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Upcoming changes to the Permissible Indications Determination

14 August 2019

All indications available for use in listed medicines and any restrictions pertaining to them are listed in the Therapeutic Goods (Permissible Indications) Determination. For information on for permitted indications including transition arrangements refer Permitted indications for listed medicines. The Determination is continually reviewed by the TGA to ensure that all indications are appropriate for use in low-risk medicines. It is updated through the addition or removal of indications, and the clarification, removal or addition of requirements relating to the use of those indications for listed medicines.

Subject to the approval of the Delegate of the Minister of Health, the following changes will be made to the Therapeutic Goods (Permissible Indications) Determination in August 2019. The proposed changes include:

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

A complete list of pending changes to the Permissible Indications Determination, along with actions sponsors of affected medicines may need to take, is provided below.

If you have any questions relating to these proposed changes please email complementary.medicines@health.gov.au

New indications

New indication Evidence requirement Requirements
Decrease/reduce/relieve urinary urgency associated with medically diagnosed overactive bladder Scientific

Must 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 bladder Scientific

Must include 'medically diagnosed' in the indication.

Label requirement: 'If symptoms persist seek the advice of a healthcare professional'

Helps reduce occurrence of mild migraines General Product presentation must only refer to mild migraine.
Decrease/reduce duration of symptoms of haemorrhoids General Label statement: If symptoms persist, talk to your health professional.

Changed indications

1. Corrections to indication wording - same meaning and intent
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. It is not anticipated that label changes will be required as the revised indications have the same meaning and intent.

2. Correction to indication wording - change in meaning and intent
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).
3. Correction to indication requirement - same meaning and intent
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'.

Requirement 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 when the indications referring to osteoporosis (specified in column 2 of Table of this instrument) are also made for the relevant medicine

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.

4. Correction to indication requirement - addition of requirement
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)

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.

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. 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.