Thailand Tightens Import Controls on Health Products Through Customs Database Integration

Effective 31 May 2025 (within 30 days of 1 May 2025, the date the Notification was published in the Royal Gazette), Thailand’s Food and Drug Administration (“FDA”), in collaboration with the Thai Customs Department, implemented the Notification of the Food and Drug Administration Re: Control of Health Products Listed in the Customs Department's Controlled Goods Database, B.E. 2568 (2025) (“Notification”), a new regulatory framework that will control health products listed in the Customs Department’s Controlled Goods Database via the Thailand National Single Window (Thai NSW) system. This initiative is part of the Thai government's broader strategy to modernize trade and strengthen public health protections through integrated digital systems.

The Notification is a significant step toward enhancing cooperation between two key regulatory bodies—the FDA and the Customs Department—with intent to streamline compliance procedures, eliminate duplication, and improve the accuracy of product verification during the import and export process.

Broad Coverage

The Notification applies to a comprehensive range of health products that fall within the FDA’s supervision and are listed in the Controlled Goods Database, including:

• Pharmaceuticals
• Medical devices
• Food and dietary supplements
• Cosmetics
• Herbal products
• Hazardous substances for consumer and industrial use

Traders who deal in items that fall within any of these categories are required to comply with the updated procedures in the new system.

Definitions (Notification, Clause 3)

To ensure clarity, the Notification contains a variety of definitions, including:

• Health Products: Products listed in the Customs Department’s Controlled Goods Database that are regulated under laws administered by the FDA, including medicines, food, medical equipment, cosmetics, narcotics, psychotropic substances, hazardous household items, and herbs
• Government Authorities: The FDA or any governmental agency designated by the FDA to issue approvals or supporting documents, in electronic or physical form, for import or export purposes.
• Customs Tariff Code and Statistical Code: The 8-digit product classification code (comprised of Chapter, Heading, and Subheading), as well as the 3-digit statistical code, as established by the Thai Customs Department.
• List of Goods: The names and descriptions of products, as categorized in the relevant customs tariff codes and statistical codes.
• Permit: A license or certificate required under applicable laws (e.g., Drug Act, Food Act, Hazardous Substances Act) before import or export of relevant items is permitted.
• License per Invoice (LPI): A document issued by the FDA in connection with the importation of health products, intended for electronic data linkage. It serves as a notice of importation of health products into the Kingdom of Thailand, as listed in the invoice. A License per Invoice is not considered a legal permit under the laws that govern the regulatory authority of the FDA.
• Importer/Exporter: Any person or entity that imports or exports health products and is responsible for ensuring that the relevant products are declared correctly and comply with all relevant laws.
• Connection of electronic information: The data link between the government and/or private electronic systems for import/export, through) Thailand National Single Window (THAI NSW)
• Controlled Goods Database: The database system maintained by the Customs Department, which lists goods subject to control by various government agencies, including health products regulated by the FDA.

New Procedures for Importers and Exporters (Notification, Clauses 4 to 7)

Step 1: Identify Controlled Products

Check whether the product is listed in the Controlled Goods Database published by the Thai Customs Department at www.customs.go.th. Only products categorized as under the FDA’s supervision and listed with the proper Customs Tariff Code and Statistical Code require permits and electronic submissions.

Step 2: Submit Import Data via THAI NSW

Before applying for an import permit, the importer must submit product information through the Thailand National Single Window (THAI NSW)—a centralized platform for electronic data submission and inter-agency coordination.

• The importer must record the List of Goods on the invoice accurately and ensure that all items are health products regulated by the FDA.
• The importer then must obtain a License per Invoice (LPI) from the FDA. The LPI serves as a notification, not a permit, and is linked electronically to the customs system.

Step 3: Import Permit and Customs Declaration

Once the LPI is received:

• The importer must enter the Permit Number and LPI into the Import/Export Declaration Detail (Permit) form.
• This information is transmitted to the Customs Department electronically, to generate a customs declaration and proceed with clearance.

