ASMI FAQs in relation to the Therapeutic Goods Advertising Code (TGAC)
These answers have been provided by ASMI to assist its members
to comply with the TGAC.
In all instances members are reminded of section 3(2) of the
TGAC which states that:
"The conformity of an advertisement with this Code should be
assessed in terms of its probable impact upon the reasonable person
to whom the advertisement is directed."
There are informative discussions on how a panel might assess
the probable impact of an advertisement on the reasonable consumer in
the following ASMI and CRP determinations:
Nurofen For Children Complaint before the ASMI Panel (2013):
Swisse Complaints 2011/11/001 and 2011/11/009:
Q. The definition of "specified media" is not always
clear. In particular, what about posters displayed in shop
windows? Is it true that the difference between "specified" and
other media is only the side of the glass to which the poster is
A. The TGAC explicitly excludes "displays … inside individual
shops" (see the definition of "specified media" in Section 2).
Effectively this means that a poster on the inside of the shop
window (even facing onto the street) is located "inside" the shop
and so not considered to be "specified media". The same poster
located on the outside of the window would fall within the
definition of specified media. So if it is on the outside of the
window it requires pre-approval and is within the jurisdiction of
the CRP. If it is on the inside then pre-approval is not required
and it cannot be complained about to the CRP.
Q. If there is a breach of the TGAC in a catalogue
for a pharmacy chain, who is responsible for the breach? The
pharmacy chain or the product sponsor?
A. Both the publisher and the sponsor have responsibilities for
ensuring compliance with the TGAC. Both may be asked to respond to
the CRP if a complaint is raised. However, if a non-compliant ad
was published without the sponsor's knowledge then thesponsor may
be excused if they can demonstrate that lack of knowledge.
Q. How do I know whether to complain to the CRP or
A. The CRP handles complaints about material in specified media
(which includes TV, radio, digital and some print). You can
complain about any advertiser regardless of whether they belong to
an industry association or not. More information about the CRP
processes is available on the "Procedures" page of the Complaints
Resolution Panel website (HERE). The
ASMI Complaints Panel handles complaints about material in all
media, but only if the advertiser is an ASMI member. The ASMI Code
of Practice does contain a mechanism for non-members to agree to be
bound by the ASMI Code. More information about the ASMI processes
is available on the on the "Code Determinations" page of the ASMI
Q. What is the difference between bona fide news and
A. The definition of "advertisement" in the TGAC (see Section2)
is very broad and sponsors need to be mindful that it includes
statements which even indirectly promote the use or supply of the
goods. This captures press releases prepared by sponsors, and may
even capture articles written by journalists based on those press
There have been instances where the CRP has found that the
proximity between a piece of "news" and an advertisement was such
that the two pieces would be considered by a reasonable consumer to
form a single advertisement. The two pieces do not even have to be
on the same or adjacent pages to be considered together; in the
past the CRP has found that a consumer could associate pieces in
this way even if they were several pages apart.
Q. Can you please explain the exemptions in relation
to advertisements which display only the "name, picture and/or
price and/or point of sale"?
A. This exemption is in section 3(3) of the TGAC in relation to
pre-approval and is also in section 6(2) in relation to the minimum
requirements of an advertisement. These exemptions are
extremely narrow and restrict the advertiser to including these
four elements and nothing else. The inclusion of any other information
(e.g. marketing claims such as "new" or "hot price") takes the
advertisement outside the exemption. Note that neither the product
name nor the pack shot can include a therapeutic claim. If an
advertisement does not fall within the exemption, then it may
require pre-approval and must meet the minimum requirements of an
Q. What are the minimum requirements of an
A. The minimum requirements of an advertisement are set out in
section 6 of the TGAC and include: the trade name, a reference to
the approved indications and certain mandatory statements.
Q. Do I have to reference my
A. Section 4(4) of the TGAC provides the only mandatory
referencing requirement. Other than this there is no requirement to
reference a claim in an advertisement (however it may be prudent to
do so). Members are reminded that section 5.1.4 of the ASMI Code
imposes an obligation to provide claim substantiation without delay
upon request. Section 4(4) of the TGAC is discussed in more detail
Q. What does the section on "Scientific Information"
(section 4(4)) actually require me to do?
