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
Contents
- Introduction
- How to apply for a change
- Identifying all planned changes in the table
- Related information and guidance
- Changes under section 9D of the Act
- Correction to an ARTG entry (subsection 9D(1) requests)
- Changes that create a separate and distinct good
- Retaining an existing AUST L or AUST L(A) number
- New AUST L or AUST L(A) number
- Fees
- Changes to listed medicines
- Application types
- Determining the application type for changes to listed medicines
- Finalising your application
- Changes to assessed listed medicines
- Application types
- Determining the application level for changes to assessed listed medicines
- Supportive documentation for assessed listed medicines changes
- Evaluating and requesting information
- Timeframes and fees for applications to change assessed listed medicines
- Finalising your application
- Listed and Assessed Listed Medicines Change Tables
- Terminology used in the Change Tables
- Table A: Product detail changes
- Table B: Active ingredient formulation changes
- Table C: Excipient ingredient formulation changes
- Table D: Proprietary ingredient (PI) formulation changes
- Table E: Label changes for assessed listed medicines
- Table F: Other changes
- Glossary
- Version history
Additional resources
The TGA has developed checklists to assist sponsors (or agents) who want to request the following changes to their medicine’s ARTG entry (under paragraph 9D(1)(a) of the Therapeutic Goods Act 1989);
- Correct omissions or mistakes that were made at the time of listing the medicine; and/or
- Replace a Proprietary Ingredient with the individual ingredients included in the Proprietary Ingredient’s formulation (where there is no change to the formulation, ingredients or quantity).
The checklists will help you determine if the request meets the general eligibility requirements for variation under this pathway.
Supporting documents
Changing a listed or assessed listed medicine
[PDF, 636.01 KB]
Changing a listed or assessed listed medicine
[Word, 7.42 MB]
This webpage on the TGA website was printed on 12 Sep 2024. Printed content may be out of date. For up-to-date information, always refer to the digital version: https://www.tga.gov.au/resources/resource/guidance/changing-listed-or-assessed-listed-medicine-application-levels-and-change-tables