Application for Permission Relating to Facility

In applying for a permission in relation to a facility, the business operator who manufactures, imports, exports, or possesses a hazardous substance shall submit the application through the e-submission system.

Type 1 hazardous substance

Manufacturer, importer, exporter or possessor of type 1 hazardous substance must comply with the prescribed rules and procedures regarding the manufacturing, importation, and place of storage of hazardous substance (Notification of the Ministry of Public Health Re: Rules and Procedures for the Manufacturing, Importation, Exportation, Transit, and Possession of Hazardous Substance for providing service in regard of the hazardous substances under the Responsibility of the Food and Drug Administration ,B.E. 2565 (2022).

Type 2 and type 3 hazardous substance

Manufacturer, importer, exporter or possessor of type 2 hazardous substance must notify the undertaking regarding the manufacturing, importation, exportation, or possession of hazardous substance (as the case may be) to the competent official prior to such undertaking, while manufacturer, importer, exporter or possessor of type 3 hazardous substance must apply for a license to manufacture, import, export, or possess hazardous substance (as the case may be) to the competent official prior to such undertaking.

In both cases, all of those business owners must comply with the prescribed rules and procedures regarding the manufacturing, importation, and place of storage of hazardous substances. (Notification of the Ministry of Public Health Re: Rules and Procedures for the Manufacturing, Importation, Exportation, Transit and Possession of Hazardous Substance for providing service in regard of the hazardous substances under the Responsibility of the Food and Drug Administration, B.E. 2565 (2022).

Notification of type 2 hazardous substance requires the following documents and evidence:

In the case where the place of manufacturing/place of storage has received a permission.

In the case where the place of manufacturing/place of storage has yet received a permission.

- A notification receipt of type 2 hazardous substance is valid until 31st December of the third year as from the year the receipt is issued.

- No fee for the application for notification receipt.

- No fee for receipt renewal for notification receipt.

Application for a license in relation to type 3 hazardous substance requires the following documents and evidence:

In the case where the place of manufacturing/place of storage has received a permission.

In the case where the place of manufacturing/place of storage has yet received a permission.

- A license is valid until 31st December of the third year as from the year the license is issued.

- License fee is calculated based on the quantity manufactured, imported, or exported per year, or the quantity and the size of storage space (in the case of possession) (Ministerial Regulation on Prescription of Fees Relating to Hazardous Substances, B.E. 2552 (2009)).

- License renewal fee is equal to the license fee of each type.

Note:

1. As criteria for the consideration of place of storage and place of manufacturing of hazardous substance, reference will be made to the license to manufacture/import/export already granted (previous facility).
2. Check the time and costs of the consideration processes for the granting of hazardous substance permissions. 
3. Other information on the expenses would be available on the website as the Regulation or the  Announcement as follows:

1) The Announcement of the Ministry of Public Health Expenses to be collected from the applicant in the hazardous material product approval process under the responsibility of the Food and Drug Administration B.E. 2565 (2022)

2) Ministerial Regulations Prescribing Fees Related to Hazardous Substances (Rev. 2) B.E 2563(2021)