Products required having license
- Narcotic drug schedule 3
- Psychotropic substance schedule 3 and 4
- Government Fee (new drugs) 736,000
- Government Fee (generic drugs) 41,000
- Remark: The exact government fee will be known after submit to Thai FDA due to the chemical substance that combines in drugs.
Procedure and Timeline
- We will provide the application form that needed to be filled.
- We will submit to Thai FDA.
- We need to keep close communication during that time in case the additional charge may occur or additional documents may require.
- **It will take around 167 working days for new drug registration and 130 working days for generic drugs registration.**
- A copy of license to manufacture or import the narcotics of category 3 and psychotropic substance 3 or 4.
- In case that the sell representative is available; a copy of license to sell the narcotics of category 3 and psychotropic substance 3 or 4 is also required.
- Certificate of Pharmaceutical Product or Certificate of Free Sale is required for the import product.
- Good Manufacturing Practices (GMP) certificate.
- Photograph of the pharmaceutical product(s).
- Drafts of the labels and patient information leaflets.
- The formulation of one unit.
- The complete batch manufacturing master formula.
- Method of manufacture.
- In-process specification and the control method.
- Raw material specification and the control method.
- Certificate of analysis of the raw material of the active ingredient.
- Analytical data and the chromatogram or spectrum of the raw material of the active ingredient.
- Finished product specification and the control method.
- Certificate of analysis of the finished product.
- Analytical data and the chromatogram or spectrum of the finished product.
- Packaging, labeling and storage.
- Method validation, in the case that the analysis methods used does not conform to the one(s) in the official pharmacopoeias.
- Data from the stability study.
- Drug sample.
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