https://www.tga.gov.au/ All articles en https://www.tga.gov.au/news/media-releases/philips-recall-action-sleep-apnoea-and-respiratory-care-machines-final-chance-register-replacement-device If you use a Philips Continuous Positive Airway Pressure (CPAP) machine or a Bi-level Positive Airway Pressure (Bi-Level PAP) machine you may be affected by this recall action. Register your machine for repair or replacement to avoid any potential risks. Thu, 07 Dec 23 12:00:00 +0000 Thu, 07 Dec 23 12:00:00 +0000 https://www.tga.gov.au/news/media-releases/philips-recall-action-sleep-apnoea-and-respiratory-care-machines-final-chance-register-replacement-device https://www.tga.gov.au/news/safety-updates/new-warnings-romosozumab-evenity-cardiovascular-risks Be alert to new warnings of romosozumab (Evenity) cardiovascular risks for patients with a history of heart attack or stroke. If you're a health professional, read our Medicine safety update. Thu, 07 Dec 23 12:00:00 +0000 Thu, 07 Dec 23 12:00:00 +0000 https://www.tga.gov.au/news/safety-updates/new-warnings-romosozumab-evenity-cardiovascular-risks https://www.tga.gov.au/news/blog/create-content-plays-rules If you create content, you should know how to protect yourself and your business when it comes to promoting therapeutic goods. Tue, 05 Dec 23 12:00:00 +0000 Tue, 05 Dec 23 12:00:00 +0000 https://www.tga.gov.au/news/blog/create-content-plays-rules https://www.tga.gov.au/news/media-releases/court-proceedings-initiated-against-cda-clinics-qld-pty-ltd-and-its-former-director-alleged-unlawful-advertising-medicinal-cannabis We have alleged that the advertising on the company's website and social media was unlawful because medicinal cannabis products are prescription-only medicines that can't be advertised directly to consumers. Mon, 04 Dec 23 12:00:00 +0000 Mon, 04 Dec 23 12:00:00 +0000 https://www.tga.gov.au/news/media-releases/court-proceedings-initiated-against-cda-clinics-qld-pty-ltd-and-its-former-director-alleged-unlawful-advertising-medicinal-cannabis https://www.tga.gov.au/news/media-releases/new-regulations-place-stronger-controls-importation-manufacture-and-supply-vapes The changes will help address the significant public health issues caused by vaping in Australia, while keeping legitimate patient access to therapeutic vapes. Tue, 28 Nov 23 12:00:00 +0000 Tue, 28 Nov 23 12:00:00 +0000 https://www.tga.gov.au/news/media-releases/new-regulations-place-stronger-controls-importation-manufacture-and-supply-vapes https://www.tga.gov.au/news/blog/do-you-know-what-tga-does-and-doesnt-regulate If you have ever taken medicines, received an implant, had a blood transfusion or been given a vaccine, the TGA regulates those products. Did you know that the TGA also regulates some common products you’ll find in your local supermarket or health store? Wed, 22 Nov 23 12:00:00 +0000 Wed, 22 Nov 23 12:00:00 +0000 https://www.tga.gov.au/news/blog/do-you-know-what-tga-does-and-doesnt-regulate https://www.tga.gov.au/news/safety-updates/product-information-safety-updates-november-2023 If you're a health professional, get the latest information about medicines with safety related updates to their product information.   Mon, 20 Nov 23 12:00:00 +0000 Mon, 20 Nov 23 12:00:00 +0000 https://www.tga.gov.au/news/safety-updates/product-information-safety-updates-november-2023 https://www.tga.gov.au/news/news/new-medicine-adverse-event-search-sponsors We have launched a new search feature in the Adverse Event Management System (AEMS) portal.  