https://www.tga.gov.au/ Media releases 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/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/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/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/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/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/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/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/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/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/natures-puff-pty-ltd-and-director-fined-105600-alleged-unlawful-advertising-nicotine-vaping-products We have issued 8 infringement notices totalling $105,600 to Nature’s Puff Pty Ltd and a director, for the alleged unlawful advertising of nicotine vaping products. Tue, 11 Jul 23 12:00:00 +0000 Tue, 11 Jul 23 12:00:00 +0000 https://www.tga.gov.au/news/media-releases/natures-puff-pty-ltd-and-director-fined-105600-alleged-unlawful-advertising-nicotine-vaping-products 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 https://www.tga.gov.au/news/media-releases/icmra-statement-safety-covid-19-vaccines This International Coalition of Medicines Regulatory Authorities (ICMRA) statement provides the general public with important information regarding the safety of COVID-19 vaccines, which have now been in use for more than two years. Mon, 10 Jul 23 12:00:00 +0000 Mon, 10 Jul 23 12:00:00 +0000 https://www.tga.gov.au/news/media-releases/icmra-statement-safety-covid-19-vaccines https://www.tga.gov.au/news/media-releases/pracmed-healthcare-pty-ltd-fined-39960-alleged-unlawful-advertising The TGA has issued three infringement notices totalling $39,960 to Queensland-based company Pracmed Healthcare Pty Ltd for alleged unlawful advertising of complementary medicines. Wed, 14 Jun 23 12:00:00 +0000 Wed, 14 Jun 23 12:00:00 +0000 https://www.tga.gov.au/news/media-releases/pracmed-healthcare-pty-ltd-fined-39960-alleged-unlawful-advertising https://www.tga.gov.au/news/media-releases/infringement-notices-totalling-588840-issued-three-sydney-based-tsg-stores-and-jaradat-and-sabbagh-group-pty-ltd The TGA has issued 38 infringement notices totalling $588,840 to four Sydney-based entities for allegedly importing 22 consignments containing a total of 379,600 nicotine vaping products. Tue, 13 Jun 23 12:00:00 +0000 Tue, 13 Jun 23 12:00:00 +0000 https://www.tga.gov.au/news/media-releases/infringement-notices-totalling-588840-issued-three-sydney-based-tsg-stores-and-jaradat-and-sabbagh-group-pty-ltd https://www.tga.gov.au/news/media-releases/affinity-corp-australia-pty-ltd-fined-66600-alleged-unlawful-advertising-medicinal-cannabis-products The TGA has issued 5 infringement notices to Affinity Corp Australia Pty Ltd for the alleged unlawful advertising of medicinal cannabis products. Fri, 09 Jun 23 12:00:00 +0000 Fri, 09 Jun 23 12:00:00 +0000 https://www.tga.gov.au/news/media-releases/affinity-corp-australia-pty-ltd-fined-66600-alleged-unlawful-advertising-medicinal-cannabis-products https://www.tga.gov.au/news/media-releases/2023-seasonal-influenza-vaccines Influenza vaccines can change from year to year as new strains of influenza virus appear. This is one reason vaccination against influenza is given every year. Thu, 01 Jun 23 12:00:00 +0000 Thu, 01 Jun 23 12:00:00 +0000 https://www.tga.gov.au/news/media-releases/2023-seasonal-influenza-vaccines https://www.tga.gov.au/news/media-releases/queensland-individual-fined-nearly-16000-after-allegedly-importing-unregistered-nicotine-vaping-products It is alleged that the individual attempted to import six different types of nicotine vaping products (prescription medicines). The