We continue to see unlawful imports of therapeutic goods into Australia by registered health practitioners, including medicines and medical devices.
Cosmetic injectables: import and supply in Australia
We’ve developed a factsheet for healthcare practitioners to aid in their understanding of the rules surrounding importation of cosmetic injectables: Cosmetic injectables: import and supply in Australia.
Who can import therapeutic goods to supply in Australia
Only the approved supplier (sponsor), as entered in the Australia Register of Therapeutic Goods (ARTG), or their agent, can lawfully import therapeutic goods into Australia for commercial supply.
Supply is defined broadly and includes administering, dispensing, selling or otherwise using a product as part of clinical care.
Therapeutic goods imported for commercial supply must be the version manufactured and approved for the Australian market and not a parallel import.
The products must be entered in the ARTG, under the name of the supplier, prior to importation unless an exemption, approval or authority applies, like lawful access via an unapproved product pathway like the Special Access Scheme. For more information see Access an unapproved therapeutic good (health practitioners).
Health professionals must not import therapeutic goods unless:
- they are the Australian approved supplier (sponsor), or their agent
- an exemption, approval or authority applies.
Parallel import
Many therapeutic goods, including cosmetic injectables, are available both in Australia and overseas.
Parallel import occurs when a legitimate version of an overseas product is imported with the intention of being sold in the Australian marketplace.
While these goods may be authentic and manufactured by the company indicated on the packaging, they are not the version of the product assessed for the Australian market and entered in the ARTG.
Parallel imports should not be imported into Australia for commercial supply unless an exception applies.
Risks of parallel imports
All prescription only medicines, and medical devices in the ARTG undergo assessment by us to ensure they meet quality, safety and efficacy standards.
Parallel imports:
- are unapproved goods and have not been assessed by us
- do not necessarily meet the same quality and safety standards as the Australian versions.
Patients are at increased risk of adverse events when administered or treated with products that have not been approved for supply in Australia.
For example, one of the known issues with parallel imports is that they may not be delivered using appropriate cold chain storage protocols or other acceptable conditions that affect or maintain product viability. In the case of cosmetic injectables, this has been associated with acquired botulism infection as a severe adverse event following cosmetic injection procedures.
How to know if your product is a parallel import
If your business intends to import and supply a therapeutic good to consumers or other businesses in Australia, you should obtain those products via formal manufacturer distribution channels.
Where you obtain genuine products without authorisation from the manufacturer, you may be purchasing a parallel import.
If any of the following apply to your product, it may be a parallel import.
- It has been purchased from an international online supplier, or direct from the international manufacturer.
- It has been purchased from a supplier other than the Australian Sponsor, or its authorised distributor.
- It has not been assessed by us for the Australian market.
- The price is cheaper than is ordinarily expected to purchase the product in Australia.
- It has a pack or label that is different compared to the version of the product approved for supply in Australia, e.g. packaging and instructions for use are not in English.
- It is not delivered in appropriate cold chain storage, where required.
- There are no Australian sponsor details on the package.
Responsibilities of health practitioners when importing therapeutic goods
You must always ensure that any therapeutic goods you import and supply comply with Australian therapeutic goods legislation including:
- the Therapeutic Goods Act 1989
- the packaging and labelling requirements
- the Therapeutic Goods Regulations 1990
- the Therapeutic Goods (Therapeutic Goods Advertising Code) Instrument 2021.
Health practitioners need to be aware of the regulatory requirements and lawful access pathways for unregistered goods such as the Special Access Scheme (SAS) or Authorised Prescriber (AP) pathway.
The safest way to obtain therapeutic goods for supply in the Australian market is to obtain them via formal domestic manufacturer distribution channels.
Consequences of unlawfully importing unapproved therapeutic goods
Loss of product
Under instruction from us, the Australian Border Force can seize and destroy unlawful imports of therapeutic goods. This means that the cost of the purchase of the product is also likely lost.
Fines or court action
We investigate unlawful import, supply and advertising of therapeutic goods in Australia and encourage compliance with Australian laws by providing education and guidance in the first instance. Failing to adhere to the Australian rules can attract significant penalties.
For repeated and deliberate non-compliance, we take escalated regulatory action which can include injunctions, infringement notices, civil court proceedings and criminal prosecution.
We have issued infringement notices to several companies and individual medical practitioners for the alleged importation of unregistered medicines for clinical use when equivalent products could be obtained lawfully in Australia.
Recent civil court outcomes reflect that any person undertaking business relating to therapeutic goods must be familiar with the regulations prior to undertaking that business. Ignorance of the applicable laws is not a defence.[1]
Referral to Ahpra
We may also refer registered health practitioners to Ahpra and the relevant National Board.
Further information
Footnotes
[1] Secretary, Department of Health v Enviro Tech Holdings Pty Ltd [2022] FCA 865.