We regulate therapeutic goods, including medicines, medical devices and biologicals under the Therapeutic Goods Act 1989 and related legislation.
We evaluate, assess and monitor the safety, quality and effectiveness of therapeutic goods and their ingredients, product labelling and advertising.
In Australia, peptide products that are regulated as therapeutic goods must be included in the Australian Register of Therapeutic Goods (ARTG) before they can be imported, manufactured, supplied, exported or advertised.
Some limited exceptions apply, such as where there is a specific approval, authority or exemption under the legislation.
Products that are not included in the ARTG are generally referred to as ‘unapproved’ therapeutic goods. This means we have not assessed them for quality, safety or effectiveness.
Disclaimers that a product is for ‘research use only’ or ‘not for human use’ do not change whether a product is regulated as a therapeutic good. These claims do not remove advertising, manufacture, import, export or supply obligations.
Approved peptide-based medicines
Some peptide-based medicines are approved and are included in the ARTG for specific therapeutic purposes.
Examples include:
- insulin and insulin analogues
- glucagon-like peptide-1 (GLP‑1) receptor agonists such as semaglutide
- oxytocin
- vasopressin analogues such as desmopressin
- somatostatin analogues such as octreotide.
Before approval, these medicines are tested broadly in human clinical trials, the information forming part of a submission to us to be assessed for quality, safety and effectiveness.
Many approved peptide-based medicines are prescription-only. This means they can only be prescribed, dispensed or supplied by authorised health practitioners and cannot generally be advertised to the public. For more information see Peptide product information for health practitioners.
Unapproved peptide products
Many peptide products promoted and sold through websites, social media, messaging apps, wellness clinics and overseas suppliers are not included in the ARTG and are generally unapproved therapeutic goods.
Unapproved peptide products may come from unknown and unregulated sources. They may be sold in many forms, including injectable products, powders for injection, capsules, tablets, oral liquids, nasal sprays, creams, gels, serums or sublingual drops.
There are significant known health risks associated with the use of these products.
We have not assessed unapproved peptide products for safety, quality or effectiveness. This means there is no assurance they are safe, effective, are correctly labelled, are sterile or are made to appropriate quality standards. See Risks of buying peptide products online.
In limited circumstances, health practitioners may be able to access an unapproved therapeutic good for a patient through established access pathways. This should only occur after clinically appropriate treatment options included in the ARTG have been considered. See information for health practitioners for more information.
Information for importers and suppliers
Unapproved peptide products cannot be imported or supplied in Australia unless a valid exemption, approval or authority applies. For more information see our web page on unapproved therapeutic goods.
Individuals may be able to import unapproved peptide products under the Personal Importation Scheme, but only if all conditions of the scheme are met. The scheme does not allow commercial supply or public advertising of unapproved therapeutic goods.
We work with the Australian Border Force (ABF) to identify and stop unlawful imports of unapproved peptide products at the border.
If an import appears to be unlawful, the goods may be seized and destroyed. You may lose the products and the money you paid.
Information for manufacturers
Australian manufacturers of medicines, biologicals (other than class 1 biologicals) and other therapeutic goods generally need a manufacturing licence. The licence must specifically authorise the manufacture of those goods, including unapproved goods, unless an exemption applies.
Manufacturing therapeutic goods without a valid licence and where no exemption applies, is unlawful. For more information see Manufacturing.
Information for advertisers, influencers and online platforms
It is generally unlawful to advertise unapproved therapeutic goods to the Australian public, including unapproved peptide products. It is also generally unlawful to advertise prescription-only medicines to the public.
These restrictions apply to advertising and promotion on websites, social media platforms, online marketplaces, influencer content and other channels.
Influencers, affiliates, online sellers, health services and anyone else promoting unapproved peptide products may be held accountable for unlawful advertising and should ensure they understand their legal obligations.
For more information, see Advertising and our warning to unapproved peptide product promoters and suppliers.
Compliance and enforcement action
We can take enforcement action for unlawful importation, manufacture, supply, export or advertising of unapproved peptide products.
If we identify serious non-compliance with the Act, we may take action in line with our regulatory compliance framework.
Regulatory action may include:
- import interventions
- product seizures
- infringement notices
- civil penalties
- criminal penalties.
We are prioritising compliance action against entities involved in the unlawful importation, manufacture, advertising and supply of unapproved peptide products, including online advertising and social media promotion.
For more information, see our warning to unapproved peptide product promoters and suppliers.