How is the Food and Drug Administration authority’s role defined?

The FDA or equivalent authority in any country is usually responsible for establishing and enforcing policies relating to efficacy and safety standards of both veterinary and human pharmaceuticals, drugs, biological agents, products of animal origin and food supply. The scope of work that the authority deals with can vary greatly from country to country. In some countries they may also be responsible for regulations concerning cosmetics and medical devices.  The FDA is usually a self regulating organization. This means that some departments within the organization will craft the relevant policies and operational procedures while another department will enforce them and take entities that fail to meet these conditions to task.

The FDA or similar authority in any country is usually empowered to levy penalties and fines on errant importers or exporters who fail to meet the operational requirements for certain activities. For example, some products containing animal content may require approval prior to import into Thailand and failing to get the necessary approvals may result in Thai FDA refusing to allow the importer to clear Customs.

Do I need the FDA to approve my import?

If you deal with a product that could possibly be injurious to public health due to poor quality standards, then you probably need FDA to approve your import. If your product is found to require FDA approval to import, you will likely be required to arrange for an FDA inspection before you can clear import Customs.

Since FDA’s regulations deal with matters relating to public health and safety, traders can expect authorities to be strict about approving and allowing impacted products from entering a country. If you are importing an item for the first time into a country, it is advisable to seek guidance from an experienced Customs broker or consultant.

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