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FAQs on issues raised by industry in relation to permitted indications

12 June 2019

On 7 March 2018 the TGA implemented a list of permitted indications for medicines listed under Section 26A of the Therapeutic Goods Act 1989 (the Act). The list of permitted indications is contained within the Permissible Indications Determination (Determination) and can also be accessed via the TGA Business Services website. For more information about permitted indications see:

Below are answers to some frequently asked questions to help sponsors understand the new regulatory requirements.

Evidence for indications and qualifiers

The Evidence guidelines: Guidelines on the evidence required to support indications for listed complementary medicines classifies indications as 'specific' and 'non-specific' to help sponsors determine the level of evidence required to support the use of an indication.

The indications included in Permissible Indications Determination are not categorised as 'specific' or 'non-specific' because the overall presentation of a medicine (including such things as the combination of indications, the product name and pictorials) needs to be considered to determine if indications are 'specific' or 'non-specific' for a particular medicine.

For example: An individual indication, 'Maintain digestive health' may be considered 'non-specific'. However, if this indication is linked with 'Helps decrease/reduce/relieve symptoms of mild gastritis' in the medicine's ARTG entry and on the medicine label, then it is likely that such an indication would be considered specific.

Sponsors need to assess the overall presentation of their medicine and refer to the Evidence Guidelines to determine the appropriate level of evidence required to support all of their medicine's indications.

In general, the TGA will not evaluate evidence to support the use of a proposed new indication or qualifier at the time of an application. A full evaluation of evidence occurs at the time of a compliance review, should this information be requested, and is reviewed in accordance with the Evidence Guidelines. However, consistent with TGA consideration of any other application, we may request further information to inform our decision.

Appendix 1 of the Permitted indications guidance is an assessment tool that shows what we consider when making a decision to accept or refuse an application for a new indication.

For example: In order for an indication to be considered not misleading as per the Therapeutic Goods Advertising Code (Question 8 of the Permitted indication assessment tool) the indication must be scientifically plausible or consistent with a documented tradition of use. If an initial assessment of an application raises questions about the scientific plausibility of an indication, the applicant will be required to provide a justification in order for the application to proceed.

Applications for new indication qualifiers may also be required to provide justification that the qualifier, when combined with a core permitted indication, is suitable for listed medicines.

For example: Indication qualifiers must not have the potential to increase the risk of an indication by referring to a vulnerable population.

For some applications to proceed, the sponsor may be required provide a justification that the:

  • proposed new indication meets the criteria for permitted indications
  • proposed new qualifier is appropriate for use with permitted indications in low risk listed medicines

While a justification may not be required for all applications, the provision of a justification at the time of application will expedite any approval process. A justification should:

  • be a robust scientific explanation for the rationale behind the application for a new qualifier or indication
  • make reference to, and be substantiated, by credible evidence and/or provide examples of evidence that would be held to support use of the proposed qualifier or indication.

If proposing a new indication or qualifier for a potentially vulnerable population such as pregnant women, infants or the elderly, it is expected that applicants address how the availability of the indication or qualifier presents a positive benefit: risk outcome in the context of the indications that are currently available. The justification may also include a consideration of the clinical need for the proposed indication and a discussion of the types of ingredients that may be used (and their suitability for use in the intended population).

For applications for new indication qualifiers, given the intent of using qualifiers for an indication is to align with the evidence a sponsor holds, the justification provided by an applicant should clearly outline how the proposed qualifier is necessary to align with the evidence held for a particular medicine. It should also outline why the existing available qualifiers are unsuitable.

For example: A proposed qualifier may be a gender specific population of athletes. A justification for this specific population may relate to potential differences in nutritional requirements for male and female subsets of athletes. This justification would demonstrate plausibility of the proposed qualifier and context of use, however, should also be supported by credible evidence substantiating these relevant differences.

Some permitted indications refer to multiple 'targets' as the terms are considered synonymous (or very similar) and would likely be supported by the same type of evidence (or evidence for one could be extrapolated to the other).

For example: The indication 'soothe/relieve mild skin burns/sunburns' includes the targets 'skin burns' and 'sun burns' as evidence that a medicine soothes sunburn is also likely to support use of the substance(s) to soothe a skin burn from other heat sources.

