1. Product classification
In order to identify the type of herbal products, including risk assessment.
2. Application for place of production/importation
Apply for a place of producing/importing herbal products in the case where the applicant has no licensed place of production/importation, or wishes to obtain a new license.
However, the applicant can skip this process if they hire a person who is authorized to produce or import herbal products by law.
3. Application for permission to produce/import sample
Apply for permission to produce/import product sample; once granted, product sample shall be produced/imported and sent for examination or analysis as required.
4. Dossier Preparation
The applicant prepares documents for the application in accordance with the requirement of the product type.
5. Application submission
The applicant submits the application for the registration, notification or listing of herbal products to the licensing authority, as the case may be.
6. Assessment of herbal products quality, efficacy and safety
Enter the process of quality, efficacy and safety review; once permission is granted, the product may be distributed through the channels specified in the permission, which consist of “for general sale”, “for sale at licensed establishment” and “for healthcare facility only”.
7. Herbal products advertisement
If the applicant wishes to advertise the product, application for permission to advertise is required in every case.
The application process, accompanying documents and evidence required for each step by:
- Where the place of production/importation is located in Bangkok, the application may be submitted at the Food and Drug Administration;