We will have limited operations from 15:00 Wednesday 24 December 2025 (AEDT) until Friday 2 January 2026. Find out how to contact us during the holiday period.
To find out more about varying your ARTG entry please click on the links below.
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.
Forms
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FormsPrescription medicines Minor Variation E-form now available
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PageOur Business Services online application system for variations to prescription medicines was updated.
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PageUpdates to FAQs re the prescription medicines variations e-form
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
Product types