The therapeutic target terms included in a permitted indication (separated by "/") can be used interchangeably. This means that sponsors do not need to include all the targets on their label, rather they should only include the one they determine is most reflective of their evidence. If a sponsor has specific evidence that only supports one of the targets, they should provide a justification to this effect in their supportive evidence package.

Using indication qualifiers

Permitted indications can be qualified using the qualifying terms available in the Code Tables. This allows you to make a permitted indication more specific to align with the evidence you hold for your medicine.

Indications can be qualified either:

  • Explicitly - by using an indication qualifier (which sponsors can select using the drop down lists in ELF) directly in relation to the indication entered in the ARTG, on the product label and advertising material. While this is optional, it is the recommended approach as it puts beyond doubt what the indications for the medicine are and will give sponsors confidence that there is consistency between the ARTG and the label/advertising.
  • By implication - by including the qualifier in the overall product presentation, such as the name of the medicine and/or directions for use (for example, the name 'Women's Multivitamins' suggests the vitamins are formulated for women). Care needs to be taken here to ensure that:
    • the qualifier is available in the Code Tables
    • the overall presentation of the product is consistent with the ARTG entry
    • the product is consistent with the certifications made at the time of listing
    • the overall presentation of the medicine is not misleading

When applying to list a medicine, applicants are required to certify (under subparagraphs 26A(2)(fba)(i) and 26A(2)(fba)(ii) of the Act), that:

An indication will be taken to be 'covered by' the Determination, if the indication:

  • is specified in the Determination (i.e. it is word for word); or
  • is a more specific version of an indication specified in the Determination by use of indication qualifiers (from the TGA Code Tables) that specify use in a certain target population or for a particular time of use; or
  • when used on the medicine label, the indication does not differ in intent or meaning from the indication specified in the determination and included in the medicine's ARTG entry.

Section 4(2) of the Permissible Indications Determination allows sponsors to modify a selected permitted indication to align it with the supporting evidence they hold for their medicine by using indication qualifiers in the Code Tables. Note that:

  • sponsors must only use the indication qualifiers included in the Code Tables to qualify their medicine indications
  • if a sponsor chooses to select an indication qualifier for use with any of the indications specified in the Determination, the combined indication and qualifier/s in the medicine's ARTG entry (the qualified indication) is the accepted indication for that medicine

No - the use of explicit qualifiers from the Code Tables (accessible via the TGA Business Services website) for each indication is optional for sponsors when they enter their medicine in the ARTG via the electronic listing facility (ELF).

However, it is important to note that the indications included in the ARTG (the accepted indications) must be consistent with those on the label or other advertising material [in accordance with the certification provisions in subparagraphs 26A(2)(fba)(i) and 26A(2)(fba)(ii) of the Act and the equivalent provision in section 9(d) of the Therapeutic Goods Advertising Code].

This means that:

  • an indication must be qualified on medicine labels (or other advertising), either explicitly or by implication, if it is qualified in the ARTG entry
  • an indication must not be qualified (explicitly or by implication) on a medicine label (or other advertising) if it is not qualified in the ARTG entry

Refer to 'Selecting indication qualifiers for your permitted indication' in the Permitted indications for listed medicines guidance for more information.

Indications on a label can be qualified explicitly by adding the population to the indication, or by implication (e.g. in the directions for use, product name or other aspects of the presentation of the product).

Sponsors need to take particular care when qualifying indications through the medicine name or directions for use to ensure that the target population on their label (and in other advertising) is consistent with the ARTG entry. For example, the product name should not be used to refer to a population group that is not available in the list of population qualifiers available in the Code Tables (unless the specific indication referring to the population, where available, is included in the medicine's ARTG entry e.g. foetal development), nor imply an indication that is not included in the Permitted Indications Determination.

Statements on the medicine label that suggest that the product has uses different from, or in addition to, the indications included in the ARTG entry (i.e. if a target population is specified or implied on the label or advertising that is not specified in the ARTG listing) would not comply with:

  • the condition of listing (refer to paragraph 28(5)(ab) of the Act)
  • the listing certifications
  • the Advertising Code

Table 2 provides examples of population qualifiers on the label and in the ARTG entry.

