Administration of unregistered or unlisted therapeutic goods

The Therapeutic Goods Act 1989 [Commonwealth] (the Act) and associated regulations establishes a uniform, national system of regulatory controls to ensure the quality, safety, efficacy and timely availability of therapeutic goods for human use in Australia.

Under the Act, therapeutic goods for human use that are imported into, supplied in, or exported from Australia must be included in the Australian Register of Therapeutic Goods (ARTG). Persons in breach of the above provisions under the Act could face civil or criminal penalties of up to five years imprisonment and/ or up to $720,000 for each offence for an individual or $3.6 million for a corporation.

Additionally, the supply or administration of imported medicines, including injectable botulinum toxin, hyaluronic acid dermal fillers and injectable local anaesthetics, which are not registered for use in Australia in the ARTG is also an offence under the Poisons and Therapeutic Goods Act 1966 (NSW) that may attract a penalty of up to $2,200 for each offence.

Administration and supply of injectable botulinum toxin or hyaluronic acid dermal fillers by unauthorised persons

​Substances such as botulinum toxin, hyaluronic acid dermal fillers, injections or local anaesthetics, and other prescription only medications can only be administered by a medical or nurse practitioner, or by a nurse under the direct supervision of these practitioners. ​

Penalties of up to $1,650 or imprisonment of up to 6 months, or both apply for each offence. In the case of some prescription only medications, the penalties may be up to $2,200, or imprisonment of up to two years, or both for each offence​.

Current as at: Monday 8 April 2024
Contact page owner: Pharmaceutical Services