Selling and advertising of cancelled listed medicines: Questions and answers

It is an offence under section 19B(4) of the Therapeutic Goods Act 1989 (the Act) for a sponsor to import, export, manufacture or supply a product that is a therapeutic good in Australia unless the product is listed or registered in the Australian Register of Therapeutic Goods (ARTG) or is exempt from registration or listing, or is subject of an approval or authority under the Act (for instance under sections 18A, 19 or 19A).

The sponsor is the person who exports, or arranges the exportation of the product from Australia, who imports or arranges for the importation of the product into Australia, or who in Australia manufactures or arranges for another person to manufacture the goods for supply (whether in Australia or elsewhere).

It is also an offence under section 21 of the Act for a person who is not a sponsor to supply therapeutic goods to another person who is not the ultimate consumer of the goods if the goods are not on the ARTG or otherwise exempt or subject to an approval or authority under the Act.

It follows that where a product that has been cancelled from the ARTG, then depending on the circumstances, product that was available for retail supply at the time of cancellation may continue to be sold by retail (assuming the seller is not a "sponsor" or selling wholesale as described above). However, any future introduction of product into the market (via import, or manufacture and supply) by a sponsor or wholesaler after the cancellation would, so long as the product is not included in the ARTG, be a breach of the Act.

It may also be an offence under State law to supply therapeutic goods that are not included in the ARTG.

It is an offence under section 42DL(1)(g) of the Act for any person to publish or broadcast an advertisement about therapeutic goods which are not included in the ARTG.

"Advertisement" includes any statement, pictorial representation or design, however made, that is intended, whether directly or indirectly, to promote the use or supply of the goods; and

It is also an offence under section 22(6) of the Act for any person to make a claim by any means, that the person or another person can arrange the supply of therapeutic goods (not being exempt goods) that are not listed or registered in the ARTG.