Legislation
This page lists legislation that is referred to in our Guidance content.
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128 result(s) found, displaying 51 to 75
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LegislationThis Determination specifies goods that are excluded from regulation for the purposes of the Therapeutic Goods Act 1989.
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LegislationThis Determination specifies the foreign countries in which therapeutic goods must be approved for general marketing if the Secretary is to approve the importation or supply of those therapeutic goods that are not on the Australian Register of Therapeutic Goods, under subsection 19A(1) of the Therapeutic Goods Act 1989.
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LegislationThis 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.
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LegislationThis 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.
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LegislationThis Specification facilitates the release of information about the materials used in the production of specified medical devices to specified persons for certain purposes.
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LegislationTo read the full text, visit the Federal Register of Legislation.
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LegislationThis 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).
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LegislationThis Specification facilitates the public release of specified therapeutic goods information.
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LegislationThis 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).
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LegislationThis 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.
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LegislationThis legislation specifies information requirements for therapeutic vaping products and devices in Australia for regulatory and safety purposes.
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LegislationThis 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.
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LegislationTo read the full text, visit the Federal Register of Legislation
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LegislationThis Instrument amends the Therapeutic Goods Regulations 1990 to increase fees relating to therapeutic goods to support cost recovery.
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LegislationTo read the full text, visit the Federal Register of Legislation.
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LegislationThese 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.
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LegislationThis Specification specifies therapeutic goods information that may be released by the Secretary in relation to compliance reviews of listed medicines.
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LegislationThis Determination sets out conditions for listing specified listed medicines on the Australian Register of Therapeutic Goods (ARTG).
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LegislationThis 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.
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LegislationTo read the full text, visit the Federal Register of Legislation.
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LegislationThis Order constitutes an optional medical device standard for therapeutic vaping devices and therapeutic vaping device accessories.
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LegislationTo read the full text, visit the Federal Register of Legislation.
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LegislationThese Rules specify circumstances in which a health practitioner is authorised to supply specified medical devices which are not included in the Australian Register of Therapeutic Goods (ARTG), under the TGA's Special Access Scheme category C pathway.
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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.