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What's new
94 result(s) found, displaying 51 to 75
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Market actionsMindray Medical Australia Pty Ltd is conducting a product correction for the BeneHeart C Series Automated External Defibrillator (AED).
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PageEstablished AI limits form some nitrosamine impurities that we consider acceptable. These apply for all routes of administration and are listed in Appendix 1.
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PageSearch for infringement notices whereby a financial penalty may be issued in response to certain breaches of the Therapeutic Goods Act 1989 (the Act).
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News articlesThe TGA is updating information for nitrosamine impurities and other nitroso-structure impurities in medicines including acceptable intakes (AI).
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Safety alertsWe are issuing an updated safety advisory regarding imported counterfeit unregistered melatonin products.
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Media releasesWe have issued 11 infringement notices totalling $43,560, to 6 individuals, for the alleged importation and unlawful advertising of therapeutic goods.
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GuidanceGuidance about how Clinical Decision Support System (CDSS) software is regulated. Find out when this software is exempt from inclusion in the Australian Register of Therapeutic Goods (ARTG).
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PageRevisions includes updates to nitrosamine and other nitroso-structure acceptable intake (AI) limit information published by the TGA.
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PageInformation about the shortage, Serious Scarcity Substitution Instrument and overseas-registered alternative
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PageFind out about our compliance review activities for listed medicines and how to avoid common compliance issues.
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PageWe will be initiating targeted compliance reviews of selected listed medicines that include indications related to diarrhoea and are subject to specific warning statements.
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News articlesWe conducted targeted compliance reviews of selected listed medicines using indications related to diarrhoea that are required to display a warning statement
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Medicine shortage alertsInformation and approvals to manage Presolol 200 tablet shortage
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PageThis page contains a list of therapeutic vaping goods, for use in smoking cessation or the management of nicotine dependence, that can be legally supplied in Australia. Healthcare practitioners can use this list when prescribing and supplying unapproved therapeutic vaping goods as they have been notified as complying with applicable standards.
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PageSerious Scarcity Substitution Instruments (SSSIs) allow community pharmacists to substitute specific medicines without prior approval from the prescriber so long as the permitted circumstances within the SSSI are met.
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Media releasesOn 23 January 2026 we, with support from Victoria Police, executed a search warrant at a pop up retail store in Inverloch, Victoria.
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Safety alertsTGA continues to see imports of counterfeit Botox vials despite a previous warning issued in July 2025.
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Meeting statementsAdvisory Committee on Complementary Medicines meeting statement for 6 November 2025
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PageThe TGA has undertaken a post-market review of all home-use foetal dopplers included in the Australian Register of Therapeutic Goods (ARTG).
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PageLists of unapproved products authorised for supply under SAS Category C.
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Medicine shortage alertsSerious Scarcity Substitution Instrument extended due to continued shortages of HRT patch products.
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Media releasesThis statement provides guidance to industry about how the Therapeutic Goods Act 1989 applies in relation to sunscreen labelling.
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GuidanceFind out how TGA regulates software and artificial intelligence (AI) based medical devices.