unapproved nicotine vaping products were intercepted by the Australian Border Force and have been seized and will be destroyed under advice from the TGA. Thu, 25 May 23 12:00:00 +0000 Thu, 25 May 23 12:00:00 +0000 https://www.tga.gov.au/news/media-releases/queensland-individual-fined-nearly-16000-after-allegedly-importing-unregistered-nicotine-vaping-products https://www.tga.gov.au/news/media-releases/tga-targets-unlawful-importation-prescription-medicines The TGA has issued 5 infringement notices to 3 health practitioners for the alleged unlawful importation of unregistered prescription-only medicines. Tue, 16 May 23 12:00:00 +0000 Tue, 16 May 23 12:00:00 +0000 https://www.tga.gov.au/news/media-releases/tga-targets-unlawful-importation-prescription-medicines https://www.tga.gov.au/news/media-releases/tga-makes-final-decision-reduce-paracetamol-pack-sizes The TGA has published a final decision to reduce the maximum size of packs for various paracetamol products. Wed, 03 May 23 12:00:00 +0000 Wed, 03 May 23 12:00:00 +0000 https://www.tga.gov.au/news/media-releases/tga-makes-final-decision-reduce-paracetamol-pack-sizes https://www.tga.gov.au/news/media-releases/removal-prescribing-restrictions-ivermectin From 1 June 2023, prescribing of oral ivermectin for ‘off-label’ uses will no longer be limited to specialists such as dermatologists, gastroenterologists and infectious diseases specialists. Wed, 03 May 23 12:00:00 +0000 Wed, 03 May 23 12:00:00 +0000 https://www.tga.gov.au/news/media-releases/removal-prescribing-restrictions-ivermectin https://www.tga.gov.au/news/media-releases/modernas-covid-19-vaccine-spikevax-receives-approval-full-registration The TGA has approved Moderna Australia’s application to transition its COVID-19 vaccine, SPIKEVAX (elasomeran), from provisional to full registration. Mon, 24 Apr 23 12:00:00 +0000 Mon, 24 Apr 23 12:00:00 +0000 https://www.tga.gov.au/news/media-releases/modernas-covid-19-vaccine-spikevax-receives-approval-full-registration https://www.tga.gov.au/news/media-releases/infringement-notices-totalling-66600-given-three-sydney-based-companies-and-two-individuals-alleged-unlawful-importation-nicotine-vaping-products The TGA has issued nine infringement notices to three companies and two associated individuals for the alleged unlawful importation of nicotine vaping products. Thu, 20 Apr 23 12:00:00 +0000 Thu, 20 Apr 23 12:00:00 +0000 https://www.tga.gov.au/news/media-releases/infringement-notices-totalling-66600-given-three-sydney-based-companies-and-two-individuals-alleged-unlawful-importation-nicotine-vaping-products https://www.tga.gov.au/news/media-releases/company-director-sentenced-2-years-imprisonment-personal-and-company-fines-over-25-million-selling-illegal-sarms Christopher Ramsey, the Director of AusLabs, Smart Labs and iSARMs, has been sentenced 2 years imprisonment and fined $300,000 for his role in the manufacture, supply and advertising of illegal Selective Androgen Receptor Modulators and nootropic products. Mr Ramsey’s three companies also received significant fines totalling $2,225,000. Tue, 28 Mar 23 12:00:00 +0000 Tue, 28 Mar 23 12:00:00 +0000 https://www.tga.gov.au/news/media-releases/company-director-sentenced-2-years-imprisonment-personal-and-company-fines-over-25-million-selling-illegal-sarms https://www.tga.gov.au/news/media-releases/jshealth-vitamins-fined-13320-alleged-unlawful-supply-complementary-medicine The TGA has issued an infringement notice for $13,320 to Sydney company JSHealth Vitamins Pty Ltd for an alleged breach of the Therapeutic Goods Act 1989. Fri, 10 Mar 23 12:00:00 +0000 Fri, 10 Mar 23 12:00:00 +0000 https://www.tga.gov.au/news/media-releases/jshealth-vitamins-fined-13320-alleged-unlawful-supply-complementary-medicine