Proposal for an Alternative
Regulatory Model for Creating
Consumer Awareness of
Pharmacist Only Medicines
April 2013
Table of Contents
1
Introduction ............................................................................................................................................3
2
Overview of the Australian framework governing access to medicines .................................................3
3
2.1
Scheduling of medicines...............................................................................................................3
2.2
The Scheduling Policy Framework (SPF) ...................................................................................5
Overview of Australian advertising controls for direct-to-consumer advertising of medicines ...........10
3.1
Co-regulatory controls ...............................................................................................................10
3.2
Self-regulatory controls .............................................................................................................11
4
Australia compared to other international jurisdictions.......................................................................11
5
Impact of advertising restrictions .........................................................................................................12
6
Proposed new model ............................................................................................................................12
6.1
Key objective ...............................................................................................................................12
6.2
Goals ............................................................................................................................................12
6.3
Key components and aspects of the proposed model .............................................................13
6.4
Default regulatory position and exceptions .............................................................................15
6.5
The model in practice .................................................................................................................15
7
Summary ...............................................................................................................................................15
8
Existing controls and arrangements that will accommodate the proposed model ..............................17
9
Legislative & other amendments required to implement the model ...................................................17
9.1
Amendments to the Therapeutic Goods Act .............................................................................17
9.2
Amendments to the SUSMP (the Poisons Standard) ...............................................................19
9.3
Amendments the NCCTG Scheduling Policy Framework for Medicines and Chemicals .......19
9.4
Amendments to the Schedule 3 Advertising Guidelines..........................................................19
9.5
Amendments to the Therapeutic Goods Advertising Code (TGAC) ........................................19
An alternative regulatory model for
creating consumer awareness of
Pharmacist Only Medicines
Introduction
In Australia the full potential of the value of Pharmacist Only (Schedule 3) Medicines to
individuals and the community as well as to pharmacists has not been realised. The main
reason for this is the inability of sponsors to create consumer awareness because of the
restrictions on the advertising of Schedule 3 medicines.
The ageing population and increasing burden of disease pose enormous challenges for
continuing to provide health services at sustainable levels. Empowering consumers to take
more responsibility for their health and measures to make better use of scarce healthcare
resources are some of the policy responses to these challenges.
It is recognised that community pharmacists are a vastly under-utilised resource and by
expanding their professional role they are well-placed to play a greater part in the delivery
of primary healthcare. This will have the added benefit of reducing the burden on general
practitioners (GPs), freeing up their time to manage more serious conditions.
The Australian regulatory framework for direct-to-consumer communication of Schedule 3
medicines is out of step with comparable international jurisdictions, such as New Zealand,
the UK and Canada. These markets do not have any restrictions on consumer
communications about medicines available without a prescription by a medical practitioner.
Raising public awareness of Schedule 3 medicines will deliver benefits for all – for
consumers by increasing awareness of a broader range of therapeutic options; for
community pharmacists by promoting their professional role in managing conditions with
Schedule 3 medicines; for government by making better use of available healthcare
resources; and for industry by encouraging research to generate the regulatory data to
support application for rescheduling of appropriate medicines from Prescription Only
(Schedule 4) to Schedule 3. This, in turn, will result in increased access to medicines.
Overview of the Australian framework governing access to medicines
Scheduling of medicines
Scheduling is a national classification system that controls how medicines and chemicals are
made available to the public. Medicines and chemicals are classified into “Schedules” to
control access to these substances.
Page 3 of 19
The Schedules are published in the Standard for the Uniform Scheduling of Medicines and
Poisons (SUSMP) and are given legal effect through state and territory legislation. The
SUSMP is legally referred to as the Poisons Standard1.
1 Poisons Standard 2012 - F2012L01200
(www.comlaw.gov.au/Details/F2012L01200)
Page 4 of 19
Table 1: The Medicines Schedules
Schedule 1 Not currently in use
Schedule 2 Pharmacy Medicine
Schedule 3 Pharmacist Only Medicine
Schedule 4 Prescription Only Medicine
Schedule 5 Caution
Schedule 6 Poison
Schedule 7 Dangerous Poison
Schedule 8 Controlled Drug
Schedule 9 Prohibited Substance
The Poisons Standard also provides guidance on interpretations, labelling requirements,
exemptions, warning statements and other relevant information on supply and access to
medicines and poisons.
The Scheduling Policy Framework (SPF) 2
The SPF sets out the scheduling process, guidance for amending the Poisons Standard, the
classification system for medicines and chemicals, guidelines for applications, public
consultation and confidential information as these relate to scheduling applications.
The SPF has been developed by the National Coordinating Committee on Therapeutic Goods
(NCCTG), (a subcommittee of the Australian Health Ministers' Advisory Council) which
oversees the development of a national approach to regulatory policy and administrative
protocols related to the availability and accessibility of medicines and chemicals. The NCCTG
comprises representatives of each state and territory Government, the Australian
Government and the New Zealand Ministry of Health, and is chaired by the National
Manager of the Therapeutic Goods Administration (TGA).
Key aspects of the SPF
The following are the key aspects of the model for the scheduling of medicines and
chemicals in Australia:

A single point of reference for scheduling policy through the National Coordinating
Committee on Therapeutic Goods (NCCTG);
2 NCCTG
scheduling policy framework (www.tga.gov.au/industry/scheduling-spf.htm)
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

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
The Secretary of the Department of Health and Ageing (or delegate) being the
decision-maker on the scheduling of medicines and chemicals and other changes to
the Poisons Standard;
Two separate Committees: the Advisory Committee on Medicines Scheduling
(ACMS) and the Advisory Committee on Chemicals Scheduling (ACCS) to advise the
decision-maker;
A single Poisons Standard as the Commonwealth legislative instrument; and
A single scheduling secretariat to ensure ongoing consistency and cohesiveness of
the process.
The Advisory Committee on Medicines Scheduling (ACMS)3
The ACMS comprises up to 15 expert members with expertise in one or more of the
following areas:







the regulation of scheduled medicines in Australia;
toxicology or pharmacology;
clinical pharmacology;
pharmacy practice;
medical practice;
consumer health issues relating to the regulation of therapeutic goods; and
industry issues relating to the regulation of therapeutic goods.
Factors involved in scheduling
There are criteria for inclusion of a medicine in a particular schedule, as outlined in the
NCCTG Scheduling Policy Framework4 and the Poisons Standard5. In making scheduling
decisions, the ACMS and the Delegate are required to assess the risk vs. benefit of the
medicine, the need for intervention by a healthcare professional (i.e. the level of access),
and, therefore, availability to consumers.
For the purposes of this paper and to provide context the criteria for inclusion in Schedules
2 and 3 are outlined below.
Pharmacy Only (Schedule 2) Medicines
1. The quality use of the medicine can be achieved by labelling, packaging, and/or provision of
other information; however access to advice from a pharmacist is available to maximise the safe
use of the medicine. The medicine is for minor ailments or symptoms that can easily be
recognised and are unlikely to be confused by the consumer with other more serious diseases or
conditions. Treatment can be managed by the consumer without the need for medical
3 Advisory committees on medicines &
chemicals scheduling (ACMS & ACCS)
(www.tga.gov.au/about/committees-acmcs.htm )
4 NCCTG
scheduling policy framework (www.tga.gov.au/industry/scheduling-spf.htm)
5 Poisons Standard 2012 - F2012L01200
(www.comlaw.gov.au/Details/F2012L01200)
Page 6 of 19
2.
3.
4.
5.
intervention. However, the availability of a pharmacist at the point of sale supports the
consumer in selecting and using the appropriate medicine.
The use of the medicine is substantially safe for short term treatment and the potential for harm
from inappropriate use is low. Suitable for diagnosis and treatment by the consumer in the
management of minor ailments.
The use of the medicine at established therapeutic dosage levels is unlikely to produce
dependency and the medicine is unlikely to be misused, abused or illicitly used. Medicines which
do not meet this factor are not suitable to be classified as Schedule 2 Pharmacy Medicines,
irrespective of any other applicable factors.
The risk profile of the medicine is well defined and the risk factors can be identified and managed
by a consumer through appropriate packaging and labelling and consultation with a medical
practitioner if required. There is a low and well-characterised incidence of adverse effects;
