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Changes to permissible indications for listed medicines

12 September 2019

This page outlines changes that were made to the Therapeutic Goods (Permissible Indications) Determination No. 1 of 2018 (the 2018 Determination) in February 2019.

Since the implementation of the 2018 Determination in March 2018, stakeholders have brought to our attention issues that sponsors have encountered when selecting indications for their listed medicines. We also engaged a Traditional Chinese Medicine (TCM) expert to undertake a further review the TCM indications included in the Determination to confirm that they are appropriate for listed medicines.

Based on stakeholder and subject matter expert feedback, the Determination was amended with the changes outlined below. The new Determination is titled the Therapeutic Goods (Permissible Indications) Determination No. 1 of 2019 (the 2019 Determination).

Transition arrangements

New listings from the date that the 2019 Determination comes into force will need to comply with the new requirements immediately.

We understand that sponsors are working hard to update their medicines to comply with the legislation for permitted indications in the transition period.

For existing medicines that have already transitioned to using permitted indications we will take a pragmatic approach to our compliance activity in relation to these changes during the transition period for permitted indications. Where a medicine is not compliant with the 2019 Determination (but would have been compliant with the 2018 Determination), in particular in relation to required label statements, the action taken will involve a reminder about the requirements under the 2019 Determination, but is unlikely (in the absence of other non-compliance) to attract more serious action. As indicated below, these medicines 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 indication Evidence requirement
Maintain/support energy production Scientific or Traditional
Helps decrease/reduce/relieve cartilage loss/wear/tear/damage Scientific
Maintain/support joint cartilage health Scientific
Helps enhance/improve/promote joint mobility Scientific or Traditional
Maintain/support good/beneficial/friendly gut flora during antibiotic use Scientific
Help restore good/beneficial/friendly gut flora after antibiotic use scientific evidence
Enhance promote stomach health Scientific or Traditional
Decrease/reduce/relieve symptoms of menstruation Scientific or Traditional
Helps maintain/support skin pH balance Scientific
Helps decrease/reduce/relieve symptoms of minor skin wounds (cuts, scratches and abrasions) Scientific or Traditional
Female tonic Traditional
Decrease/reduce oily skin Scientific or Traditional
Maintain/support foetal CNS/brain development Scientific
Helps decrease/reduce/relieve symptoms of mild mastitis while lactating/breastfeeding Scientific or Traditional
Helps reduce occurrence of symptoms of mild mastitis while lactating/breastfeeding Scientific or Traditional
2. Removal of indications
Deleted indication Reason

Ayurvedic indications:

  • Medohara/helps dissipation of fats and liquids
  • Meha hara/helps maintain blood sugar health
  • Pandu hara/helps improve dietary iron
These indications are not appropriate to be supported by evidence of traditional use and were included in error in the first Determination.

Traditional Chinese medicine indications:

  • Stabilise mind
  • Open body orifices
Indications determined to be not suitable for listed medicines following further review by TCM expert.

TCM indications:

  • Unblock/open/relax channels
  • Strengthen/enrich/restore kidney Jing
These indications are duplicates of other indications included in the list.

What sponsors of affected medicines need to do

If you are a sponsor of a medicine using one of the indications that has been removed from the Determination, you will need to amend your ARTG entry to remove the deleted indication and if needed, select alternative indications. Note that there is a 'fee-free' period for sponsors to update their ARTG indications during this transition period which ends on 6 March 2021.