Table 2: Examples of population qualifiers on the label and in the ARTG entry
ARTG indications On the label TGA comment

Product name: Everyday multivitamin

  • Maintains general health and well-being in females
  • Maintain/Support healthy eyesight in females
  • Maintain/Support healthy skin in females

Product name: Everyday multivitamin

  • Maintains/supports general health and wellbeing in women including healthy eyesight and healthy skin

Population is explicitly qualified in the indications in the ARTG and on the label.

Product name: Women's multivitamin

  • Maintains general health and well-being in females
  • Maintain support healthy eyesight in females
  • Maintain support healthy skin flora in females

Product name: Women's multivitamin

  • Maintains/supports general health and wellbeing, healthy eyesight and healthy skin flora

Population is explicitly qualified in the ARTG entry and implied in the product name on the medicine label. In this example it is clear from the product name that the indications match with the ARTG entry.

Reference to population in the name of the medicine results in all indications on the label of the medicine to be taken to be qualified for that population. Sponsors need to ensure that all indications are appropriate for the population.

Product name: Women's multivitamin

  • Maintains general health and well-being
  • Maintain support healthy eyesight
  • Maintain support healthy skin

Product name: Women's multivitamin

  • Maintains/supports general health and wellbeing, healthy eyesight and healthy skin

Qualification for a population is implied in the product name in the ARTG and on the medicine label. In this example it is clear from the ARTG name and label name that the indications are targeted at women.

Reference to population in the name of the medicine results in all indications on the label of the medicine to be taken to be qualified for that population. Sponsors need to ensure that all indications are appropriate for the population.

Product name: Premium bone and muscle support

  • Maintain/support bone health
  • Maintain/support muscle health
  • Decrease/reduce/relieve symptoms of mild arthritis

Product name: Premium bone and muscle support

  • Nutritional support for the elderly
  • Relieves symptoms of mild arthritis
  • Supports bone and muscle health

Label includes graphics of elderly individuals

The product presentation is targeted towards the elderly. Qualification of a population is not explicitly included in the indications or implied by the product name in the ARTG. In this example, the product presentation is not consistent with the ARTG entry. In this case, each indication should be qualified in the ARTG entry.

Product name: Pregnancy multivitamin

  • Maintains general health and well-being
  • Maintain/Support healthy hair
  • Maintain/Support healthy skin

Product name: Pregnancy multivitamin

  • Maintains/supports general health and wellbeing, healthy hair  skin in pregnancy

'In pregnancy' is not available in the Code tables for selection as a qualifier.

For a medicine to be indicated for pregnancy, specific pregnancy indications are required to be included in the ARTG entry. If a medicine name includes reference to pregnancy, then only the specific permitted indications referring to pregnancy can be used.

Legend

  • Green: high probability of compliance
  • Orange: sponsors need to take particular care to ensure compliance
  • Red: high probability of non-compliance

The Evidence Guidelines state that, if a medicine indication is not directed towards a specific population sub-group (i.e. it is not qualified), the supporting evidence would need to be relevant to the general Australian population. That is, we would assume, and the sponsor must hold evidence to support, use of the medicine in:

  • males and females
  • that are generally healthy
  • aged 18-65 years
  • socio-culturally similar to the Australian population

As stated in the Evidence Guidelines, the health status of the study population should be representative of the target population for the medicine. The results from studies conducted in specific sub-populations are therefore not relevant to the general population.

For example: Clinical studies that only use females as the treatment group are not relevant to the general population.

If sponsors hold evidence to support the use of a medicine in the general Australian population, it would be optional to qualify the indications in the ARTG to refer to a sub-population within the general Australian adult population in order to differentiate their products in the market (e.g. Men's multi vitamin).

As stated in the Evidence Guidelines, extrapolation of results obtained from subjects outside the specific target population group (e.g. from a sub-population to the general population) is normally not accepted unless it can be appropriately justified. Therefore, if you only hold evidence referring to a specific sub-population that is not within the general adult population (for example: children or the elderly) specific qualifiers may be required to align the indications with the evidence held for a medicine. If sponsors do not qualify their indication when they only hold evidence for use of a medicine in a specific sub-population, rather than the general adult population, then the product may not comply with all regulatory requirements:

  • the condition of listing (paragraph 28(6) of the Act)
  • the listing certifications (paragraph 26A(2)(ja) of the Act); and
  • may be considered misleading under the Advertising Code.

