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Variations to prescription medicines - excluding variations requiring evaluation of clinical or bioequivalence data: Process guidance

Version 3.0, July 2019

10 July 2019

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This guidance describes how to make variations to existing entries for prescription medicines in the Australian Register of Therapeutic Goods (ARTG). The variations included in this guidance are quality and product information (PI) changes where evaluation of clinical and bio-equivalence data is not required. These applications are not lodged under the Prescription Medicines Registration Process.

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Any questions regarding variations to prescription medicines should be directed to AET.application.entry.team@health.gov.au.

Variations to prescription medicines - excluding variations requiring evaluation of clinical or bioequivalence data: Process guidance

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Contents

  • Introduction
  • 1. Legislative basis for varying products
  • 2. Variation category groups and categories
  • 3. How to apply for a variation
  • 4. Changes not submitted via the Variation e-form
  • 5. Fees for variations
  • 6. Processing and approvals

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