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Registration Product License of Hazardous substance

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Description

Provision Cost
• Government Fee 5,200
• Evaluation of the toxic, risks, criteria 12,000
and testing quality which does not meet benefits with labeling, and evaluate new product and new technology
• If the evaluation is different from mentioned above 15,000

Procedure and Timeline
• Step1. We will provide the application form.
• Step2. We will collect the required documents from your side.
• Step3. We will submit to Thai FDA.
It will take 100 working days to get the approval license.
Note: The validity of registration certificate is not exceeding 6 years.

Required Documents
1. Labels : format and text
2. Hazardous substance information
a. General information
b. Physical and chemical properties
c. Analytical methods
d. Toxicological data
e. Environmental impact
f. Indication/use rate/usage
g. Safety data sheet (SDS)
h. Summary of hazardous substances data list
3. Product information
a. Product formula and their function
b. Physical and chemical properties
c. Manufacturing process
d. Oral-rat LD50 data
e. Safety data sheet(SDS) of product or of all ingredients
f. Indication/use rate/usage
g. Efficacy test results or other references
h. Report of analysis of active ingredient content
i. Copy of permitting to manufacture or import product samples for efficacy test
j. Certificate of free sale(if imported)
4. Certified letter (confirming that the product has been registered by Thai FDA)
5. Power of Attorney
6. Sample photo of hazardous substance or container, packing container (in case the officer asked for the supporting sample photos)
Remark: These are the general required documents for registration every hazardous substance, however, there are some different data requirements for registration of existing hazardous substance, new hazardous substance, technical grade pesticides, pre-mixed pesticides and finished products which we can discuss case by case.

Type of Hazardous Substances
The type 1 hazardous substance is the hazardous substance that has low risk or less impact on human health and environment rather than the other types. Therefore, manufacturers and importers are not required to register their products however the product information must be notified to the authority.
The type 2 hazardous substance is the hazardous substance that has the degrees of hazards or risks higher than type 1. Therefore, the product registration certificate is required for manufacturers and importers.
The type 3 hazardous substance is the hazardous substance that has the degrees of hazards or risks higher than the above mentioned types. Manufacturers and importers must obtain product registration certificates.
The type 4 hazardous substance is the hazardous substance that has high degrees of hazards or high risks either from its applications or its intrinsic properties, thus, manufacturing, import, export or possession of such substances is prohibited.

For more information, please feel free to contact us:
Phone Nos.: +66 2933 6121, +66 2933 6122, +66 2933 5601
(for call inside Thailand use 0 instead of +66)
Fax: +66 2933 6120
Email: mgr@panwa.co.th
Please CC: to our alternate email: panwagroup@gmail.com

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Listing ID: 3045b693c8044350

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