Updates to the Permissible Indications Determination

The TGA has advised us that updates to the Therapeutic Goods (Permissible Indications) Determination will be made in the next 2-3 weeks. The changes include;

• addition of 4 new indications
• changes to 32 existing indications to clarify/correct the wording of indications and/or indication requirements.

New Indications

The 4 new indications are listed below;

• Decrease/reduce/relieve urinary urgency associated with medically diagnosed overactive bladder
• Decrease/reduce/relieve urinary incontinence associated with medically diagnosed overactive bladder
• Helps reduce occurrence of mild migraines
• Decrease/reduce duration of symptoms of haemorrhoids

Sponsor Action Required

The indication ‘Shukrala/aphrodisiac/enhance sexual vitality‘ has been amended to ‘Shukrala/spermatogenic/increase semen‘ due to the translation of Shukrala not being synonymous with aphrodisiac and/or enhancing sexual vitality.

The ARTG records will update automatically for these changes.

Sponsors of affected medicines will need to update their product labels (to remove reference to aphrodisiac and/or enhancing sexual vitality); or, alternatively, add other permitted indications to their ARTG entry to be consistent with their current product labels (where they hold appropriate evidence).

Indications with additional requirements

The below list of indications have had an update to the indications requirements and now have additional requirements.

The ARTG entries of these medicines will automatically update.

Sponsors of affected medicines will need to update their product labels to include the new label statements (as per the transition arrangements specified in the determination) if the medicine labels do not already include this statement.

The below list of indications all require the Label statement: (COLD) – Adults only OR Not to be used in children under two years of age without medical advice (or words to that effect). Listed medicines already on the ARTG will have until March 2021 to comply with this requirement. Any new listings from the date that the Determination is in force will need to comply with the new requirements immediately.

• Decrease/reduce/relieve the severity of symptoms of mild upper respiratory tract infections
• Relieve symptoms of mild upper respiratory tract infections
• Helps reduce occurrence of symptoms of upper respiratory tract infections
• Decongestant/relieve nasal congestion
• Decrease/reduce/relieve bronchial mucous congestion
• Decrease/reduce/relieve mild upper respiratory tract congestion
• Kasa hara/relieve cough
• Antitussive/cough suppressant
• Decrease/reduce/relieve mild bronchial cough
• Decrease/reduce/relieve cough
• Relieve dry unproductive cough
• Enhance/improve/promote/increase cough productivity

The indication, decrease/reduce/relieve morning sickness, requires the label statement: If symptoms persist or worsen talk to your medical practitioner. This statement was inadvertently not included in the first determination for this indication.

No Sponsor Action Required

Changed indications

Below is a list of changed indications. Please note these are updated for consistency and have the same intent and meaning as the previous indications so will not require updates to labels unless the sponsor wishes to make the update.

The ARTG records will update automatically for these changes.

The below list is of indications that have had an update to the indications requirements but have the same intent and meaning.

The ARTG entries of these medicines will automatically update. No sponsor action is required.