Legislation

These regulations provide requirements relating to the manufacturing, supply and advertising of therapeutic goods in Australia.

This Determination specifies medicines which are reportable medicines for the purposes of the Therapeutic Goods Act 1989.

This Specification specifies medicines and classes of medicine which are restricted medicines for the purposes of the Therapeutic Goods Act 1989.

This Instrument declares that there is a serious scarcity across Australia of specified medicines (ORENCIA abatacept (rch) 125 mg single dose syringe and ClickJect prefilled autoinjector) and specifies the medicines that pharmacists are permitted to dispense in substitution, and the circumstance in which they may do so.

This legislation amends rules for fluoxetine substitution during serious shortages, ensuring continued access to essential medication for patients needing this antidepressant.

This legislation addresses serious scarcity of gliclazide, allowing substitution of alternative medicines to ensure continued treatment for patients with diabetes.

This Therapeutic Goods Order constitutes a standard for biologicals in relation to labelling.

This Therapeutic Goods Order constitutes a standard for disinfectants, sanitisers, sanitary fluids and sanitary powders.

This Order sets out the regulatory and quality requirements that apply to medicines manufactured in Australia for export.

This Therapeutic Goods Order constitutes a standard for faecal microbiota transplant products.

The Order establishes mandatory requirements for the screening of donors of human cell and tissue products in Australia to ensure the safety, quality, and efficacy of these products for therapeutic use.

The TGO 112 Order 2024 sets forth the quality standards for MDMA (3,4-methylenedioxymethamphetamine) products, which must comply with specific requirements to ensure safety and efficacy.

This Therapeutic Goods Order constitutes a standard for medicinal cannabis products.

The TGO 99 Order 2018 outlines the regulatory framework for menstrual cups, which are classified as therapeutic goods in Australia.

This Instrument amends TGO 110 to introduce minimum safety and quality requirements for therapeutic vaping substances and related goods, and to restrict the available flavours of therapeutic vaping substances and substance accessories.

The Therapeutic Goods (Standard for Psilocybine) (TGO 113) Order 2024 establishes new quality standards for psilocybine products in Australia.

The Therapeutic Goods (Standard for Tablets, Capsules and Pills) (TGO 101) Order 2019 outlines the quality standards for therapeutic goods such as tablets, capsules, and pills in Australia.

The Therapeutic Goods (Standard for Tampons) (TGO 103) Order 2019 is a regulation in Australia that ensures tampons are manufactured to minimise health risks.

This Therapeutic Goods Order constitutes a standard for therapeutic vaping substances, therapeutic vaping substance accessories, therapeutic vaping kits and goods in a therapeutic vaping pack.

This Therapeutic Goods Order sets out general and specific requirements relating to all biologicals, human musculoskeletal tissue products, human cardiovascular tissue products, human ocular tissue products, human skin products and human amnion products.

This Instrument amends the Therapeutic Goods Advertising Code to include a reference to the Therapeutic Goods (Restricted Representations—COVID-19 Vaccines) Permission 2022.

This Instrument contains the Therapeutic Goods Advertising Code. The Code specifies a range of requirements to protect the Australian public from the personal and public health risks associated with unethical, inaccurate or misleading advertising practices relating to the advertising of therapeutic goods.

This Specification facilitates the public release of therapeutic goods information that has been provided to the TGA by a sponsor in an Online Notification Form that relates to the transition of a medical device from certain European Directives to the new EU medical devices regulation.

This Determination specifies the kinds of vaping goods which may be supplied or possessed by specified persons or classes of persons and under what circumstances or conditions.

The Therapeutic Goods (Vaping Goods—Advertising) Authorisation 2024 regulates the advertising of vaping products in Australia.