As a sponsor, you can access adverse event reports about your medicines and biologicals. Mon, 20 Nov 23 12:00:00 +0000 Mon, 20 Nov 23 12:00:00 +0000 https://www.tga.gov.au/news/news/new-medicine-adverse-event-search-sponsors https://www.tga.gov.au/news/media-releases/joint-operation-seizes-2-million-worth-unlawfully-imported-therapeutic-goods We've worked with the Australian Border Force to keep more than 307,000 units of unlawfully imported medicines and medical devices out of the Australian market. Thu, 16 Nov 23 12:00:00 +0000 Thu, 16 Nov 23 12:00:00 +0000 https://www.tga.gov.au/news/media-releases/joint-operation-seizes-2-million-worth-unlawfully-imported-therapeutic-goods https://www.tga.gov.au/news/media-releases/instantscripts-pty-ltd-fined-742500-alleged-unlawful-advertising-therapeutic-goods We have issued 45 infringement notices totalling $742,500 to InstantScripts Pty Ltd for the alleged unlawful advertising of prescription-only medicines. Tue, 14 Nov 23 12:00:00 +0000 Tue, 14 Nov 23 12:00:00 +0000 https://www.tga.gov.au/news/media-releases/instantscripts-pty-ltd-fined-742500-alleged-unlawful-advertising-therapeutic-goods https://www.tga.gov.au/news/news/global-event-promotes-side-effect-reporting It's #MedSafetyWeek, a global movement to encourage the reporting of medicine side effects (known as ‘adverse events’). You can join in and help spread the word. Mon, 06 Nov 23 12:00:00 +0000 Mon, 06 Nov 23 12:00:00 +0000 https://www.tga.gov.au/news/news/global-event-promotes-side-effect-reporting https://www.tga.gov.au/news/covid-19-vaccine-safety-reports/covid-19-vaccine-safety-report-02-11-23 In line with the official end of the COVID-19 emergency response, this will be our last regular COVID-19 Vaccine Safety Report. We will continue safety monitoring of COVID-19 vaccines. Thu, 02 Nov 23 12:00:00 +0000 Thu, 02 Nov 23 12:00:00 +0000 https://www.tga.gov.au/news/covid-19-vaccine-safety-reports/covid-19-vaccine-safety-report-02-11-23 https://www.tga.gov.au/news/notices/therapeutic-goods-poisons-standard-covid-19-vaccine-pfizer-raxtozinameran-labelling-exemption-2023 We've granted a labelling exemption for the COVID-19 Vaccine, Pfizer (raxtozinameran), under the current Poisons Standard. Mon, 30 Oct 23 12:00:00 +0000 Mon, 30 Oct 23 12:00:00 +0000 https://www.tga.gov.au/news/notices/therapeutic-goods-poisons-standard-covid-19-vaccine-pfizer-raxtozinameran-labelling-exemption-2023 https://www.tga.gov.au/news/media-releases/vapor-kings-pty-ltd-and-director-penalised-total-5-million-advertising-nicotine-vaping-products The Federal Court of Australia has ordered Vapor Kings Pty Ltd to pay $4.9 million for unlawfully advertising nicotine vaping products. A company Director was also ordered to pay $100,000 in penalties. Fri, 27 Oct 23 12:00:00 +0000 Fri, 27 Oct 23 12:00:00 +0000 https://www.tga.gov.au/news/media-releases/vapor-kings-pty-ltd-and-director-penalised-total-5-million-advertising-nicotine-vaping-products https://www.tga.gov.au/news/media-releases/ovira-pty-ltd-fined-alleged-unlawful-advertising-health-product We have issued infringement notices totalling $82,632 to Ovira Pty Ltd, and an individual, for the alleged unlawful advertising of an analgesic TENS system. Thu, 26 Oct 23 12:00:00 +0000 Thu, 26 Oct 23 12:00:00 +0000 https://www.tga.gov.au/news/media-releases/ovira-pty-ltd-fined-alleged-unlawful-advertising-health-product https://www.tga.gov.au/news/notices/update-listed-medicine-ingredients-october-2023 Find out how listed medicine ingredients, and requirements for their use, have been updated in the Therapeutic Goods (Permissible Ingredients) Determination (No. 4) 2023. Wed, 25 Oct 23 12:00:00 +0000 Wed, 25 Oct 23 12:00:00 +0000 https://www.tga.gov.au/news/notices/update-listed-medicine-ingredients-october-2023 https://www.tga.gov.au/news/covid-19-vaccine-safety-reports/covid-19-vaccine-safety-report-19-10-2023 Information about the TGA's safety monitoring of COVID-19 vaccines. Thu, 19 Oct 23 12:00:00 +0000 Thu, 19 Oct 23 12:00:00 +0000 https://www.tga.gov.au/news/covid-19-vaccine-safety-reports/covid-19-vaccine-safety-report-19-10-2023 https://www.tga.gov.au/news/safety-updates/use-caution-when-prescribing-baclofen-label Recent coronial inquiries have highlighted the need for health professionals to be alert to the well documented risk of overdose with baclofen. Thu, 19 Oct 23 12:00:00 +0000 Thu, 19 Oct 23 12:00:00 +0000 https://www.tga.gov.au/news/safety-updates/use-caution-when-prescribing-baclofen-label https://www.tga.gov.au/news/news/warnings-supply-and-advertising-haytox ‘Haytox’ has not been approved by the TGA or included in the Australian Register of Therapeutic Goods (ARTG). Thu, 19 Oct 23 12:00:00 +0000 Thu, 19 Oct 23 12:00:00 +0000 https://www.tga.gov.au/news/news/warnings-supply-and-advertising-haytox https://www.tga.gov.au/news/safety-updates/product-information-safety-updates-october-2023 Medicines Safety Update - Information for health professionals Thu, 12 Oct 23 12:00:00 +0000 Thu, 12 Oct 23 12:00:00 +0000 https://www.tga.gov.au/news/safety-updates/product-information-safety-updates-october-2023 https://www.tga.gov.au/news/media-releases/tga-seizes-70000-vapes-nsw We have executed warrants on storage units in Sydney and seized more than 70,000 vaping products, with an estimated street value of over $2.1 million. They will be tested for dangerous and undeclared chemicals at our labs. Mon, 09 Oct 23 12:00:00 +0000 Mon, 09 Oct 23 12:00:00 +0000 https://www.tga.gov.au/news/media-releases/tga-seizes-70000-vapes-nsw https://www.tga.gov.au/news/covid-19-vaccine-safety-reports/covid-19-vaccine-safety-report-05-10-2023 Information about the TGA's safety monitoring of COVID-19 vaccines. Thu, 05 Oct 23 12:00:00 +0000 Thu, 05 Oct 23 12:00:00 +0000 https://www.tga.gov.au/news/covid-19-vaccine-safety-reports/covid-19-vaccine-safety-report-05-10-2023 https://www.tga.gov.au/news/notices/therapeutic-goods-database-adverse-event-notifications-arrangement-computer-programs-instrument-2023 Arrangement under subsection 7C(1) of the Therapeutic Goods Act 1989 Thu, 28 Sep 23 12:00:00 +0000 Thu, 28 Sep 23 12:00:00 +0000 https://www.tga.gov.au/news/notices/therapeutic-goods-database-adverse-event-notifications-arrangement-computer-programs-instrument-2023 https://www.tga.gov.au/news/covid-19-vaccine-safety-reports/covid-19-vaccine-safety-report-21-09-2023 Information about the TGA's safety monitoring of COVID-19 vaccines. Thu, 21 Sep 23 12:00:00 +0000 Thu, 21 Sep 23 12:00:00 +0000 https://www.tga.gov.au/news/covid-19-vaccine-safety-reports/covid-19-vaccine-safety-report-21-09-2023 https://www.tga.gov.au/news/news/covid-19-vaccine-janssen On 28 August 2023, Janssen-Cilag Pty Ltd voluntarily cancelled COVID-19 VACCINE JANSSEN from the Australian Register of Therapeutic Goods (ARTG). Mon, 18 Sep 23 12:00:00 +0000 Mon, 18 Sep 23 12:00:00 +0000 https://www.tga.gov.au/news/news/covid-19-vaccine-janssen https://www.tga.gov.au/news/media-releases/naturally-elevated-pty-ltd-and-individual-fined-138600-alleged-unlawful-advertising-medicinal-cannabis We have issued infringement notices to the company Naturally Elevated Pty Ltd and an individual for the alleged unlawful advertising of medicinal cannabis on websites and social media pages. Mon, 18 Sep 23 12:00:00 +0000 Mon, 18 Sep 23 12:00:00 +0000 https://www.tga.gov.au/news/media-releases/naturally-elevated-pty-ltd-and-individual-fined-138600-alleged-unlawful-advertising-medicinal-cannabis https://www.tga.gov.au/news/safety-updates/product-information-safety-updates-september-2023 Medicines Safety Update - Information for health professionals Wed, 13 Sep 23 12:00:00 +0000 Wed, 13 Sep 23 12:00:00 +0000 https://www.tga.gov.au/news/safety-updates/product-information-safety-updates-september-2023 https://www.tga.gov.au/news/news/medical-devices-vigilance-program-pilot We are starting a new medical device pilot program to support medical device sponsors to comply with their ongoing post-market surveillance responsibilities. Mon, 11 Sep 23 12:00:00 +0000 Mon, 11 Sep 23 12:00:00 +0000 https://www.tga.gov.au/news/news/medical-devices-vigilance-program-pilot https://www.tga.gov.au/news/notices/therapeutic-goods-mercury-form-application-import-or-export-approval-2023 This instrument is made under subregulation 10JD(4) of the Therapeutic Goods Regulations 1990. Mon, 11 Sep 23 