Traditional Medicines and OTC Products
All legal aspects surrounding traditional medicines and OTC products in Thailand. Prepared in association with Tilleke & Gibbins, a leading law firm in Thailand, this is an extract from The Pharma Legal Handbook: Thailand, available to purchase here for GBP 75.
1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices?
In April 2019, the Thai FDA published and implemented the Herbal Product Act. This is now the main act regulating herbal or traditional medicine in Thailand.
The authorization process for the marketing of traditional medicines and herbal products is similar to that of other health products. Prior to product registration, any party who wishes to import or manufacture an herbal product must register its place of business as an herbal product importer or herbal product manufacturer with the Thai FDA. Subsequently both the importer and manufacturer can register and obtain a license/certificate for importation or manufacturing of the specific herbal product.
Pursuant to the Herbal Product Act B.E. 2562 (2019) and Ministerial Regulation Re: Registration of Herbal Products B.E. 2563 (2020), herbal products can be classified into three categories, determined by the risk level of the indications/health claims and the policies of the government authority.
(1) Notification Herbal Product
The requirements for Notification Herbal Products are the least stringent. Herbal products under this category must be well established, widely used, and have bibliographical evidence. The Thai FDA has published a list of “official formulations” that are recognized as Notification Herbal Products in the FDA Guideline (available on the Thai FDA website). The validity of a Notification Herbal Product certificate is five calendar years and is renewable.
(2) Detailed Notification Herbal Product
Herbal products in this category are subject to a less intensive review procedure than Licensed Herbal Products. Detailed Notification Herbal Products are products adapted from the official formulation of Notification Herbal Products e.g., combinations of the active ingredients that are listed as the official formulation. The validity of a Detailed Notification Herbal Product certificate is five calendar years and it is renewable.
(3) Licensed Herbal Product
This is the most strictly controlled class of herbal products. Any herbal product that does not qualify for classification as a Detailed Notification Herbal Product or a Notification Herbal Product will fall under this classification. The validity of a Licensing Herbal Product certificate is five calendar years and is renewable.
As of today, subordinate laws in relation to licensing, product registration/notification, official classification, etc., are under revision and/or public hearing. Currently, if an individual or company aims to register a herbal product, they must follow the regulations prescribed by the Drug Division (for herbal medicine) and Food Division (for food supplements). It is anticipated that new registration schemes and specific requirements will be published and officially implemented in 2021.
2. Can these traditional, herbal, complementary, or alternative products be advertised directly to the public?
Yes, herbal medicines can be advertised directly to the public. Any advertisement for herbal medicines must comply with the advertising conditions prescribed in the accompanying Notifications, which have not yet been released.
3. What health, advertising, and marketing claims may be made for traditional, herbal, complementary, or alternative products?
Advertising and marketing claims for herbal products must comply with the advertising conditions prescribed by the Thai FDA. In addition, any statements or information provided in an advertisement must not go beyond what is provided on the product label, leaflet, or packaging.
In general, any claim is acceptable, as long as it does not:
- Boast that a medicine can miraculously or absolutely treat, cure, or prevent a disease or illness;
- Exaggerate or falsely declare properties of the medicine; or
- Give the impression that the drug has a substance as its chief or component ingredient that it does not have, or has in a lower quantity than is believed to be present.
4. What are the regulatory requirements for over-the-counter (non-prescription) medications?
The regulatory requirements for household remedy drugs (OTCs) are the same as those for other drugs, and the Drug Act, as amended, is the main legislation that regulates them.
Before launching OTC products into the market, an importer or manufacturer will need to obtain three licenses/approvals from the FDA:
- An import or manufacturing license;
- An approval for sample product importation and approval for GMP Clearance of the overseas manufacturing site; and
- Market authorization license.
Because there are no limitations on the channel of distribution for OTCs, they can be sold anywhere (e.g., supermarket, online, etc.) and the seller does not need to obtain a license to sell them.
5. Are there any limitations on locations or channels through which OTC products may be sold?
No, there are no limitations of the channel of distribution for OTC products.
6. What health, advertising, and marketing claims may be made for OTC products?
OTC products are subject to the same advertising and marketing restrictions mentioned in question 17 in Marketing, Manufacturing, Packaging & Labeling, Advertising.
7. Can OTC products be marketed or advertised directly to the public?
Yes, OTC products can be marketed or advertised directly to the public, once the advertisement has been approved by the Thai FDA.
8. What is the mechanism by which a prescription-only product can be converted to an OTC product?
In order to convert from a prescription-only product to an OTC product, the licensee must submit a reclassification letter, together with safety data, to the Secretary-General of the Thai FDA.
9. What are the requirements for the importation of either traditional medicines or OTC products?
First and foremost, an import license must be obtained before any import activity takes place. In order to obtain an import license for traditional medicines or OTC products, the applicant must:
- Be the owner of the business, and have sufficient assets and structure to be able to establish and operate the business;
- Be at least 20 years of age;
- Be a resident of Thailand;
- Not have been convicted for an offence against certain laws (e.g., laws concerning narcotics and psychotropic substances);
- Have the premises to produce, sell, import, or store drugs and equipment for use in the production, sale, or storage of drugs, and the control or maintenance of drug quality and quantity as prescribed in ministerial regulations;
- Use a trade name for the drug business that is not a repetition of, or similar to, a trade name used by another active licensee or a licensee whose license has been suspended or revoked for less than a full year.
After a license has been obtained, both OTCs and traditional drugs must be registered with the Thai FDA before they can be distributed in Thailand.