CMA Advertising Seminar Permitted indications: What you can and cant - - PowerPoint PPT Presentation

CMA Advertising Seminar

Permitted indications: What you can and can’t say

Adam Cook Complementary and OTC Medicines Branch Medicines Regulation Division, TGA May 2019

Implementation of permitted indications

• .
• The permitted indications reform commenced on 6 March 2018

All indications permitted for use by listed medicines are now contained in the Permissible Indications Determination. Sponsors listing a medicine in the ARTG can only use indications from the permitted indications list A ‘Free text” field is no longer available for new medicines. Sponsors can apply to have new indications considered for inclusion in the Permissible Indication Determination - an application fee applies.

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What hasn’t changed - sponsor responsibilities

• It is the sponsors responsibility to ensure the correct indications have been

selected for their medicine. Sponsors must continue to hold supporting evidence for all their medicine indications and other claims. There must not be inconsistency between the indications that are included in the Register and on the label. Sponsors are responsible for making sure that any advertising about their medicine (including the label) complies with the Advertising Code.

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Legislation overview

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Legislative requirements for listed medicines

Is your medicine eligible for listing?

• ß

ß ß

• Approved

ingredients Preparation not in Poison Standard Qty restrictions not exceeded Not required to be sterile

M ust only use permitted indications Sponsor certifies that the medicine is eligible for listing Product is listed – assigned ARTG number (AUST L XXXX)

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Legislative amendments for permitted indications

• §

§

• §
• Establishment of the list of permitted indications

Consequential amendments Conditions of listing Cancellation provisions Application procedures for new indications Application form, fee and assessment criteria Transitional arrangements for existing products

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Legislative requirements for permitted indications

• –

– – When applying to list a medicine applicants are required to certify under section 26A of the Act that: Each indication entered in the Register is ‘covered by’ the Permissible Indications Determination. Each indication included on the medicine label is ‘covered by’ the Permissible Indications Determination. Each indication included on the medicine label is also included in the ARTG entry.

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Legislative requirements for permitted indications

An indication is ‘covered by’ the Permissible Indications Determination when: a) a) a) It is specified in the determination (i.e. it is word for word); OR It is a more specific version of an indication specified in the determination (i.e. uses optional indication qualifiers from the TGA Code Tables that specify a certain target population or time of use); OR When used on the medicine label, the indication does not differ in intent or meaning (i.e. indications on the label and in the Register are consistent)

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Indications covered by the Determination

For example: ARTG indication: Maintain/support gastrointestinal health a) b) c)

• ß

Word for word: Maintain/support gastrointestinal health More specific version: Maintain/support gastrointestinal health in women Intent and meaning: same intent and meaning: Maintains healthy gut different meaning: Maintain healthy intestinal flora

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Transition period for permitted indications

• §

§ § There is a 3 year transition period for existing listed medicines, ending 6 March 2021. Changes to update indications before 6 September 2019 can be done free of charge. On 7 March 2021 medicines that do not have permitted indications will be cancelled from the ARTG. AUST L numbers will not change (where ‘grouping’ applies) We will be holding a webinar on 7 May to provide sponsors guidance on how to transition to permitted indications in ELF - register via our website.

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Transition arrangements - product changes

• –

– – – –

• Any product that is the subject to changes that make it a separate and distinct good under the

Act must transition to permitted indications at the time of making the change. These include changes to: active ingredient or quantity of active ingredient dosage form product name excipients indications Other product changes (9D variations) will not be required to transition at the time of the change. For more information see: Guidance on Product Changes

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Transition arrangements – when a fee applies

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Type of Change Fee Payable New ARTG number issued? Must transition to permitted indications? New Standard listing fee Yes Yes Grouping (indications

• nly)

Nil No Yes Grouping (other than indications) Standard listing fee Yes as sponsors also required to update indications Yes as is considered a new product Variation Standard variation fee No No Correction to ARTG record Nil No No

The list of permitted indications

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The list of permitted indications

• §

§ ‒ The list of permitted indications is contained in a legislative instrument that provides: a comprehensive list of low risk indications that must be used to list a medicine in the ARTG 'requirements’ relating to the use of indications including general rules for how permitted indications are entered in the register and used

• n medicine labels

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What is an indication?

