Have you made the required changes to ensure your products comply with updates to TGA/FSANZ legislation?
Changes to legislation that affect your products can be difficult to keep up to date with and many sponsors and food businesses end up missing important transition dates for labels and product formulations.
The TGA are taking changes to listed medicine legislation very seriously and will conduct post market reviews on products that require amendments usually within 6 months of the transition period. Businesses found to be non-compliant are being subject to recalls and fines.
Don’t be one of those businesses!
Important dates to consider in order to ensure your products are updated to comply with the legislative requirements for listed medicines and foods are:
| Listed medicines | Changes required |
| 28 February 2023 | End of transition period for existing products that contain pyridoxine to change from 200mg to 100 mg MRDD; and for the inclusion of warning statements on labels for products containing > 10 mg pyridoxine per MRDD. |
| 28 February 2023 | End of transition period to include a pregnancy warning for certain existing artemisinin containing ingredients. |
| 28 February 2023 | End of transition period to include a new warning for mollusc derived ingredients. |
| 1 March 2024 | End of transition period for existing products that contain Valeriana officinalis for the inclusion of warnings statements on labels. |
| Foods | Changes required |
| 30 November 2023 | Tablets, Capsules and pills for oral administration which are (expressly or implicitly) represented for the improvement or maintenance of physical or mental performance in sport, exercise or recreational activity are Therapeutic Goods. |
| 24 February 2024 | Plain English food allergen labelling (PEAL) transition period ends. |
| 12 August 2024 | End of transition period for changes to Standard 2.6.2 for Electrolyte Drinks. |
We strongly encourage all listed medicines sponsors and food business to review their labels and formulations to ensure they comply with the upcoming changes before the end of the relevant transition periods.
If you require further information or assistance to implement these changes please contact us.
