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What's new
62 result(s) found, displaying 1 to 25
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Meeting statementsAdvisory Committee on Medicines meeting statement
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GuidanceThis guidance is to assist you to apply for a Certificate of Free Sale or an Export Certificate for medical devices, including in-vitro diagnostic medical devices (IVDs) and Other Therapeutic Goods (OTGs).
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Scheduling decisions (final)This web publication constitutes a notice for the purposes of regulation 42ZCZS and regulation of the 42ZCX Therapeutic Goods Regulations 1990 (the Regulations).
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PageIndividuals can legally import most therapeutic goods for personal use under the Personal Importation Scheme, provided certain conditions are met.
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PageLearn more about the TGA's post-market review of mercury-containing medical devices.
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Scheduling submissionsFind out about the public submissions on scheduling matters referred to the ACMS, ACCS & Joint ACMS-ACCS MARCH, 2024
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PageInformation about the shortages of HRT products for patients and healthcare professionals
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Media releasesAn individual has been sentenced for unlawfully advertising and supplying black salve and bloodroot capsules, and for advertising other unapproved therapeutic goods to treat serious conditions such as anxiety.
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Safety updatesInformation for health professionals about medicines with safety related updates to their Product Information.
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PageThe Freedom of Information disclosure log gives access to information we've released in response to an FOI request.
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PageInformation about current processing times, workload, priorities, and key messages for GMP Clearance applications.
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PageThe ARGLM will help you navigate the regulatory requirements for listed and assessed listed medicines in Australia.
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PageInformation for health professionals importing and supplying medical devices.
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PageUnderstand the regulatory requirements and legislative framework to help you get started as a new sponsor.
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Media releasesWe have issued 2 infringement notices totalling $37,560 to Booty N Buff Nutrition Caringbah Pty Ltd (Booty N Buff Nutrition) for the alleged unlawful advertising of therapeutic goods in contravention of the Therapeutic Goods Act 1989 (the Act).
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PageCheck this page for key information and updates on the Trulicity shortage.
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Market actionsKmart Australia Ltd is recalling their Anko Small Gel Pak and Anko Large Gel Pak because they contain ethylene glycol, a toxic substance.
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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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News articlesOn 17 December 2025, the TGA made the decision to approve the registration of lenacapavir (YEYTUO).
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Advertising permissionThis instrument is made under section 42DK of the Therapeutic Goods Act 1989
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PageThe ARGOM will help you navigate the regulatory requirements for over-the-counter (OTC) medicines in Australia.
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ChecklistsThis checklist assists sponsors to prepare a change application at the C1 level for a registered OTC medicine.
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PageFor health professionals. Links to fact sheets and other resources about urogynaecological (transvaginal) surgical mesh.
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Australian public assessment report (AusPar)Sondelbay, Teriparintas and Teriparaccord have been approved for the treatment of osteoporosis.