Examples of indications requiring population qualifiers are provided in Table 1.

Table 1: Examples of indications requiring population qualifiers in the ARTG
Medicine indication in ARTG Study population in the evidence held by the sponsor Requires population qualification in the ARTG, label and advertising
Relieves cough in children. Male and female participants aged 2-17 years; generally healthy population with cough associated with a range of non-serious conditions. Yes. Use in children.
Calcium helps maintain healthy/ strong bones. Male and female participants aged 18-65 years; generally healthy population; dietary and lifestyle pattern similar to the Australian population. No. Qualification is optional for populations covered by the general Australian population - e.g. 'in adults' 'in men', 'in women'.
Maintain/support bladder health. Female participants; aged 18 - 40 years; postpartum. Yes. Without adequate justification for extrapolation to the general Australian population, the indication should be qualified with a population qualifier such as: 'in post-partum women'.
Helps enhance/improve/promote/increase physical/exercise performance in children. Male participants aged 18-35 years; participating in strenuous exercise. This indication should be qualified by a qualifier such as: 'in males'. Extrapolation of the evidence beyond this population to refer to a specific sub-population (i.e. children) is inconsistent with the evidence held by the sponsor.

Legend

  • Green: high probability of compliance
  • Orange: sponsors need to take particular care to ensure compliance
  • Red: high probability of non-compliance

If your medicine is indicated for population groups outside the general population, these need to be included in the ARTG for each indication.

For example:

ARTG indication 1: Maintain/support bone strength in elderly individuals

ARTG indication 2: Maintain/support bone strength in healthy children

ARTG indication 3: Maintain/support bone strength in post-menopausal women

Alternatively if the medicine's presentation, such as the medicine name, specifies a population e.g. 'Women's multivitamin', it is implicit that all indications for that medicine are indicated for that population and therefore do not need to be individually qualified. However, note that the product name should not be used to refer to a population group that is not available in the list of population qualifiers available in the Code Tables unless that population is specifically included in a permitted indication in the medicine's ARTG entry -refer to Q19.

No. Qualification, whether implicitly or explicitly, of an indication on the product label with a target population that is not available in the Code Tables has the effect of modifying the indication to be one that is not covered by the Determination. This qualified indication would not be compatible with the sponsor's certification under 26A(2)(fba)(i) of the Act.

Directions for use are critical to ensure the safe use of medicines for different target populations using the same medicine, or people using the same medicine for different purposes. As defined in section 3 of the Act, directions for use include information on:

  • appropriate doses of the goods
  • the method of administration or use of the goods
  • the frequency and duration of treatment for each indication for the goods
  • the use of the goods by persons of particular ages or those with particular medical conditions

Inclusion of directions for use on product labels is required by operation of the labelling orders. Sponsors are not required to enter directions for use in the ARTG.

Sponsors are not required to qualify their indications in the ARTG in order to provide directions for use for different population groups within the general Australian population (the default population) on their product label (e.g. in 'women', 'in adults', 'in men').

However, directions for use cannot specify a target population, directly or by implication, that is not consistent with the information included in the ARTG for the medicine.

For example: A medicine with an unqualified indication for health and wellbeing in the ARTG could not have directions of use for specific sub-populations such as: pregnant women; breastfeeding women; children; or elderly persons.

If sponsors do not qualify their indications in the ARTG (either through the product name or explicitly in relation to the indications) and the medicine label has directions of use for specific sub-populations that are not within the general Australian adult population (as described in the Evidence Guidelines, refer Q4), then the certification made under subparagraph 26A(2)(fba)(ii) of the Act may be incorrect.

If specific target populations are mentioned in the directions for use, sponsors are also required to hold evidence to support the use(s) in those populations. Table 3 provides examples of population qualifiers and directions for use on medicine labels.

Table 3 Examples of population qualifiers and directions for use on medicine labels
ARTG indication Direction for use on label Requires qualification in the ARTG
Calcium helps maintain healthy strong bones

Men: take 2 tablets per day

Women: take 1 tablet per day

No. Qualification is optional, as the indication refers to the general Australian population. The sponsor would be required to hold evidence to support the difference in dosing for each population.
Maintain/support energy levels

Directions for use:

Take 1 tablet per day. Suitable for use during pregnancy.

Yes. Pregnant women are a vulnerable population group.

