The Permissible Indication Determination (No. 2) 2019 has been published on the Federal Register of Legislation and commenced on the 14th November 2020. It replaces the Therapeutic Goods (Permissible Indications) Determination (No. 1) 2019.
New listings must comply with the updated requirements from the 14th November 2019. Existing listings need to be updated by 6th March 2021.
The changes include;
8 new indications added
- Decrease/reduce/relieve urinary urgency associated with medically diagnosed overactive bladder.
- Decrease/reduce/relieve urinary incontinence associated with medically diagnosed overactive bladder.
- Decrease/reduce duration of symptoms of haemorrhoids.
- Maintains/supports refreshing sleep.
- Helps reduce occurrence of mild migraines.
- Helps reduce the occurrence of sore throat.
- Helps reduce carbohydrate metabolism.
- Helps reduce the occurrence of symptoms of medically diagnosed gluten-sensitivity caused by inadvertent gluten ingestion.
More restrictive changes
As mentioned in previous blogs there have been changes to the wording of the indication;
- Shukrala/aphrodisiac/enhance sexual vitality.
Additional warnings are now required for the following indications;
- 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;
- and decrease/reduce/relieve the severity of symptoms of mild upper respiratory tract infections.
The indication ‘decrease/reduce/relieve morning sickness’ requires the below new warning statement and presentation requirement;
- If symptoms persist or worsen talk to your medical practitioner.
- Product presentation must not imply or refer to severe morning sickness such as hyperemesis gravidarum.
The below indications have been updated to include the word ‘helps’ to improve consistency with the existing indications;
- Maintain/support joint cartilage health
- Maintain/support good/beneficial/friendly gut flora during antibiotic use
- Maintain/support foetal CNS/brain development
For less restrictive changes please visit the TGA website to read about these and the implications for sponsors for the above changes.