New Labelling Order for Non-Prescription Medicines.
TGO 116 Commences 30th September 2026.
The Therapeutic Goods Administration has released the Therapeutic Goods (Standard for Labelling of Non-Prescription Medicines) (TGO 116) Order 2026.
TGO 116 commences on Thursday, 30 September 2026. It replaces TGO 92 and introduces updated labelling requirements for non-prescription medicines, following public consultation.
Five-year transition period – how does it work?
Medicines released for supply before 1 October 2031 may:
- continue to comply fully with TGO 92
- comply fully with TGO 116
- continue to comply with TGO 92 while adopting one or more specified provisionslisted in the transition table in Part 6 of the new Order. Only the TGO 116 provisions specifically included in the table can be adopted individually while the label otherwise remains compliant with TGO 92. (i.e. it’s not a mix and match from both Orders as you choose scenario!).
All medicines released for supply on or after 1 October 2031 must comply fully with TGO 116. Products released for supply before that date may continue to be supplied through the distribution and retail chain.
Key changes – a selection
- Active ingredients on the main label: listed medicines other than sunscreens containing two or more active ingredients may display the active ingredient names and quantities elsewhere on the label.
- Cohesive unit requirements: Revised requirements provide more flexibility for distinguishing marks and certain additional information alongside name of the medicine and active ingredient information.
- Large oral dosage forms: Tablets, pills and capsules exceeding specified dimensions are subject to new warnings, directions to swallow with water and “actual-size” image requirements.
- Declarable substances: Schedule 1 requirements have been updated for substances including wheat, molluscs, milk and milk products, and sulfites.
What if I have an existing section 14 consent?
Sponsors relying on a section 14 consent for a TGO 92 labelling issue should check whether the issue is addressed by TGO 116.
If the relevant TGO 116 provision is included in the Part 6 transition table, the consent may no longer be needed. If it is not included, the sponsor may need to keep or renew the consent, change the label or move fully to TGO 116.
Further guidance and amendments
TGA has advised that supporting guidance will be available at a later date to assist in interpretation of the new Order.
TGA have also advised that the new Order is not complete and that some of the proposed amendments to the Order relating to expression of vitamins, minerals and some biologicals are still under consideration and may take up to 12 months to deliver. Due to this, AWRS are currently of the view that sponsors seriously consider whether there is benefit in moving to the new labelling requirements, until the final amendments are released, given the currently excluded updates will likely have a significant impact on the overall presentation/expression of ingredients on the label.
Do you need assistance assessing the impact of TGO 116 on your labels, planning an efficient transition or determining if your existing section 14 consent is affected? Contact us here.
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