Inclusion of the statement 'Suitable for use during pregnancy' implies the medication is indicated for pregnancy. Requires inclusion of an indication for pregnancy in the ARTG and the label must include the required pregnancy label advisory statement.

Caution should be taken to ensure that other indications present on the label and advertising that are not qualified for pregnancy in the Determination, are not implied for pregnancy on the label.

Relieves cough.

Dosage instructions:

Ages 2 - 6 one tablet per day,

Ages 6-12 one tablet twice per day,

Ages 13-17 years 2 tablets twice per day.

Yes. The dosing instructions imply that the product is intended for use in children and would require qualification in the ARTG indication.

Legend

  • Green: high probability of compliance
  • Red: high probability of non-compliance

No. Consistent with their low risk status, listed medicines may only use low level indications that should not lead to their unsafe or inappropriate use. Permitted indications have been assessed against a set of criteria and determined to be appropriate for listed medicines. As such, they only allow listed medicines to make indications for health maintenance and health enhancement or certain indications for non-serious, self-limiting conditions. It is assumed therefore that they are intended for use by generally healthy individuals from the general Australian (or 'default') population. Likewise, the list of available qualifiers in the Code Tables refers to specific sub-populations but not to diseased groups.

Therefore, generally speaking, the 'in healthy individuals' qualifier does not need to be used to preclude the use in unhealthy populations. However, this population qualifier is available if sponsors choose to use it.

Traditional indications must be qualified with the 'traditional context qualifier' in the ARTG entry and on the product label and in advertising [refer to paragraph 4(3)(e) of the Determination and the equivalent provision in section 23 of the Advertising Code].

If a medicine has a majority of traditional indications, then the medicine should be adequately qualified as being 'traditionally used' on the main medicine label, so that the presentation of the good is not misleading.

Table 4 provides examples of traditional qualifiers being used on a main label. All representations of the indications, on the label or in advertising, must be appropriately qualified to meet these requirements. This includes instances where the back panel list the indications in full but the main label only lists a brief summary of the indications. Consumers may not always read the full indications included on the back or side panel of the label.

Table 4 Examples of traditional qualifiers being used on a medicine's main label
ARTG indications Main label TGA comment

Medicine 1:

'Traditionally used in Western herbal medicine to relieve the symptoms of common colds and flu'

Product name: Common cold Tonic

'Traditional Western herbal medicine to relieve common cold symptoms

Traditional paradigm of use clearly stated on main label.

Product name: Traditional Western Herbal Cold Tonic

'Relieves symptoms of common colds and flu'

The traditional use is included in the medicine name on the main label.

Sponsors must ensure that the traditional paradigm/s (i.e. Western herbal medicine) is specified on the back/side label with the indications for use.

Product name: Cold and Flu Relief

'Relieves colds and flu symptoms'

Presentation of the good may be misleading as the indication on the label does not match that entered in the ARTG.

Medicine 2

  1. 'Traditionally used in Western herbal medicine to relieve the symptoms of common colds and flu'
  2. 'Traditionally used in Chinese medicine to relieve the symptoms of common colds and flu'
  3. 'Traditionally used in Ayurvedic medicine to relieve the symptoms of common colds and flu'

Product name: Common cold relief

Combination of ingredients used in multiple traditional paradigms to relieve symptoms of common colds and flu

In this multiple paradigm medicine, it may not be possible to provide each paradigm on the main label. However, in this example, the main label clearly indicates that the evidence is based on multiple paradigms. The sponsor must ensure that each paradigm is specified on the back/side label.

Legend

  • Green: high probability of compliance
  • Orange: sponsors need to take particular care to ensure compliance
  • Red: high probability of non-compliance.

Combining indications

Yes you can, for certain indications.

In general, permitted indications contain a single 'target' (e.g. a disease or symptom) and do not link general symptoms (e.g. 'relieves runny nose') to related conditions (e.g. 'relieves runny nose associated with common cold'). You can enter individual indications referring to symptoms and an indication referring to the symptoms of a disease or condition in your ARTG entry and then combine these on your medicine label, providing that the intent of the individual indications has not changed.