https://www.tga.gov.au/news/media-releases/australian-manufacturer-fined-almost-160000-allegedly-breaching-conditions-its-medicines-manufacturing-licence The TGA has issued 12 infringement notices totalling $159,840 to a manufacturer of listed complementary medicines after a recent inspection of the company’s premises identified unacceptable manufacturing practices. Thu, 09 Mar 23 12:00:00 +0000 Thu, 09 Mar 23 12:00:00 +0000 https://www.tga.gov.au/news/media-releases/australian-manufacturer-fined-almost-160000-allegedly-breaching-conditions-its-medicines-manufacturing-licence https://www.tga.gov.au/news/media-releases/tga-seizes-more-55000-potentially-dangerous-products-assistance-nsw-police On 22 February the TGA, with the assistance of NSW Police, executed 3 search warrants connected to an individual operating in the Newcastle area of New South Wales. Tue, 07 Mar 23 12:00:00 +0000 Tue, 07 Mar 23 12:00:00 +0000 https://www.tga.gov.au/news/media-releases/tga-seizes-more-55000-potentially-dangerous-products-assistance-nsw-police https://www.tga.gov.au/news/media-releases/consumers-warned-about-ozempic-scams The TGA is aware of several scams targeting consumers seeking semaglutide (Ozempic). Consumers are strongly advised not to use products unless they have come from a trusted source. Wed, 01 Mar 23 12:00:00 +0000 Wed, 01 Mar 23 12:00:00 +0000 https://www.tga.gov.au/news/media-releases/consumers-warned-about-ozempic-scams https://www.tga.gov.au/news/media-releases/pholcodine-cough-medicines-cancelled-tga-and-recalled-pharmacies-safety-reasons Following a safety investigation into pholcodine the TGA are cancelling 55 products (from the ARTG) and recalling them from pharmacy shelves due to an increased risk of anaphylactic reactions. Tue, 28 Feb 23 12:00:00 +0000 Tue, 28 Feb 23 12:00:00 +0000 https://www.tga.gov.au/news/media-releases/pholcodine-cough-medicines-cancelled-tga-and-recalled-pharmacies-safety-reasons https://www.tga.gov.au/news/media-releases/tga-grants-provisional-approval-modernas-covid-19-bivalent-spikevax-bivalent-originalomicron-ba4-5-booster-dose-vaccine On 17 February, the TGA granted provisional approval to Moderna’s bivalent COVID-19 vaccine. This is the second bivalent vaccine targeting the Omicron BA.4-5 subvariants that has been provisionally approved by the TGA Mon, 20 Feb 23 12:00:00 +0000 Mon, 20 Feb 23 12:00:00 +0000 https://www.tga.gov.au/news/media-releases/tga-grants-provisional-approval-modernas-covid-19-bivalent-spikevax-bivalent-originalomicron-ba4-5-booster-dose-vaccine https://www.tga.gov.au/news/media-releases/sport-supplement-suppliers-check-products-latest-wada-banned-substances The TGA are updating the Therapeutic Goods (Declared Goods) Order 2019 (Declared Goods Order) on 1 March 2023. This is the first time since 2020 that the Declared Goods Order has been amended to capture an update to WADA’s World Anti-Doping Code International Standard Prohibited List (Prohibited List). Fri, 17 Feb 23 12:00:00 +0000 Fri, 17 Feb 23 12:00:00 +0000 https://www.tga.gov.au/news/media-releases/sport-supplement-suppliers-check-products-latest-wada-banned-substances https://www.tga.gov.au/news/media-releases/change-classification-psilocybin-and-mdma-enable-prescribing-authorised-psychiatrists From 1 July this year, medicines containing the psychedelic substances psilocybin and MDMA can be prescribed by specifically authorised psychiatrists for the treatment of certain mental health conditions. Fri, 03 Feb 23 12:00:00 +0000 Fri, 03 Feb 23 12:00:00 +0000 https://www.tga.gov.au/news/media-releases/change-classification-psilocybin-and-mdma-enable-prescribing-authorised-psychiatrists