12:00:00 +0000 Mon, 11 Sep 23 12:00:00 +0000 https://www.tga.gov.au/news/notices/therapeutic-goods-mercury-form-application-import-or-export-approval-2023 https://www.tga.gov.au/news/covid-19-vaccine-safety-reports/covid-19-vaccine-safety-report-07-09-2023 Information about the TGA's safety monitoring of COVID-19 vaccines. Thu, 07 Sep 23 12:00:00 +0000 Thu, 07 Sep 23 12:00:00 +0000 https://www.tga.gov.au/news/covid-19-vaccine-safety-reports/covid-19-vaccine-safety-report-07-09-2023 https://www.tga.gov.au/news/news/changes-regulation-sports-supplements-medicinal-dosage-forms From 30 November 2023, some sports supplements will be regulated as therapeutic goods and must be included in the Australian Register of Therapeutic Goods (ARTG). Fri, 01 Sep 23 12:00:00 +0000 Fri, 01 Sep 23 12:00:00 +0000 https://www.tga.gov.au/news/news/changes-regulation-sports-supplements-medicinal-dosage-forms https://www.tga.gov.au/news/news/scam-alert We are aware that a small number of people have received calls from scammers impersonating the TGA. Fri, 01 Sep 23 12:00:00 +0000 Fri, 01 Sep 23 12:00:00 +0000 https://www.tga.gov.au/news/news/scam-alert https://www.tga.gov.au/news/media-releases/tga-seizes-40000-vapes-part-multi-agency-operation-queensland On 29 August 2023, the TGA executed multiple warrants on storage units and residences in Brisbane and seized over 40,000 vaping products with an estimated street value of over $1.2 million Thu, 31 Aug 23 12:00:00 +0000 Thu, 31 Aug 23 12:00:00 +0000 https://www.tga.gov.au/news/media-releases/tga-seizes-40000-vapes-part-multi-agency-operation-queensland https://www.tga.gov.au/news/news/post-market-review-facemasks-closed The COVID-19 pandemic post-market review of facemasks is now finished. Thu, 31 Aug 23 12:00:00 +0000 Thu, 31 Aug 23 12:00:00 +0000 https://www.tga.gov.au/news/news/post-market-review-facemasks-closed https://www.tga.gov.au/news/safety-updates/product-information-safety-updates-august-2023 Medicines Safety Update - Information for health professionals Thu, 31 Aug 23 12:00:00 +0000 Thu, 31 Aug 23 12:00:00 +0000 https://www.tga.gov.au/news/safety-updates/product-information-safety-updates-august-2023 https://www.tga.gov.au/news/news/changes-choline-salicylate-access-start-1-october-2023 Find out about changes to choline salicylate access, starting from October 2023. Thu, 31 Aug 23 12:00:00 +0000 Thu, 31 Aug 23 12:00:00 +0000 https://www.tga.gov.au/news/news/changes-choline-salicylate-access-start-1-october-2023 https://www.tga.gov.au/news/news/product-information-inserts-are-no-longer-required-injectable-medicines-administered-health-professionals Find out how Product Information inserts won’t be required in the packaging of injectable medicines, given by health professionals, starting from September 2023. Wed, 30 Aug 23 12:00:00 +0000 Wed, 30 Aug 23 12:00:00 +0000 https://www.tga.gov.au/news/news/product-information-inserts-are-no-longer-required-injectable-medicines-administered-health-professionals https://www.tga.gov.au/news/media-releases/nius-development-pty-ltd-fined-26640-allegedly-importing-unapproved-cosmetic-injectable-products We have issued infringement notices for $26,640 to Nius Development Pty Ltd for the alleged unlawful import of unapproved cosmetic injectable products. Tue, 29 Aug 23 12:00:00 +0000 Tue, 29 Aug 23 12:00:00 +0000 https://www.tga.gov.au/news/media-releases/nius-development-pty-ltd-fined-26640-allegedly-importing-unapproved-cosmetic-injectable-products https://www.tga.gov.au/news/media-releases/empirelabz-australia-pty-ltd-fined-115500-alleged-unlawful-advertising-and-supply-sport-supplements The TGA has issued 7 infringement notices totalling $115,500 to the company for the alleged unlawful advertising and supply of sport supplement products containing banned substances. Mon, 28 Aug 23 12:00:00 +0000 Mon, 28 Aug 23 12:00:00 +0000 https://www.tga.gov.au/news/media-releases/empirelabz-australia-pty-ltd-fined-115500-alleged-unlawful-advertising-and-supply-sport-supplements