Certain indications can have other indications linked to them in ELF - these are called 'parent indications'. Parent indications are those that include the term 'symptoms of'. The indication code (indication codes are the TGA's unique identification number for indications and are viewable in TBS) of a parent indication ends in '- PR'

When a sponsor selects a parent indication in ELF, they are given the option to link symptom indications to it. However, parent indications can also be used as standalone indications.

For example:

Parent indication: RTCCY-G-PR Decrease/reduce/relieve symptoms of common cold in adults

Linked indication: Decrease/reduce/relieve cough

Note that if a parent indication includes an indication qualifier (e.g. 'in adults') it is applicable to all indications linked under the parent indication.

Paragraph 4(3)(c) of the Determination allows sponsors to, on their product labels, vary the wording of indications entered in the ARTG (i.e. they don't have to be used word-for-word) and/or combine them into sentences. However:

  • modifying/combining, must not result in the indications being different in meaning between the label and ARTG (i.e. the combined sentence must have the same targets and actions as that of the individual indications)
  • the modified/combined indications must not infer or imply that a medicine is for the treatment of a serious disease/condition
  • the modified/combined indications must not infer or imply that a medicine is for the prevention or cure of any disease/condition

An indication would have a different meaning if:

  • it described a different therapeutic action or effect of a medicine - i.e. if 'reduce occurrence of' was replaced with 'prevents'
  • it described a different physiological/psychological factor or process; or a different disease, ailment, defect or injury - i.e. if it referred to 'gastrointestinal pain' in place of 'gastrointestinal health'

Two combined indications would generally be considered to have the same intent and meaning if together they described a therapeutic action and target (a health benefit) that is consistent with the individual indications. If sponsors combine indications entered in the ARTG on their medicine label to give them a different meaning, then the certification made under paragraph 26A(2)(fba) of the Act may be incorrect. Table 5 provides example of combining indications.

Table 5: Examples of combining indications
ARTG indications Label indications TGA comment

Helps decrease/ reduce/relieve symptoms of common cold

  • Linked indication in ARTG: Helps decrease/reduce /relieve cough
  • Linked indication in ARTG: Helps decrease/reduce /relieve watery eyes
  • Linked indication in ARTG: Helps decrease/reduce /relieve nasal congestion

Relieves symptoms of common cold, including:

  • coughs
  • watery eyes
  • nasal congestion
Here it is clear from the ARTG entry that the linked general indications are intended to be combined on the medicine label. The label indications are consistent with the ARTG entry.

Decrease/reduce/relieve symptoms of mild arthritis/mild osteoarthritis

  • Linked indication- Decrease/reduce/relieve mild joint stiffness
  • Linked indication: Decrease/reduce/relieve mild joint pain/soreness
Relieve symptoms of pain and stiffness in mild arthritis

The label indications are consistent with the ARTG indications.

Sponsors must ensure that the product presentation only refers to mild osteoarthritis.

  • Maintain/support gastrointestinal health
  • Maintain/support intestinal good/beneficial/friendly flora
Restore healthy gut flora after diarrhoea

The label indications are not equivalent to the ARTG indications:

  • Action - 'support' in ARTG, but 'restore' on label
  • Target - diarrhoea is a different target to the indications in the ARTG
  • Decrease/reduce/relieve mental overactivity in children
  • Maintain/support mental concentration/focus/clarity
  • Calmative/nervous system relaxant
A natural nervous system relaxant to calm mental overactivity and support mental focus for your child Here the combined indication likely implies a restricted representation- Attention Deficit Disorder

Legend

  • Green: high probability of compliance
  • Orange: sponsors need to take particular care to ensure compliance
  • Red: high probability of non-compliance.

Indications for pregnancy and foetal development

Pregnant women are a particularly vulnerable population group who may be susceptible to being persuaded that a medicine is imperative for the optimal health of their unborn child. Given the vulnerability of this population group, the Code Tables do not include qualifiers for pregnancy and foetuses, as it is not appropriate for all permitted indications to be able to be directed for use in pregnant women.

Instead, there are specific indications for pregnancy and foetal development included in the Determination, for example: 'Maintain/support healthy pregnancy'; 'Maintain/support healthy foetal development'; 'Decrease/reduce/ relieve morning sickness'. All indications directed to pregnant women require the label statement: 'Advise your doctor of any medicine you take during pregnancy, particularly in your first trimester'.

