Thailand FDA license.

The Thai Food and Drug Administration is responsible for the protection of the consumer’s health and safety by ensuring the quality and efficacy of health products.

Thailand FDA license

FDA procedures in 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 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)

Food control.

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:

A. Specific controlled food

TypesThe notification of the Ministry of Public HealthProvinces are empowered to approve
1. Beverages in sealed containers(No. 214) B.E. 2543 (2000) and (230) B.E. 2544 (2001)Yes, certain elements
2. Sodium cyclamate and food containing sodium cyclamate(No. 113) B.E. 2531 (1988)No
3. Modified milk for infants and follow-up formula modified milk for infants and young children(No. 156) B.E. 2537 (1994)No
4. Flavored milk(No. 266) B.E. 2545 (2002)No
5. Cultured milk(No. 46) B.E. 2523 (1980) and (No. 99) B.E. 2529 (1986)No
6. Cow’s milk(No. 265) B.E. 2545 (2002)No
7. Other milk products(No. 267) B.E. 2545 (2002)No
8. Food additivesNo. 84 B.E. 2527 (1984) and No. 119 B.E. 2532 (1989)No
9. Infant foods and follow-up formula food for infants and young childrenNo. 157 B.E. 2537 (1994) and No. 171 B.E.2539 (1996)No
10. Weight-control foodsNo. 121 B.E. 2532 (1989)No
11. Supplementary foods for infants and young childrenNo. 158 B.E. 2537 (1994)No
12. Foods in sealed containersNo. 144 B.E. 2535 (1992), No. 179 B.E. 2540 (1997), and(1997), and (No. 253) B.E. 2545 (2002)No
13. Ice cream(No. 222) B.E. 2544 (2001) and (No. 257)B.E. 2545 (2002)All types except for powder ice cream

B. Prescribed food to have quality or standard

TypesThe notification of the Ministry of Public HealthProvinces are empowered to approve
1. Coffee(No. 197) B.E. 2543 (2000) and (No. 276) B.E. 2546 (2003)Yes
2. Iodized table saltNo. 153 B.E. 2537 (1994)Yes
3. Vitamin fortified riceNo. 150 B.E. 2536 (1993)Yes
4. Alkaline-preserved eggs(No. 236) B.E. 2544 (2001)Yes
5. Cream(No. 208) B.E. 2543 (2000)Yes
6. Electrolyte drinks(No. 195) B.E. 2543 (2000)Yes
7. ChocolateNo. 83 B.E. 2527 (1984)Yes
8. Tea(No. 196) B.E. 2543 (2000) and (No. 277) B.E. 2546 (2003)Yes
9. Some particular kinds of sauces(No. 201) B.E. 2543 (2000)Yes
10. Soybean milk in sealed containers(No. 198) B.E. 2543 (2000)Yes
11. Vinegar(No. 204) B.E. 2543 (2000)Yes
12. Peanut oilNo. 23 B.E. 2522 (1979) and (No. 233) B.E. 2544 (2001)Yes
13. Coconut oilNo. 57 B.E. 2524 (1981) and (No. 235) B.E. 2544 (2001)Yes
14. Palm oilNo. 56 B.E. 2524 (1981) and (No. 234) B.E. 2544 (2001)Yes
15. Butter oil(No. 206) B.E. 2543 (2000)Yes
16. Fat and oil(No. 205) B.E. 2543 (2000)Yes
17. Fish sauce(No. 203) B.E. 2543 (2000)Yes
18. Natural mineral water(No. 199) B.E. 2543 (2000)Yes
19. Butter(No. 277) B.E. 2544 (2001)Yes
20. Honey(No. 211) B.E. 2543 (2000)Yes
21. Cheese(No. 209) B.E. 2543 (2000)Yes
22. Margarine(No. 207) B.E. 2543 (2000)Yes
23. Ghee(No. 226) B.E. 2544 (2001)Yes
24. Food seasoning derived from the hydrolysis or fermentation of soybean protein(No. 202) B.E. 2543 (2000) and (No. 248) B.E. 2544 (2001)Yes
25. Jam, jelly and marmalade in sealed containers(No. 213) B.E. 2543 (2000)Yes
26. Royal jelly and royal jelly products(No. 212) B.E. 2543 (2000) and (No. 241) B.E. 2544 (2001)No
27. Semi-processed foods(No. 210) B.E. 2543 (2000)Yes
28. Drinking water in sealed containersNo. 61 B.E. 2524 (1981), No. 135 B.E. 2534 (1991), (No. 220) B.E. 2544 (2001), and(No. 256) B.E. 2545 (2002)Yes
29. IceNo. 78 B.E. 2527 (1984), No. 137 B.E. 2534 (1991), and (No. 254) B.E. 2545 (2002)Yes

