The Therapeutic Goods (Permissible Indications) Determination commenced on the Federal Register of Legislation (FRL) on 14 November 2019. The Determination is titled the Therapeutic Goods (Permissible Indications) Determination (No. 2) 2019. The changes from the previous Determination are provided in the tables below.
Transition arrangements
New listings from 14 November 2019 will need to comply with the new requirements. Listed medicines already in the ARTG will be expected to be compliant with the new requirements by the end of the transition period for permitted indications on 6 March 2021.
| New indication | Evidence requirement | Requirements |
|---|---|---|
| Decrease/reduce/relieve urinary urgency associated with medically diagnosed overactive bladder | Scientific or tradition of use | The product presentation must only refer to medically diagnosed overactive bladder. Label requirement: If symptoms persist or worsen talk to your medical practitioner |
| Decrease/reduce/relieve urinary incontinence associated with medically diagnosed overactive bladder | Scientific or tradition of use | The product presentation must only refer to medically diagnosed overactive bladder. Label requirement: If symptoms persist or worsen talk to your medical practitioner |
| Decrease/reduce duration of symptoms of haemorrhoids | Scientific or tradition of use | Label statement: If symptoms persist or worsen talk to your medical practitioner |
| Maintains/supports refreshing sleep | Scientific or tradition of use | |
| Helps reduce occurrence of mild migraines | Scientific or tradition of use | Product presentation must only refer to mild migraine. If symptoms persist, worsen, talk to your medical practitioner. |
| Helps reduce the occurrence of sore throat | Scientific or tradition of use | Label requirement: If symptoms persist, worsen or episodes become more frequent, talk to your medical practitioner |
| Helps reduce carbohydrate metabolism | Scientific | Product presentation must not imply or refer to lowering or raising blood sugar/glucose levels from outside of the normal healthy range. If product is indicated for weight loss, label statement: When used in conjunction with a program of reduced intake of dietary calories and increased physical activity. |
| Helps reduce the occurrence of symptoms of medically-diagnosed gluten-sensitivity caused by inadvertent gluten ingestion. | Scientific | Product presentation must not imply or refer to individuals with coeliac disease or dermatitis herpetiformis. Label statement: For use only in conjunction with a gluten-free diet. Label statement: If symptoms persist, worsen or episodes become more frequent talk to your medical practitioner. |
| Current indication | Amended indication | Reason |
|---|---|---|
| Maintain/support joint cartilage health | Helps maintain/support joint cartilage health | Addition of the word 'helps' for consistency with other similar indications. |
| Maintain/support good/beneficial/friendly gut flora during antibiotic use | Helps maintain/support good/beneficial/friendly gut flora during antibiotic use | Addition of the word 'helps' for consistency with other similar indications. |
| Maintain/support foetal CNS/brain development | Helps maintain/support foetal CNS/brain development | Addition of the word 'helps' for consistency with other similar indications. |
What sponsors of affected medicines need to do
The ARTG entries of these medicines will automatically update. Existing medicine labels will not require updating. Listed medicines already in the ARTG will be expected to be compliant with the new requirements by the end of the transition period for permitted indications on 6 March 2021.
| Current indication(s) | Amended indication(s) | Reason |
|---|---|---|
| Shukrala/aphrodisiac/enhance sexual vitality | Shukrala/spermatogenic/increase semen | Shukrala translates to spermatogenic/increase semen and is not synonymous with aphrodisiac and/or enhancing sexual vitality. |
What sponsors of affected medicines need to do
The ARTG entries of these medicines will automatically update. As the revised indication has a different meaning and intent, sponsors of affected medicines may 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).
| Current indication/s | Change in requirement | Reason |
|---|---|---|
Maintain/support preconception health Helps enhance/promote preconception health | Addition of the wording 'If directed for women': to the current label requirement: 'Advise your doctor of any medicine you take during pregnancy, particularly in the first trimester'. | This requirement has been amended to clarify that it is not applicable to products directed to men only. |
Aids/assists healthy bone development/growth/building Help maintain/support bone mineralisation Helps enhance/promote bone healing/repair Helps enhance/promote bone health Helps enhance/promote bone mass/density Helps enhance/promote bone mineralisation Helps enhance/promote bone strength Helps enhance/promote/increase metabolism of (state mineral) in bones Maintain/support (state mineral) absorption in bones Maintain/support bone healing/repair Maintain/support bone health Maintain/support bone mass/density/integrity Maintain/support bone strength | Addition of note (see below) to the current requirement 'Product presentation must not imply or refer to bone disease or disorders e.g. rheumatoid arthritis, juvenile arthritis, debilitating osteoarthritis or osteoporosis'. Note: this requirement is not intended to apply where the indications referring to osteoporosis specified in column 2 of Table 2 of this instrument are also used | The requirement has been amended to clarify that these indications may be used concurrently with indications referring to osteoporosis (that are allowed for certain calcium and vitamin D supplements). |
What sponsors of affected medicines need to do
The ARTG entries of these medicines will automatically update. No sponsor action is required.
| Current indication/s | Change in requirement | Reason |
|---|---|---|
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 | 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) | The warning statement (COLD) - Adults only. OR Not to be used in children under 2 years of age without medical advice' was previously required for cough and cold medicines but was not included in the first Determination. Statement reinstated as there may be serious consequences of inappropriately treating cold and flu in children without medical attention, e.g. a child may appear to have a cold but actually be suffering from a more serious illness. |
| Decrease/reduce/relieve morning sickness | Label statement: 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 'If symptoms persist...' label statement requirement was inadvertently not included in the first determination for this indication. |
What sponsors of affected medicines need to do
The ARTG entries of these medicines will automatically update. Listed medicines already in the ARTG will be expected to be compliant with the new requirements by the end of the transition period for permitted indications on 6 March 2021.
| Current indication/s | Change in requirement | Reason |
|---|---|---|
| Hepatoprotectant/protect the liver | Evidence requirement changed from 'traditional' to 'traditional or scientific evidence' | Outcome of an application to change the Permissible indications Determination. |
What sponsors of affected medicines need to do
The ARTG entries of these medicines will automatically update. Nil sponsor action required.
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