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Labelling changes: information for sponsors
New labelling requirements
The TGA has introduced labelling requirements for medicines supplied in Australia. These changes were introduced on 31 August 2016.
Labelling requirements have been split into two new labelling Orders:
- TGO 91 - Standard for labels of prescription and related medicines (TGO91)
- TGO 92 - Standard for labels of non-prescription medicines (TGO92)
This split was applied to better consider the different risk levels for prescription and non-prescription medicines and also to improve overall readability.
TGO 91 and TGO 92 are registered on the Federal Register of Legislation and a new guidance document is available to assist you in complying with the new requirements.
These Orders came into effect on 31 August 2016, which started the four year transition period.
Transition period - what sponsors need to do
The four year transition period for these changes will start on 31 August 2016 and end on 31 August 2020. During this time, you can choose to comply with the old labelling requirements under Therapeutic Goods Order No. 69 - General requirements for labels of medicines (TGO69) or the new labelling requirements under TGO 91/92 (whichever applies). However, we encourage you to transition to the new labelling requirements as early as possible to reduce confusion for medicine users.
Labels must fully comply with all requirements of either the old or the relevant new Order. A label cannot selectively comply with parts of multiple Orders.
Sponsors can continue to store and supply medicines that are TGO 69 compliant if they are released for supply on or before 31 August 2020.
From 1 September 2020, all medicines released for supply must comply with either TGO 91 or TGO 92.
TGA has been reviewing medicine labelling requirements in collaboration with sponsors and health professionals for many years. We would like to thank you for working with us on this challenging reform. Together we have achieved significant improvements to medicine labels that will benefit both consumers and healthcare practitioners.
- Submissions from the most recent 2015 targeted consultation and the RIS are available. Please note that targeted consultation was conducted with those individuals and organisations that provided comment to the 2014 public consultation.
The Regulation Impact Statement for the new Orders has been published and includes information about TGA's consideration of the issues and practicalities of implementation.
Amendments to TGO 91 and TGO 92
These amendments were made in August 2017.
The TGA has made several minor amendments to the new labelling Orders Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines (TGO 91) and Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines (TGO 92).
Many of the recent amendments were made as a direct result of feedback from industry stakeholders.
The recent updates were necessary to:
- correctly reflect the name of the re-made TGO 69 (2017), which replaces the previous TGO 69, as well as including necessary consequential amendments;
- provide that medicines not required to be included in the Register before their lawful supply under the health practitioner notification arrangement under subsection 19(7A) of the Act (introduced recently by the Therapeutic Goods Amendment (2016 Measures No.1) Act 2017) are not required to comply with the Orders;
- provide a note in Schedule 1 to the Order to exclude glycerol from the entry for sugar alcohols;
- amend the entry for 'sorbates' in Schedule 1 to the Order to clarify its intent;
- correctly state the entries for sodium and potassium in Schedule 1 to the Order, ensuring that both Orders align;
- clarify the introductory text in Schedule1 to the Order to confirm that multiple substance declarations can be made within the same sentence, aligning with similar provisions in the Poisons Standard; and
- amend the units for bromelains in Schedule 3 to TGO 92, to allow insertion of 'million' before the unit 'PU' in Column 1 and before 'Papain units' in Column 2, to ensure the references are technically correct and consistent with agreed use. (TGO 92 only)
The compilations which incorporate the recent amendments to the labelling Orders have now been registered on the Federal Register of Legislation (FRL):
- 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)
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