Final decision to amend the Valerian labelling requirements for listed medicines
TGA have released their final decision in relation to the variation to the Permissible Ingredients Determination for ingredients containing Valeriana officinalis. The 3 ingredients containing valerian will be amended within the Permissible Ingredients Determination commencing on 1 March 2023 to include the following requirements. Sponsors will be provided a 12-month transition period from this time to bring existing listed medicines into compliance.
| Ingredient names | New specific requirements |
| VALERIAN DRY
VALERIAN POWDER VALERIANA OFFICINALIS (And ingredients thereof) |
The following warning statement is required on the medicine label when the medicine is for oral use:
‘In rare cases, valerian may harm the liver. Stop use and see a doctor if you have yellowing skin/eyes or unusual: fatigue, nausea, appetite loss, abdominal pain, dark urine or itching.’ |
A one-year transition period for existing medicines will be introduced to allow sponsors to update their labels and listings, ending on 1 March 2024.
Sponsors should ensure that existing medicines are not released for supply after the end of the transition period unless the product is compliant with the new requirements.
For more information on the consultation and the TGA’s rationale for the new requirements please check out the Proposed changes to requirements for listed medicine ingredients: Annual low-negligible risk changes 2022-2023 Final Decisions
If you require further information or assistance updating your labels and checking the listing has the updated warning please contact us.
