The Herbal Products Act B.E. 2562 (2019) is the central statute governing the manufacture, import, sale, and registration of herbal products in Thailand. For cannabis business operators, this Act has become impossible to ignore: any cannabis-based product that is processed, formulated, packaged, or sold as a finished herbal product falls within its licensing perimeter, alongside the parallel licensing regime administered by the Department of Thai Traditional and Alternative Medicine (DTAM) for raw cannabis flower.

This guide explains, in practical terms, what the herbal products license is for, who must obtain one, where to apply, the documents and physical premises required, the step-by-step procedure, the fees, the timeline, the validity period, and how to renew. It draws on the Herbal Products Act B.E. 2562, ministerial regulations and notifications issued by the Ministry of Public Health, official guidance from the Thai Food and Drug Administration (FDA), and the One Stop Service Center procedures published by Provincial Public Health Offices.

Cannabis operators should read carefully. The licensing intersections with the Notification of the Ministry of Public Health Re: Controlled Herbs (Cannabis) and the requirements for Good Agriculture and Collection Practices (GACP) certification mean that a single business may need several different authorisations to operate lawfully.

The Legal Foundation: Herbal Products Act B.E. 2562

The Herbal Products Act B.E. 2562 was published in the Royal Gazette on 30 April 2019 and came into force on 29 June 2019. It consolidated, into one statute, regulatory powers that were previously scattered between the Drug Act B.E. 2510 and the Protection and Promotion of Traditional Thai Medicine Wisdom Act B.E. 2542. The Act creates a single licensing perimeter for "herbal products", which it defines broadly to include traditional Thai medicines, herbal medicines, herbal cosmetics with claimed medicinal effects, dietary herbal products, and other products derived in whole or in part from herbs that are intended to maintain or improve human health.

The competent authority under the Act is the Minister of Public Health, with day-to-day administration delegated to the Secretary-General of the Thai Food and Drug Administration. The Herbal Products Committee, established under Sections 9 to 16 of the Act, advises the licensing authority and approves matters such as product formulations, quality standards, and the categories of herbs eligible for each registration track.

The Act sets out two principal regulatory mechanisms. The first is operating licenses, which permit a person or juristic person to manufacture, import, sell, or advertise herbal products. The second is product authorisations, which permit a specific herbal product to be placed on the market through one of three tracks of differing rigour: notification (jod-jaeng), detailed notification (jaeng-rai-la-iad), and registration of formulary (khuen-thabian-tam-rab).

The official Thai-language text of the Herbal Products Act B.E. 2562 is published by the FDA at laws.fda.moph.go.th and on the parliamentary library at library.parliament.go.th. The official English-language application portal is operated by the FDA Herbal Products Division at en.fda.moph.go.th.

Why Cannabis Operators Must Pay Close Attention to the Herbal Products Act

Cannabis was removed from the narcotics list on 9 June 2022, but it has never been "free" in the sense of being unregulated. After the issuance of the Notification of the Ministry of Public Health Re: Controlled Herbs (Cannabis) B.E. 2565 on 11 November 2022, and especially after the amended Notification effective 26 June 2025, cannabis flower is classified as a controlled herb under the Protection and Promotion of Traditional Thai Medicine Wisdom Act B.E. 2542. Anyone who wishes to study, research, export, sell, or process cannabis flower for commercial purposes must hold a Section 46 license issued by the DTAM.

That regime, however, governs only the raw cannabis flower. The moment cannabis is incorporated into a finished product (an oil, tincture, capsule, balm, beverage, traditional Thai formula, or any other preparation marketed for medicinal or wellness purposes) the product itself becomes a herbal product and falls within the scope of the Herbal Products Act. The operator therefore needs not only the DTAM Section 46 license to handle the flower, but also one or more licenses under the Herbal Products Act to manufacture, import, or sell the resulting product, plus a product authorisation (notification, detailed notification, or registration) for each finished SKU.

Operators sometimes assume that holding a Section 46 license is sufficient. It is not. A dispensary that prepares its own cannabis tinctures, edibles, or topical balms for retail sale is, in legal terms, both a seller of a controlled herb (Section 46 license) and a manufacturer of a herbal product (manufacturing license under the Herbal Products Act). Failure to hold the correct combination of licenses has been the most common cause of administrative penalties since the 2025 reforms tightened enforcement. Our overview of the regulatory landscape is set out at Understanding the Current State of Cannabis Law in Thailand, and the practical retail-level requirements are described at Getting a License to Sell Cannabis in Bangkok.