interactions with commonly used substances or food and contra-indications.
The use of the medicine at established therapeutic dosage levels is not likely to mask the
symptoms or delay diagnosis of a serious condition. Appropriate labelling and packaging can
manage any risks.
Pharmacist Only (Schedule 3) Medicines*
1. The medicine is substantially safe with pharmacist intervention to ensure the quality use of the
medicine. There may be potential for harm if used inappropriately. The consumer can identify the
ailments or symptoms that may be treated by the medicine but counselling and verification by a
pharmacist is required before use. Pharmacist-consumer dialogue is necessary to reinforce
and/or expand on aspects of the safe use of the medicine.
2. The use of the medicine at established therapeutic dosages is not expected to produce
dependency. Where there is a risk of misuse, abuse or illicit use identified, the risk can be
minimised through monitoring by a pharmacist.
3. The risk profile of the medicine is well defined and the risk factors for adverse effects and
interactions are known, identifiable and manageable by a pharmacist.
4. Where the medicine is intended for recurrent or subsequent treatment of a chronic condition,
pharmacist intervention is required to monitor safe use of the medicine following
recommendation by a medical practitioner or a pharmacist. The consumer may not be able to
self-monitor the safe ongoing use of the medicine. The condition does not require medical
diagnosis or only requires initial medical diagnosis, and the consumer does not require close
medical management.
5. The use of the medicine at established therapeutic dosage levels may mask the symptoms or
delay diagnosis of a serious condition. Pharmacist-consumer dialogue is required to detect the
risk of masking a serious disease or compromising medical management of a disease, and to deal
with it appropriately.
In general terms, the key differences between Schedule 2 and Schedule 3 medicines are
summarised below, in Table 2.
Table 2: Key differences between Schedule 2 and Schedule 3 medicines
Schedule
of Classification
the SUSMP
of schedule
Meaning of Classification
Schedule 2
Substances (medicines), the safe use of which may require
professional advice from a pharmacist and which should be
available from a pharmacy, or where a pharmacy service is not
Pharmacy
Medicine
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Schedule
of Classification
the SUSMP
of schedule
Meaning of Classification
available, from a licensed person. No prescription is required.
Schedule 3
Pharmacist
Only Medicine
Substances (medicines), the safe use of which requires
mandatory professional advice but which should be available to
the public from a pharmacist without prescription.
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Advertising of Pharmacist Only Medicines
Schedule 3 medicines are not permitted to be advertised directly to consumers except those
listed in Appendix H of the SUSMP. No other Schedule 3 medicines may be advertised to
consumers, despite being available without a prescription.
Exemptions from the restrictions on advertising (gaining Appendix H entry)
The NCCTG guidelines for advertising of substances in Schedule 3 of the Poisons Standard
(November 2000) describe the process for determining whether a substance in Schedule 3
of the SUSMP may be advertised6.
The ACMS, which determines the scheduling of a substance, also determines whether to
grant an exemption from the restrictions on advertising having regard for a range of