• §

§ An indication describes the therapeutic use or claimed health benefit for a medicine. Therapeutic use for listed medicines means use in, or in connection with, ‘influencing, inhibiting or modifying a physiological process in persons’ Indications can be: specific (e.g. refer to a named non-serious condition); or non-specific (e.g. general health maintenance) For more information see the Permitted Indications Guidance

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Specific and non-specific indications

• The Evidence guidelines for listed complementary medicines classifies indications

as ‘specific’ and ‘non-specific’ level of supportive evidence. Permitted indications are not categorised as ‘specific’ or ‘non-specific’ because the

• verall presentation of a medicine needs to be considered.

For example: ‘Decrease/reduce/relieve skin dryness’ may be considered ‘non- specific’. However, if this indication is linked with ‘Decrease/reduce/relieve symptoms of mild eczema/dermatitis’ in the medicine ARTG entry and on the medicine label, then it is likely that such an indication would be considered specific.

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Criteria for permitted indications

• Permitted indications meet the criteria for low-level indications:

Health enhancement, e.g. ‘May reduce fatigue’ Health maintenance, e.g. ‘Helps support healthy joints’ Prevention of dietary deficiency, e.g. ‘May prevent calcium deficiency’ A non serious form of a disease or ailment etc., e.g. ‘Helps decrease/ reduce/relieve symptoms of common cold’ These are conditions that are self-diagnosable or self-manageable There is an exception to this criteria is for three indications linked to substance-based restricted representation approvals (folic acid, calcium and vitamin D) For more information see the Permitted Indications Guidance

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Evidence requirements for permitted indications

Scientific indications Must be supported by scientific evidence, such as clinical studies or systematic reviews, for example: ‘Help maintain/support bone mineralisation’. Traditional indications Must be supported by evidence of traditional use in a recognised paradigm

• utside modern conventional medicine. Indications can be used across different

traditional paradigms, for example: ‘Blood cleanser/purifier’ Traditional Chinese Medicine indications Must be supported by evidence of traditional use within traditional Chinese medicine (TCM). These indications use specific terminology used in TCM, for example: ‘Traditionally used in Chinese medicine to disseminate Lung Qi’. Traditional Ayuvedic Medicine indications Must be supported by evidence of traditional use within Ayurvedic medicine. These indications use specific terminology used in Ayurvedic medicine, for example: ‘Traditionally used in Ayurvedic medicine to relieve aggravated Vata’. * Traditional medicines must include a traditional use qualifier in the ARTG and on the product label

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Requirements for permitted indications

• –

– – There are requirements relating to the use of certain indications. The requirements specify circumstances when an indication can or cannot be used

• r specify conditions that must be met. For example, requirements may:

Require a warning statement to be included on product labels, e.g. 'If symptoms persist consult your healthcare practitioner (or words to that effect)’ Specify a vulnerable population for which the indication is not suitable, e.g. ‘Not suitable for use in children under the age of 12 months’. Require that the presentation of the medicine must not refer to or imply a serious form of a disease.

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Permitted indications - examples

The legislation allows for cancellation of a medicine from the ARTG if the requirements relating to the use of the permitted indication are not complied with

1 2 Column 1 Column 2 Indication Column 3 Type of evidence Column 4 Other requirements Aids/assists gum development Scientific Anti-inflammatory/ relieve inflammation Scientific or Traditional Label statement: If symptoms persist, seek the advice of a healthcare professional. 3 Helps in the maintenance of a healthy body weight Scientific 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.

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How to use permitted indications for your listed medicine

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Review the evidence that you hold

• §

§ §

• Sponsors must hold evidence for all indications and

claims made for their medicine. The Evidence Guidelines provides guidance on: Types of indications and evidence sources. Assessing relevance, quality and credibility. Obtaining, recording and presenting evidence. All indications and claims must also comply with the Advertising requirements.

