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WTO notification · TBT

AustraliaUpdated: check whether it is now adopted or in force

Pharmaceutical products – Australia

Official title

Medicine labels: Proposed changes to rules for the new standards replacing TGO 91 and TGO 92

Australia issued an addendum on 22 October 2026 to the earlier TBT notification G/TBT/N/AUS/195. Addenda often report that a measure was adopted, changed, postponed or withdrawn. The measure was first notified on 19 December 2025. The comment period closed on 17 February 2026.

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Source: WTO ePing (opens in a new tab). Summaries by Expodite, which is independent of the WTO.

Published here:

Updated here:

At a glance

Products

Medicines

HS codes
  • 30 · Pharmaceutical products
    • 30
Notifying member
Australia
Status
Updated: check whether it is now adopted or in force
Objectives
  • Consumer information, labelling
  • Protection of human health or safety
Area
TBT: Technical product rulesTechnical barriers to trade
Notification type
Regular notification
Document symbol
G/TBT/N/AUS/195Latest notice: G/TBT/N/AUS/195/Add.1
Keywords
Labelling

Key dates

Distributed by the WTO
Comment deadline
Closed on 17 February 2026
Proposed adoption
To be determined
Proposed entry into force
To be determined

How to comment

The comment period closed on 17 February 2026. You can still raise concerns about the measure with your country's WTO TBT enquiry point, quoting the document symbol G/TBT/N/AUS/195/Add.1; it can take them up with Australia.

Find your country's enquiry point on WTO ePing (opens in a new tab)

What the notification says

Latest notice (⁨G/TBT/N/AUS/195/Add.1⁩, 22 October 2026)

Medicine labels: Proposed changes to rules for the new standards replacing TGO 91 and TGO 92

Following consultation with stakeholders, the Therapeutic Goods Administration (TGA) introduced 2 new medicine labelling standards in September 2026 to support the safe use of medicines and reflect current labelling practices: Therapeutic Goods (Standard for Labelling of Prescription Medicines) (TGO 115) Order 2026; Therapeutic Goods (Standard for Labelling of Non-Prescription Medicines) (TGO 116) Order 2026. These standards were registered on the Federal Register of Legislation on 28 September 2026 and commenced on 30 September 2026. They replace: Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines (TGO 91); Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines (TGO 92). Medicine sponsors have a 5-year transition period to comply with TGO 115 and TGO 116. During the transition period: prescription medicines may comply with either TGO 91 or TGO 115; non-prescription medicines may comply with either TGO 92 or TGO 116. Sponsors may also adopt certain provisions in TGO 115 and TGO 116, in place of corresponding provisions in TGO 91 and TGO 92, before fully transitioning to the new standards. All medicines released for supply from 1 October 2031 must comply with the new standards. For more information about the transition arrangements and implementation of the new standards, see: New medicine labelling standards; Medicine labelling requirements: information for sponsors. Following consideration of stakeholder…

The Therapeutic Goods Administration (TGA) is Australia's regulatory authority for therapeutic goods. We regulate therapeutic goods for safety, efficacy, performance and quality to help protect and improve the health of Australians. There are provisions under the Therapeutic Goods Act 1989 to establish quality standards for therapeutic goods. These standards, known as Therapeutic Goods Orders (TGOs), can specify particular labelling, packaging or other requirements. Once approved, TGOs are registered as legislative instruments on the Federal Register of Legislation in Australia. The following TGOs for labelling medicines are due to sunset (expire) on 1 October 2026: Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines (TGO 91); Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines (TGO 92). They apply to medicines entered in the Australian Register of Therapeutic Goods (ARTG) for supply in Australia. TGO 91 and TGO 92 set out the type of information that must be included on the label and in what circumstances, as well as general requirements, to support the safe and quality use of medicines. TGO 91 and TGO 92 are working well, but several areas for improvement have been identified. We plan to replace them with new standards before they expire. The new standards will include some changes to requirements to further support the safe use of medicines and give more clarity to medicine sponsors. The TGA is…

Notices on this measure

Every notice about this measure published here, newest first. Each one is the notifying member's own text.

  1. AddendumG/TBT/N/AUS/195/Add.1

    Medicine labels: Proposed changes to rules for the new standards replacing TGO 91 and TGO 92

    Following consultation with stakeholders, the Therapeutic Goods Administration (TGA) introduced 2 new medicine labelling standards in September 2026 to support the safe use of medicines and reflect current labelling practices: Therapeutic Goods (Standard for Labelling of Prescription Medicines) (TGO 115) Order 2026; Therapeutic Goods (Standard for Labelling of Non-Prescription Medicines) (TGO 116) Order 2026. These standards were registered on the Federal Register of Legislation on 28 September 2026 and commenced on 30 September 2026. They replace: Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines (TGO 91); Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines (TGO 92). Medicine sponsors have a 5-year transition period to comply with TGO 115 and TGO 116. During the transition period: prescription medicines may comply with either TGO 91 or TGO 115; non-prescription medicines may comply with either TGO 92 or TGO 116. Sponsors may also adopt certain provisions in TGO 115 and TGO 116, in place of corresponding provisions in TGO 91 and TGO 92, before fully transitioning to the new standards. All medicines released for supply from 1 October 2031 must comply with the new standards. For more information about the transition arrangements and implementation of the new standards, see: New medicine labelling standards; Medicine labelling requirements: information for sponsors. Following consideration of stakeholder…

  2. Regular notificationG/TBT/N/AUS/195

    Comment deadline: Closed on 17 February 2026

    Medicine labels: Proposed changes to rules for the new standards replacing TGO 91 and TGO 92

    The Therapeutic Goods Administration (TGA) is Australia's regulatory authority for therapeutic goods. We regulate therapeutic goods for safety, efficacy, performance and quality to help protect and improve the health of Australians. There are provisions under the Therapeutic Goods Act 1989 to establish quality standards for therapeutic goods. These standards, known as Therapeutic Goods Orders (TGOs), can specify particular labelling, packaging or other requirements. Once approved, TGOs are registered as legislative instruments on the Federal Register of Legislation in Australia. The following TGOs for labelling medicines are due to sunset (expire) on 1 October 2026: Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines (TGO 91); Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines (TGO 92). They apply to medicines entered in the Australian Register of Therapeutic Goods (ARTG) for supply in Australia. TGO 91 and TGO 92 set out the type of information that must be included on the label and in what circumstances, as well as general requirements, to support the safe and quality use of medicines. TGO 91 and TGO 92 are working well, but several areas for improvement have been identified. We plan to replace them with new standards before they expire. The new standards will include some changes to requirements to further support the safe use of medicines and give more clarity to medicine sponsors. The TGA is…

Sources

Expodite writes its summary from the official record. The notification and the documents it notifies are on the WTO's own websites.

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