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Collection content
116 result(s) found, displaying 31 to 40
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GuidanceAustralian recommendations and requirements
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GuidanceGuidance about how to make variations to Australian Register of Therapeutic Goods (ARTG) entries for prescription medicines.
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GuidanceGuidance about the types of notifications and variations for biological medicines.
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GuidanceGuidance about the types of notifications and variations for chemically derived (non-biological) prescription medicines.
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GuidanceGuidance about application pathways and data requirements for new generic medicines, and variations to existing medicines.
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GuidanceGuidance to understand the quality requirements of Therapeutic Goods Order No. 101 - Standard for tablets, capsules and pills (TGO 101, the Order).
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GuidanceGuidance for sponsors about how to apply for orphan drug designation for a prescription medicine.
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GuidanceGuidance on submitting the CPD for prescription medicines.
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GuidanceGuidance on specific criteria and paperwork required for submission to the TGA to ensure conformance with TGO 93.
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GuidanceGuidance on how to prepare your application for orphan drug designation so that it meets eligibility criteria and requirements.