A. Section 4(4) of the TGAC introduces additional requirements
in relation to the presentation of scientific information in an
advertisement. This section introduces four new terms to the TGAC
(none of which is defined). These terms are: "scientific
information", "scientific terminology", "publication" and "research
We take a similar approach to interpreting these new terms in
section 4(4) as we do in relation to the terms "direct marketing"
and "internet marketing" in section 6 of the TGAC (see FAQ
In relation to section 4(4) it is reasonable to assume that the
terms "publication" and "research results" do not mean the same
things as the terms previously used in the TGAC. The drafters meant
something different and they used different words to indicate this
In examining section 4(4) it is useful to note that
"identify[ing] the researcher and the financial sponsor of the
research" is not
synonymous with referencing the study. While it may be useful for
practical reasons to cite the reference, compliance with section
4(4) simply requires an identification of the researcher and the
financial (and not a full citation).
So what does "publication of research results" mean? On the one
hand it could be something very precise (e.g. the initial
publishing in a journal of a research paper) (e.g. the initial
presentation of a poster at a conference). On the other hand it
could be something more general (e.g. a detailed reference to the
journal article). In any event "publication of research results"
has to be something different to (and more than) a "claim", a
"statement" or an "implication" (since these are the terms used in
the preceding section of the TGAC - 4(2)).
A useful discussion of this section of the TGAC is contained in
the 2012/10/020 in relation to the product Hypercal (HERE).
With the above in mind, it is therefore useful to think of three
tiers of claims:
- 1. A "claim", a "statement"
or an "implication" (per section 4(2) of the TGAC). This
would be a broad reference for which identification required by
section 4(4) did not apply. For example "this product
relieves pain within 15 minutes.
- 2. A "general statement
about the evidence" (per the CRP discussion in complaint
2012/10/020) which is something less than publication of research
results and does not trigger section 4(4). For example "four
clinical trials have shown that this product relieves pain in 15
- 3. "Publication of research
results" which is something more than a general statement about the
evidence and which does trigger section of the TGAC. For example
"in a 2011 trial involving 3,000 patients in Mexico, the majority
of patients recorded statistically significant pain relief within
Please note that this approach is consistent with the TGACC's
approach in 2008 when recommending that the TGA make revisions to
section 4(4). At that time, the TGACC recommended that the section
be revised to read:
Publication of references to a specific research study must
sufficiently identify the study as to allow consumers to access
it. Any direct financial sponsorship that has been provided
by the sponsor of the product or the advertiser, where known, must
be included in the advertisement.
What is scientific
What is scientific
Although the terms "scientific information" and "scientific
terminology" are not defined in the TGAC, ASMI's view is that the
words ought to be given their ordinary meaning. Also, they ought to
be approached from the point of view of the reasonable person to
whom the advertisement is directed (per section 3(2) of the
The requirement for "scientific information" to be accurate,
balanced and not misleading, is simply a re-statement of the
requirements in sections 4(1)(b) and 4(2)(c) , so there is no
additional requirement particular to scientific information. It is
therefore not critical to determine what "scientific information"
is because it has to be treated exactly the same as all other
The requirements for the "scientific terminology" to be
appropriate, clearly communicated and able to be readily understood
by the audience are additional to those of sections 4(1)(b) and
4(2)(c). So it is important to firstly identify what scientific
terminology is and, secondly to make sure that it is communicated
in a manner consistent with section 4(4). In ASMI's view,
what amounts to scientific terminology will depend on the audience,
but in any event it would involve technical terms that are not
commonly used by the audience and that may be out outside the
normal l experience or knowledge of the audience members. If your
advertisement includes such language then the requirements of
section 4(4) will need to be met.
Q. Is it okay to provide incentives to pharmacy
assistants to sell or recommend products?
A. Section 4(3) of the TGAC prohibits advertisements from
including an incentive to pharmacy assistants to sell or recommend
a product. Section 5.1.8 of the ASMI Code contains a similar
prohibition. Together, these two Codes prohibit members from
offering such incentives through any advertising medium.