While some nutritional supplementation is recommended for pregnant women, the safety of many substances in pregnancy is unknown. In relation to nutritional supplementation for pregnancy, the Department of Health's Pregnancy Care Guidelines advise that some supplements (folic acid, iodine) are recommended for all women during pregnancy, while others (vitamins A, C and E) are not of benefit and may be harmful, and that iron should only be supplemented if a deficiency is identified.

It is important that sponsors of medicines indicated for pregnancy hold evidence that their medicine is safe for use in pregnancy. Sponsors cannot rely on inclusion of an ingredient in the Therapeutic Goods (Permissible Ingredients Determination) as assurance that the ingredient has been determined to be safe for inclusion in listed medicines for use in pregnancy. Sponsors should also be aware that products making pregnancy-related indications may be subject to compliance reviews any time while they remain on the ARTG and that the sponsor may be requested to provide the evidence they hold that the medicine is safe for use in pregnancy.

Yes. However, the product name must not be used to specify a target population that is not available in the Code Tables unless that population is specifically included in a permitted indication in the medicine's ARTG entry.

If a product name includes the word pregnancy, all indications on the medicine label are, because of the product name, taken to be indicated for use in pregnant women. As such, only the specific permitted indications for pregnancy should be used, as it is not appropriate for any permitted indication to be able to be directed for use in pregnant women. For more information see Q.5 and Q18.

If you want to make pregnancy and foetal development indications not currently covered by the Permitted Indications Determination, you can apply for more specific pregnancy indications to be added to the Determination (using the 'Indication and Qualifier application' form via the TGA Business Services website ), noting that robust justification is expected as outlined in Q3. Alternatively, sponsors may be able to apply to enter their products in the ARTG via the assessed listed medicines or registration pathways.

Given the high probability of changing their intent, meaning and/or implying a disease or condition, it is not appropriate to combine indications for pregnancy with other permitted indications. However, it is possible that a medicine may have concurrent indications for different population groups. That is, you may have evidence that your medicine supports immune system health in women. You may also have other evidence that your medicine supports a healthy pregnancy. The medicine ARTG entry and label can include these separate indications concurrently (but not combined in a sentence).

For example:

Product name: Women's multi vitamin

Indications:

  • Supports healthy pregnancy
  • Supports skin health in women

Sponsors need to take particular care when using indications relating to pregnancy and foetal development with other permitted indications on their medicine label to ensure that the overall presentation of the medicine does not change the intent and/or meaning of the selected indications.

For example, if a sponsor selects 'Maintain/support healthy pregnancy' then any other indication included on the medicine label should be consistent with the maintenance of general health. There is a high probability that concurrent indications will have a different meaning if together they described a therapeutic action and target (a health benefit) for any disease or condition in pregnancy as this would not be consistent with the low risk status of listed medicines. Table 6 provides examples of using indications for pregnancy with other permitted indications.

Table 6: Examples of combining indications for pregnancy
ARTG indications Label indications TGA comment
  • Maintain/support maternal health
  • Maintain/support hair health in women
  • Maintain/support skin health in women

Supports maternal health

Maintains healthy hair and skin in women

Here, the concurrent label indications are consistent with maintaining health.
  • Maintain/support healthy pregnancy
  • Maintain/ support healthy foetal development
Nutritional support for healthy pregnancy and healthy foetal development. Here, the combined label indications are equivalent to the ARTG indications.
  • Maintain/support healthy pregnancy
  • Maintain/support eye development
Support healthy foetal eye development

Here, the combined label indication is more specific than the ARTG indications:

Targets in ARTG - Pregnancy and eye development

Target on label- foetal eye development

Care needs to be taken when combining indications to ensure that the therapeutic action and target (a health benefit) is consistent with the individual indications.

  • Maintain/support healthy pregnancy
  • Relieve indigestion in women
  • Decrease/reduce/relieve abdominal cramping
Relieve indigestion and abdominal cramping to maintain a healthy pregnancy The combined indications are not consistent with maintaining a healthy pregnancy as they refer to symptom relief.
  • Helps enhance/promote maternal postnatal health
  • Support healthy emotional/mood balance
Promotes healthy mood in postnatal women The combined label indications are not equivalent to the ARTG indications. The combined indications may imply a serious condition - post natal depression.

