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712 result(s) found, displaying 51 to 75
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Media releasesWe have issued a combined total of $396,000 in infringement notices to 20 Melbourne retail businesses for the alleged unlawful supply of vaping goods.
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Regulatory decision noticesThis consent is given under sections 14 and 14A of the Therapeutic Goods Act 1989.
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Regulatory decision noticesThis instrument is made under subsections 19(5AA), 32CM(1A) and 41HC(1A) of the Therapeutic Goods Act 1989.
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Therapeutic Goods (Special Access Scheme - Application and Notification Forms) Approval (No. 2) 2024
Regulatory decision noticesThis instrument is made under the Therapeutic Goods Regulations 1990, the Therapeutic Goods (Medical Devices) Regulations 2002 and the Therapeutic Goods Act 1989. -
Media releasesThe defendant faces a maximum penalty of 12 months’ imprisonment and/or a fine of up to $222,000 for each charge.
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Media releasesWe have issued infringement notices totalling $37,560 for the alleged unlawful possession of a commercial quantity of vaping goods.
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Media releasesThe TGA and cooperating agencies have seized a large volume of alleged illicit vapes, tobacco and other substances in coordinated operations across Australia.
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Regulatory decision noticesMRA GMP clearances that are expiring on 31 December 2024 will be automatically extended.
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Regulatory decision noticesThis instrument is made under section 39 of the current Poisons Standard.
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Regulatory decision noticesThis instrument is made under section 39 of the current Poisons Standard.
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Regulatory decision noticesWe are providing a 12-month period of labelling exemptions for signal words for certain Pharmacy medicine and Pharmacist Only medicine products.
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Media releasesThe TGA has settled judicial review proceedings brought by InstantScripts in respect of infringement notices issued to it by the TGA.
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Media releasesIn a significant move against the illicit vaping market, the TGA has played a vital role in joint enforcement activity with Victoria Police, resulting in the seizure of 200,000 vapes, worth more than $8 million
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Media releasesTGA has taken further action to combat the unlawful sale of vapes in Queensland, issuing an infringement notice to a retailer for the unlawful possession of a commercial quantity of vaping goods
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Media releasesThe TGA worked alongside Victoria Police officers as part of an ongoing investigation targeting a significant crime syndicate involved in the illicit tobacco market.
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Media releasesThe 3G network shutdown may impact certain medical devices. Consumers, healthcare providers, manufacturers, and suppliers should take precautions to prevent disruption in essential medical services.
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Media releasesWe are aware of misinformation that claims the COVID-19 mRNA vaccines are contaminated with excessive levels of DNA. This is not the case.
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South African and Australian health product regulators to share regulatory information and expertise
Media releasesSAHPRA and TGA have signed a Memorandum of Understanding which will strengthen collaboration between the two health product regulators. -
Media releasesWe are introducing strengthened product standards for therapeutic vapes including vaping substances, vaping substance accessories, vaping devices and vaping device accessories.
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Media releasesPatients 18 years or over can purchase therapeutic vapes from participating pharmacies without a prescription. A consultation with a pharmacist is required, and purchase is subject to certain conditions as well as any state and territory restrictions.
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Regulatory decision noticesFind out how listed medicine ingredients and requirements for their use have been updated in the Therapeutic Goods (Permissible Ingredients) Determination (No. 3) which commenced on 27 September 2024.
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Regulatory decision noticesThis instrument is made under section 39 of the current Poisons Standard.
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Media releasesThe Federal Court of Australia has ordered Medtronic Australasia Pty Ltd (Medtronic) to pay $22 million in penalties for unlawfully supplying 16,267 units of the Infuse Bone Graft Kit between 1 September 2015 and 31 January 2020.
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Media releasesWe have issued an infringement notice to the New South Wales based company for the alleged supply of a complementary medicine that was missing a mandatory warning statement.
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Regulatory decision noticesSummary of Changes made to transition eCTD AU Module-1 v3.1 to eCTD AU Module-1 v3.2