This does not prevent ASMI members from offering incentives to
pharmacy or retail assistants to participate in product
Q. Is it okay to describe fish oil products as being
'mercury tested'? Or does this bring into play a breach of section
4(2)(d) of the Code (by being likely to bring about 'fear or
distress' in consumers)?
A. As outlined in the following summary, section 4(2)(d) does
not prevent this claim from being made:
- In 2004, ASMI refused an application to advertise fish oil
capsules as '99.99999% mercury free'. On appeal, the TGA delegate
(on the advice of the TGACC) confirmed this decision. The claim was
refused on the basis that it implied that the goods were safe or
that their use could not cause harm, breaching s 4(2)(i) of the
TGAC. The delegate also determined that the claim constituted an
unacceptable comparison (s 4(5)), as the statement was likely to
give the impression that other fish oil products may be
- The matter was again considered in 2008, when CHC refused the
claim 'tested for pesticides and heavy metals including mercury'.
The delegate confirmed this decision, taking into consideration
advice from the TGACC (from the December 2008 meeting). CHC
reasoned that the claim breached sections 4(2)(c), 4(2)(d), 4(2)(i)
and 4(5) of the TGAC. They determined that the intrinsic safety of
a product (including determinations about the presence or absence
of mercury) in therapeutic goods was a market entry issue within
the TGA's responsibility. By stating such claims in an
advertisement, a misleading impression was created that other
products may not be of comparable relative safety, breaching s
4(5). They also reasoned that the claim exploited the lack of
knowledge of consumers as most consumers do not have a detailed
knowledge of the various pre-market requirements which need to be
satisfied about product safety prior to marketing authorisation
being granted, breaching s 4(2)(d) of the TGAC.
- The 2008 decision was subject to a merits review by the
Administrative Appeals Tribunal. The AAT set aside the decision of
the delegate, and granted approval for a print advertisement which
included the claim 'tested for pesticides and heavy metals
including mercury'. This decision was made in July 2009.
Q. When do the additional minimum requirements in
A. Section 6(3)(c)(i) of the TGAC introduces additional minimum
requirements in relation to "direct marketing" and "internet
marketing". This section introduces these new terms to the TGAC
(neither of which is separately defined). We take a similar
approach to interpreting the new terms in section 6(3)(c)(i) as we
do in relation to the terms "scientific information", "scientific
terminology", "publication" and "research results" in section 4(4)
(see FAQ above). That is, when the drafters of the TGAC introduce
new terms, these new terms do not mean the same things as the terms
previously used in the TGAC. Importantly, the drafters used the
word "marketing" as distinct from the word "advertising". It is
therefore appropriate to conclude that internet marketing is not the
same as internet advertising.
In ASMI's view, section 6(3)(c)(i) only applies where a product
is being advertised AND being sold.
Section 6(3)(c)(i) does not apply where a product is only being
Q. Can you please provide clarity on who is and
isn't a 'healthcare professional'?
A. 'Healthcare professional' is defined in section 42AA of the
Therapeutic Goods Act. This was updated in 2009 to remove reference
to veterinarians and scientists working in medical laboratories.
The previous definition still appears as Appendix 2 of the
Sponsors should note that section 4(6)(b)(iv) of the TGAC states
that advertisements must not contain or imply endorsement 'by
individuals, who are healthcare professionalsby way of their
representationin advertisements or academic qualifications, and/or
who are likely to be known as healthcare professionals by the
reasonable person'. Sponsors should be mindful that the
average consumer may not be able to discern whether the talent in
an advertisement is 'actually' a healthcare professional; ambiguity
should be avoided. The following determination provides a useful
Sensodyne Complaint 2013/05/009:
Q. Can you please clarify circumstances where a
healthcare professional can promote a therapeutic
A. Promotion by healthcare professionals is permissible only
with respect to availability, as per section 4(6)(b)(iii) of the
TGAC. For instance, a pharmacist could relay the bland message 'the
full range of product X is available at pharmacy Y'. This message
must not include statements that imply that professional's
endorsement of the product, such as 'I've got just the thing!'