The Four Operating Licenses Available Under the Act

Sections 17 to 22 of the Herbal Products Act B.E. 2562 establish four distinct operating licenses. A business will hold one or several of them depending on the activities it carries out. The licenses are not interchangeable: a sales license does not authorise manufacturing, and a manufacturing license does not, by itself, authorise the sale of products to the public.

Manufacturing License (ใบอนุญาตผลิตสมุนไพร)

The manufacturing license authorises the licensee to produce herbal products at a specified site. It is issued under Section 17(1) and is required for any commercial production, however small, including extraction, mixing, formulation, encapsulation, bottling, or any other transformation of herbal raw material into a finished herbal product. The applicant must own or lease the site, have an approved building plan, and employ a qualified practitioner (phu-mi-na-thi-pa-ti-bat-kan) responsible for production. The official fee is 5,000 THB.

For cannabis operators, this license is mandatory for the production of cannabis oils, tinctures, balms, capsules, traditional Thai formulae containing cannabis, and any food supplement classified as a herbal product. It is also required for in-shop preparation of cannabis-based products at dispensaries, even where production volumes are modest.

Import License (ใบอนุญาตนำเข้าสมุนไพร)

The import license authorises the licensee to bring herbal products into Thailand from abroad. It is issued under Section 17(2) and is required regardless of whether the importer also intends to sell the product domestically or re-export it. The applicant must operate from a registered warehouse or place of business, employ a qualified practitioner responsible for imports, and demonstrate the ability to verify the quality of imported goods. The official fee is 20,000 THB, the highest among the four operating licenses, reflecting the additional regulatory burden of cross-border movement.

Cannabis-based herbal products may not be imported for personal use under any circumstance, and a commercial import of herbal products containing cannabis remains exceptional and subject to additional approvals. Operators who plan to import herbal raw materials for downstream Thai manufacturing should also review the import-export licensing framework that applies to cross-border trade.

Sales License (ใบอนุญาตขายสมุนไพร)

The sales license authorises the licensee to sell herbal products at retail or wholesale from a specified premises. It is issued under Section 17(3) and is required for any place of business that sells herbal products to consumers or to other licensees, including dispensaries, traditional Thai medicine clinics, online retailers operating from a physical warehouse, and supermarkets selling herbal preparations in their healthcare aisle. The official fee is 1,500 THB, the most accessible of the four. The premises must display the prescribed signage and the practitioner must be present during opening hours.

Advertising License (ใบอนุญาตโฆษณา)

The advertising license authorises the licensee to advertise a specific herbal product or service in any medium (print, broadcast, online, or out-of-home). It is issued under Section 76 and is required before the advertisement is published. The official fee is 2,500 THB. Advertising of cannabis flower for commercial purposes is now entirely prohibited across all media under the 2025 Notification on Controlled Herbs, but the advertising license remains relevant for non-cannabis herbal products and for medical-channel communications about cannabis-containing finished products to qualified prescribers.

Product Registration: Three Tracks for Bringing a Herbal Product to Market

An operating license is necessary but not sufficient. To place a specific herbal product on the Thai market, the licensee must also obtain a product authorisation through one of three tracks established by the Ministerial Regulation Re: Registration of Herbal Products B.E. 2563 (2020). The choice of track depends on the risk profile of the product, the strength of the health claim, and whether the formulation is novel.

Notification (จดแจ้ง)

The notification track, often called jod-jaeng, applies to low-risk herbal products with simple traditional indications drawn from the official formulary. Examples include single-ingredient teas, traditional Thai herbal compresses, and standard cosmetic-style preparations using a permitted herb. The applicant submits a notification form, the formulation, the manufacturing process, the labelling, and stability data. The FDA reviews the submission and issues a Certificate of Notification. The official fee is 900 THB per product. The certificate is valid for five calendar years and is renewable.

Detailed Notification (แจ้งรายละเอียด)

The detailed notification track applies to products with moderate risk profiles, such as adapted versions of an officially listed traditional formula, or new combinations of permitted active ingredients. The submission includes more extensive documentation: full quality control data, microbial testing, heavy metal limits, supporting literature for the indication, and a more detailed labelling review. The official fee is 2,500 THB per product. The certificate is also valid for five calendar years and is renewable.

