Request FDA License of Hazardous Substance

Services

  • Request product registration
  • Request import/export license of product

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 Example: Import Hazardous substance Type 3 to Thailand

Provision Cost

Government Fee                   2,530

Note: the import license fee (500-3,000) will depend on the amount of importing

Procedure and Timeline

I.Request product registration for type 3

Step 1: Prepare the required documents and fill application form

No Required Documents Original Copies Remarks
1 Company affidavit   2  
2 Copy of ID card/ passport and work permit   2  
3 Label of sample product 1 3  
4 List of new substance with name and page numbers of each document including the resource or reference letter  3  
5 General information of new substance  3  
6 Physical and chemical properties of new substance  3  
7 Identification and quantitative analysis of new substance  3  
8 Toxicological data of new substance 3  
9 Environmental Impact of new substance  3  
10 Destruction of new substance or heat temperature to destruct new substance  1 3  
11 Safety data sheet of new substance  3  
12 Benefits, usage and recommended information of new substances  3  
13 Semi or finished product information   3  
14 Specification regarding to the formulation of product  3  
15 Manufacturing process of product  3  
16 Benefits, usage and recommended information of product  1 3  
17 Toxicological data of product  3  
18 Safety data sheet of product or active ingredient  1 3  
19 Efficacy test for insect control or animal control  1 3  
20 Report of analysis of active ingredients of product  3  
21 Packaging identification, wrapping or bonding container  1 3  
22 Certificate of Free Sale from manufacturer  3  
23 Sample product or sample packaging or photo of product or photo of packaging  3  
24 Copy import license of sample hazardous substance   4  
25 Other related documents  3 Trademark registration, etc..
26 Power of attorney which original is submitted to FDA   2  
27 Statement of compliances to rules and terms   2  

Step 2: Submit to Thai FDA

The officer will check the accurate of evidence and supporting documents by taking 116 working days, if there is no additional requirement, they will approve the license by taking 4 working days.

Remark: If there are no additional documents required and no accurate of evidence document occurred, the time will not be varied. Please note that we will start counting the day after we prepare all the required documents and signed by the applicant.

Step 3: Receive the approval license of importation

The license will be valid till 31st December of year 6.

II.Request import license of hazardous substance for new storage place

Step 1: Prepare the required documents and fill application form

No Required Documents Original Copies  Remarks
1 Company affidavit   2  
2 Copy of ID card / passport and work permit   2  
3 Product information 1 1  
4 Paper that show product package or container  1 1  
5 Safety data sheet of hazardous substance  1 1  
6 Certificate of Hazardous substance registration   2  
7 Map of storage place and surrounding place  1 1  
8 Diagram of inside storage place and surrounding place  1  
9 Color photo of storage building and surrounding place  1 1  
10 Color photo of floor: inside storage building 1  
11 Color photo of pallet for raw materials and finished goods  1  
12 Color photo of equipment : vent, entrance-exit way, adjustable air blower 1  
13 Photo of “hazardous substance” label sign in front of storage building  1  
14 Photo of “9 Warning Facts” label sign regarding to the regulations of public health toward importing/ owning hazardous substance  1 1  
15 Photo of “No Smoking, Drinking or Eating” label sign in front of  storage room  1  
16 Color photo of  “Danger” label sign such as “Flammable Liquid” and “Poison”   1  
17 Color photo of system or safety equipment inside the storage room or nearby such as fire extinguisher which is not higher than 1.5M to prevent from falling and convenient in using including medicine cabinet and medicine supplies with nurse  1  
18 Photo of equipment for managing overturned or leak of chemical such as sand bin, sawing, husk, absorbent material and trash bin  1  
19 Photo of safety for personal uniform and accessories  1  
20 Registered address of storage place with details of the house owner  1  
21 Power of attorney which original is submitted to FDA   2  
22 Statement of compliances to rules and terms    2  

Step 2: Submit to Thai FDA

The officer will check the accurate of evidence and supporting documents by taking 14 working days, if there is no additional requirement, they will approve the license by taking 2 working days.

Remark: If there are no additional documents required and no accurate of evidence document occurred, the time will not be varied. Please note that we will start counting the day after we prepare all the required documents and signed by the applicant.

Step 3: Receive the approval license of importation

The license will be valid till 31st December of year 3.

III.Notify the Physical Fact for importing

Step 1: Apply for the membership (Wor Orr/ Orr Kor.6)

No Required Documents Original  Copies Remarks
1 Copy of registered address and ID card/passport and work permit of applicant   1 Ordinary Person
2 Copy of ID card and passport and work permit of cooperate representative    1 Juristic Person
3 Company affidavit   1 Not over 6 months
4 Invoice   1  
5 Packing List   1  
In case of giving authorized to one party
6 Power of attorney   1 Duty Stamp 30
7 Copy of ID card/ passport and work permit of both parties   1  
8 Copy of registered address of both parties   1  

 

Step 2: Submit to Department of Industrial Works

The officer will check the accurate of evidence and supporting documents by taking 5 working days, if there is no additional requirement, they will approve and inform the result within 7 working days.

Remark: If there are no additional documents required and no accurate of evidence document occurred, the time will not be varied. Please note that we will start counting the day after we prepare all the required documents and signed by the applicant.

Step 3: Receive the approval document of membership

Remark: Must have shipping provider or import/export license in order to import to Thailand.

For more information, please feel free to contact us:

Phone Nos.: +66 2933 9000

(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