https://www.tga.gov.au/news/media-releases/tga-makes-interim-decision-reduce-maximum-paracetamol-pack-sizes The TGA has today published an interim decision to reduce the maximum pack sizes for various paracetamol products. Fri, 03 Feb 23 12:00:00 +0000 Fri, 03 Feb 23 12:00:00 +0000 https://www.tga.gov.au/news/media-releases/tga-makes-interim-decision-reduce-maximum-paracetamol-pack-sizes https://www.tga.gov.au/news/media-releases/jshealth-vitamins-pty-ltd-fined-13320-alleged-unlawful-supply-complementary-medicine The TGA has issued an infringement notice totalling $13,320 to Sydney company JSHealth Vitamins Pty Ltd for supplying a complementary medicine that allegedly did not conform with legal requirements. Thu, 02 Feb 23 12:00:00 +0000 Thu, 02 Feb 23 12:00:00 +0000 https://www.tga.gov.au/news/media-releases/jshealth-vitamins-pty-ltd-fined-13320-alleged-unlawful-supply-complementary-medicine https://www.tga.gov.au/news/media-releases/caveman-nutrition-pty-ltd-cave-nutrition-store-pty-ltd-and-their-director-fined-208000-alleged-unlawful-advertising-sports-supplements-containing-dangerous-substances The TGA has issued infringement notices to Caveman Nutrition Pty Ltd, The Cave Nutrition Store Pty Ltd and to the director of these companies for the alleged unlawful advertising of sports supplements and therapeutic goods not included in the ARTG. Thu, 02 Feb 23 12:00:00 +0000 Thu, 02 Feb 23 12:00:00 +0000 https://www.tga.gov.au/news/media-releases/caveman-nutrition-pty-ltd-cave-nutrition-store-pty-ltd-and-their-director-fined-208000-alleged-unlawful-advertising-sports-supplements-containing-dangerous-substances https://www.tga.gov.au/news/media-releases/tga-confirms-performance-australian-approved-rapid-antigen-tests-covid-19-variants The TGA has confirmed the performance of COVID-19 rapid antigen tests available on the Australian market with COVID-19 variants. Wed, 01 Feb 23 12:00:00 +0000 Wed, 01 Feb 23 12:00:00 +0000 https://www.tga.gov.au/news/media-releases/tga-confirms-performance-australian-approved-rapid-antigen-tests-covid-19-variants https://www.tga.gov.au/news/media-releases/mode-medical-pty-ltd-and-executive-officer-fined-almost-160000-alleged-unlawful-advertising-intravenous-infusion-products The TGA has issued infringement notices to Mode Medical Pty Ltd for the alleged unlawful advertising to Australian consumers on a company website and social media. Tue, 31 Jan 23 12:00:00 +0000 Tue, 31 Jan 23 12:00:00 +0000 https://www.tga.gov.au/news/media-releases/mode-medical-pty-ltd-and-executive-officer-fined-almost-160000-alleged-unlawful-advertising-intravenous-infusion-products https://www.tga.gov.au/news/media-releases/tga-grants-provisional-approval-pfizers-covid-19-bivalent-comirnaty-originalomicron-ba4-5-covid-19-vaccine-booster-dose-vaccine This is the first vaccine provisionally approved by the TGA that is designed to specifically target the Omicron variants BA.4/BA.5 and follows provisional approval of the Pfizer BA.1 Omicron/original bivalent vaccine. Mon, 23 Jan 23 12:00:00 +0000 Mon, 23 Jan 23 12:00:00 +0000 https://www.tga.gov.au/news/media-releases/tga-grants-provisional-approval-pfizers-covid-19-bivalent-comirnaty-originalomicron-ba4-5-covid-19-vaccine-booster-dose-vaccine https://www.tga.gov.au/news/media-releases/tga-commences-evaluation-moderna-covid-19-vaccine-spikevax-potential-transition-full-registration The TGA has commenced evaluation of an application from Moderna Australia Pty Ltd to transition its COVID-19 vaccine, SPIKEVAX, to full registration for the immunisation of individuals 6 years and over, and as a booster dose for individuals aged 12 years and older. Fri, 20 Jan 23 12:00:00 +0000 Fri, 20 Jan 23 12:00:00 +0000 