https://www.tga.gov.au/news/covid-19-vaccine-safety-reports/covid-19-vaccine-safety-report-24-08-2023 Information about the TGA's safety monitoring of COVID-19 vaccines. Thu, 24 Aug 23 12:00:00 +0000 Thu, 24 Aug 23 12:00:00 +0000 https://www.tga.gov.au/news/covid-19-vaccine-safety-reports/covid-19-vaccine-safety-report-24-08-2023 https://www.tga.gov.au/news/news/new-reporting-requirements-medicine-shortages Companies supplying medicines in Australia will be required to provide additional information if their products go into shortage. Thu, 17 Aug 23 12:00:00 +0000 Thu, 17 Aug 23 12:00:00 +0000 https://www.tga.gov.au/news/news/new-reporting-requirements-medicine-shortages https://www.tga.gov.au/news/covid-19-vaccine-safety-reports/covid-19-vaccine-safety-report-10-08-2023 Information about the TGA's safety monitoring of COVID-19 vaccines. Thu, 10 Aug 23 12:00:00 +0000 Thu, 10 Aug 23 12:00:00 +0000 https://www.tga.gov.au/news/covid-19-vaccine-safety-reports/covid-19-vaccine-safety-report-10-08-2023 https://www.tga.gov.au/news/covid-19-vaccine-safety-reports/covid-19-vaccine-safety-report-27-07-2023 Information about the TGA's safety monitoring of COVID-19 vaccines. Thu, 27 Jul 23 12:00:00 +0000 Thu, 27 Jul 23 12:00:00 +0000 https://www.tga.gov.au/news/covid-19-vaccine-safety-reports/covid-19-vaccine-safety-report-27-07-2023 https://www.tga.gov.au/news/media-releases/trava-health-pty-ltd-fined-alleged-unlawful-advertising-medicinal-cannabis The TGA has issued five infringement notices totalling $82,500 were issued to the company, and 3 notices totalling $9,900 were issued to an individual. Thu, 27 Jul 23 12:00:00 +0000 Thu, 27 Jul 23 12:00:00 +0000 https://www.tga.gov.au/news/media-releases/trava-health-pty-ltd-fined-alleged-unlawful-advertising-medicinal-cannabis https://www.tga.gov.au/news/media-releases/notice-published-pursuant-order-federal-court-australia Read the notice. Thu, 27 Jul 23 12:00:00 +0000 Thu, 27 Jul 23 12:00:00 +0000 https://www.tga.gov.au/news/media-releases/notice-published-pursuant-order-federal-court-australia https://www.tga.gov.au/news/news/vaping-products-medicinal-cannabis-and-wellness-industry-included-2023-24-compliance-and-enforcement-priorities Read about our import, advertising and supply compliance priorities for 2023-24. Tue, 25 Jul 23 12:00:00 +0000 Tue, 25 Jul 23 12:00:00 +0000 https://www.tga.gov.au/news/news/vaping-products-medicinal-cannabis-and-wellness-industry-included-2023-24-compliance-and-enforcement-priorities https://www.tga.gov.au/news/safety-updates/product-information-safety-updates-july-2023 Understand the Medicines Safety Update for July 2023 - Information for health professionals and consumers. Mon, 24 Jul 23 12:00:00 +0000 Mon, 24 Jul 23 12:00:00 +0000 https://www.tga.gov.au/news/safety-updates/product-information-safety-updates-july-2023 https://www.tga.gov.au/news/covid-19-vaccine-safety-reports/covid-19-vaccine-safety-report-13-07-2023 Information about the TGA's safety monitoring of COVID-19 vaccines. Thu, 13 Jul 23 12:00:00 +0000 Thu, 13 Jul 23 12:00:00 +0000 https://www.tga.gov.au/news/covid-19-vaccine-safety-reports/covid-19-vaccine-safety-report-13-07-2023 https://www.tga.gov.au/news/news/sponsors-and-manufacturers-reminded-about-upcoming-financial-deadlines A reminder about financial deadlines that are approaching for sponsors and manufacturers. Wed, 12 Jul 23 12:00:00 +0000 Wed, 12 Jul 23 12:00:00 +0000 https://www.tga.gov.au/news/news/sponsors-and-manufacturers-reminded-about-upcoming-financial-deadlines https://www.tga.gov.au/news/media-releases/amendments-restrictions-prescribing-ms-2-step-mifepristone-and-misoprostol Find out how the prescribing and dispensing requirements for MS-2 Step have changed. Tue, 11 Jul 23 12:00:00 +0000 Tue, 11 Jul 23 12:00:00 +0000 https://www.tga.gov.au/news/media-releases/amendments-restrictions-prescribing-ms-2-step-mifepristone-and-misoprostol