Guidance on product changes in ELF3

This document is subject to change. It was last updated in August 2008.

Following the inclusion of a product as a Listed medicine in the Australian Register of Therapeutic Goods (ARTG), sponsors may wish to change certain details previously advised to the TGA. Factors such as product stability, manufacturer changes and developing marketing strategies may require changes to product details that were entered at the time of the product's inclusion in the ARTG. This guidance document has been developed to provide assistance to sponsors so that they are able to determine if a change to their ARTG entry for a particular product is necessary and the regulatory impact that making certain changes to currently Listed products may have.

This guidance applies only to medicines Listed in the ARTG for supply in Australia. It does not apply to Registered medicines or medicines Listed in the ARTG for Export Only. This document supersedes the 16 September 2004 Product Changes document.

All changes required to be made to existing Listed complementary medicines are to be undertaken via the Electronic Listing Facility Version 3 (ELF 3) system.

For more information on Product Changes (the Grouping Order, types of changes etc), sponsors should refer to the Australian Regulatory Guidelines for Complementary Medicines (ARGCM), Part II - Listed Complementary Medicines, Section 9 <http://www.tga.gov.au/docs/html/argcm.htm#argcmp2>.

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