The TGA has advised that changes will be made to the Therapeutic Goods (Permissible Indications) Determination this month. These include the addition of four new indications and changes to 32 existing indications to improve their wording.
The new indications will be:
| New indication | Evidence requirement | Requirements |
|---|---|---|
| Decrease/reduce/relieve urinary urgency associated with medically diagnosed overactive bladder | Scientific | Must include ‘medically diagnosed’ in the indication.Label requirement: ‘If symptoms persist seek the advice of a healthcare professional’ |
| Decrease/reduce/relieve urinary incontinence associated with medically diagnosed overactive bladder | Scientific | Must include ‘medically diagnosed’ in the indication.Label requirement: ‘If symptoms persist seek the advice of a healthcare professional’ |
| Helps reduce occurrence of mild migraines | General | Product presentation must only refer to mild migraine. |
| Decrease/reduce duration of symptoms of haemorrhoids | General | Label statement: If symptoms persist, talk to your health professional. |
A full list of changes can be found here.
Should you require assistance with updating your product as a result of these changes, please do not hesitate to contact us.