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Update to listed medicines indications in November 2019

Published

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 - external site. 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.

1. New indications
New indicationEvidence requirementRequirements
Decrease/reduce/relieve urinary urgency associated with medically diagnosed overactive bladderScientific 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 bladderScientific 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 haemorrhoidsScientific or tradition of useLabel statement: If symptoms persist or worsen talk to your medical practitioner
Maintains/supports refreshing sleepScientific or tradition of use 
Helps reduce occurrence of mild migrainesScientific 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 throatScientific or tradition of useLabel requirement: If symptoms persist, worsen or episodes become more frequent, talk to your medical practitioner
Helps reduce carbohydrate metabolismScientific

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.

2. Corrections to indication wording - same meaning and intent
Current indicationAmended indicationReason
Maintain/support joint cartilage healthHelps maintain/support joint cartilage healthAddition of the word 'helps' for consistency with other similar indications.
Maintain/support good/beneficial/friendly gut flora during antibiotic useHelps maintain/support good/beneficial/friendly gut flora during antibiotic useAddition of the word 'helps' for consistency with other similar indications.
Maintain/support foetal CNS/brain developmentHelps maintain/support foetal CNS/brain developmentAddition 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.

3. Correction to indication wording - change in meaning and intent
Current indication(s)Amended indication(s)Reason
Shukrala/aphrodisiac/enhance sexual vitalityShukrala/spermatogenic/increase semenShukrala 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).
4. Correction to indication requirement - same meaning and intent
Current indication/sChange in requirementReason

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.

5. Correction to indication requirement - addition of requirement
Current indication/sChange in requirementReason

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.

6. Change to indication requirement - broadening of requirement
Current indication/sChange in requirementReason
Hepatoprotectant/protect the liverEvidence 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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