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Selecting permitted indications

• §

§ § Sponsors can then select an indication that aligns with their evidence All the indications available for use in listed medicines are included in the Permissible Indications Determination and on the TGA Business Services (TBS) site. On the TBS site you can search using: Evidence Requirement e.g. Scientific or tradition of use Key word / phrase e.g. ‘cough’ or ‘itchy’ Body system / part e.g. ‘Body - ear’ or ‘Gastrointestinal - Bowel’

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Linking indications in ELF- ‘parent indications’

• 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 unique indication code 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 a standalone indications. When linking general symptom indications, you must hold evidence for the selected symptoms for that disease or condition.

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Case study – linking indications

a) Indications can be entered individually in the ARTG: b) Indications in the ARTG can also be linked to a ‘parent’ indication

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Linking indications in the ARTG -example

.

• Parent indication

Linked symptom indications in the ARTG Helps decrease/ reduce/relieve symptoms of common cold Helps decrease/reduce/relieve cough Helps decrease/reduce/relieve watery eyes Helps decrease/reduce/relieve nasal congestion These symptoms can be linked to ‘symptoms of common cold’ Indication on medicine label

Helps decrease symptoms of common cold, such as cough, watery eyes and nasal congestion

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Case study – linking indications on the medicine label

• Indications, whether they are linked in the ARTG or not, can be combined together on

the label to form simple sentences. For example:

The indications match what is on the ARTG. The evidence held must demonstrate that these symptoms are relieved in patients with medically diagnosed IBS. This is marketing claim which doesn’t need to be included in the

• ARTG. However, you must still have evidence to support it.

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Modifying a permitted indication in the ARTG

• Sponsors can modify a selected indication to

align with the evidence they hold for their medicine by using indication qualifiers.

• Sponsors can only use the indication qualifiers

included in the TGA Code Tables to qualify their medicine indications.

• If a sponsor chooses to select a qualifier, that is

the approved indication for the medicine and must be made clear in the overall presentation

• f the product.

Qualifiers can be viewed via the TGA Business Services site.

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Modifying a permitted indication in the ARTG

4 types of qualifiers

Traditional context A mandatory qualifier for indications supported by evidence of a tradition of use, e.g.: ‘Traditionally used in Chinese Medicine…’ Population qualifier An optional qualifier and specifies the target population, e.g.: ‘in adults’ or ‘in children’. TCM pattern An optional qualifier for TCM medicines and specifies the underlying pattern that cases rise to the symptoms of the indication, e.g.: ‘in spleen Qi deficiency pattern’ Time of use An optional qualifier and indicates the time of therapeutic benefit for the medicine, or the time of occurrence of a symptom e.g. ‘Relieves muscle stiffness after exercise’.

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Case study – qualified indications

a) Indications can be entered individually in the ARTG without qualifiers: b) Indications in the ARTG can also be qualified e.g. in females/women:

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Case study – indications on the medicine label

• You can choose to demonstrate the target population in relation to the indication
• r elsewhere on the product presentation (e.g. the product name).

Medicine name includes qualifier Indications have been qualified Indications have not been qualified but the target population is clear from the product name

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Case study – indications on the medicine label

• If the indications were qualified in the ARTG, then the label must be consistent

with the qualified indication.

Medicine name does not include qualifier Indications have not been qualified This is inconsistent with the indications included in the ARTG entry

ARTG entry Label

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Summary – entering permitted indications in the ARTG

Time of use Healthy target population

• 3. Select specifying qualifiers

(Optional) Sponsors can choose to apply one or more pre- approved qualifiers from a drop down list.