matters.7
Appendix H – Schedule 3 medicines permitted to be advertised
The SUSMP No.3 (June 2012) Appendix H list includes the following list of medicines:
Therapeutic class
Example of medicines
Topical antifungals
Butoconazole*, clotrimazole*, econazole*, miconazole*, nystatin* for
vaginal candidiasis.
Topical
corticosteroid:
Hydrocortisone*
Gastrointestinal
Diphenoxylate
Oral antifungal
Fluconazole, single dose for vaginal candidiasis
Non-steroidal
inflammatory
Other
anti- Diclofenac*
Dimenhydrinate, only when used for prevention or relief of motion sickness
* The active ingredient is also available in some Schedule 2 medicines, which may be
advertised.
Considering that a number of the medicines within Appendix H are allowed to be advertised
to consumers when in Schedule 2 medicines, it may be seen that Appendix H does not
reflect a meaningful proportion of the range of useful medicines currently in Schedule 3.
6 Schedule 3
advertising guidelines (www.tga.gov.au/industry/advertising-schedule3.htm)
7 Schedule 3
advertising guidelines (www.tga.gov.au/industry/advertising-schedule3.htm)
Page 9 of 19
Schedule 3 medicines not permitted to be advertised
Examples of medicines currently in Schedule 3 that are not listed in Appendix H include the
Proton Pump Inhibitors (PPIs) for gastro-oesophageal reflux disease (GORD), combination
ibuprofen plus paracetamol, and higher strength non-steroidal anti-inflammatory
medicines.
Overview of Australian advertising controls for direct-to-consumer
advertising of medicines
The advertising of medicines which are permitted to be advertised to consumers is
controlled through co- and self-regulatory arrangements. Co-regulatory arrangements are
underpinned in the Therapeutic Goods Legislation and apply to ALL advertisers. In addition
to these co-regulatory arrangements the main industry bodies, the Australian SelfMedication Industry (ASMI) and the Complementary Healthcare Council (CHC), also apply
self-regulatory controls through their respective codes of practice. These controls only apply
to members of the industry bodies.
Co-regulatory controls
The Therapeutic Good Advertising Code (TGAC)
Advertisements for therapeutic goods are subject to the requirements of the Therapeutic
Goods Act 1989 (the Act8) and Regulations9, the Competition and Consumer Act 201010 and
other relevant laws. Additionally, advertisements for therapeutic goods directed to
consumers must comply with the TGAC11.
The object of the TGAC is to ensure that the marketing and advertising of therapeutic goods
to consumers is conducted in a socially responsible manner that promotes the quality use of
therapeutic goods and does not mislead or deceive the consumer.
The Therapeutic Goods Advertising Code Council (TGACC) is responsible for the currency of
the TGAC while the TGA administers it.
Pre-approval of direct-to-consumer advertising
Certain types of advertisements (colloquially referred to as “above-the-line”) directed at
consumers require prior approval by a Delegate of the Secretary of the Department of
Health and Ageing:
8 Therapeutic Goods Act 1989
- C2013C00132 (www.comlaw.gov.au/Details/C2013C00132)
9 Therapeutic Goods Regulations 1990 - F2012C00807 (www.comlaw.gov.au/Details/F2012C00807)
10 Competition and Consumer Act 2010
- C2013C00004 (www.comlaw.gov.au/Details/C2013C00004)
11 Therapeutic Goods Advertising Code 2007 - F2007L00576
(www.comlaw.gov.au/Details/F2007L00576)
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
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

