TGA releases new guidance on advertising restrictions for prescription medicines

The Therapeutic Goods Administration (TGA) has published new guidance on advertising restrictions for prescription medicines. This is to help individuals and businesses comply with Australia’s regulatory requirements.

Under the Therapeutic Goods Act 1989 (the Act), advertising prescription medicines to the public is prohibited, except under very limited circumstances. Prescription medicines can carry specific risks, and so decisions about their use should be made by patients in consultation with an appropriately qualified health practitioner. These decisions should not be influenced by advertising.

The TGA takes compliance action against illegal advertising and the promotion of prescription medicines to the public, particularly when occurring online. This includes advertising services that prescribe or supply products such as cosmetic injectables, peptides, weight loss injections, medical cannabis, intravenous (IV) drip therapies, and medicines for erectile dysfunction.

The guidance provides practical examples to help individuals and businesses to understand their obligations. It explains the types of advertising and promotional activities likely to be prohibited across websites and social media, or in business names and logos, booking systems, product catalogues, price information and other materials.

The guidance, Complying with the restrictions on advertising prescription medicines to the public, is available on the TGA’s website.

The TGA has also updated its related guidance, Advertising health services that involve therapeutic goods, to address concerns about the promotion of health services to access specific prescription medicines. These services include online and telehealth services.

The TGA urges all individuals and businesses supplying, selling or promoting prescription medicines to review their content carefully to ensure it complies with relevant advertising restrictions.

The TGA works with industry to support high levels of voluntary compliance in the first instance. Businesses are expected to take prompt action to review and, where necessary, amend or remove content that does not comply with the advertising restrictions.

Where serious non-compliance with the Act is identified, the TGA may take action in line with its regulatory compliance framework. This may include issuing infringement notices, directions or prevention notices, or initiating civil or criminal proceedings. Penalties for breaches of the Act include civil penalties of up to $1.65 million per breach for individuals or $16.5 million per breach for corporations, as well as fines or imprisonment.

If you suspect non-compliance relating to therapeutic goods, or their advertising, you can Report a perceived breach or questionable practices at any time.

Contact for members of the media:

• Email: news@health.gov.au
• Phone: 02 6289 7400