Regulations Overview - Rx to OTC
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Regulations Overview - Rx to OTC
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Regulatory Overview - Rx to OTC Switch
Thailand
The below version control table serves to document all updates made to the report. The purpose is to ensure the information is always accurate and up-to-date.
| Version Number | Content Creation Date | Publishing Date | Section(s) Updated & Reason(s) for Update |
|---|---|---|---|
| V0 | 15 December 2023 | 29 February 2024 | N/A (new report) |
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1. Product Classifications in Thailand
According to the Drugs Act 1967, medicines in Thailand are classified according to the following four classifications [1]:
Category | Definition |
Specially Controlled Drugs | Medicines that can only be dispensed against a prescription from a physician. |
Dangerous Drugs | Medicines that can be dispensed by a pharmacist but which do not require a prescription. |
Non-dangerous Drugs | Medicines that can be sourced from a pharmacy without a prescription. |
Household Remedies | Medicines that can be sourced from general retail stores without a prescription. |
Drugs in these three categories - especially controlled drugs, dangerous drugs, and household remedies - must be formally designated by the Thai FDA. Drugs that are not included in the other three categories are automatically classified as non-dangerous drugs.
Other than specially controlled drugs, all other medicines can be considered as being available OTC with differing levels of oversight from pharmacists.
2. Process to Switch from Rx to OTC in Thailand
Medicines may be reclassified once they have been in the market for more than 5 years and the adverse events profile has been established. Applications to switch classification should take into consideration the risk associated with the administration of the product with a reduced level of oversight. Typically, products can only move down one category at a time.
In order to request that a product be converted from a prescription-only medicine (Specially Controlled Drug) to an OTC product (Dangerous Drug), the sponsor must submit a reclassification letter together with safety data to the Secretary General of the Thai FDA.
Conclusion
Based on the review conducted of the drug classification regulations in Thailand, it has been confirmed that medicines may be supplied without a prescription if they are classed as either Dangerous Drugs, Non-Dangerous Drugs, or Household Remedies.
The sponsor can apply for reclassification by writing to the Secretary General of the Thai FDA with the supporting rationale and safety data. In preparing a submission for reclassification, the sponsor should take into consideration the dosing and pack size of the product to present the lowest possible risk to patients.
3. References
https://faolex.fao.org/docs/pdf/tha181028.pdf
2. Thailand Food and Drug Administration
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