Licensed Herbal Products: Formula Registration (ขึ้นทะเบียนตำรับ)

The licensed track applies to higher-risk products, novel formulations, products with stronger therapeutic claims, and any herbal product containing controlled herbs (including cannabis). The submission must include full safety, efficacy, and quality data, often supported by clinical evidence, and the FDA conducts a substantive review. The official fee for the resulting Certificate of Registration of Herbal Product Formulary is 2,500 THB per product. The certificate is valid for five calendar years and is renewable.

For cannabis-containing finished products, the registration track is normally the only available pathway because cannabis remains a controlled herb. The FDA's review will examine the cannabinoid content (especially THC, capped at 0.2 percent by weight in many product categories), the source of the cannabis (which must be GACP-certified), the manufacturing site, the labelling, and the proposed therapeutic claims.

Where to Apply

The place of submission depends on where the manufacturing or sales site is located. For sites located in Bangkok, applications are submitted to the Herbal Products Division of the Thai Food and Drug Administration at the Ministry of Public Health complex in Nonthaburi. For sites located outside Bangkok, applications are submitted to the Provincial Public Health Office (Sam-nak-ngan Sa-tha-rana-suk Jang-wat) of the province where the site is located, through the Consumer Protection Group, which usually operates a dedicated One Stop Service Center. Many provincial offices, such as the Kanchanaburi Provincial Public Health Office at www.kanpho.go.th, publish dedicated guidance and intake forms for herbal product applications.

The FDA also operates an electronic submission system, the SkyNet portal, accessible at privus.fda.moph.go.th, which is increasingly used for product notifications and simpler applications. For the manufacturing license, however, an in-person component remains necessary because the building plan must be reviewed and the site physically inspected before the license can be issued.

Who Can Apply: Eligibility and the Practitioner Requirement

Both natural persons (individuals of legal age, ordinarily resident in Thailand, with no disqualifying criminal record) and juristic persons (Thai limited companies, partnerships, public companies, and registered cooperatives) may apply for an operating license under the Herbal Products Act. For foreigners, ownership of a Thai company is required, with the usual considerations on foreign shareholding limits and, in many cases, the obtention of a Foreign Business License or BOI promotion. We discuss the corporate framework in detail at Company Registration in Thailand and BOI Registration, and the cannabis-specific corporate structure at Setting Up a Cannabis Business in Thailand.

Every operating license issued under the Act must be paired with a practitioner who is responsible for the day-to-day technical operation of the licensed activity. Section 23 of the Act requires the practitioner to be present at the licensed premises during opening hours and to supervise the regulated activity. The qualifications depend on the type of license.

For a manufacturing license, the practitioner must be a pharmacist (Bor.Phor.), an applied Thai traditional medicine practitioner (Phor.Tor.), or a Thai traditional medicine practitioner with the relevant qualification, as specified in the Ministerial Regulation Re: Qualifications of the Practitioner B.E. 2563. For an import license, the practitioner must be a pharmacist. For a sales license, the practitioner may be a pharmacist or a Thai traditional medicine practitioner. The same person cannot serve as practitioner for two different licensees simultaneously.

Required Documents for the License Application

The documentary file is voluminous and must be assembled with care. A missing or out-of-date document is the most common cause of delay at intake. The documents are split between those concerning the applicant (or the legal representative if the applicant is a company) and those concerning the practitioner.

Documents to be submitted by the applicant (the prospective licensee):

• Application form for manufacture, import, or sale of herbal products (Form Sor.Mor.Phor.1 / สมพ.1)
• Contract between the licensee and the practitioner setting out the scope of duties
• Power of attorney appointing a representative to file the application (if not filed in person)
• Power of attorney and appointment of operating manager (if the applicant is a juristic person)
• Three colour photographs of the applicant, size 1 inch, taken within the last six months
• Certified copy of the Thai national identification card (or passport for non-Thai applicants)
• Certified copy of the house registration (Tor.Ror.14)
• Original medical certificate dated within the last 30 days, confirming fitness to operate the licensed activity
• Certified copy of the commercial registration certificate (for individual applicants) or company affidavit (for juristic persons)
• Certified copy of the house registration of the proposed manufacturing or sales site
• Lease agreement (if the site is rented) or written consent from the owner authorising use of the site, accompanied by a copy of the owner's identification card
• Certified copy of the company affidavit and the list of directors authorised to bind the company (for juristic persons)
• Building plan and floor layout of the proposed site, drawn to scale, showing front view, side view, floor plan, sectional view, room divisions, and quality control areas (mandatory for manufacturing licenses, recommended for sales licenses)
• Map and GPS coordinates of the site, with a description of how to reach it from the nearest main road

