We’re experiencing issues for some mobile devices with our ARTG dataset filter function. We apologise for any inconvenience while we work to fix this.
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