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Australia has introduced a new framework for medicine labelling, giving pharmaceutical sponsors five years to transition from the existing requirements.
In an announcement published on 29 September 2026, the Therapeutic Goods Administration (TGA) confirmed the introduction of TGO 115 and TGO 116, covering prescription and non-prescription medicines respectively. The changes follow stakeholder consultation and are intended to support the safe and correct use of medicines.
What Has Changed?
The new framework comprises two separate standards:
- TGO 115: Therapeutic Goods (Standard for Labelling of Prescription Medicines) Order 2026
- TGO 116: Therapeutic Goods (Standard for Labelling of Non-Prescription Medicines) Order 2026
Both standards commenced on 30 September 2026 and replace TGO 91 and TGO 92, which sunset on 1 October 2026.
The distinction between prescription and non-prescription medicines remains central to the framework, reflecting differences in the risks associated with these products and the information their labels must communicate.
Official TGA information on the new standards:
https://www.tga.gov.au/products/medicines/labelling-and-advertising/medicines-and-biologicals-labelling-and-packaging/standards-labels-and-packaging
Sponsors Have Until October 2031 to Complete the Transition
Although the new standards are now in effect, sponsors are not required to move every product to the new requirements immediately.
The TGA has established a five-year transition period during which both the previous and replacement standards can be used.
For prescription medicines, sponsors may follow either TGO 91 or TGO 115. For non-prescription medicines, the corresponding options are TGO 92 and TGO 116.
The transition arrangements also allow sponsors to implement certain new provisions while continuing to follow the previous standards in other respects. These provisions are outlined in Part 6 of TGO 115 and TGO 116.
The key compliance deadline is 1 October 2031. Medicines released for supply after this date must comply with the applicable new standard.
How Will the Changes Affect Existing Section 14 Consents?
Another aspect of the new framework concerns medicines supplied under Section 14 consents.
Some medicines currently rely on such consents because their labels do not satisfy particular requirements of TGO 91 or TGO 92.
The alternative provisions introduced under TGO 115 and TGO 116 may address some of these situations. As a result, certain sponsors may no longer need some existing consents.
However, medicines that do not comply with the applicable standards still require prior consent before they can be released for supply.
Further information is available through the TGA’s medicine labelling requirements for sponsors:
Further Regulatory Guidance Is Expected
The publication of the new standards is not the final stage of their implementation.
The TGA is preparing guidance to explain how sponsors should interpret and apply the updated requirements. Until that guidance becomes available, existing guidance relating to TGO 91 and TGO 92 remains valid.
The TGA has also indicated that it will work with stakeholders during the initial months of implementation to identify any unintended drafting errors. Amendments to the standards may be considered if necessary.
The development of the framework followed consultation with industry and other stakeholders. Information about that process is available through the TGA consultation page:
What Will Consumers and Healthcare Professionals Notice?
The introduction of the new standards does not mean that every medicine label in Australia will change at once.
Instead, updated labels are expected to enter circulation progressively as sponsors implement the requirements, new stock reaches the market, and existing stock is sold.
The TGA has explained that this gradual approach is intended to accommodate the time needed for labelling changes while helping maintain medicine supply.
More information about the specific changes expected on medicine labels will be provided by the TGA.
Labelling Changes Within the Regulatory Lifecycle
For pharmaceutical sponsors, the transition creates a defined period for reviewing applicable Australian labelling requirements and determining how existing product documentation aligns with the replacement standards.
Labelling also forms part of broader regulatory lifecycle activities, particularly for companies maintaining product information across multiple jurisdictions.
This is relevant to areas such as regulatory intelligence, product information management, and the preparation and localization of market-specific documentation. These activities are reflected in Baupharma’s Regulatory Affairs & Market Entry and Medical Translation & Scientific Writing services.
Looking Ahead
The introduction of TGO 115 and TGO 116 establishes a new basis for medicine labelling in Australia while allowing sponsors to transition from the previous standards over an extended period.
The transition arrangements, including the option to adopt selected new provisions early, provide sponsors with different routes toward compliance before the October 2031 deadline.
Further TGA guidance will provide additional detail on implementing the standards and the changes expected to appear on medicine labels.
Official source:
https://www.tga.gov.au/news/news-articles/new-medicine-labelling-standards
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