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Collection content
110 result(s) found, displaying 71 to 80
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GuidanceGuidance on the regulatory requirements for therapeutic goods that contain, or are produced from, human blood or plasma.
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Medicine shortage alertsInformation and approvals to manage Presolol 200 tablet shortage
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Medicine shortage alertsSerious Scarcity Substitution Instrument extended due to continued shortages of HRT patch products.
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FormsUpdated form used to notify us of proprietary ingredient mixtures for use in therapeutic goods.
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User guideInformation on how to compile a literature based submission (including mixed applications).
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User guideHow to search TGA business services for approved ingredients and accepted TGA terminology.
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Medicine shortage alertsPharmaceutical companies Novo Nordisk and Eli Lilly are discontinuing some of their insulin products.
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User guideThis document replaces AU eCTD specification - Module 1 and regional information Version 3.0 and contains updated information.
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FormsUse this form for Category 1 and Comparable Overseas Regulator (COR) report-based prescription medicines applications, or variations.
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FormsFind out what process to follow if a product is manufactured using a human embryo or a human embryonic stem cell, or any material sourced from such an embryo or stem cell.