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Guidance on product changes in ELF3

31 August 2012

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Product changes

Following the inclusion of a product as a Listed medicine in the Australian Register of Therapeutic Goods (ARTG), sponsors may need to update certain product details. For example, developing marketing strategies may prompt changes to product details or manufacturer details may need to be updated. This document has been developed to provide assistance to sponsors so that they are able to determine the regulatory impact and cost that making changes may have to currently Listed medicines.

This guidance applies only to medicines Listed on the ARTG for supply in Australia. It does not apply to Registered medicines or medicines Listed in the ARTG for Export Only.

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

When a change to the product record is made, ELF 3 will, upon validation, recognise the type of change made in accordance with the changes described in the following tables. These changes have been determined by the legislative requirements of the Therapeutic Goods Act 1989 (the Act), the Therapeutic Goods Regulations 1990 (the Regulations) and Therapeutic Goods (Groups) Order No.1 of 2001 (the Groups Order). A summary of fees charged by the TGA for Listed medicines is available on the TGA website.

For more information on product changes (the Grouping Order, types of changes etc), sponsors should refer to Section 9 of Part II - Listed Complementary Medicines of the Australian Regulatory Guidelines for Complementary Medicines (ARGCM).

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