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114 result(s) found, displaying 11 to 20
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PageFind out about obtaining Good Manufacturing Practice (GMP) clearance for an overseas manufacturing site.
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PageInformation on proposing a new ingredient name to be included on the approved list.
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PageGLP-1 receptor agonists such as Ozempic (semaglutide) and its derivatives are regulated as prescription-only medicines.
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PageApplications for extension of indications to align with a reference product can be submitted via the Variation e-form. This electronic form is available through the TBS portal.
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PageFind out about the discontinuation of Protaphane InnoLet insulin cartridges and the substitute product available.
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GuidanceGuidance to help sponsors and manufacturers of medicines meet the Australian labelling requirements in TGO 91 and TGO 92.
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GuidanceGuidance on how to apply to register a biosimilar medicine on the Australian Register of Therapeutic Goods (ARTG) and ongoing sponsor responsibilities.
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GuidanceGuidance for sponsors on the fees payable and timeframes for different types of prescription medicine applications.
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GuidanceGuidance to assist sponsors and manufacturers comply with Therapeutic Goods (Microbiological standards for medicines) (TGO 100) Order 2018.
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GuidanceGuidance on requirements relating to impurities in prescription medicines entered in the Australian Register of Therapeutic Goods (ARTG).