Documents to be submitted by the practitioner:

• Practitioner's letter of certification (Form Sor.Mor.Phor.4 / สมพ.4) confirming acceptance of duties and continuous attendance during opening hours
• Certified copy of the practitioner's national identification card
• Certified copy of the practitioner's house registration
• Original medical certificate dated within the last 30 days
• Certified copy of the practitioner's professional license (pharmacy license, applied Thai traditional medicine license, or Thai traditional medicine license, as applicable)

For manufacturing licenses, additional technical documents are required: details of the wastewater management system, the solid waste and hazardous waste disposal arrangements, the air handling and ventilation system, the water supply system used in production, and the security system protecting the site. The applicant must obtain approval of the building plan from the licensing authority before commencing construction or fit-out, in accordance with the Notification of the Ministry of Public Health Re: Criteria, Methods, and Conditions Concerning the Manufacture of Herbal Products under the Herbal Products Act B.E. 2562, dated 2021, which is available at herbal.fda.moph.go.th/law-herbal/law-21.

Step-by-Step Application Process

The process is sequential, with several checkpoints at which the application may be returned for correction. The flow set out below corresponds to the One Stop Service Center procedure used by Provincial Public Health Offices and is broadly the same as the FDA process at headquarters.

Step 1: Pre-application classification. The operator first identifies which products it intends to manufacture, import, or sell, and classifies each product against the three product tracks (notification, detailed notification, registration). The FDA's e-consult service at en.fda.moph.go.th can be used to confirm the classification. This step matters because the operating license application must be consistent with the product portfolio that the operator declares.

Step 2: Site selection and building plan approval. For manufacturing licenses, the applicant submits the proposed building plan to the licensing authority for prior approval. Construction or fit-out should not commence until the plan has been approved. The licensing authority typically responds within 30 to 45 working days, depending on the complexity of the plan.

Step 3: Document assembly and submission. The applicant assembles the documents described in the previous section and submits them, together with Form Sor.Mor.Phor.1 and the practitioner's Form Sor.Mor.Phor.4, to the FDA (Bangkok) or the Provincial Public Health Office (provinces). Submission may be in person or, increasingly, through the SkyNet portal.

Step 4: Intake review and screening. The intake officer screens the application for completeness within 7 to 15 working days. Incomplete files are returned with a list of corrections. A complete file is forwarded to the technical officer for substantive review.

Step 5: Premises preparation by the operator. While the substantive review proceeds, the applicant prepares the physical premises, including the prescribed signage, the practitioner's photo and qualification sign, the storage and display arrangements, the document files (procedures, registers, training records), and the security and hygiene measures.

Step 6: Photographic submission. The applicant photographs the exterior and interior of the premises and sends the photographs to the case officer by email. This step has been formalised since the COVID-19 period and is now standard practice for sales licenses, allowing the officer to identify obvious deficiencies before the formal site inspection.

Step 7: Site inspection. The licensing authority inspects the premises in person. The inspection covers compliance with the layout requirements, the signage, the practitioner's presence, the documentary records, and, for manufacturing sites, the technical systems. If deficiencies are identified, the operator is given a deadline to correct them and a follow-up inspection is scheduled. If the inspection is passed, the file proceeds to the next stage.

Step 8: Drafting of the license and signature. The licensing authority drafts the license document, obtains the necessary signatures, and notifies the applicant that the license is ready for collection.

Step 9: Fee payment and license collection. The applicant attends the licensing authority to pay the official fee and collect the license. The license is then displayed at the licensed premises.

Premises and Signage Requirements

Sales Premises

Every place of sale of herbal products must display two signs in clearly visible locations. The first sign carries the words "สถานที่ขายผลิตภัณฑ์สมุนไพร" (Place of Sale of Herbal Products), or the equivalent for manufacturing or import as the case may be. The letter height must be no less than 3 centimetres, the background colour must be green, and the lettering must be white. The sign panel must measure at least 70 centimetres wide by 20 centimetres tall.

