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Changing a listed or assessed listed medicine: application levels and change tables

(Replaces previous publication: Guidance on product changes in ELF3)
20 May 2020
Download Changing a listed or assessed listed medicine: application levels and change tables

Description

Guidance for sponsors on changing information in the ARTG for a listed or assessed listed medicine:

  • The regulatory process you need to follow
  • Relevant guidance documents
  • Listed and Assessed Listed Medicines Change Tables, which is a tool to help sponsors obtain essential regulatory information about change:
    • whether prior approval is required
    • the applicable section of the Therapeutic Goods Act 1989 (the Act)
    • the application type (listed medicines) or application level (assessed listed medicines) for the change

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