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 USD 99.
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. With that said, the guidelines and requirements of traditional/herbal drugs are not yet published.
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
- 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 of 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.