Legislation
This page lists legislation that is referred to in our Guidance content.
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128 result(s) found, displaying 101 to 125
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LegislationThis Determination specifies the information that must accompany an application to register a prescription medicine on the Australian Register of Therapeutic Goods (ARTG).
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LegislationThis 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.
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LegislationThis 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).
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LegislationThese 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.
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LegislationThis Determination specifies medicines which are reportable medicines for the purposes of the Therapeutic Goods Act 1989.
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LegislationThis Specification specifies medicines and classes of medicine which are restricted medicines for the purposes of the Therapeutic Goods Act 1989.
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LegislationThis 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.
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LegislationThis legislation amends rules for fluoxetine substitution during serious shortages, ensuring continued access to essential medication for patients needing this antidepressant.
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LegislationThis legislation addresses serious scarcity of gliclazide, allowing substitution of alternative medicines to ensure continued treatment for patients with diabetes.
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LegislationThis Therapeutic Goods Order constitutes a standard for biologicals in relation to labelling.
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LegislationThis Therapeutic Goods Order constitutes a standard for disinfectants, sanitisers, sanitary fluids and sanitary powders.
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LegislationThis Therapeutic Goods Order constitutes a standard for faecal microbiota transplant products.
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LegislationTo read the full text, visit the Federal Register of Legislation.
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LegislationThis Therapeutic Goods Order constitutes a standard for medicinal cannabis products.
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LegislationTo read the full text, visit the Federal Register of Legislation.
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LegislationThis 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.
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LegislationTo read the full text, visit the Federal Register of Legislation.
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LegislationTo read the full text, visit the Federal Register of Legislation.
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LegislationTo read the full text, visit the Federal Register of Legislation.
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LegislationThis Therapeutic Goods Order constitutes a standard for therapeutic vaping substances, therapeutic vaping substance accessories, therapeutic vaping kits and goods in a therapeutic vaping pack.
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Therapeutic Goods (Standards for Biologicals—General and Specific Requirements) (TGO 109) Order 2021
LegislationThis 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. -
LegislationThis Specification facilitates the release of specified therapeutic goods information held by the TGA in the database known as the System for Australian Recall Actions (SARA), relating to recall actions involving therapeutic goods.
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LegislationThis Instrument amends the Therapeutic Goods Advertising Code to include a reference to the Therapeutic Goods (Restricted Representations—COVID-19 Vaccines) Permission 2022.
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LegislationThis 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.
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LegislationThis 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.