Step 4: Products Requiring a Permit

If a product is listed in the Controlled Goods Database and falls within FDA regulation, it must be accompanied by a valid Permit (such as a license under the Drug Act, Food Act, or Hazardous Substances Act). The permit must be linked to Customs electronically through THAI NSW.

Step 5: Manual Submission in Exceptional Cases

If the importing Government Authority does not have the technical ability to transmit the LPI electronically (e.g., due to a system error or agency limitations), the FDA will allow customs clearance based on paper documents in temporary, case-specific conditions.

Exemptions and Special Categories (Notification, Clauses 8 to 11)

The Notification also outlines specific exempt categories that reduce the burden of documentation for low-risk or special-purpose goods. These include:

• EXEMPT 2: Special-purpose imports not requiring a license
  • Medicine for scientific/laboratory use (excluding narcotics/hazardous substances)
  • Goods exempted by the Department of Public Health (excluding narcotics/psychotropics)
  • Goods for sports or sporting events
  • Household/public-use hazardous substances for cleaning/disease control (excluding insecticides)
  • Ingredients used in non-health industries (excluding medicine, narcotics, psychotropics)
• EXEMPT 3: Already licensed by other government agencies
  • Hazardous substances licensed by agencies like:
    • Department of Agriculture
    • Department of Fisheries
    • Department of Livestock
    • Department of Industrial Works
    • Ministry of Energy
  • Food ingredients for production of animal feed licensed by other agencies
• EXEMPT 99: Spare parts, components, and research-only equipment not requiring a license
  • Components and materials not classified as medical devices but used as parts
  • Spare parts not legally defined as medical devices
  • Equipment or software for research use only (not for clinical use under the Medical Device Act)
• EXEMPT 99: Not requiring a license because license notification cannot be submitted, but prior FDA approval exists
  • No LPI required if:
    • Importer submits a clarification letter and documents at customs
    • FDA reviews the goods list and shipping documents
  • Not applicable to ingredients used in herbal products regulated under the Herbal Act
• EXEMPT 100: FDA system failure (case-by-case exemption)
  • No license required if:
    • FDA’s system is non-functional
    • Importer notes the issue in the “Permit Number” field

Note: Import shipments using exemption codes EXEMPT 99 and EXEMPT 100 must be presented to the FDA officer at the port for inspection of the goods list prior to customs release.

Alternative Procedures Established by Government Authorities (Notification, Clause 12)

If a Government Authority establishes rules or procedures stating that an Importer or Exporter must follow specific procedures or methods that differ from those outlined in the Notification, the relevant procedures must be for the purpose of ensuring that the health products listed in the Controlled Goods Database are properly, efficiently, and legally monitored. The Importer or Exporter must comply with the procedures or methods specified by the relevant Government Authority.

Summary and Practical Implications for Businesses

Businesses importing or exporting health-related products now must align their operations with the new FDA regulations via integration with the Thailand National Single Window (THAI NSW). This includes accurately identifying whether their products fall within the scope of FDA supervision and ensuring correct use of Customs Tariff Codes and Statistical Codes.

Importers are required to obtain a License per Invoice (LPI) for every shipment of health products, even though it is not a formal permit. The LPI must be electronically linked to customs declarations. Where a formal permit is required (e.g., under the Drug Act or Food Act), it also must be linked to the customs system properly to avoid clearance delays.

The regulations provide for several categories of exemptions (e.g., EXEMPT 2, 3, 00, 99, and 100) that may relieve businesses of certain documentation requirements in low-risk or special cases. Importers must understand the scope and conditions of each exemption and be prepared to submit justification documents where needed.

In exceptional situations, such as system failures or where special procedures are mandated by other government authorities, businesses must be ready to follow temporary or alternative procedures, which may include manual (paper-based) submissions. Companies should establish internal compliance protocols, train staff, and maintain thorough records to ensure smooth customs clearance and regulatory compliance.

This article is intended merely to provide an overview of the new regulations, it is not comprehensive, and is not intended to constitute or provide legal advice. If you have any questions on this or on other areas of law, please do not hesitate to contact the authors:

Nuttaros Tangprasitti
Partner

Maychaya Phoraksa
Associate

Authors