Temporary Disabled. :) please Go back Therapeutic Goods Administration (TGA) | Australian Government Department of Health www.fgks.org » Address: [go: up one dir, main page] Include Form Remove Scripts Accept Cookies Show Images Show Referer Rotate13 Base64 Strip Meta Strip Title Session Cookies Skip to Content Skip to Main Navigation Skip to Search Contact TGA: info@tga.gov.au | 1800 020 653 | More contact info Translate | Subscribe Therapeutic Goods Administration (TGA) Australian Government Department of Health Main menu Home Safety informationReport a problem or side effectReporting adverse events involving medicines, vaccines or medical devices Report an issue with packaging or storage of a medicine AEMS guidance for health professionals AEMS guidance for sponsors Help us promote adverse event reporting: promotional resources kit AlertsCurrent year alerts All alerts RecallsAbout Australian recall actions Recall actions database Uniform recall procedure Prescription opioids Medicine shortages Early warning systemMonitoring communications About the Early Warning System Early Warning System: consumer questions and answers Early Warning System: health professional questions and answers Black Triangle SchemeBlack Triangle Scheme: Information for sponsors Safety information & educationMedicines safety Medical devices safety Database of Adverse Event Notifications (DAEN) COVID-19COVID-19 rapid antigen self-tests COVID-19 treatmentsCOVID-19 treatments: Provisional determinations Labels for COVID-19 treatments Therapeutic Goods (Poisons Standard) (COVID-19 Treatment - Roche) (Casirivimab and Imdevimab) Labelling Exemption 2021 COVID-19 treatments: Provisional registrations COVID-19 treatments: Treatments undergoing evaluation COVID-19 treatments: Advertising compliance COVID-19 treatments: Information for consumers and health professionals COVID-19 treatments: Information for sponsors (industry) COVID-19 vaccinesCOVID-19 vaccine approval process COVID-19 vaccines undergoing evaluation Provisional registrations COVID-19 vaccine safety monitoring and reporting News and updates COVID-19 vaccine advertising and import compliance Information for consumers and health professionals Information for sponsors (industry) International collaboration ConsumersReport a problem or side effectReporting adverse events involving medicines, vaccines or medical devices Travelling with medicines and medical devicesLeaving Australia Entering Australia Helpful links for travellers Buying medicines and medical devices onlineCounterfeit medicines and devices Can I import it?Personal importation scheme Medicinal cannabis: importation and the traveller's exemption MedicinesHow we regulate medicines Prescription medicines Complementary medicines Over-the-counter (OTC) medicines Vaccines What's on my medicine label? 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Find out more » COVID-19 Latest regulatory and safety information on COVID-19 vaccines, treatments, face masks and medical devices Find out more » Consumers Personal importation For travellers Buying online Health Professionals Reporting problems Unapproved products Special access scheme Industry SME Assist Regulation basics Scheduling basics Recalls and suspensions Philips recall action for CPAP, Bi-Level PAP devices and mechanical ventilators 23 September 2021 Consumer and regulatory updates CHATTANOOGA Ultrasound Gel Products and Lotions 14 September 2021 Recall due to risk of bacterial contamination Neutrogena Ultra Sheer Body Mist Sunscreen Spray SPF 50+ (aerosol sunscreen) 2 August 2021 Recall - Possible presence of benzene Ospolot (sulthiame) tablets 200 mg 3 June 2021 Product Defect Alert - child-resistant caps may not function correctly More safety information » Safety information COVID-19 vaccine weekly safety report - 04-11-2021 4 November 2021 Information about the TGA's safety monitoring of COVID-19 vaccines. S.W.A.G II Platinum 33K 4 November 2021 S.W.A.G II Platinum 33K products pose a serious risk to your health and should not be taken. Panther Power Platinum 11000 4 November 2021 Panther Power Platinum 11000 capsules pose a serious risk to your health and should not be taken. 777K products 3 November 2021 777K products pose a serious risk to your health and should not be taken. More safety information » News Melbourne-based individual fined $7,992 for alleged unlawful importation of nicotine vaping products 5 November 2021 The TGA has issued three infringement notices, totalling $7,992, to a Melbourne-based individual for alleged importation breaches involving nicotine vaping products. Supply and wholesaling of medicinal cannabis products (MCP) 5 November 2021 The guidance sets out the regulatory requirements for importing, manufacturing and supplying finished medicinal cannabis products. RV Global Ecommerce Pty Ltd fined $39,960 for alleged unlawful advertising of nicotine vaping products 5 November 2021 The TGA has issued three infringement notices totalling $39,960 to Sydney-based company RV Global Ecommerce Pty Ltd for alleged unlawful advertising of nicotine vaping products. Medical devices reforms: Personalised medical devices 5 November 2021 Guidance updated to reflect recent regulatory refinements to personalised medical devices. 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The Therapeutic Goods Administration is part of the Health Products Regulation Group