treatment date with the treatment provider.
Pre-requisites
  1. The kiln/heat treatment facility should be approved by the relevant authority.
  2. The wood/Wood Packaging Material (WPM) should be free from bark, dirt, and other debris.
  3. The wood/WPM should be properly identified and labeled.
  1. BFDA-IS-FM-52 Application for issuance of Phytosanitary Certificate
  2. Submission of a duly filled application form (BFDA-IS-FM-51) for in-country movement permit with supporting documents to the nearest BFDA office.
  3. BFDA-IS-FM-51 Application Form for In-Country Movement Permit
  4. Upon fulfillment of the requirements, a permit is issued with a fee Nu 20.
Any individual or entity (ies) who wants to engage in commercial production and sale of seeds are required to register with BFDA for Seed Certification. The Technical Clearance from the concerned Departments (depends on the scope of the seed business)and Business License from the Department of Cottage and Small Industry (DoCSI) are the prerequisites for processing registration with BFDA.
BFDA will conduct periodic field inspection and monitoring of all the critical operations such as seed sampling, testing, processing, packaging and transportation as per the Minimum Seed Standard of Bhutan 2019. Only the compliant seed stocks will be certified and issued Seed Certificate.

Animal Biosecurity & Veterinary Public Health Section

Animal Biosecurity services:

A copy of these documents should be submitted to the BFDA office before the actual importation to ensure completeness.

The importer must submit an import application to the nearest BFDA office, detailing the processed livestock products to be imported (as specified in the BFDA-IS-FM application form), including the country of origin and the entry point. The import application must be submitted at least two weeks in advance with the required documents to the Officer In-charge of the respective BFDA field office.
Requirements for Import:
  1. Import of Animal Products and Animal Feed: The application form no. BFDA-IS-FM-118- Application for the Import of Animal Products & Animal Feed , Valid trade license for commercial/CID copy for personal, health certificate, HACCP/GHP/GMP Certificate, Certificate of Analysis (COA) and Aflatoxin test report for Animal Feed import.
  2. Live animals including Fingerlings and Poultry: The application form BFDA-IS-FM-119- Application for Import of Live Animal Including Fingerlings & Poultry , Valid trade license for commercial, Technical clearance from Department of Livestock, CID copy for personal, Zoo sanitary certificate from Government Authority.
  3. Permits will be issued upon fulfilment of import conditions with validity of one month and Nu 300/- per permit for commercial and Nu 100/- per permit for individuals.
  4. The approved permit can be accessed from any BFDA office using the generated application number. The BFDA office collects the applicable permit fee and issues the import permit to the applicant.
  5. Upon arrival at the entry point, the importer must declare the imported consignment to the ICP/BFDA officials on duty along with the necessary documents.
  6. The consignments are transported to the designated inspection bench, where the BFDA official on duty conducts import inspection, including document verification and physical inspection of the consignment (organoleptic inspection), and collects necessary samples for analysis if required.
  7. Once the import inspection process of the consignment passes, it is released.
Applicants for meat shop licensing  are required to fill the form no. BFDA-IS-FM-166- Application Form – Meat Business Licensing) and submit to nearby BFDA field offices for processing.
Applicants for feed safety licensing  are required to fill the form no. BFDA-IS-FM-155- Application Form- Feed Business Licensing and submit to nearby BFDA field offices.
Upon fulfilment of the requirements on Good Hygiene Practice and Good Manufacturing Practice(GHP/GMP) criteria for Feed licensing, Feed safety License (FdSL) will be issued.
  1. Dully filled application (BFDA-IS-FM 193) https://docs.google.com/document/d/1OBqvHCq9PKEVnqMNazeI1xQdZHAVmFmU/edit?usp=sharing&ouid=108980434426716017535&rtpof=true&sd=true with supporting documents like authentication letter from Local government and Animal health certificate should be submitted to nearby BFDA field offices.
  2. Upon fulfillment of the requirements, In-Country movement permit is issued with validity of one week and Nu 20/- per permit will be collected.
  1. The applicant must  submit application form no. BFDA-IS-FM-48- Application for Zoo sanitary Certificate for Export of Animal & Animal Products with the required documents (Animal Health certificate from Government veterinary official, Technical clearance from the relevant agency and test report for products) to the nearest BFDA office.
  2. Export permit fees Nu. 300/- for   commercial and Nu 100/- for individuals.
  1. The client must register with nearby BFDA field offices for training with a medical certificate form no. BFDA-IS-FM-165- medical  Certificate for medical meat Handlers, which is valid for 6 months.
  2. Citizenship Identity Card photo copy.
  3. Fee Nu: 100/-
  1. All  imported animals are subjected to quarantine for the period of fifteen days. After screening if animals are tested positive for diseases, the quarantine period is extended to 21 days. 
  2. Day Old Chicks ( DoC) are quarantined at designated farms. 
  3. Pets are home-quarantined for 15 days, and  for commercial purposes with an undertaking letter in the prescribed format,  it shall be quarantined at the designated quarantine station at the expenses of the importer.
When the animals are transported from one  place to another, it is mandatory to follow Animal Welfare Standards. http://www.bfda.gov.bt/wp-content/uploads/2024/08/Welfare-standards-for-transport-of-animals-1.pdf.

Information

  1. List of Marketing Authorized pharmaceutical products
  2. Listed Supplements
  3. List of Marketing Authorized medical devices
  4. List of registered Competent Person
  5. List of authorised premises for sale and distribution of medicinal products
  6. List of authorised premises for manufacture of medicinal products;
  7. List of cancelled Marketing Authorization
  8. List of withdrawn Marketing Authorization
  9. List of recalled medicinal products
  10. List of Lot Released medicinal products
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