A member asked over 7 years ago

Importing product

Hi. I'm thinking about importing products from overseas. Both products are listed as having: Certificates: KFDA, CE, ISO & Certificates: CE, ISO, GMP, KFDA.  What are the extra steps that I need to proceed with distributing this product? Will I need FDA approval as well? Are the certificates provided enough? Thanks.

Law Advisor Research Team
Researchers at LawAdvisor

Hi there. Without further details about the two products you wish to import and distribute in Australia, it is difficult to say what further legal requirements you may need to satisfy. The following information may provide some assistance in understanding your general obligations when importing goods to Australia.

You may first want to determine how your goods are classified according to customs laws. While there is no general requirement for importers to hold an import licence, certain goods or classes of goods known as ‘restricted imports’, may require additional documentation and approval before being imported. In this case, an importer will need to request permission from the relevant authority and may also need to obtain import and quarantine permits to ensure clearance through customs. For goods that attract quarantine permits, they will most likely also require treatment (e.g. for pests). You should visit the Australian Customs website (www.border.gov.au) to see whether your goods are classified as restricted.

Certain goods or classes of goods must also be correctly labelled with a trade description (i.e. details of where and by who they were made, packed or prepared). Where a trade description is required, an importer is responsible for ensuring that the label, and where it is positioned, complies with customs laws. Failure to meet labelling requirements may delay the importing process or result in the goods being seized. You should visit the Australian Customs website to determine what labelling requirements apply to your goods, particularly if they include food or prepacked articles. The certificates you mentioned will probably only satisfy some, but not all, of these obligations.

You may also need to consider what duties and fees are payable. Import processing charges (IPCs) are calculated on the value of the shipment and the cargo channel used to transport the goods. Customs duties are calculated on the customs value of the goods, being approximately 5% of the price the importer paid for the goods. A goods and services tax (GST) is also incurred on most goods imported into Australia, and is calculated as 10% of the value of the taxable importation. You should familiarise yourself with the duties and fees payable in your situation, as imported goods cannot be cleared by customs until the applicable duties and fees are paid by the importer.

The Food and Drug Administration (FDA) is a government authority in the United States, not Australia. For goods imported into Australia, FDA approval is unlikely to be required, especially as Australia has its own Therapeutic Goods Administration (TGA) which regulates imported goods in this area and performs a similar function to that of the FDA in the United States. See the TGA website for more information (www.tga.gov.au).

Suggested way forward

Understanding and complying with your obligations as an importer of goods into Australia can be a complex and time consuming process. The consequences for failing to comply with your obligations under Australian customs laws range from financial penalties to imprisonment for serious offences. You should speak to a lawyer who is accredited and licensed as a customs broker to assist you in navigating the process and preparing the relevant documentation. By pressing the “Consult a Lawyer” button, LawAdvisor can help you search for experienced lawyers and obtain fee proposals for their services. Costs for legal advice and representation will vary between providers based on experience and the scope of services.

Answered about 7 years ago   Legal disclaimer

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