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Collection content
111 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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PageA substitution with dapsone 50 mg tablets has been approved for use during the shortage.
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FormsForms for notifying the TGA of a change in sponsorship.
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Medicine shortage alertsSupply constraints will continue until 31 January 2027.
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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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User guideThis document replaces AU eCTD specification - Module 1 and regional information Version 3.0 and contains updated information.
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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.
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FormsSponsors can use this form to apply for an additional trade name for a registered prescription medicine, under section 23 of the Therapeutic Goods Act 1989.