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93 result(s) found, displaying 1 to 25
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Regulatory decision noticesThis instrument is made under Schedule 5A to the Therapeutic Goods Regulations 1990 and Schedule 4 to the Therapeutic Goods (Medical Devices) Regulations 2002.
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Media releasesThe TGA has updated its Advertising therapeutic goods on social media guidance to help advertisers to understand their responsibilities when promoting therapeutic goods via these platforms.
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News articlesThis Legislation Amendment makes changes to the way testing of goods is conducted under the Therapeutic Goods Regulations 1990.
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Regulatory decision noticesThe TGA has identified a discrepancy between the wording of the ‘POTAS1’ warning statement available in the Code Tables compared to the requirements for potassium chloride and glucosamine sulfate potassium chloride in the Therapeutic Goods (Permissible Ingredients) Determination (the Determination).
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News articlesIn 2025, the Therapeutic Goods (Exempt Monographs) Amendment Determination was introduced under the Therapeutic Goods Act 1989. This amendment updates the 2021 determination to exempt specific labelling requirements in certain pharmacopoeial monographs.
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News articlesFollowing a public consultation process , the TGA has adopted the following 19 international scientific guidelines.
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Regulatory decision noticesThis instrument is made under subsection 7C(1) 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. -
News articlesFind out about new requirements for labels of injectable electrolyte medicines and updates to guidance for medicine sponsors.
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News articlesFollowing our Essential Principles presentations on 11-12 September 2024, we have collated questions asked into themes to simplify finding information of relevance to you.
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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 the Therapeutic Goods Regulations 1990 and the Therapeutic Goods (Medical Devices) Regulations 2002.
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News articlesTwo new quality standards, one for MDMA and another for psilocybine, have been published.
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Regulatory decision noticesThis instrument is made under regulations 10AC, 10FA and 10HA of the Therapeutic Goods Regulations 1990.
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Regulatory decision noticesThis instrument is made under regulations 10AB, 10F and 10H of the Therapeutic Goods Regulations 1990.
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News articlesSome changes are rolling out soon to improve your experience using guidance on our website. We’re aiming to make our content clearer, more accessible and easier to navigate.
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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. 2) 2024, which commenced on 14 June 2024.
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Media releasesThe Minister for Health and Aged Care, the Hon Mark Butler MP, introduced a bill that aims to reduce the widespread availability of vapes by controlling all levels of the supply chain.
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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. 1) 2024.
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Media releasesThe TGA has issued 2 infringement notices totalling $37,560 to Queensland-based company Akula Foods Pty Ltd for the alleged unlawful import of unregistered complementary medicines
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Media releasesThe Australian Border Force (ABF) and partners have seized more than five and a half million cigarette sticks and prevented hundreds of thousands of prohibited vapes and drug items from reaching the streets of Sydney.
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Regulatory decision noticesThis instrument is made under regulation 97 of the Therapeutic Goods Regulations 1990.
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Regulatory decision noticesThis instrument is made under Schedule 5A to the Therapeutic Goods Regulations 1990 and Schedule 4 to the Therapeutic Goods (Medical Devices) Regulations 2002.
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Regulatory decision noticesThis instrument is made under Schedule 5A of the Therapeutic Goods Regulations 1990 and Schedule 4 of the Therapeutic Goods (Medical Devices) Regulations 2022.