Q. Can you please clarify circumstances where a
healthcare facility or hospital can endorse a
A. Section 4(6)(a) states 'An advertisement may include
reference to sponsorship of any government agency, hospital or
other facility providing healthcare services, provided that
sponsorship isexplicitly acknowledgedand isnot presented as an
endorsement of a therapeutic good'. For instance, the claim
'company X is a proud sponsor of Sydney Children's Hospital' is
acceptable (provided adequate supporting documentation is forwarded
to the ASM).
Sections 4(6)(b)(i) and(ii) state that advertisements must not
contain or imply endorsement by 'any government agency' or
'hospitals and other facilities providing healthcare services'. For
example, the claim 'product X appears on Sydney Children's Hospital
formulary' implies the Hospital's endorsement of that product, and
is not compliant.
Q. Can you please clarify circumstances where
a professional body can endorse a product?
A. There are certain circumstances (set out in section
4(6)(b)(c) of the TGAC) where a peak healthcare professional body
or association may endorse a product. The advertisement must name
the body/association, the endorsement must be authenticated (this
documentation to be forwarded to the ASM), the nature of the
endorsement must be clearly disclosed, and the endorsement be based
on an objective assessment of available scientific data supporting
the use of that product. Where the endorsement is not based on an
objective assessment, and the body/association has received
valuable consideration for its endorsement, the advertisement must
acknowledge that consideration.
For instance, an advertisement may contain a statement like
'product X is a recommended sunscreen of the Dermatological Society
of Australia' (provided that that Society does not provide
healthcare services). If the Society received payment for making
that endorsement, the advertisement would need to disclose that
Q. What is a "sample"?
A. A 'sample' is not defined in the Therapeutic Goods
legislation. The TGAC previously referred to a 'free sample'. The
word 'free' was removed after the CRP considered a series of
advertisements offering samples of therapeutic goods for as little
as five cents. An offer of a 'free trial' of a product would
certainly be considered an offer of a sample.
Section 4(8) has long been taken to mean that there should be an
exchange of valuable consideration in purchasing a therapeutic
This does not necessarily prohibit heavy discounting, especially
in an era of discount pharmacy.
The TGACC has already recommended that this section of the Code
be amended to refer to "an offer of a sample of a therapeutic
good". The revised s 4(8) would be phrased:
"An advertisement for therapeutic goods must not contain an
offer of a sample of any therapeutic good, other than a sample of
therapeutic devices and/or sunscreens."
Q. What are some of the issues with promotional
activities such as "Buy 1 get 1 free"?
'Buy one get one free' and 'buy this, get that' promotions
should be considered in light of the principles of Quality Use of
Medicines. QUM is defined in the ASMI Code as 'selecting diagnostic
and treatment options wisely based on the best available evidence
and the consumer's needs; choosing suitable therapeutic products if
this is considered necessary; and using therapeutic products safely
and effectively'. The consumer should autonomously determine
whether a specific therapeutic good is actually appropriate or
necessary for them.
Value offers may enliven a breach of s 4(2)(f) of the TGAC, by
encouraging inappropriate or excessive use of a therapeutic good.
However, it can be difficult to establish whether a promotion
actually encourages inappropriate or excessiveuseof a product; this
clause doesn't necessarily prohibit 'excessive' purchase.
Generally, a 'buy one get one free' offer of the same product
will comply with the TGAC, as long as the promotion does not
incentivise excessive/inappropriate use.
Q. What about "Buy this and get that" and gifts with
'Buy this, get that' promotions are regarded differently, as the
second product is not the same as the product purchased. Even if
the second product is from the same therapeutic class, the consumer
has not self-selected it. As such, it would be considered a sample
of a therapeutic good, and breach s 4(8) of the TGAC.
'Gifts with purchase' (of non-therapeutic goods) are generally
compliant, provided the promotion is not likely to encourage
inappropriate or excessiveuseof the product. These gifts are
typically of nominal value.
