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26 result(s) found, displaying 1 to 25
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News articlesWe initiated targeted compliance reviews of selected listed medicines containing Vitamin D to verify whether sponsors had appropriate evidence to support their bone strength claims.
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Regulatory decision noticesListed medicines indications and requirements for their use have been updated in the Therapeutic Goods (Permissible Indications) Determination (No. 1) 2025.
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News articlesThe Assessed listed medicine evidence guidelines have been updated, based on feedback, to aid sponsors in preparing their product applications.
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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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News articlesNew guidelines and mandatory requirements for listed medicines ingredients have come into effect on 1 February 2023.
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Regulatory decision noticesListed medicine ingredients and requirements are updated in the Therapeutic Goods (Permissible Ingredients) Determination (No. 5) 2022.
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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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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 noticesListed medicine ingredients and requirements are updated in the Therapeutic Goods (Permissible Ingredients) Determination (No. 3) 2022.
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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 noticesA new Therapeutic Goods Determination for listed medicine ingredients commenced on 18 January 2022.
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Regulatory decision noticesA new Therapeutic Goods Determination for listed medicine ingredients commenced on 25 October 2021.
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Regulatory decision noticesThe Therapeutic Goods (Permissible Ingredients) Determination has been updated.
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Regulatory decision noticesThe Therapeutic Goods (Permissible Ingredients) Determination has been updated.
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Regulatory decision noticesThe Therapeutic Goods (Permissible Indications) Determination has been updated
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Regulatory decision noticesThe Therapeutic Goods (Permissible Ingredients) Determination has been updated.
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Media releasesToday the TGA announced a final decision to down-schedule certain low dose cannabidiol (CBD) preparations
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Regulatory decision noticesThe Therapeutic Goods (Permissible Ingredients) Determination has been updated.
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Regulatory decision noticesThe Therapeutic Goods (Permissible Ingredients) Determination has been updated.
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BlogHow to find information about the inactive ingredients in your medicines.
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Regulatory decision noticesListed medicine ingredients and requirements have been updated.
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Regulatory decision noticesThe Permissible Ingredients Determination has been updated.
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Regulatory decision noticesThe Permissible Ingredients Determination has been updated.
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Regulatory decision noticesThe Therapeutic Goods (Permissible Indications) Determination has been updated
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Regulatory decision noticesAn amendment to the Therapeutic Goods (Permissible Ingredients) Determination commenced on 2 September 2019.