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:
The approval of FDA is required in order to manufacture or import any of these above products.
The FDA’s approval is based upon five different sorts of control:
The FDA implements and enforces the Food Act and makes sure that the quality and safety of food, by means of, amongst others:
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.
A distinction has to be made between manufacturing and importing food for what concerns the premises.
There are three categories to check in what category the imported or manufactured food lies:
Based on these three categories, you can determine which form should be completed in order to apply for the certification.
If you are trying to figure out where to apply for the approval of the product and premises, find out below:
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.
The handling of an application for the certificates is managed by the Drug Control Division.
The following documents are required: a completed application form, the drug formula, the drug literature and the drug labeling and packaging.
In this case, a lot more information has to be provided:
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.
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.
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.
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