Legend

  • Green: high probability of compliance
  • Orange: sponsors need to take particular care to ensure compliance
  • Red: high probability of non-compliance.

If you want to make pregnancy and foetal development indications not currently covered by the Permitted Indications Determination you can apply for more specific pregnancy indications noting that robust justification is expected as outlined in Q3 above. Alternatively, sponsors may be able to apply to enter their products in the ARTG via the assessed listed medicines or registration pathways.

Permitted indications and advertising

There has been some sponsor confusion that permitted indications are compliant with the advertising code and therefore approved for use in advertising. This is not the case - permitted indications have only been assessed to confirm they are suitable for listed medicines. One of the criteria for permitted indications is that the indication is capable of complying with the advertising requirements, including the Act and the Advertising Code when included on product labels and promotional materials. However, this does not mean that an advertisement containing the product's indications are compliant with the Advertising Code, as this requires consideration of the advertisement in its entirety and the likely consumer take out message - i.e. the likely impact of the advertisement on the reasonable consumer to whom the advertisement is directed.

Sponsors are responsible for ensuring that the overall presentation of their medicine [including interaction between, and acceptability of, indications as a group (see examples in Table 7), the label and any advertising used or provided to any other person for their use] is compliant with the labelling order, the advertising requirements in the Act, Regulations and the Advertising Code.

It is possible, for example, for permitted indications (which individually are low risk) to be combined to imply that a medicine is for the treatment of a serious disease which is not suitable for listed medicines. In these circumstances the certification made under paragraph 26A(2)(fe) of the Act that their medicine complies with the requirements set out in the Determination (that they must not imply treatment of serious diseases) would not be correct.

Table 7: Examples of indication combinations and medicine name that would be considered non-compliant with the advertising code
ARTG indications Medicine name and label/advert indications TGA comment
  • Aid/assist/helps digestion of (state nutrient)
  • Decrease/reduce/relieve diarrhoea
  • Decrease/reduce/relieve abdominal cramping

Name: Coeliac relief

Aids digestion of gluten and decreases diarrhoea and cramping.

Product name and indication combination specifies or implies therapeutic use that is not acceptable for listed medicines i.e. coeliac disease.
  • Mild joint inflammation and swelling in children
  • Relieves fever in children
  • Reduce joint pain in children

Name: Juvenile joint formula

Relieves joint pain and swelling and fever in children.

ARTG indications and product presentation implies that the medicine can be used to treat a serious disease i.e. juvenile arthritis.

Legend

Red: high probability of non-compliance.

The required label statements for permitted indications relating to talking to a 'health professional', 'health practitioner' or a 'medical practitioner' have a specific intent and meaning:

  • A health professional as defined in the Act, is any person belonging to certain health occupations such as medical practitioners, herbalists, naturopaths etc.
  • A health practitioner as defined in the Act, is a person who, under a law of a State or internal Territory, is registered or licensed to practice certain health professions such as nursing, pharmacy etc. The label symptom statement relating to health practitioners have been intentionally specified in a small number of cases (e.g. for indications qualified by 'medically diagnosed') to avoid the indications being treated as restricted representations. Similarly, the statements for indications directed at pregnant women refer to health practitioner to reflect the potential vulnerability of this specific population group.
  • A Medical practitioner is a person who is registered under the Health Practitioner Regulation National Law in the medical profession. For a small number of indications, sponsors must use the term medical practitioner (or words to the effect, e.g. doctor) on their label to reflect the more serious nature of the indication.

Care needs to be taken when including these statements on product labels to ensure that the intent and meaning of these statements is not changed.

Table 8: Examples of symptoms statements in the Permissible Indications Determination
Label statement When required
If symptoms persist, talk to your health professional. Indications relating to a symptom of a disease, condition, ailment or defect other than those below.
If you are concerned about the health of yourself or your baby, talk to your health practitioner Indications directed to post-partum women e.g. breast feeding women.
Advise your doctor of any medicine you take during pregnancy, particularly in your first trimester. All indications directed to pregnant women.
If symptoms persist or worsen talk to your medical practitioner. Indications that must be qualified by 'medically diagnosed'
If symptoms persist, worsen or episodes become more frequent talk to your medical practitioner Indications for usually chronic or recurring conditions that must be qualified by 'medically diagnosed' e.g. 'gout'