Thailand FDA License

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About Service

FDA License Thailand

The FDA thus controls the following products on the Thai market (manufactured or imported): foods, drugs, psychotropic substances, narcotics, medical devices, volatile substances, cosmetics and hazardous substances. 

 The Thailand FDA has very subjective requirements depending on the intended business activities and will not approve all business premises.

For example, some business premises may be considered too small for the intended business activities by the Thailand FDA. The Thailand FDA can also demand for a business to install specific types of equipment or fixtures prior to approving a license. We highly recommend consulting with the Thailand FDA in person prior to obtaining a business premises.

The FDA’s approval is based upon five different sorts of control:

  • Pre-marketing control of the factory, product, and advertising
  • Post-marketing control: regular checks of the previously controlled facilities and products
  • Surveillance program for consumers’ safety once the product has been launched (e.g. verify whether or not there are any adverse effects)
  • Consumer Education: Is the information given to the consumer sufficient and accurate?
  • Technical support and cooperation with other agencies (e.g. seminars organized or attended to by the FDA)
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Service price: 140,000 ฿
Time for complete: 1 months or more

Food control FDA license is required

The FDA implements and enforces the Food Act (B.E.2522) and guarantees the quality and safety of food, by means of, amongst others:

  • Setting up food standard and specification as well as hygienic and labeling requirements
  • Controlling of the production and importation of food products
  • Approval for advertisement and packaging materials and
  • The conduction of epidemiological studies. They FDA can issue the following certificates:
    • Certification of Free-sale
    • Sanitary Certification
    • GMP Certification
    • HACCP Certification
Application for the certification.

The application is done in two steps; the premises have to be approved before it can be permitted to manufacture or import the product.

Approval of the premises

For what concerns the premises, a distinction has to be made between manufacturing and importing food.

Manufacturing of food:

  • One is producing food as a sample for registration or purchase consideration: form Orr 15 should be used to apply for the license
  • The production of food is only temporary: form Orr 11 should be used to apply for the license
  • The intention is to produce food ‘indefinitely’, and not more than seven workers are employed nor equipment more than five horsepower is used: apply for the license with a completed form Sor Bor 1
  • The intention is to produce food ‘indefinitely’, and more than seven workers are employed or equipment of more than five horsepower is used: apply for the license with a completed form Orr 1
  • Import of food:
    • One is importing food for registration or purchase consideration: form Orr 16 should be used to apply for the license
    • The import of food is only temporary (e.g. Trade exhibition of research): form Orr 12 should be used to apply for the license
    • Food is imported in order to sell it in Thailand: apply for the license with a form Orr 6.
Approval of the product

First of all, it has to be checked in what category the imported or produced food fall. There are three:

Our FDA License application service includes the following:

  • Advise client on all required information and documents to apply for a FDA license.
  • Prepare a FDA license application with the assistance of the client.
  • Filing the application with the FDA.
  • Accompanying the representatives of the client in meetings with the FDA if necessary.
  • Follow up the application with the FDA.
  • Submit any additional information or documents required by the FDA with the assistance of the client.
  • Receive the FDA license.
  • Provide an English translation of the FDA license.
  • Correspondence by email, telephone and in person meetings when necessary.
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93/1 Witthayu Rd, Lumphini, Pathum Wan, Bangkok.
info@thailicense.com

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