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What's new
72 result(s) found, displaying 26 to 50
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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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PageA list of established AI limits for some other N-nitroso-structures. N-Nitroso-structures include N nitrosoguanidines, N nitroso-indoles and N nitrosoureas.
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PageRead the latest news and updates related to medicinal cannabis.
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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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PageRevisions includes updates to nitrosamine and other nitroso-structure acceptable intake (AI) limit information published by the TGA.
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PageKnow the ways we respond to breaches such as warnings, fines and legal action.
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Regulatory decision noticesThe delegate believes, on reasonable grounds, that it is in the interests of public health or safety to give Hwangbo SS Pty Ltd and [REDACTED] directions under section 42YT of the Therapeutic Goods Act 1989.
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PageWe can require a person to take steps to address non-compliance in relation to goods under the Therapeutic Goods Act 1989.
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PageInformation about the shortage and the Serious Scarcity Substitution Instrument
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PageA Microsoft Excel template for sponsors and manufacturers to upload UDI records in bulk to the Australian UDI Database.
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PageThe Australian UDI Data Dictionary includes a list of the fields in the database, including element names, descriptions, permitted values and other metadata.
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PageRead the latest enhancements and fixes to the Australian UDI Database Pre-Production environment.
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PageResources and technical documents for Machine to Machine (M2M) HL7 SPL users in the Australian Unique Device Identification Database (AusUDID).
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Market actionsProduct correction: Ypsomed Australia is reminding users to ensure they use a compatible smart device and operating system (OS) when using the Mylife CamAPS FX app.
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Medicine shortage alertsWe have extended the Therapeutic Goods (Serious Scarcity and Substitutable Medicine) (Labetalol) Instrument 2025 (SSSI) to 31 December 2025.
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PageRSS feeds (Really Simple Syndication feed) for immediate notifications of updates to the TGA website.
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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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PageSet up your account and understand the different system roles.
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News articlesWe have made changes to our website to make finding information easier. These improvements are based on your feedback.
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Media releasesWe have issued a warning to online delivery service providers not to breach Australian laws regarding the supply and advertising of vaping goods.
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Advertising permissionApproval under section 42DF for use of restricted representations by BMedical Pty Ltd
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PageInformation about the shortages of IV fluid products
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PageInformation about the supply of oral opioid medicines that are in shortage and products that have been discontinued.
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Media releasesProfessor Tony Lawler, Head of Australia’s Therapeutic Goods Administration, has been elected Chair of ICMRA, the International Coalition of Medicines Regulatory Authorities.