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195 result(s) found, displaying 76 to 100
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Regulatory decision noticesSection 7 declarations provide greater clarity for consumers, industry and regulators about whether a product is a therapeutic good.
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Regulatory decision noticesThe TGA has granted provisional approval to Biocelect Pty Ltd (on behalf of Novavax Inc) for its COVID-19 vaccine, NUVAXOVID.
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Regulatory decision noticesUpdate to the manufacturing principles for medicinal products
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Regulatory decision noticesThis labelling exemption is granted under section 1.5.5 of Part 2 of the current Poisons Standard.
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Regulatory decision noticesThis labelling exemption is granted under section 1.5.5 of Part 2 of the current Poisons Standard.
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Regulatory decision noticesThis labelling exemption is granted under section 1.5.5 of Part 2 of the current Poisons Standard.
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Regulatory decision noticesThe TGA has issued a direction notice to 13 Vape Pty Ltd and an executive officer to cease promoting the use and supply of nicotine vaping products to Australian consumers.
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Regulatory decision noticesListed medicine ingredients and requirements are updated in the Therapeutic Goods (Permissible Ingredients) Determination (No. 4) 2022.
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Regulatory decision noticesThis labelling exemption is granted under section 1.1(3) of Part 2 of the current Poisons Standard.
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Regulatory decision noticesThe TGA has issued a direction notice to Phenix Health Pty Ltd to cease alleged unlawful advertising of nicotine vaping products.
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Regulatory decision noticesDirection Notice issued to cease advertisement of prescription and illegal products
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Regulatory decision noticesThis Order revokes Therapeutic Goods (Groups) Order No. 1 of 1992.
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Regulatory decision noticesThis Order may be cited as Therapeutic Goods (Groups) Order No. 1 of 1992.
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Regulatory decision noticesThis Order revokes Therapeutic Goods (Groups) Order No. 1 of 1991.
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Regulatory decision noticesThe TGA has provisionally approved the Pfizer Australia Pty Ltd COVID-19 vaccine, COMIRNATY, for use as a booster in individuals aged 12 to 15 years old.
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Regulatory decision noticesListed medicine ingredients and requirements are updated in the Therapeutic Goods (Permissible Ingredients) Determination (No. 3) 2022.
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Regulatory decision noticesSix monthly report – supply of unapproved therapeutic goods by a sponsor.
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Regulatory decision noticesPrevention notice under section 42DKB of the Therapeutic Goods Act 1989.
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Regulatory decision noticesA new Therapeutic Goods Determination for listed medicine ingredients commences on 1 March 2022.
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Regulatory decision noticesThis labelling exemption is granted under section 1.5.5 of Part 2 of the current Poisons Standard.
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Regulatory decision noticesLabelling exemption for COVID-19 Vaccine - Novavax.
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Regulatory decision noticesA new Therapeutic Goods Determination for listed medicine ingredients commenced on 18 January 2022.
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Regulatory decision noticesThis instrument is the Therapeutic Goods (Poisons Standard) (COVID-19 Treatment—Merck Sharp and Dohme) (Molnupiravir) Labelling Exemption 2022.
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Regulatory decision noticesThis labelling exemption is granted under section 1.5.5 of Part 2 of the current Poisons Standard.
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Regulatory decision noticesThe TGA granted provisional determination to Vaxine Pty Ltd in relation to their COVID-19 vaccine, Recombinant CoV-2-S-ΔTM protein with Advax-CpG55.2.