Legislation
This page lists legislation that is referred to in our Guidance content.
Loading...
Search
128 result(s) found, displaying 76 to 100
-
LegislationThis Specification specifies kinds of medical devices that cannot be approved for marketing in Australia if they are intended to be used exclusively for one or more specified purposes.
-
LegislationThis Determination specifies the information that must accompany an application to include a medical device in the Australian Register of Therapeutic Goods (ARTG).
-
LegislationThis Instrument amends the Therapeutic Goods (Medical Devices—Specified Articles) Instrument 2020 to specify certain articles and components for use in the manufacture of therapeutic vaping devices or their accessories that are medical devices for the purposes of the Therapeutic Goods Act 1989.
-
LegislationThis Instrument specifies certain classes of articles that are considered medical devices for the purposes of the Therapeutic Goods Act 1989.
-
LegislationThis Specification facilitates the publication of aggregated and de-identified statistical information in relation to medicinal cannabis products under the authorised prescriber (AP), special access scheme category A (SAS A) and special access scheme category B (SAS B) pathways.
-
LegislationThis Specification facilitates the publication of information about medicinal cannabis products that have been the subject of the authorised prescriber (AP) scheme or the Special Access Scheme (SAS) B.
-
LegislationThis Specification sets out the required advisory statements for specified non-prescription medicines, including over the counter and registered complementary medicines.
-
LegislationThis Specification facilitates the open publication of certain kinds of therapeutic goods information relating to ingredients of medicines and components of biologicals in the Australian Register of Therapeutic Goods (ARTG).
-
LegislationThese Rules authorise specified classes of health practitioners to supply specified therapeutic goods in certain circumstances, under the TGA's Special Access Scheme category C pathway.
-
LegislationThis Determination sets out the list of reportable medicines which forms the Medicines Watch List under s 30EJ(1) of the Therapeutic Goods Act 1989.
-
LegislationThese Rules amend the Therapeutic Goods (Medicines—Authorised Supply) Rules 2022 to include the authorised supply of certain therapeutic vaping goods by specified health practitioners under certain conditions, and update references to the Special Access Scheme (SAS) Guidelines.
-
LegislationThis Therapeutic Goods Order constitutes a standard for medicines in relation to serialisation and the use of data matrix codes.
-
LegislationTo read the full text, visit the Federal Register of Legislation.
-
LegislationThis Specification facilitates the release of therapeutic goods information relating to the importation or exportation of therapeutic goods that are mercury to specified government bodies, to support Australia’s international obligations under the Minamata Convention on Mercury.
-
LegislationThis Therapeutic Goods Order determines various publications which constitute standards for medicine manufactured in Australia, or imported into Australia, for export only.
-
LegislationThis Therapeutic Goods Order constitutes a standard relating to the kinds of information required to be included on the label of prescription and other related medicines.
-
LegislationThis Therapeutic Goods Order constitutes a standard relating to the kinds of information required to be included on the label of non-prescription medicines.
-
LegislationThis Therapeutic Goods Order constitutes a standard in relation to therapeutic goods that are haematopoietic progenitor cells derived from cord blood.
-
LegislationThis Therapeutic Goods Order constitutes a standard for child-resistant packaging for specified kinds of medicines.
-
LegislationThis Determination specifies the information that must accompany an application to register an over the counter medicine on the Australian Register of Therapeutic Goods (ARTG).
-
LegislationThis Determination sets out overseas bodies which are overseas regulators of medical devices for the purposes of the Therapeutic Goods Act 1989.
-
LegislationThis 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).
-
LegislationThis Determination sets out a list of ingredients which have been assessed or otherwise considered to be safe for use in medicines that are listed on the Australian Register of Therapeutic Goods (ARTG) (including assessed listed medicines), and associated requirements to be followed when using particular ingredients in such medicines.
-
LegislationThis 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.
-
LegislationThis 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).