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.
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:
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.
