Registration of Food Supplement in Australia

Regulatory Authority

Therapeutic Goods Administration (TGA)

https://www.tga.gov.au/

5 Years

45 to 210 days

Complementary medicine means a therapeutic good consisting wholly or principally of 1 or more designated active ingredients, each of which has a clearly established identity and a traditional use.

In Australia, the TGA oversees regulating pharmaceuticals and other therapeutic commodities. Before higher-risk medications can be supplied lawfully in Australia, they evaluate them for efficacy, quality, and safety. The question of whether a product performs as promised is known as its efficacy. 

Lower risk medications’ safety and quality are regulated by limiting their use to pre-approved low-risk substances and pre-approved low-risk or minor medical problems, as well as by enforcing high manufacturing standards. If they perform a formal compliance review of the medicine, the commercial sponsor is also obliged to have proof that their product is effective, and they are obligated to furnish the TGA with this proof.

The strategy used by the TGA lowers the price of approving low-risk medications. Should we evaluate every low-risk product for effectiveness prior to allowing it on the market, the extra expenses would be transferred to the end user.

Vitamins are controlled as either prescription drugs or complementary medications, depending on the vitamin and dosage. Most vitamins are classified as low-risk supplementary medications, which means that the TGA solely oversees their quality and safety.

Pre-market evaluations by the TGA of low-risk medications and supplemental vitamins entail items that satisfy certain requirements:

• Only components from a pre-approved list that the TGA has previously evaluated for quality and safety may be found in the product.

• The product’s commercial sponsor is required to select a use from a pre-approved list that is limited to minor health issues. Claims about serious and life-threatening conditions are not allowed on products.

• The product needs to be produced in an approved facility that satisfies quality requirements.

• The product’s sponsor is required to provide proof that the product performs as promised.

The TGA does not review the final product and its label for low-risk medications, nor does it assess the commercial sponsor’s proof of product efficacy prior to the product’s release onto the market. Nonetheless, we reserve the right to review any product as part of our sporadic and focused examination of items available for purchase. In this way, we evaluate several hundred goods annually.

We have the authority to revoke a sponsor’s approval to distribute a product in Australia if a TGA review determines that the sponsor does not have enough proof of the product’s effectiveness. Cancellation may also result from other non-compliance, such as incorrect or unsuitable labeling. On the TGA website, we frequently post lists of canceled items.

The labels of all medications that the TGA has approved for distribution have one of two numbers: AUST R or AUST L.

• AUST R codes are assigned to registered medications whose safety, efficacy, and quality have been assessed by the TGA.
• The TGA exclusively regulates low-risk listed medications for safety and quality, such as the majority of vitamin supplements, under AUST L codes.

It’s possible that medications lacking these codes won’t be permitted for sale in Australia. This is particularly problematic for products that are offered online because they can include unlisted, potentially harmful substances.