You may be knowing that the FDA in Thailand requires the drugs and medicines importers and manufacturers to obtain FDA approval. If you don’t know already, the Thai FDA classifies drugs by general, traditional, modern, and veterinary medicines.
In case you are seeking FDA license for drug importation, you will need to provide these;
- “Duly filled application form
- Drug sample
- Complete drug formula
- Drug literature
- Permit to manufacture or import drug sample
- Manufacturing method
- Drug analytical control method
- Pharmacological and toxicological study (if any)
- GMP certificate (in case of imported drug)
- In-process control with acceptable limits
- Clinical trials, safety, and efficacy study (if any)
- Certificate of analysis of active ingredient(s)
- Final labeling and packaging including the registration number, quantity of drug per packaging, name of manufacturer and address, manufacturing date, the expiry date…
- Legalized (by the authorized officer) and by the Thai Embassy endorsed the certificate of free sale (in case of imported drug)
- Raw material specifications of active(s) and inert ingredients with the corresponding control methods in details
- Finished product specification with the corresponding control methods in details
- Packaging (Must be according to the Thai regulations)
- Storage conditions (Should be favorable for the type of the good)
- Stability studies of the finished product”
We have assisted in registering food supplements, medical devices, and pharmaceuticals. If you need a legal expert to obtain FDA license we can help.
