TGA's Industry- Only Consultation on Proposed Update to limited aspects of TGO 92 Labelling Order - Medicine Name presentation & 'distinguishing marks'

*Privileged Government information for industry members only: Not authorised for copying, distribution or publication outside of your company*

The following information may be of interest to:

- Sponsors / brands, particularly those with s9(2) s14/14A consents from TGA

- Any member interested in how medicine name and labels are presented for supply

- Manufacturers releasing for supply

Sponsors of complementary medicines currently have labelling restrictions in section 9(2) of the TGO 92 on how medicine names are presented in combination with distinguishing marks (may include registered trademark, a graphic image, icon or logo, a brand name, slogan or tagline), within or adjacent to the medicine name, which occurred as part of changes to TGO 92 that was introduced between 2016-2020.

This means that brands may not be able to be presented optimally for commercial purposes, or existing formats may be non-compliant with the labelling standard.

CMA has been working with the TGA for several years to help ensure that medicine name presentation can be preserved for medicine sponsors to ensure trademark use, label presentations, and protect export considerations. Many CMA sponsors have been provided consent to supply goods with existing medicine name presentation, since TGO 92 took full effect in 2020.

The consultation newly released is intended to provide greater flexibility to industry on presenting labels that include distinguishing marks within or adjacent to the medicine name, provided that overall consumer identification of the product for recall or other purposes is not unduly affected. This is intended to ensure that those with existing s14/14A "consents to supply" for non-compliance with TGO 92 s9(2) will - in most, if not all circumstances - be considered compliant and therefore no longer need to obtain these after the update is implemented. This is intended to occur prior to the current expiration date of the notices on 31 August 2021.

Please see details of the consultation in today's member alert.

CMA appreciates all the member feedback on this issue to date and looks forward to finalising these issues with you in this industry consultation from TGA. We encourage members to consult with their legal departments on the proposed updates to ensure needs will be met.

Please contact Lucy.Lang@cmaustralia.org.au and technical@cmaustralia.org.au with your feedback and responses to CMA preferable by COB Friday 15 July. 

Members who received invitation to comment by the TGA have until COB Tuesday 19th July to respond to TGA.