FDA Registration Thailand

For those interested in importing pharmaceuticals, food, food supplements, products for animal health, or other medical, narcotic and toxic substances, they must apply for registration with the Food and Drug Administration of Thailand.  The amount of time required for filing products with the FDA can range widely—from one day for cosmetics, one week for general medical devices, four months for food products and can be much longer for other pharmaceutical products.

Drug Registration Process Thailand

A license from the Thai FDA is necessary in the case of importing and/or manufacturing drugs in Thailand.  Thailand’s FDA categorizes drugs into modern, general medicines, traditional medicines and veterinary medicines, all of which have separate registration requirements.  General medicines are further divided into generic medicines, new medicines and new generics.  Each category has a separate set of requirements.   The Thai FDA issues drug licenses for an indefinite period.

Food Registration Process Thailand

In order to import controlled food products into Thailand, products must be registered with the Thai FDA with labels translated into the Thai language.  The food must be analyzed, including details of its processing and ingredients, meeting Thai FDA standards.  A manufacturing license must be procured as well. Necessary import licensed must be renewed every 3 years.

Obtaining Thai FDA Licenses Thailand

Acquiring a license to import or manufacture food or drugs in Thailand can be an extensive process, but a qualified law firm can ensure that documents are complete, with experience knowing how the product will be classified with the Thai FDA.  Filing a complete and thoroughly reviewed application can expedite the length of the filing process. FDA fees range from around 2, 000 THB for the registration of a new drug to 5, 000 THB for a controlled food product.