Are you importing cosmetic injectables into Australia for use in clinical practice? You must be the legal sponsor on the Australian Register of Therapeutic Goods (ARTG).
The regulatory scheme is important to the safety of Australian consumers.
The Therapeutic Goods Administration (TGA) regulates all medicines, medical devices and biologicals under the Therapeutic Goods Act 1989 (the Act).
The Act prohibits the import, export, manufacture, supply and advertising of unapproved therapeutic goods for human use, which have not been subject to approvals, exemptions, or permits. Unless a specific exemption applies, a therapeutic good must be entered on the Australian Register of Therapeutic Goods (ARTG), or it cannot be supplied in Australia.
Only legal sponsors are permitted to lawfully import therapeutic goods. A sponsor is a person or company who is legally responsible for supplying goods on the ARTG in Australia.
Cosmetic injectables are regulated as Schedule 4 substances (prescription only medicines). You cannot publish an advertisement to the public about therapeutic goods that contains a statement referring to goods, or substances or preparations containing goods, included in Schedules 3, 4 or 8 of the Poisons Standard.
Health professionals and cosmetic or beauty clinics are not permitted to advertise references to the active ingredients in cosmetic injections. Abbreviations of either the trade or ingredient names are also unacceptable. Further information is available at advertising cosmetic injections.
Cosmetic injections require a prescription from an accredited professional, and can only be stored and administered by qualified, authorised practitioners. You need to be aware of your obligations under State and Territory legislation for storage of Schedule 4 substances. Cosmetic injectables are considered high risk products and clients must be assessed by a medical professional before their use.
The TGA takes action against illegal activity
The TGA investigates suspected illegal activity relating to therapeutic goods, including unlawfully supplied products. Appropriate regulatory action is taken where necessary, ranging from education and support through to seizure and destruction of unapproved therapeutic goods, fines and court proceedings. Targeting legislative non-compliance disrupts the illegal trading of unapproved and counterfeit therapeutic goods in the domestic market.
The TGA encourages the reporting of illegal cosmetic injectable procedures in Australia. These reports can prevent potentially serious consequences and safeguard the health of the Australian community.
If you suspect non-compliance regarding cosmetic injectable products, you can report illegal or questionable practices anonymously online to the TGA, or by calling 1800 020 653. You can also, report suspected supply of counterfeit medicines and medical devices. Information provided should include sufficient details for further enquires to be undertaken.
Advertising complaints can also be made online. Any person, including businesses, must comply with the TGA requirements for advertising.
The Australian Health Practitioner Regulation Agency (AHPRA) can be notified if you have concerns about practitioners.