C. Prescribed food to have label

TypesThe notification of the Ministry of Public HealthProvinces are empowered to approve
1. Bread(No. 224) B.E. 2544 (2001)Yes
2. Sauces in sealed containers(No. 200) B.E. 2543 (2000)Yes
3. Brine for cooking(No. 225) B.E. 2544 (2001)Yes
4. Husked rice flourNo. 44 B.E. 2523 (1980)Yes
5. Garlic products(No. 252) B.E. 2544 (2001)No
6. Some meat products(No. 243) B.E. 2544 (2001)Yes
7. Flavoring agents(No. 223) B.E. 2544 (2001)Yes
8. Processed gelatin and jelly dessertsNo. 100 B.E. 2529 (1986) and (No. 263) B.E. 2545 (2002)Yes
9. Chewing gum and candy(No. 228) B.E. 2544 (2001)Yes
10. Ready-to-Cook foods and Ready-to-Eat foods(No. 237) B.E. 2544 (2001)Yes
11. Special purposed foods(No. 238) B.E. 2544 (2001)Yes
12. Irradiated foodsNo. 103 B.E. 2529 (1986)No
13. General food obtained through certain techniques of genetic modification or genetic engineering(No. 251) B.E. 2545 (2002)Yes

Based upon these categories, one can determine which form will have to be completed in order to apply for the certification:

Specific controlled food (Category 1)Prescribed food to have quality or standard (Category 2)Prescribed food to have label (Category 3)General food or other food
ImportForm Orr 6 and form Orr 17Form Orr 6 and form Sor Bor 5

Exception for “Royal Jelly and Royal Jelly Products:” form Sor Bor 3
Form Orr 6 and form Sor Bor 5 except for “Special Purposed Food” and “Garlic Products” (form Sor Bor 3)Form Orr 6 only (food serial number is not required except for general foods derived from Food Obtained Through Certain Techniques of Genetic Modification or Genetic Engineering)
Producers employing not more than seven workers nor using equipment with more than five horsepowerForm Sor Bor 1 and form Sor Bor 3 Form Sor Bor 1 and Sor Bor 5 except for Honey, Soybean Milk, Iodized Table Salt while “Royal Jelly and Royal Jelly Products apply by form Sor Bor 3Form Sor Bor 1 and form Sor Bor 5 except for “Special Purposed Food” and “Garlic Products” apply by form Sor Bor 3Do not require to apply by any forms and food serial number is not required (with the same exception as mentioned here above)
Manufactures employing more than seven workers or using equipment with more than five horsepowerForm Orr 1 and form Orr 17 Form Orr 1 and form Sor Bor 5 except for “Royal Jelly and Royal Jelly Products “apply by form Sor Bor 3 Form Orr 1 and form Sor Bor 5 except for “Special Purposed Food” and “Garlic Products” apply by form Sor Bor 3 Form Orr 1 only and food serial number is not required (with the same exception as mentioned here above)

Authorized services.

Where to apply for the approval of the premises and product?

  • One is producing food as a sample for registration or purchase consideration: form Orr 15 should be used to apply for the license

  • The head office is located in a provincial area: the application form can be filed at the particular provincial public health office
  • The application form for the temporary import has to be filed at the Import-Export Inspection Division, Food and Drug Administration

Timeframe.

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 get imported or manufactured. In any case, if the license is approved it will remain valid for three years.

Drug control.

The Drug Control Division is responsible for handling the application for the certificates.

Application for the certificate.

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 labelling and packaging.

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
  • Storage conditions
  • Stability studies of the finished product
  • A certificate of GMP (in case of imported drug)

Application for the certificate.

Same as for food, it depends on the product how fast the drug will be approved. This license is valid for an indefinite period.

Others.

The same kind of procedures have to be followed in case you want to manufacture or import psychotropic substances, narcotics, medical devices, volatile substances, cosmetics or hazardous substances.

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