Presentation: CMA Advertising Seminar

CMA Advertising Seminar
Adam Cook
Complementary and OTC Medicines Branch
Medicines Regulation Division, TGA
May 2019
Permitted indications: What you can and can’t say

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.
TGA / CMA Advertising Seminar – May 2019
1

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.
2

Legislative requirements for listed medicines
Is your medicine eligible for listing?
 Approved
ingredients
 Preparation not in
Poison Standard
 Qty restrictions
not exceeded
 Not required
to be sterile
 Must only use permitted indications
 Sponsor certifies that the medicine is eligible for listing
Product is listed – assigned ARTG number (AUST L XXXX)
4

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
5

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.
6

Legislative requirements for permitted indications
An indication is ‘covered by’ the Permissible Indications Determination when:
a) It is specified in the determination (i.e. it is word for word);
OR
a) 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
a) 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)
7

Indications covered by the Determination
For example:
ARTG indication: Maintain/support gastrointestinal health
a) Word for word: Maintain/support gastrointestinal health
b) More specific version: Maintain/support gastrointestinal health in women
c) Intent and meaning:
 same intent and meaning: Maintains healthy gut
 different meaning: Maintain healthy intestinal flora
8

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.
9

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
10

Transition arrangements – when a fee applies
11TGA / CMA Advertising Seminar – May 2019
Type of Change Fee Payable New ARTG
number issued?
Must transition to
permitted indications?
New Standard listing fee Yes Yes
Grouping (indications
only)
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
12

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
on medicine labels
13

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
14

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
overall 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.
15

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
16

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
outside 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
17

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
or 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.
18

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
Column 1
Column 2
Indication
Column 3
Type of evidence
Column 4
Other requirements
1
Aids/assists gum
development
Scientific
2
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.
19

How to use permitted indications for your listed medicine
20

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.
21

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’
22

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.
23

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
24

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
25

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.
26

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
of the product.
Qualifiers can be viewed via the TGA Business
Services site.
27

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’.
28

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:
29

Case study – indications on the medicine label
• You can choose to demonstrate the target population in relation to the indication
or 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
TGA / CMA Advertising Seminar – November 2018 30

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 entryLabel
31

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
or 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
32

Including indications on medicine label
• 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’
33

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
34

Case study – Modifying indications on medicine labels
 Mandatory qualifier not included
on 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.
35

Frequently asked questions and issues raised by sponsors
36

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'.
37

Using indications for vulnerable populations
• 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.
38

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
39

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.
40

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
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 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.
TGA / CMA Advertising Seminar – May 2019 41

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.
TGA / CMA Advertising Seminar – November 2018
42

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.
43

Population qualifiers and directions for use
• 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.
44

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.
45

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.
46

Non-indication statements and claims
• 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
47

Non-indication statements and claims
 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
48

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.
49

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.
50

• 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
out in the Determination (that they must not imply treatment of serious
diseases) may not be incorrect.
Are permitted indications approved for use in advertising?
51

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
52

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.
53

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
54

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