Guidance on product changes in ELF3

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31 August 2012

Version history

Version Description of change Author Effective date
V1.0 Original publication OCM 01/08/2008
V1.1 Added new changes to clarify rules for amendments to MDD / MSD for restricted ingredients; and changes to indications / MDD or MSD occurring simultaneously with a product name change OCM 30/07/2012

Note

The Changes Tables included in this document should not be considered an exhaustive list and will be updated by the TGA from time to time.

The tables refer to changes using the same terminology that is designated in the ELF 3 system. For further information on the types of changes detailed, sponsors should make reference to the terms defined in Section 9.5 – Terminology Used to Describe the Changes of the Australian Regulatory Guidelines (ARCGM) Part II – Listed Complementary Medicines.

This document supersedes the September 2004 changes document.

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