The second sign carries the name and frontal photograph of the practitioner on duty, together with the practitioner's qualification (for example, Phor.Tor.Bor. or Bor.Phor.) and the operating hours. The letter height must be no less than 3 centimetres, the background colour must be blue, and the lettering must be white. The sign panel must measure at least 70 centimetres wide by 20 centimetres tall.

Manufacturing Premises

Manufacturing sites must comply with the substantive layout, hygiene, and quality assurance requirements set out in the Notification of the Ministry of Public Health Re: Criteria, Methods, and Conditions Concerning the Manufacture of Herbal Products under the Herbal Products Act B.E. 2562, dated 2021. The Notification incorporates the principles of Good Manufacturing Practice for Herbal Products (Thailand GMP for Herbal Products), which align broadly with the WHO and ASEAN guidelines but have local specificities. The site must include separate areas for raw material reception, sampling, weighing, processing, packaging, finished product storage, and quality control, with appropriate environmental controls (temperature, humidity, air quality), wastewater treatment, solid waste management, and security.

Timeline: How Long the Process Takes

The realistic timeline depends on the type of license, the completeness of the file, and the workload of the licensing authority. For a sales license, with a complete file and a compliant premises, the total elapsed time from submission to license collection is typically 30 to 60 working days. For a manufacturing license, the timeline is longer because of the building plan approval and the more rigorous site inspection, typically 90 to 180 working days. For an import license, the timeline is broadly similar to the sales license but can extend to 90 working days where the FDA requires additional information about the foreign manufacturer.

For cannabis operators, additional time should be budgeted for the parallel Section 46 license at the DTAM (typically two to three months) and, for the source of supply, the GACP certification, which itself takes 90 to 180 days to obtain depending on the readiness of the cultivation site. Operators planning a fully integrated cannabis business should expect a total preparation timeline of six to nine months before commercial activity can begin.

License Validity, Renewal, and Replacement

Each operating license issued under the Herbal Products Act is valid for five calendar years from the date of issuance, expiring on 31 December of the fifth year. The renewal application must be filed before the expiry date, and the same is true for the renewal of the practitioner's certification. Failure to renew on time means that the licensee must restart the application process from scratch and may not lawfully operate during the gap.

The renewal fee is set by Ministerial Regulation at one half of the fee for the original license of the same type. A duplicate or replacement license, certificate of registration, certificate of detailed notification, or certificate of notification can be obtained for an official fee of 200 THB.

The fees above are payable on the day the license or certificate is collected and not at the time of submission. Payment is made directly to the Treasury account through the cashier of the licensing authority.

Penalties for Operating Without a License

Sections 91 to 102 of the Herbal Products Act establish a graduated regime of penalties. Manufacturing herbal products without a manufacturing license is punishable by imprisonment of up to three years and a fine of up to 300,000 THB. Importing without an import license is punishable by imprisonment of up to two years and a fine of up to 200,000 THB. Selling without a sales license is punishable by a fine of up to 50,000 THB. Marketing a product that has not been the subject of a notification, detailed notification, or registration, as the case may be, is punishable by imprisonment of up to one year and a fine of up to 100,000 THB. Advertising without an advertising license is punishable by a fine of up to 100,000 THB and a daily fine of 10,000 THB while the violation continues.

The licensing authority may also suspend the license for up to 120 days, revoke the license, and order the destruction of non-compliant goods. Where the unlicensed activity also breaches the Notification on Controlled Herbs (Cannabis), the parallel penalties under the Protection and Promotion of Traditional Thai Medicine Wisdom Act apply cumulatively.

How Juslaws & Consult Can Assist

Our regulatory team handles end-to-end licensing under the Herbal Products Act, including the preparation of the corporate structure, the drafting and review of the application file, the engagement of qualified practitioners, the building plan submission for manufacturing sites, the site inspection preparation, and the post-issuance compliance programme (including the renewal calendar and the reporting obligations). For cannabis operators, we coordinate the parallel DTAM Section 46 application, the GACP certification of the cultivation source, and the integration with the corporate and tax structure of the business. Our practice areas are listed under Business & Commercial, with specialised pages on Thai FDA, Setting Up a Cannabis Business, and Other Business Licensing.

Frequently Asked Questions

This article is provided for general information only and does not constitute legal advice. The Thai regulatory framework for herbal products and cannabis evolves rapidly. Operators should obtain advice tailored to their specific facts before relying on the information set out above. For a confidential consultation, please contact Juslaws & Consult.