Q. Do promotions including offers of 'money back
guarantees' or '100% cash back' comply with the
An advertisement containing a 'money back guarantee' may comply
with the Therapeutic Goods Advertising Code, if the context of the
advertisement in which it appears clearly indicates that the
advertised product may not work for all consumers. This will avoid
breaching s 4(2)(h) of the TGAC (an advertisement for therapeutic
goods must not contain any claim, statement or implication that it
is effective in all cases of a condition). A 'money back guarantee'
will usually not be taken to breach s 4(8) of the TGAC, as the
expectation is that the product has been purchased.
'100% cash back' offers, however, are more likely to enliven a
breach of s 4(8) of the TGAC. Depending on context, these
promotions tend not to emphasise the possibility that the product
may not work for every consumer, but rather effect a 'free trial',
or offer of a sample, of the advertised product.
Q. Do advertisements require mandatory statement(s)
if one or more websites are included? Inclusion of the recommended
information in internet marketing is not always possible due to
issues such as space restrictions.
A. Digital advertising is not exempted from the requirement to
display mandatory statements. It is useful to embed the mandatory
statements in a website template. This ensures that the statements
appear on every page featuring the advertised product. These can be
included at the bottom of a page, provided they are clear and
While all advertisements must include the mandatory statements,
some pragmatism is necessary. ASMI considers that it would be
reasonable for a digital 'banner' ad to not include the mandatory
statements, so long as these were visible on a full advertising
webpage, accessed by clicking on the banner.
The CRP considered an example of 'direct marketing' and
'internet marketing' issued by Chemist Warehouse in Complaint
2012/08/007. The Panel found that this email advertisement lacked
the minimum requirements of 'direct' and 'internet' marketing set
out in s 6(3)(c)(i) of the Code.
The CRP's determination in Complaint 2012/08/007 can be found
There have not been any recent determinations published where
the CRP has considered the mandatory statements appearing in
digital marketing is sufficiently 'prominently displayed or
Q. Are there specific mandatory statements
forvitamins and weigh loss products? For example is the statement
"vitamin supplements should not replace a balanced diet" mandatory
for vitamin products under section 7 of the TGAC?
A. The TGAC sets out 'vitamins' and 'weight management' as
special categories. However, there is no formal requirement to
include statements like 'Vitamins do not replace a balanced diet',
or 'To be used in conjunction with a calorie controlled diet'.
These are not 'mandatory' statements. Sponsors should be mindful of
the wording of section 7 of the TGAC, and the need to ensure that
the messages in the advertisement itself are compliant; the
inclusion of a pseudo-mandatory statement like 'vitamins do not
replace a balanced diet' will be inadequate if the advertisement
itself tells a different narrative.
Q. Which body - CHC or ASMI - is to approve a print
ad if both complementary and OTC products are advertised in the
A. If a print advertisement (appearing in mainstream media)
contains complementary and OTC products, it will require approval
by both ASMI and CHC. These bodies are only empowered to review
print advertising of either OTC or complementary medicines; only
OTC products will be considered in an ASMI review and only
complementary products will be considered in a CHC review. Sponsors
should be aware that these advertisements must display both CHC and
ASMI approval numbers, and be mindful of approval timelines.
Q. Is there a difference between "Clinically
proven", "clinically tested", "clinically trialled"
A. The CRP has indicated that "clinically proven" and
"clinically tested" are essentially the same claim and both require
the same high level of proof. The CRP's view is expressed in the
following three determinations:
Remifemin Complaint 2012/06/024 (see paragraphs 35 to 39):
Actinica Complaint 2012/07/005 (see paragraph 23):
Swisse Complaints 2011/11/001 and 2011/11/009 (especially
The CRP decision highlight looking at "clinically proven" is
also useful and is available HERE
Q. When does a catalogue become
A. A publication is classified as mainstream if it fits the
definition in section 3 of theTherapeutic Goods Act. Note that this
definition is about thecontentof the publication and not the method
of distribution. Publication without approval is a breach of
section 42C. A catalogue on its own therefore does not require
approval (unless the method of distribution makes it "mainstream").
Adding content to a catalogue will make it more like a mainstream
publication. For example, the inclusion of things like recipes,
editorials, competitions, news etc. is more likely to bring the
publication within the definition in the Act.
