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Changes to permissible indications for listed medicines
Related information
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.
| 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 |
| Deleted indication | Reason |
|---|---|
|
Ayurvedic indications:
|
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:
|
Indications determined to be not suitable for listed medicines following further review by TCM expert. |
|
TCM indications:
|
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.
| 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.
| 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.
| 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.
| 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.
| 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.
| 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.