• 2. Select permitted

indication (Mandatory) At least one core indication is selected in ELF using drop down lists

• r key word search.
• 1. Select tradition of use

Mandatory for traditional indications. Core permitted indication Decrease/reduce/relieve muscle pain/ache/soreness Specifying qualifiers Healthy target population: ‘in healthy individuals’ Time of use: ‘after exercise’ Final permitted indication on product label Relieves muscle aches and pains after exercise in healthy individuals. Tradition of use N/A

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Including indications on medicine label

• §
• ß

Indications do not have to be included ‘word for word’ on your label or advertising material. However, the intent and meaning of the indication must not change i.e. the same therapeutic action and target For example: ARTG indication: ‘Maintain/support gastrointestinal health’ Label indication - same meaning: ‘Maintains healthy gut’ Label indication - different meaning: ‘Maintain healthy intestinal flora’

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Case study – modifying indications on medicine labels

a) Indications included in the ARTG

Uses mandatory qualifier ‘medically diagnosed’

b) Modifying indications on the medicine label

Indications can be combined into simple sentences Terms separated by the “/” can be used interchangeably

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Case study – Modifying indications on medicine labels

ß ß . ß Mandatory qualifier not included

• n label

Indications infer or imply that a medicine is for the treatment of a serious disease Indications combined or overall presentation has a different, broader or more specific meaning

Does not have the mandatory qualifier ‘medically diagnosed’ Implies that the medicine is for a treatment of a serious disease Is more specific than the ‘healthy eyesight’ indication included in the ARTG.

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Frequently asked questions and issues raised by sponsors

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Why are there not ‘population’ or ‘time of use’ qualifiers available for pregnancy and foetuses?

• Pregnant women are a vulnerable population group who may be susceptible to being persuaded

that a medicine is imperative for the optimal health of their unborn child. The Code Tables do not include indication qualifiers for pregnant women or foetuses, as it is not appropriate for all permitted indications to be able to be directed for use in pregnant women. Where appropriate, a number of specific indications for vulnerable population group are included in the list, such as: 'Maintains/ support healthy foetal development'.

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Using indications for vulnerable populations

• ß

ß

• Take care in selecting the available indications for these groups:

Only use the indications that are available Always include required label advisory statements. Don’t use the product name, graphics etc. to target these groups if this isn’t consistent with the ARTG Don’t combine indications inappropriately to imply or refer to serious diseases or conditions. If a product name includes the word pregnancy, then the whole medicine is taken to be indicated for use in pregnant women only. As such, only the permitted indications for pregnancy should be used.

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Can indications be combined with pregnancy indications?

• –

§ § – High probability of changing their intent, meaning and/or implying a disease or condition inappropriate to combine indications for pregnancy with other permitted indications. A medicine may have concurrently used indications for different population groups. Example: evidence both for supports immune system health in women 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 immune function

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Does the TGA assess evidence or require information for applications for new indication and qualifiers?

• –
• In general, we will not evaluate evidence to support the use of a proposed new

indication or qualifier at the time of an application. We may request further information to inform our decision. Appendix 1 of the Permitted indications guidance : considerations when making a decision on an application for a new indication. 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.

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What evidence is required to support multiple targets?

• Multiple targets are included in some indications 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).

• The sponsor does not need to include all the targets on their label, rather they should
• nly 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 can

provide a justification to this effect in their supportive evidence package. For example: If a sponsor had evidence that their medicine soothes a skin burn from the sun it is likely that the substance would also assist soothe a skin burn from another heat source.

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What evidence is required to support population qualifiers?

• §

§

• Sponsors of listed medicines must hold evidence to support all the indications and

claims made for their medicine. The evidence must: be related to the same medicine or active ingredient/s; and have the same therapeutic action and context, for example: the same target population. If an indication is not directed for a specific population sub-group (i.e. it is not qualified), the supporting evidence would need to be relevant to the general Australian population (healthy adults aged 18 to 65 years). If a sponsor only held evidence where the study population is a specific sub- population (for example: children or elderly) the indications would need to be qualified.

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Examples of evidence and use of population qualifiers

Indication Relevant population Requires qualification in ARTG, the label and advertising Relieves cough in children. Male and female participants aged 2-18 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. But use is optional.

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Population qualifiers and directions for use

• ß

Directions for use are not required to be entered in the ARTG: Target population groups can be specified in the directions for use without having to qualify the indication in the ARTG. Directions for use cannot be used to specify a target population that is not consistent with the information included in the ARTG for the medicine.

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Does the ‘in healthy individuals’ qualifier need to be used to preclude the use in non-healthy populations?