If the publication fits the definition of "mainstream" then the
individual advertisements should each be approved.
The following two CRP determinations provide useful
Algicaps Complaint 2012/08/006:
SAFE Products Compliant 2012/02/016:
Q. What would constitute an advertisement for an
"unbranded therapeutic good" under section 6(1)(a) of the
A. The only reference to "unbranded therapeutic goods" is in the
TGAC. This term appears interchangeable with 'generic information',
which is referenced only in the Therapeutic Goods Regulations.
The TGACC should consider replacing the term 'unbranded
therapeutic goods' with 'generic information'. The definition of
'generic information' should be included in section 2
('definitions') of the TGAC. Consistent wording would ease
Q. What is meant by 'generic
'Generic information' is defined in the Therapeutic Goods Act as
'Generic information', in relation
to therapeutic goods, includes any statement, pictorial
representation or design, however made, about the composition,
properties or other characteristics of therapeutic goods, but
does not include:
(a) an advertisement about the goods; or
(b) generic information included in
an advertisement about the goods; or
(c) bona fide news.
Generic information must comply with subsections 4(1), (2), (3),
(4), (5) and (6) of the Therapeutic Goods Advertising Code (per
section 42DP(1)(b) of the Therapeutic Goods Act, and regulation
8A of the Therapeutic Goods Regulations). Note that
this includes the prohibition on healthcare professional
As generic information excludes 'advertisement', there is no
requirement to seek formal pre-approval. However, complaints about
generic information can be considered by the Complaints Resolution
Q. To what products does section 6(3)(f) of the TGAC
A. Section 6(3)(f) applies to products which can be advertised
to consumers, that are not included in schedule 2 (Pharmacy
Medicine) or Schedule 3 (Pharmacist Only Medicine) and that are
only available on the recommendation of a healthcare professional.
Some examples of these products include:
- Practitioner Only Complementary Medicines
- Contrast Media
- Folic Acid injections
- Vitamin C Injections
Q. Are statutory declarations required in order to
A. No. Section 7 of the TGAC requires testimonials to be
"documented, genuine, not misleading and illustrate typical cases
only". The TGAC does not specify how the testimonials are to be
documented (only that they must be). While it might be
best-practice to use a statutory declaration to capture the
testimonial, it is not mandatory and in some cases it may not be
possible to obtain one. On this point it is worth noting that
although section 29 of the Australian Consumer Law contains
specific coverage of testimonials, neither the Act nor the ACCC
mandates the use of statutory declarations to substantiate
Q. Do 'media engagement' activities need to comply
with the TGAC?
A. Sponsors should be mindful of the broad definition of
'advertisement' when issuing media statements. The Therapeutic
Goods legislative definition of 'advertisement' includes 'any
statement, pictorial representation or design, however made, that
is intended, whether directly or indirectly, to promote the use or
supply of the goods'. As such, media engagement is a form of
advertising, and content should comply with the TGAC. This activity
does not fall within the definition of 'specified media', so does
not require pre-approval. The ASMI Code has long included 'press
releases' as a 'below the line' category to be reviewed by the
Promotional Monitoring Panel.
The ASMI Complaints Panel has considered several complaints
involving public relations activities (or 'media engagement'). In
the 2006 complaint, Nicorette v Nicabate, the Panel noted that
'press releases' fall within the ASMI Code definition of
'advertisement/promotion'. The Panel determined that when a
publisher publishes matter derived from a press release or other
form of communication issued by a sponsor, the sponsor is
responsible for anything that finds its way from the press release
(or other communication) into the publication. They noted that the
CRP had taken a similar approach, finding both publisher and
sponsor responsible for a consumer advertisement derived from a
press release (in complaint 7-1104). In a later complaint, Somac v
Pariet (2011), the Panel determined that any content provided by a
sponsor to media (not necessarily in the form of a press release)
is considered advertising, and should comply with the TGAC.
In Nicorette v Nicabate (2006), the Panel clarified that while
sponsors are responsible for the content of media engagement
materials, they cannot be held accountable for editorial omissions,
or misinterpretations. However, sponsors are accountable for
inferences reasonably drawn from a media release.