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144 result(s) found, displaying 51 to 75
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Media releasesThe TGA has issued 5 infringement notices to Affinity Corp Australia Pty Ltd for the alleged unlawful advertising of medicinal cannabis products.
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Regulatory decision noticesArrangement under subsection 7C(1) of the Therapeutic Goods Act 1989
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Regulatory decision noticesArrangement under subsection 7C(1) of the Therapeutic Goods Act 1989
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Regulatory decision noticesDelays in processing timeframes of applications to extend GMP Clearances.
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News articlesThe TGA has updated the Australian Regulatory Guidelines for Sunscreens (ARGS) to align with the data requirements for all ingredients proposed to be included in the Therapeutic Goods (Permissible Ingredients) Determination
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Media releasesThe TGA has published a final decision to reduce the maximum size of packs for various paracetamol products.
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Regulatory decision noticesListed medicine ingredients and requirements for their use have been updated in the Therapeutic Goods (Permissible Ingredients) Determination (No. 2) 2023.
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News articlesEssential principle 7 now mentions nanomaterials explicitly (see EP 7.7)
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Media releasesThe 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.
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Regulatory decision noticesListed medicine ingredients and requirements for their use have been updated in the Therapeutic Goods (Permissible Ingredients) Determination (No. 1) 2023.
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Media releasesThe TGA has today published an interim decision to reduce the maximum pack sizes for various paracetamol products.
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Media releasesThe 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.
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News articlesNew guidelines and mandatory requirements for listed medicines ingredients have come into effect on 1 February 2023.
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Regulatory decision noticesThis instrument is made under subsection 26BD(3) of the Therapeutic Goods Act 1989.
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Therapeutic Goods (Biologicals-Application Form for Priority Applicant Determinations) Approval 2022
Regulatory decision noticesApproval of the Therapeutic Goods (Biologicals—Application Form for Priority Applicant Determinations) -
Regulatory decision noticesListed medicine ingredients and requirements are updated in the Therapeutic Goods (Permissible Ingredients) Determination (No. 5) 2022.
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Regulatory decision noticesArrangement under subsection 7C(1) of the Therapeutic Goods Act 1989 for use of computer programs to make decisions under sections 61(3)(a), 61(5AA), and 61(5AB) of the Act
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News articlesThe Pharmacovigilance Inspection Program (PVIP) Risk Assessment Survey is now open until 18 December 2022 for medicine sponsors to complete.
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Media releasesJSHealth Vitamins Pty Ltd fined for alleged unlawful advertising
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Media releasesThe TGA has published an independent expert report examining the incidence of serious injury and death from intentional paracetamol overdose.
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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 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 noticesListed medicine ingredients and requirements are updated in the Therapeutic Goods (Permissible Ingredients) Determination (No. 3) 2022.