Labelling requirements: information for sponsors

Labelling requirements

The TGA introduced new labelling requirements for medicines supplied in Australia on 31 August 2016.

Labelling requirements were split into two 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 guidance document is available to assist you in complying with the requirements.

These Orders came into effect on 31 August 2016, which started a four year transition period.

The transition period ended on 31 August 2020. All affected medicines released for supply from 1 September 2020 must comply with the labelling requirements of TGO 91 or 92.

Leftover stock in warehouses can still be supplied as long as it was released before 1 September 2020. This stock should be minimal as the four year transition period has allowed time for sponsors to update labels and release existing stock.

Consent to supply medicines that do not comply with a standard

Australian medicines that do not comply with the labelling standards cannot be released for supply without prior consent. In specific circumstances, the TGA may consider giving consent under section 14 of the Therapeutic Goods Act 1989 for individual products.

Sponsors can apply for this consent using the relevant application form. Where consent is given, the TGA publishes a record of these decisions on the TGA website.

Special processes have also been set up for medicines affected by COVID-19-triggered delays to the adoption of new labels to comply with TGO 91 and TGO 92.

Consultation

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 recent amendments were made as a direct result of feedback from industry stakeholders.

The 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)

Further information

Contact us at info@tga.gov.au