https://www.tga.gov.au/news/media-releases/tga-commences-evaluation-moderna-covid-19-vaccine-spikevax-potential-transition-full-registration https://www.tga.gov.au/news/media-releases/travellers-injectable-medicines-containing-ingredients-derived-animal-or-human-origin-no-longer-require-tga-approval-enter-australia Travellers will be able to bring up to 3-months supply of their medicine. Wed, 21 Dec 22 12:00:00 +0000 Wed, 21 Dec 22 12:00:00 +0000 https://www.tga.gov.au/news/media-releases/travellers-injectable-medicines-containing-ingredients-derived-animal-or-human-origin-no-longer-require-tga-approval-enter-australia https://www.tga.gov.au/news/media-releases/tga-consults-potential-nicotine-vaping-product-regulatory-reforms The TGA is seeking public comment on potential reforms to the regulation of nicotine vaping products in Australia. Wed, 30 Nov 22 12:00:00 +0000 Wed, 30 Nov 22 12:00:00 +0000 https://www.tga.gov.au/news/media-releases/tga-consults-potential-nicotine-vaping-product-regulatory-reforms https://www.tga.gov.au/news/media-releases/medical-practitioner-fined-2664-alleged-unlawful-advertising-nicotine-vaping-products The TGA has issued an infringement notice of $2,664 to a NSW-based medical practitioner for alleged unlawful advertising of nicotine vaping products in a social media post. Fri, 18 Nov 22 12:00:00 +0000 Fri, 18 Nov 22 12:00:00 +0000 https://www.tga.gov.au/news/media-releases/medical-practitioner-fined-2664-alleged-unlawful-advertising-nicotine-vaping-products https://www.tga.gov.au/news/media-releases/tga-grants-provisional-determination-pfizers-covid-19-bivalent-comirnaty-bivalent-omicron-ba4ba5-booster-dose-vaccine The TGA has granted a provisional determination to Pfizer's bivalent COVID-19 vaccine candidate: tozinameran & famtozinameran (COMIRNATY BIVALENT OMICRON BA.4/BA.5 COVID-19 VACCINE). Wed, 16 Nov 22 12:00:00 +0000 Wed, 16 Nov 22 12:00:00 +0000 https://www.tga.gov.au/news/media-releases/tga-grants-provisional-determination-pfizers-covid-19-bivalent-comirnaty-bivalent-omicron-ba4ba5-booster-dose-vaccine https://www.tga.gov.au/news/media-releases/aus-labs-smart-labs-isarms-and-director-christopher-ramsey-plead-guilty-over-200-charges-illegal-manufacture-supply-and-advertising-sarms-and-nootropics On 25 October 2022, Natural Franchises Pty Ltd pleaded guilty in a Sydney court to over 200 offences of the Therapeutic Goods Act 1989 for the manufacture, supply and advertising of unapproved therapeutic goods. Tue, 08 Nov 22 12:00:00 +0000 Tue, 08 Nov 22 12:00:00 +0000 https://www.tga.gov.au/news/media-releases/aus-labs-smart-labs-isarms-and-director-christopher-ramsey-plead-guilty-over-200-charges-illegal-manufacture-supply-and-advertising-sarms-and-nootropics https://www.tga.gov.au/news/media-releases/philips-recall-action-sleep-apnoea-and-respiratory-care-machines-have-you-registered-replacement The TGA is calling for anyone using a Philips Continuous Positive Airway Pressure (CPAP) machine or a Bi-level Positive Airway Pressure (Bi-Level PAP) machine to see if they are affected by the recall action. Mon, 07 Nov 22 12:00:00 +0000 Mon, 07 Nov 22 12:00:00 +0000 https://www.tga.gov.au/news/media-releases/philips-recall-action-sleep-apnoea-and-respiratory-care-machines-have-you-registered-replacement https://www.tga.gov.au/news/media-releases/imuni-pty-ltd-fined-13320-alleged-unlawful-advertising-complementary-medicine The TGA has issued one infringement notice to Queensland-based IMUNI Pty Ltd for allegedly advertising a complementary medicine for a therapeutic use that was not permitted. Tue, 01 Nov 22 12:00:00 +0000 Tue, 01 Nov 22 12:00:00 +0000 https://www.tga.gov.au/news/media-releases/imuni-pty-ltd-fined-13320-alleged-unlawful-advertising-complementary-medicine