Guidelines, Procedures and Manuals
Plant and Animal Biosecurity Division
Food Quality and Safety Division
Medical Product Division
Controlled Substances and Medical Device Division
Inspection Services
Certification Services
Plant and Animal Biosecurity Division
Plant Biosecurity:
- Guidelines for Field and Seed Inspection
- Guideline on Import of Soil for Industrial & Commercial Purpose other than Agricultural Use 2019
- Pesticides Guidelines 2019
- Inventory of Released and De-notified Crops in Bhutan (1988-2021)
- Seed Sampling Manual 2021
- Bhutan Phytosanitary Treatment Manual 2020
- Plant Quarantine Manual 2021
- Procedural Standards for Pest risk analysis (PRA) in Bhutan 2021
Animal Biosecurity:
- Guideline for Import Risk Analysis
- In-Country Livestock Biosecurity Guidelines
- Guideline on safe retailing of meat and meat products in Bhutan
- Meat Inspection Manual
- Import Risk Analysis guideline for import of animal and animal products
- Animal Quarantine Station Operation Manual
- Protocol for import of Dogs and Cat
- Protocol for import of animal and poultry feeds
- Protocol for import of breeding animals
- Protocol for Import of day-old chicks and hatching eggs
- Protocol for import of dressed and frozen chicken
- Protocol for import of fresh livestock products
- Protocol for import of livestock for processing
- Protocol for import of ornamental fish
- Protocol-for-import-of-pet-dogs-and-cats
- Protocol for import of processed livestock products
- Protocol for import of table eggs
- Protocol for import of dry fish and crustacean
Food Quality and Safety Division
Food Safety
- Procedural Manual for Codex Bhutan
- BAFRA’s Licensing Process for Food Business
- Simplified process flow for issuance of Food Safety License
- Criteria for Good Hygienic and Manufacturing Practices for Licensing of Food Business
- Risk based Inspection and Sampling Manual for Imported Food Commodities 2019
- Guideline for Import of Food into Bhutan and Good Importing Practices 2018
- Food Recall Manual 2017
- Food Safety Investigation Manual 2016
- Food Handler Training Manual 2008
- Food Handlers’ Training Manual for Food Processing Units 2014
- Training Manual for Meat Handlers 2014
- Training Manual for Street Food Vendors 2014
- Guideline for Food Safety and Quality Management of National Food Security Reserve 2020
- Hygiene and Safety Guidelines for Food Business Operators and Consumers during COVID-19 Pandemic
Biosafety
- Guideline on Environmental Risk Assessment of Genetically Modified Plants
- Guidelines for handling applications Edition 2014
- Guidelines for Inspection and Monitoring of GMOs/LMOs
- Manual for training workshop on GMO LMO-Handling of Applications and Inspection
- Risk Assessment of Food and Feed Products Derived from Genetically Modified Plants
Medical Product Division
- 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
- Guidelines for Regulating Human Vaccines
- Guideline for Cancellation, Suspension and Withdrawal of Market Authorization of Medical Products 2023
- Pharmacovigilance guide for Adverse Drug Reaction monitoring and Causality Assessment, 2017
- Guidelines for Regulating Health Supplements
- Inspection Guideline, 2018 with additional guide for GPHF-MiniLab™
- Guideline for Advertisement of Medicinal Products
- Guideline for disposal of Medical Product waste
- 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
- Guideline for Approval of premises for sale and distribution of medical products
- Guideline for registration of Biotechnology Products for Human Use
- Guideline for registration of Biotechnology Products for Veterinary Use
- Sampling Guideline for Pharmaceutical Products and Related Materials, 2019
- Guideline for regulating feed additives and supplements
Controlled Substances and Medical Device Division
Inspection Services
Certification Services
- BFDA-CS: Guideline for clients on Food Product Certification
- BFDA-CS: Simplified Process flow – Food Product Certification
- BFDA-CS: Guidance for clients enquiring about product certification
- BFDA-CS: Guidance on use of BFDA Standard Mark
- BFDA-CS: Product certification information brochure
- BFDA-CS: Guideline for closure of Application
- BFDA CS : Guideline Drawal, Coding, Sealing and Dispatch of samples