3. Changes to wording of requirements - same meaning and intent
Current requirements Amended requirements Reason
Label statement: If symptoms persist, seek the advice of a healthcare professional Label statement: If symptoms persist, talk to your health professional To be consistent with terminology in advertising code. Statement has same meaning and intent.
Label statement: If you are concerned about the health of yourself or your baby, please consult with your healthcare practitioner. Label statement: If you are concerned about the health of yourself or your baby, talk to your health practitioner To be consistent with terminology in advertising code. Statement has same meaning and intent.
Label statement: If symptoms persist or worsen consult your medical practitioner. Label statement: If symptoms persist or worsen talk to your medical practitioner To be consistent with terminology in advertising code. Statement has same meaning and intent.
Label statement: If symptoms persist, worsen or episodes become more frequent consult your medical practitioner Label statement: If symptoms persist, worsen or episodes become more frequent talk to your medical practitioner To be consistent with terminology in advertising code. Statement has same meaning and intent.
Label statement: Please seek the advice of a traditional Ayurvedic medicine practitioner if you are unsure if this medicine is right for you. If Ayurvedic terminology is used on medicine label, label statement: Talk to your Ayurvedic practitioner/health professional if you are unsure this medicine is right for you The label statement only applies when traditional Ayurvedic terminology is used on a label. However, when Ayurvedic indications are used in a multi- paradigm medicine, it may not make sense to only refer to an Ayurvedic practitioner. The label statement has been broadened to give sponsors the option to use 'health professional' or Ayurvedic professional, as appropriate for their medicine.
Label statement: Sunscreen products only. Label statement: Prolonged exposure to the sun should be avoided, it is important to wear protective clothing, hats and eyewear when exposed to the sun. Product should be kept out of the eyes. Indication for use in sunscreen products only. Required label statements removed as they are included in other legislation ( e.g. the Permitted Ingredients Determination for active sunscreen ingredients)
Label statement: Please consult with a registered traditional Chinese medicine practitioner if you are unsure if this medicine is right for you. If TCM terminology is used on medicine label, label statement: Talk to a TCM practitioner/health professional if you are unsure this medicine is right for you The label statement only applies when traditional TCM terminology is used on a label. However, when TCM indications are used in a multi-paradigm medicine, it may not make sense to only refer to a TCM practitioner. The label statement has been broadened to give sponsors the option to use 'health professional' or TCM professional, as appropriate for their medicine

What sponsors of affected medicines need to do

The ARTG entries of these medicines will automatically update. As the revised statements have the same meaning and intent, label updates should not be required.

4. Corrections to indication wording - same meaning and intent
Current indication(s) Amended indication(s) Reason
TCM indications with specific TCM terminology Minor corrections to specific terminology across all TCM indications Clarify the meaning and intent and be consistent with international nomenclature e.g. removal of capitalisations. Revised indications have same meaning and intent.
Maintain/support healthy thyroid gland health Maintain/support thyroid gland health Delete repeated word - healthy. Revised indication has same meaning and intent.
Choleretic/promote bile flow from liver Promote bile flow from liver/choleretic Rearrange wording to make more sense when used with qualifiers. Revised indication has same meaning and intent.
Carminative/decrease/reduce/relieve flatulence Decrease/reduce/relieve flatulence/carminative Rearrange wording to make more sense when used with qualifiers. Revised indication has same meaning and intent.
Helps decrease/reduce/relieve burning sensation upon urination associated with medically diagnosed cystitis Helps decrease/reduce/relieve burning sensation/irritation upon urination associated with medically diagnosed cystitis Modified to include irritation. Revised indication has same meaning and intent.

What sponsors of affected medicines need to do

The ARTG entries of these medicines will automatically update. As the revised indications have the same meaning and intent, it is not anticipated that label changes will be required.

5. Corrections to indication wording - change in meaning and intent
Current indication(s) Amended indication(s) Reason
SPF 25 Broad spectrum high protection sunscreen SPF 25 Broad spectrum medium/moderate protection sunscreen Corrected to be compliant with the Australian regulatory guidelines for sunscreens
Helps reduce occurrence of symptoms of food intolerance/allergies Helps reduce occurrence of symptoms of food intolerance Food allergies may present as a serious disease or condition and are inappropriate for listed medicines.
Antipyretic/ Antihydrotic/ febrifuge/ relieve mild fever/reduce body temperature/body cooling Antipyretic/ febrifuge/ relieve mild fever/reduce body temperature/body cooling Antihydrotic removed as it refers to reducing sweating. Alternative indication available

What sponsors of affected medicines need to do

The ARTG entries of these medicines will automatically update. As the revised indications have a different meaning and intent, sponsors of affected medicines may need to update their product labels to ensure that they match the ARTG.

6. Correction of evidence requirements
Current indications Evidence requirement Reason
Maintain/support good/beneficial/friendly bacteria adherence to intestinal mucosa (scientific evidence) 'Traditional' changed to 'Scientific' Correction

What sponsors of affected medicines need to do

The ARTG entries of these medicines will automatically update. Sponsors of affected medicines need to ensure that they hold scientific evidence to support the use of this indication.