• Consistent with their low risk status, listed medicines may only use low level

indications that will not lead to their unsafe or inappropriate use. It is assumed therefore that they are intended for use by generally healthy individuals. Therefore, generally speaking, the ‘in healthy individuals’ qualifier does not need to be used to preclude the use in non-healthy populations.

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Can I use non-indication statements and claims on my medicine label?

• Non-indication statements are not required to be

included on the ARTG in order to be used on product labels or other promotional material. However, you must certify that you hold information or evidence to support any statement/claim included on your medicine label. Your medicine may be cancelled from the ARTG if you hold incomplete or insufficient evidence to support all claims made for your product.

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Non-indication statements and claims

• ß
• ß
• ß
• Statements that do not describe a therapeutic are not included in the permitted indication list, for

example: Marketing statements For example: 20% more tablets, contains ingredients of plant origin Claims of effectiveness For example: Improves by 10%, Water resistant, Fast acting formula Directions for use For example: When taken 3 times a day

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Non-indication statements and claims

ß

• Structure, function, and/or mechanism of action statements

e.g.: ‘Calcium is a natural component of bone’. In some instances structure/ function claims can imply a therapeutic use. In the above example, the statement does imply that the product has a specific health benefit. Where this is the case, an indication of similar intent must be included in the ARTG entry, such as: Maintain support bone health

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Cosmetic claims in the list of permitted indications

• § ‘

§

• Just because an indication is in the list of permitted indications

does not mean that the use of that indication makes a product a therapeutic good. Maintain/support hair health’ could be used for a hair conditioner (cosmetic) or used for an oral vitamin/mineral supplement (therapeutic product). ‘Maintain/support bone health’ could be used for a dairy product (food) or for a calcium supplement (therapeutic good). Before listing a medicine in the ARTG, the sponsor should satisfy themselves that their product is a therapeutic good.

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Are permitted indications approved for use in advertising?

• Permitted indications have been assessed against established criteria to

confirm they are suitable for listed medicines. One of the criteria 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.

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• Sponsors are responsible for ensuring that the overall presentation of their

medicine is compliant with the labelling order, the advertising requirements in the Act, Regulations and the Advertising Code. It is possible 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. The certification made that their medicine complies with the requirements set

• ut in the Determination (that they must not imply treatment of serious

diseases) may not be incorrect.

Are permitted indications approved for use in advertising?

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Advertising / overall presentation

• §

§

• The overall presentation of your medicine (including the label and

advertising) must be: consistent with the indications entered in the ARTG and covered by the Permitted Indications List compliant with the Advertising Code. Take particular care with: § § the product name claims, graphics or other representations

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Advertising / presentation – what not to do

Product name ARTG Entry Comment

Post partum mood uplift

• Post partum tonic

Support healthy emotional/mood balance Calms the mind

• Relieve symptoms of mild

anxiety Not acceptable for this medicine to be named ‘post partum mood uplift’ as it could imply product is a treatment of a serious condition e.g. for post-natal depression. The indications selected meet the low-risk criteria for permitted indications. However, when combined here, they imply that the medicine is for the treatment of post-natal depression which is not suitable for listed medicines.

It is the sponsor’s responsibility to make sure that they choose indications which are appropriate. Some permitted indications, if stacked together or linked can imply a serious condition.

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Advertising/presentation – what not to do

• Example

ARTG Entry Product name Comment Product name specifies or implies therapeutic use that is not acceptable for listed medicines Aids digestion Supports a healthy appetite Relives diarrhoea Coeliac medicine

• Indications for coeliac disease are not

included in the permitted indications determination. The presentation of the medicine is not acceptable as it is being indicated for a purpose that is not covered by an indication in the permitted indications determination. Product presentation implies that medicine can be used to treat a serious disease Mild joint inflammation and swelling Relieves fever Reduce joint point Relieve fatigue Juvenile Joint Formula

• You must not modify a selected permitted

indication to infer or imply that a medicine is for the treatment of a serious disease e.g. juvenile arthritis The product presentation refers to a vulnerable population which is not suitable for listed medicines in this context

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Questions?

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