TGA News: Updates to the Permissible Indications Determination

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 indicationEvidence requirementRequirements
Decrease/reduce/relieve urinary urgency associated with medically diagnosed overactive bladderScientificMust 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 bladderScientificMust include ‘medically diagnosed’ in the indication.Label requirement: ‘If symptoms persist seek the advice of a healthcare professional’
Helps reduce occurrence of mild migrainesGeneralProduct presentation must only refer to mild migraine.
Decrease/reduce duration of symptoms of haemorrhoidsGeneralLabel 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.

Posted in: TGA

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