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What's new
122 result(s) found, displaying 26 to 50
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FormsUse this form to request certificates or certified copies of TGA licences and certificates.
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User guideLearn how to create and manage UDI records in the AusUDID online portal.
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GuidanceGuidance on regulatory requirements for Ahpra-registered dental practitioners making and adapting personalised medical devices for patients.
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GuidanceGuidance for sponsors of medical devices seeking to include a medical device (including in vitro diagnostic devices) in the Australian Register of Therapeutic Goods.
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PagePharmaceutical companies Novo Nordisk and Eli Lilly are gradually discontinuing some of their earlier generation insulin products. Our webpage lists affected products and includes alternative options.
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PageThe Serious Scarcity Substitution Instrument (SSSI) has lapsed and the product is available.
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PageThe shortages of most methylphenidate modified-release products have resolved.
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Meeting statementsAdvisory Committee on Medicines meeting statement
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Prescription medicine decision summaryCifoban (sodium citrate dihydrate) is approved for use in adults and children for regional citrate anticoagulation (RCA) in continuous venovenous haemodialysis (CVVHD), continuous venovenous haemodiafiltration (CVVHDF), sustained low efficiency (daily) dialysis (SLEDD) and therapeutic plasma exchange (TPE) via membrane plasma separation.
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ConsultationHave your say about proposals to amend the Poisons Standard. These will be considered at the next meeting of the Advisory Committee on Medicines Scheduling (ACMS), Advisory Committee on Chemicals Scheduling (ACCS), and the joint meeting of the ACMS and ACCS.
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Corporate reportsThis Cost Recovery Implementation Statement (CRIS) 2026-2027 provides information on how we implement, and cost recover our regulatory activities.
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Safety alertsWe are advising consumers that Grakcu capsules may pose a serious risk to your health and should not be taken.
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PageLearn how Australia’s UDI framework aligns globally and fits within the Essential Principles.
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DatasetRead our results and outcomes of listed medicine compliance reviews.
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News articlesWe've updated the Listed Medicine Compliance Reports database with the results of compliance reviews covering 13 listed medicines.
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Australian public assessment report (AusPar)Livdelzi (seladelpar) has been approved for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults who have an inadequate response to UDCA alone, or as monotherapy in those unable to tolerate UDCA.
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PageFind out how to manage a medical device supply disruption or shortage if you're a sponsor, consumer, healthcare facility or professional.
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PageInformation about how to report a medical device supply disruption or shortage
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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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PageApprovals under section 41HD enable sponsors to import and supply specific medical devices during supply emergencies under special exemptions and conditions.
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GuidanceGuidance to help applicants understand what a section 41HD application is, how to submit an application, and what evidence will be needed.
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GuidanceGuidance and examples to help you understand the regulatory framework for personalised medical devices.
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PageKey information about the shortage for patients, carers and health care professionals
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PageThe EU MDR transition web publication service provides notifications to providers and consumers going through low-risk changes, as part of the transition.
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Australian public assessment report (AusPar)Filsuvez is approved for the treatment of partial thickness wounds associated with dystrophic and junctional epidermolysis bullosa (EB) in patients 6 months and older.