Procedure to register herbal medicine in Thailand.

register herbal medicine in Thailand - Registrare medicinali fitoterapici in Thailandia

The procedure to register herbal medicine in Thailand has changed with the entry into force of the new “Herbal Product Act (2019)” and “Drug Act No. 6 (2019).
Since 2019, the so-called “traditional drug”, based on Chinese herbal products, has been replaced by the “herbal product” in accordance with the laws mentioned above. This means that the traditional drug must be registered with the new “Herbal Products” division in Thai FDA, whereas in the past it had to be registered with the Medicines Department
Adjustments are underway for the law that Thai FDA has certainly implemented but has not yet fully implemented, leaving a “gray zone” destined to last weeks or months.
In fact, herbal products, generally considered Dietary Supplements, but with typical indications of medicinal products will now have their own category, with clear facilities for the registration of products.

What’s the Procedure to register herbal medicine in Thailand?

First of all, the import license must be obtained (as usual), i.e. the permission to import and store herbal products on the territory of the Kingdom of Thailand.
This license covers many types of products, such as specially controlled foods, food additives, standardized foods, labeled foods and general foods. The period of time for obtaining the License is usually about 15 working days after we have submitted the application, assuming a simple case. Validity is three years.
Then the foreign production site must be accredited with Thai FDA. Depending on the types of extraction of the active ingredients, the standards change, but in general a review of the documentation in the Thai FDA Commission and an inspection visit of the plant made directly by the FDA or by an accredited third party is required. The costs are, as you can. Imagine, quite high.
Finally, the product is certified, with laboratory analysis of the finished product and a careful revision of the communication. In detail, Thai FDA gives a series of words or concepts that cannot be used in the packaging or in the package leaflets and the Manufacturer will comply with the communication of the product.
Once the license is obtained, the herbal medicinal product can only be sold in a pharmacy.

Who is entitled to register herbal products in Thailand?

The certification process to register herbal medicine product in Thailand can only be carried out by Thai entities (capital companies) accredited by Thai FDA. If a foreign producer wants to register a herbal medicinal product in Thailand, he must necessarily contact a local License Holder.
Kha Group provides, as a one-stop service, the registration service for herbal medicinal products in Thailand and License Holding. Contact us for more information.