The government is now operating in accordance with the Guidance on Caretaker Conventions, pending the outcome of the 2025 federal election.
To find out more about varying your ARTG entry please click on the links below.
Vary your ARTG entry for a prescription medicine
Vary your Australian Register of Therapeutic Goods (ARTG) entry for prescription medicines.
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Guidance
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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 the types of notifications and variations for biological medicines.
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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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PageLinks to information on variations to prescription medicines and biologicals.
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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 for sponsors on the eligibility criteria for reduced application and evaluation fees for major variation applications for prescription medicines.
More information
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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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PageFurther information on next steps in implementing a notifications process for registered medicines
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