The four-year transition period for the new labelling requirements (from TGO 69 to TGO 92), ends on 31 August 2020. During this time, you can choose to comply with the old labelling requirements under TGO 69 or the new labelling requirements under TGO 92. However, labels must comply fully with all requirements of either the old or the relevant new Order. A label cannot selectively comply with parts of multiple Orders.
An amendment order for the Therapeutic Goods Order No. 92 – Standard for labels of non-prescription medicines (TGO 92) was registered on the Federal Register of Legislation. The amendment order can be found at Therapeutic Goods Order No. 92A – Therapeutic Goods Order No. 92 (Standard for labels of non-prescription medicines) Amendment Order 2017 (TGO 92A).
There are no new requirements outlined in the amendment, however there are clarifications and corrections to address issues raised with the interpretation of TGO 92, which are outlined below.
The TGO 92A amendments are as follows:
- Correctly reflects the name of the re-made TGO 69 (2017), which replaces the previous TGO 69.
- Clarifies the introductory text in Schedule 1 to the Order to confirm that multiple substance declarations can be made within the same sentence;
- Corrects the requirements for potassium declaration in Schedule 1 to the Order;
- Corrects the requirements for sodium declaration in Schedule 1 to the Order;
- Amends the entry for ‘sorbates’ in Schedule 1 to the Order to clarify its intent;
- Provides a note in Schedule 1 to the Order to exclude glycerol from the entry for sugar alcohols and their associated laxative effects;
- Amends the units for bromelains in Schedule 3 to the Order;
- Provides that non-prescription medicines that are not required to be included in the ARTG 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 TGO 92
Further information regarding the labelling and packaging of listed medicines can be found on the TGA’s website.