7. Additional requirements for specific indications
Current indication(s) New requirement Reason

Helps reduce occurrence of symptoms of motion/travel/sea sickness

Reduce occurrence of nausea/vomiting

Helps reduce occurrence of abdominal bloating

Helps reduce occurrence of muscle cramp

Helps reduce occurrence of symptoms of upper respiratory tract infections

Vulnerary/wound healing

Helps reduce occurrence of skin pressure sores/bedsores

Helps reduce occurrence of symptoms of acne

Helps reduce occurrence of abdominal spasm

Anaha hara/anti flatulent

Kandu hara/relieves itching

Kasa hara/relieve cough

Kushta hara/improves skin ailments

Krimighna (anthelmintic)/assists to expel thread worms

Guda Krimi hara/assists to expel thread worms

Vrana/vulnerary/promotes wound healing

Twak dosha hara/relieves skin ailments

Shleshma praseki/liquefies Kapha/soothes sinusitis symptoms

Daha/pacify burning sensations

Atisara hara/ease diarrhoea

Asya roga hara/relieve oral complaints

Peenasa hara/relieve symptoms of cold

Shula hara/relieve pain

Trishna hara/relieves thirst from common cold

Addition: 'If symptoms persist, talk to your health professional' Requirement inadvertently not included in the first Determination

Helps decrease/reduce/relieve mild swelling of the glands associated with common cold

Decrease/reduce/relieve thirstiness associated with common cold

Decrease/reduce/relieve chills associated with common cold

Decrease/reduce/relieve symptoms of head cold

Decrease/reduce/relieve symptoms of common cold

Helps decrease/reduce/relieve the severity of symptoms of common colds and flu

Decrease/reduce/relieve common cold duration

Decrease/reduce/relieve the severity of common cold symptoms

Decrease/reduce/relieve symptoms of common colds and flu

Trishna hara/relieves thirst from common cold

Peenasa hara/relieve symptoms of cold

Addition: Label statement: (COLD) – Adults only OR Not to be used in children under 2 years of age without medical advice 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 colds and flus in children without medical attention, e.g. a child may appear to have a cold but actually be suffering from a more serious illness.

Enhance/improve/promote/increase(state vitamin/mineral/nutrient) levels in the body

Maintain/support (state vitamin/mineral/nutrient) levels in the body

Helps maintain/support cellular uptake of (state vitamin/mineral/nutrient)

Aid/assist/helps metabolism of (state vitamin/mineral/nutrient)

Additional requirement: If for supplementation, Label statement: Vitamins and minerals can only be of assistance if dietary intake is inadequate OR Vitamin and/or mineral supplements should not replace a balanced diet. Requirement is currently specified in Schedule 2 of the Therapeutic Goods Regulations 1990 and will be moved into the Determination.

Stanya/lactagogue/supports breast milk production

Lactifuge/reduce breast milk production

Label statement: If you are concerned about the health of yourself or your baby, talk to your health practitioner. Requirement inadvertently not included in the first Determination

Sthaulya hara/assists excess weight reduction

Label statement: When used in conjunction with a program of reduced intake of dietary calories and increased physical activity. Requirement inadvertently not included in the first Determination

What sponsors of affected medicines need to do

The ARTG entries of these medicines will not automatically update. Sponsors of affected medicines will need to update their product labels to include the new label statements, if they haven't already done so.

Sponsors are expected to update their product labels by the end of the permitted indications transition period on 6 March 2021.

8. Change in wording to requirements for specific indications
Current indication(s) Revised/new requirement Reason

Helps convert (state food) into energy

Helps improve/promote body metabolism/metabolic rate

Maintain/support body metabolism/metabolic rate

Maintain/support heat/energy production/thermogenesis

Change in wording to: If for weight loss, label statement...

Other requirements remain the same.
Requirement amended to clarify that the label statement is only required when in relation to 'weight loss'.

Maintain/support eye function

Maintain/support eye health

Aids/assists eye adaptation to variations in light intensity/night vision

Maintain/support healthy eyesight/vision

Removal of requirement for the 'If symptoms persist' label statement. These are not symptom reduction indications.
A diet deficient in calcium can lead to osteoporosis in later life. Calcium may help prevent osteoporosis when dietary intake is inadequate

Change in wording to: Indication can only be used for medicines containing calcium. ...

Other requirements remain the same

Current wording implies that a medicine cannot contain additional ingredients.
Helps decrease/reduce/relieve symptoms of occasional hangovers Change in wording to: Product presentation must not encourage excessive or harmful consumption of alcohol or other toxic substances Current requirement inconsistent with indication.
Help to prevent neural tube defects such as spina bifida and/or anencephaly

Change in wording to: Indication can only be used for medicines containing folic acid as an active ingredient....

Other requirements remain the same

Current wording implies that a medicine cannot contain additional ingredients.
Vitamin D helps calcium absorption (or words of like intent) and a diet deficient in calcium can lead to osteoporosis in later life.

Change in wording: Indication only for use for medicines including vitamin D...

Other requirements remain the same

Current wording implies that a medicine cannot contain additional ingredients.

What sponsors of affected medicines need to do

The ARTG entries of these medicines will automatically update. As the revised requirements are less restrictive, label updates should not be required.