The Therapeutic Goods Administration (TGA) has issued an enforceable direction to Veganic SKN Limited (ACN 142 515 437) (Veganic SKN) on the basis that a delegate of the Secretary believes, on reasonable grounds, that Veganic SKN is not complying with the Therapeutic Goods Act 1989 - external site (the Act), by unlawfully manufacturing and supplying therapeutic goods that are not entered in the Australian Register of Therapeutic Goods (ARTG).
A copy of the enforceable direction, outlining the reasons that direction was given to Veganic SKN, is available at Enforceable direction: Veganic SKN Limited.
The TGA's investigation found that Veganic SKN manufactured and supplied sunscreen products under a single ARTG listing (AUST number), but that those products were marketed under different product names to that recorded in the respective ARTG entry. These products are taken to not be included in the ARTG.
Under the Act, therapeutic goods, including sunscreens, must be entered in the ARTG before they can be lawfully manufactured and supplied in Australia, except in limited circumstances that do not apply here. Information on product labels, including the product name, must accurately reflect the details included in the ARTG entry for that product. This requirement exists for several reasons:
- it ensures consumers and businesses can properly identify the entry in the ARTG associated with a product if needed
- it facilitates adverse event reporting and post-market actions such as recalls, and
- it gives the TGA visibility of the names under which therapeutic goods are being supplied. This assists the TGA in identifying instances where the name of a therapeutic good claims that it is suitable for an indication (or purpose) that is not accepted in relation to the good in the ARTG, or where the name otherwise makes the presentation of the good unacceptable.
This requirement is an important part of the regulatory framework established under the Act, and helps to ensure the safety, quality and efficacy of therapeutic goods available to Australian consumers.
The enforceable direction requires Veganic SKN to cease the supply of sunscreen products that are taken to not be entered in the ARTG, and to quarantine all affected products for relabelling or repackaging so that they correspond with an ARTG entry. If the products are not relabelled or repackaged to comply with the Act, the direction requires the goods to be destroyed.
Failure to comply with an enforceable direction may result in further regulatory action by the TGA, including civil or criminal penalties.
The TGA has recently published information for industry and consumers about sunscreen labelling, which is available on the TGA website at TGA statement on sunscreen labelling practices.
