Thailand FDA License

The Thai Food and Drug Administration (FDA) is responsible for the protection of consumer’s health and safety. They ensure the quality and efficacy of health products. The FDA controls the following list of products on the Thai market either manufactured or imported:

• Food
• Drugs
• Psychotropic Substances
• Medical Devices
• Narcotics
• Volatile Substances
• Cosmetics
• Hazardous Substances

The approval of FDA is required in order to manufacture or import any of these above products.

Scope of FDA Approval

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

• Pre-marketing control of the factory, product, and advertising
• Post-marketing control. This includes 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 of the said product)
• Consumer Education: It is the information or awareness given to the consumer. The FDA checks whether or not the information is sufficient and accurate.
• Technical support and cooperation with other agencies (e.g. seminars organized or attended to by the FDA)

Food Control

The FDA implements and enforces the Food Act and makes sure that the quality and safety of food, by means of, amongst others:

• Setting and regulating food standards and specifications as well. This includes hygienic and labelling requirements.
• Controlling the manufacturing and importation of food products
• Approval for advertisement and packaging materials
• The conduction of epidemiological studies. Following certificates can be issued by the FDA.
  • Certification of Free Sale
  • Sanitary Certification
  • GMP Certification’
  • HACCP Certification

Application for the Certification

The application for the certification is completed in two steps; the premises have to be approved before it can be permitted to manufacture or import the product. This is done to ensure the health of the consumers.

Approval of the Premises

A distinction has to be made between manufacturing and importing food for what concerns the premises.

Manufacturing of Food

• Form Orr 15 should be used to apply for the FDA License if one is producing food as a sample for registration or purchase consideration
• If the production of food is temporary, form Orr 11 should be used to apply for the FDA 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 FDA License with a completed form SorBor1
• If the intention is to produce food ‘indefinitely’, and more than seven workers are employed or equipment of more than five horsepower is used: Form Orr 1 should be used to apply for the FDA License
• Import of food
  • If someone 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: form Orr 12 should be used to apply for the FDA License;
  • Food is imported in order to sell it in Thailand: apply for the FDA License with a form Orr 6.

Approval of the Product

There are three categories to check in what category the imported or manufactured food lies:

• Specific Controlled Food – These include beverages in sealed containers, flavored milk, cultured milk, food containing sodium cyclamate, other milk products, and food additives etc.
• Prescribed Food to Have Quality or Standard – These include coffee, iodized table salt, vitamin fortified rice, cream, tea, chocolate, vinegar, oils, butter, honey, ghee, margarine, and electrolyte drinks etc.
• Prescribed Food to Have Label – These include bread, sauces in sealed containers, husked rice flour, some meat products, flavoring agents, garlic products, and irradiated products etc.

Based on these three categories, you can determine which form should be completed in order to apply for the certification.

Authorized Services

If you are trying to figure out where to apply for the approval of the product and premises, find out below:

• If the head office of the company is located in Bangkok Metropolitan area, the application form needs to be submitted to the Food Control Division, Food and Drug Administration
• If the head office is located in a provincial area, the application form can be filed at the particular provincial public health office
• For the purpose of temporary import, the application form has to be filed at the Import-Export Inspection Division, Food and Drug Administration

Time Frame

The amount of time that will pass by before you receive the approval of the FDA highly depends on the product that you are trying to manufacture or import outside Thailand. In any case, if the license is approved it will remain valid for three years.

Drug Control

The handling of an application for the certificates is managed by the Drug Control Division.

Application for the Certificate

2.1.1. Permission to Import or Manufacture a Drug Sample in Order to Have It Registered

The following documents are required: a completed application form, the drug formula, the drug literature and the drug labeling and packaging.

2.1.2. Application for the Approval of Granted Credential Certificate

In this case, a lot more information has to be provided:

• Completed application form
• Permit to manufacture or import drug sample (see above)
• Drug sample
• Pharmacological and toxicological study (if any)
• Clinical trials, safety, and efficacy study (if any)
• Complete drug formula
• Drug literature
• Final labeling and packaging including the registration number, quantity of drug per packaging, name of manufacturer and address, manufacturing date, the expiry date…
• Legalized (by the authorized officer) and by the Thai Embassy endorsed certificate of free sale (in case of imported drug)
• Manufacturing method
• In-process control with the relevant acceptable limits
• Raw material specifications of active(s) and inert ingredients with the corresponding control methods in details
• Finished product specification with the corresponding control methods in details
• Certificate of analysis of active ingredient(s)
• Drug analytical control method
• Packaging (Must be according to the Thai regulations)
• Storage conditions (Should be favorable for the type of the good)
• Stability studies of the finished product
• A certificate of GMP (in case of imported drug)

Time Frame

It depends on the product how fast the drug will be approved. This license is valid for an indefinite period. It is same as the time period required for food.

Others

The procedure remains the same if you want to acquire a license for manufacture or import of narcotics, medical devices, volatile substances, cosmetics or hazardous substances.

Need Help? Contact Us

If you are looking to acquire an FDA license in Thailand, you need to get professional assistance. We, Sunbelt Asia Legal Advisors, are a law firm in Thailand. Our legal and accounting experts can help you acquire an FDA license in Thailand easily. We will help you compile all the required documents. We will work in close collaboration with you throughout the process. Contact us now at (+66) 02-662-7004 to know more or book a free consultation.