Dietary supplements in Thailand are under the unified regulation of the Thai Food and Drug Administration (TFDA). Its core responsibilities include the review and approval of market access for dietary supplement products, the control of product safety and efficacy, and post-marketing supervision and law enforcement.
Official Website of the Regulatory Authority:https://www.fda.moph.go.th/
Database Portal:https://porta.fda.moph.go.th/fda_search_center_new/
Food Act, B.E. 2522 (1979)
Health products (dietary supplements) in Thailand refer to edible products other than conventional food that contain nutritional or other functional ingredients. They are usually presented in the forms of tablets, capsules, powders and liquids, which are distinctly different from traditional food products in terms of form and consumption method.
① Overseas manufacturers must appoint a locally registered enterprise in Thailand as their authorized agent and provide a power of attorney issued by the manufacturer;
② Provide complete qualification information of the manufacturer;
③ Submit valid production system certificates (GMP, ISO or HACCP);
④ Provide a complete ingredient formulation list of the product;
⑤ Submit product label artwork that complies with the requirements of Thai regulations.
English or Thai
Power of attorney for the local registration holder in Thailand
Detailed product information: complete ingredient list (qualitative and quantitative, in percentage), ingredient source, manufacturing process, intended use / target population, and supporting data for health claims
Label samples (must comply with Thai labeling requirements, including product name in both Thai and English, nutritional information, manufacturer / importer information, etc.)
Quality certification: certificates such as GMP / HACCP / ISO, Certificate of Analysis (CoA) for finished products and raw ingredients, and stability data
Safety / efficacy data (as applicable): toxicological studies, safety assessment, novel ingredient assessment, and scientific evidence to support health claims
Qualifications of manufacturers / importers: Thai production or import license, power of attorney, GMP certificate of foreign manufacturers, etc.
1.Standard Registration Procedure
The overall process is divided into two major phases:
Phase 1: Pre-assessment of Specially Controlled Food Products
Check the completeness of the application form and supporting documents → Compliance assessment (additional fee applies if technical document evaluation is required) → Official review and approval → Issuance of approval document / rejection of application
Phase 2: Health Product Registration License
Sor Bor 5: Official compliance assessment → Electronic notification of results via the regulatory system
Sor Bor 7: Official compliance assessment → Electronic notification of results via the regulatory system
2.Official Timeline and Official Fees for Each Stage
Pre-assessment of Specially Controlled Food (Basic) The official processing time for this stage is 7 working days, with an official fee ranging from 3,000 to 4,000 THB.
Pre-assessment of Specially Controlled Food (with Technical Document Evaluation) This stage takes 7 working days for official processing. The technical evaluation fee for this category ranges from 45,000 to 69,000 THB.
Food Formulation Registration The official processing time for food formulation registration is 7 working days, with a fixed official fee of 5,000 THB.
Sor Bor 5 License The official review period for the Sor Bor 5 license ranges from 7 to 28 working days, with a total overall duration of 10 to 40 calendar days. The official fee for this license is 2,000 THB.
Sor Bor 7 License The official processing time for the Sor Bor 7 license is 1 to 2 working days, with an official fee of 200 THB.