Legislation

This Determination sets out overseas bodies which are overseas regulators of medical devices for the purposes of the Therapeutic Goods Act 1989.

This Determination sets out the list of permitted therapeutic claims (indications) which may be made in relation to medicines that are listed on the Australian Register of Therapeutic Goods (ARTG) under sections 26A, or 26AE, of the Therapeutic Goods Act 1989 (these are listed, and listed assessed medicines).

This Determination sets out a list of ingredients which have been assessed or otherwise considered to be safe for use in medicines that are listed in the Australian Register of Therapeutic Goods (ARTG) (including assessed listed medicines), and associated requirements to be followed when using particular ingredients in such medicines.

This Determination specifies the kind of information that must accompany an application for a recommendation by the Secretary that the Minister vary a section 26BB determination made under the Therapeutic Goods Act 1989.

This Determination specifies the approved format for an application dossier accompanying an application for registration of a prescription medicine on the Australian Register of Therapeutic Goods (ARTG).

This Determination specifies the information that must accompany an application to register a prescription medicine on the Australian Register of Therapeutic Goods (ARTG).

This Specification facilitates the release of specified therapeutic goods information relating to prescription medicines to Therapeutic Guidelines Ltd (TGL) to facilitate the publication of specified information in the journal Australian Prescriber.

This Specification facilitates the publication of specified therapeutic goods information relating to applications for the registration of prescription medicines in the Australian Register of Therapeutic Goods (ARTG).

These regulations provide requirements relating to the manufacturing, supply and advertising of therapeutic goods in Australia. These regulations also set out a number of important elements of the therapeutic goods regulatory scheme in Australia, including for instance specifying fees for applying for marketing approval for a therapeutic good or for a manufacturing licence, and setting out exemptions from the requirement for therapeutic goods other than medical devices to be included in the Australian Register of Therapeutic Goods (ARTG).

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 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.

To read the full text, visit the Federal Register of Legislation.

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

To read the full text, visit the Federal Register of Legislation.

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.

To read the full text, visit the Federal Register of Legislation.

To read the full text, visit the Federal Register of Legislation.

To read the full text, visit the Federal Register of Legislation.