Legislation

This legislation amends the settings relating to the exclusion of certain sunscreen products from the application of the Australian therapeutic goods laws.

This Determination amends the Therapeutic Goods (Excluded Goods) Determination 2018 so that vaping devices are no longer excluded goods for the purposes of the Therapeutic Goods Act 1989.

This Determination specifies goods that are excluded from regulation for the purposes of the Therapeutic Goods Act 1989.

This Determination exempts certain statements in monograph 3053 for Live Biotherapeutic Products for Human Use of both the British Pharmacopoeia (BP) and European Pharmacopoeia (EP) for particular therapeutic goods, under subsection 3C(2) of the Therapeutic Goods Act 1989.

This Determination is made under section 3C of the Therapeutic Goods Act 1989. Its purpose is to exempt certain statements found in specific monographs from the British Pharmacopoeia, the European Pharmacopoeia or the United States Pharmacopoeia-National Formulary, from being treated as legal ‘standards’ for particular therapeutic goods in Australia.

Specifies the foreign countries in which registration or approval for general marketing of specified therapeutic goods in at least one of those countries is a prerequisite for the purposes of subparagraph 19A(1)(b)(i) of the Therapeutic Goods Act 1989

This Instrument contains guidelines setting out the circumstances in which a licence issued under Part 3-3 of the Therapeutic Goods Act 1989 may cover two or more manufacturing sites.

This Specification facilitates the public release of specified therapeutic goods information relating to exemptions that do or do not apply under the Annual Charges Exemption Scheme.

This Specification facilitates the release of information about the materials used in the production of specified medical devices to specified persons for certain purposes.

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

This Specification facilitates the release of specified therapeutic goods information, relating to in-house in vitro diagnostic (IVD) medical devices, to the National Association of Testing Authorities (NATA).

This Specification facilitates the public release of specified therapeutic goods information.

This Instrument authorises the public release of specified therapeutic goods information that has been reported to the TGA and is recorded in the Database of Adverse Event Notifications (DAEN).

This Instrument authorises the release of specified therapeutic goods information relating to medicine shortages and availability data either to a specified person, body or authority or to the public.

This legislation specifies information requirements for therapeutic vaping products and devices in Australia for regulatory and safety purposes.

This amendment to the Therapeutic Goods Regulations 1990 makes various changes to support the implementation of the TGA’s Medicines Repurposing Program (MRP), and a small number of other measures.

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

This Instrument amends the Therapeutic Goods Regulations 1990 to increase fees relating to therapeutic goods to support cost recovery.

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

These Amendment Regulations amend the Therapeutic Goods Regulations 1990 and Therapeutic Goods (Medical Devices) Regulations 2002 to implement the first stage of the Government's vaping reform measures.

This Specification specifies therapeutic goods information that may be released by the Secretary in relation to compliance reviews of listed medicines.

This Determination sets out conditions for listing specified listed medicines on the Australian Register of Therapeutic Goods (ARTG).

This legislation updates the requirements for the manufacturing of therapeutic goods in Australia to ensure compliance with minimum benchmarks and to ensure the safety and quality of therapeutic goods manufactured in Australia.

This Determination sets legally enforceable standards to ensure therapeutic goods in Australia are manufactured safely, consistently, and to high quality.

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