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What's new
87 result(s) found, displaying 1 to 25
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FormsThe completed assurances form is required in Module 1.5 of your OTC new medicine N1 application
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FormsThe completed assurances form is required in Module 1.5 of your OTC new medicine N2 application
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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 on how to report an adverse event or concern about a medical device.
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GuidanceGuidance for healthcare facilities, including information about the requirements for data fields, timeframes for reporting and other considerations.
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DatasetSearch approvals to import and supply medicines not in the Australian Register of Therapeutic Goods (ARTG) to address medicine shortages.
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PageWhen and how we regulate medical devices that are or use artificial intelligence technology.
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PageInternational standards can support safety, quality and cyber security in medical device software.
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Market actionsEdgewell Personal Care Australia Pty Ltd is recalling all unexpired batches (nine in total) due to the potential for the lotions to become separated.
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PageWe are reviewing all ventilators, continuous positive airway pressure (CPAP), and bi-level positive airway pressure (BiPAP) devices in the ARTG.
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PageWe have identified additional devices (other than those supplied by Philips Electronics Australia Ltd) that contain PE-PUR foam material for sound abatement purpose in the breathing gas pathway.
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PageWe are reviewing all ventilator, CPAP, and BiPAP devices in the ARTG to clarify what devices incorporate sound abatement features.
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PageFind out more about our post-market review of ventilator, CPAP and BiPAP devices included in the Australian Register of Therapeutic Goods (ARTG).
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Market actionsGem Care Products Pty Ltd is recalling all unexpired batches (two in total) due to the potential for the lotions to become separated.
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Australian public assessment report (AusPar)Augtyro has been approved for the treatment of adult patients with ROS1-positive locally advanced or metastatic non-small cell lung cancer (NSCLC).
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Advertising permissionApproval under section 42DF for use of restricted representations by B Braun Australia Pty Ltd
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PageFind the monographs available for over-the-counter (OTC) new medicine N2 applications.
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Media releasesTGA has issued infringement notices to Prime Medic Group Pty Ltd (Prime Medic) and an individual for the alleged unlawful advertising of weight loss medicines in contravention of the Therapeutic Goods Act 1989 (the Act).
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Advertising permissionApproval under section 42DF for use of restricted representations by Stryker Australia Pty Ltd
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PageThe Poisons Standard consists of decisions regarding the classification of medicines and poisons into Schedules for inclusion in the relevant legislation of the States and Territories.
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News articlesThe Adverse Event Management System (AEMS) has moved to the cloud, delivering improved system stability and security.
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PageKey information about the shortage for patients, carers and health care professionals
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PageTo help sponsors understand and meet their ongoing regulatory obligations after consent to supply is granted and throughout the consent period.
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