Broadcast media - TV and radio
Print media - newspapers & magazines (including inserts)
Outdoors - including billboards, bus shelters, sides & interiors of buses, taxi displays
Cinema films
The Secretary of the Department of Health and Ageing or his/her delegate is responsible for
approving advertisements.
Under co-regulatory arrangements, this responsibility has been delegated to industry
associations12 and the pre-approval functions are performed under contract with the TGA:


ASMI: all advertisements in broadcast media for over-the-counter (OTC) and
complementary medicines and all OTC advertisements appearing outdoors or in
print media (newspapers & magazines)
CHC: advertisements for complementary medicines appearing outdoors or in print
media (newspapers & magazines).
Complaints handling processes
Complaints about direct-to-consumer advertising in certain media mentioned earlier plus
internet advertising are considered by the Complaints Resolution Panel (CRP), a body
established in the Therapeutic Goods Regulations.
Self-regulatory controls
The various industry codes of practice (ASMI & CHC) provide for additional requirements
and controls which extend to advertising directed to healthcare professionals. Compliance
with these codes is a condition of membership of these bodies. The industry codes provide
mechanisms for complaints handling. Complaints about direct-to-consumer advertising that
appear in other media such as leaflets, flyers, brochures, catalogues or letterbox drops
(“below-the-line”) or advertising to healthcare professionals are handled by the relevant
industry bodies under their codes of practice mentioned above.
Australia compared to other international jurisdictions
The UK, Canada, New Zealand and the US allow advertising of all medicines available
without a doctor’s prescription. Unlike Australia, no exception is made for medicines that
are classified as the equivalent of Schedule 3, where such a classifications exists, i.e. in New
Zealand and Canada.
Although there may be minor country to country differences in which medicines are listed in
Schedule 3 type classifications, other comparable markets allow direct-to-consumer
advertising of these medicines.
12 Regulation of therapeutic goods advertising in Australia (www.tga.gov.au/industry/advertising-
regulation.htm)
Page 11 of 19
In a comparable way to Australia, the UK, Canada and New Zealand have self-regulatory and
co-regulatory systems in place that feature advertising pre-clearance and independent
complaints resolution bodies. The long history of market experience in relation to the
advertising of Schedule 3 medicines combined with the similarities between the Australian
regulatory controls and those in comparable jurisdictions provide a strong argument for
harmonising without compromising public health and safety.
Impact of advertising restrictions
The current advertising restrictions are unjustified because they deliver no net public health
benefit. In fact, the restrictions have a negative impact. They constrain the ability to make
consumers aware of treatments which are available without a prescription. Consequently,
consumers continue to consult GPs for conditions which could be safely managed by
pharmacists.
The wider availability of safe, proven and affordable medicines has the potential to make a
positive impact on public health by providing consumers with easier, more convenient and
faster access to therapeutic products to treat conditions and maintain good health.
The current arrangements disempower consumers because “they are not allowed to know”
about these medicines. It is difficult to mount a public health benefit argument to support
these restrictions, especially in view of the mandatory involvement of a leaned intermediary
in the supply of these products.
Proposed new model
The proposed model for creating awareness about Schedule 3 medicines is based on a
structured framework that will ensure information is provided in a balanced way.
Key objective
The primary objective of the proposed model is to create consumer awareness of
therapeutic options in the Schedule 3 category in a structured, balanced and responsible
way. The desired outcome is better-informed consumers.
Goals
The goals for consumers are to:




Raise awareness of symptoms, conditions or ailments,
Create awareness of the range of potential therapeutic options that might be
appropriate for those symptoms, conditions or ailments,
Emphasise the essential (mandatory) role of pharmacists in the supply of Schedule 3
medicines,
Encourage consumers to consult with their pharmacists to determine whether a
particular therapeutic option is appropriate for them.
Page 12 of 19
The goals for pharmacists are to:





Ensure pharmacists and pharmacy staff are fully informed about symptoms,
conditions and ailments for which Schedule 3 medicines might be appropriate,
Ensure consumers are referred to their GPs in a timely manner to avoid delay in the
treatment of more serious conditions,
Ensure that pharmacists are fully informed about Schedule 3 medicines,
Ensure that pharmacist are skilled and confident to manage consumer requests for
Schedule 3 medicines,
Expand the professional role of pharmacists in primary healthcare delivery by
increase appropriate access to medicines.
The goals for industry are to:


Encourage sponsors to invest in the development of regulatory data to support
applications for rescheduling (switch) of medicines from Prescription Only Medicine
(Schedule 4) to Pharmacist Only Medicine,
Increase investment in consumer awareness and education programs about disease
states and therapeutic options.
Key components and aspects of the proposed model
Standardised format
Conventional advertising for Schedule 2 and unscheduled medicines (GSL) generally places
more emphasis on brand recognition, an approach needed to create brand awareness in a
‘genericised’ and crowded market environment.
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The proposed model shifts the emphasis to the provision of symptom-related and/or
disease-state related information together with the requirement for counselling by a
pharmacist. The brand awareness component is a critical element to make the model viable,
but it takes a secondary role to the more important educational aspects of the
communication.
The new model differs from “conventional” advertising by making provision for a structured
and standardised format which contain the following 3 components:



Disease state information: this should highlight the symptoms and/or condition for
which the product is indicated.
Mandatory intervention by a pharmacist: this element of the communication aims to
promote and reinforce the professional role of the pharmacist. It will emphasise the
need for counselling and assessment whether the product is appropriate for a
particular condition and/or consumer, also taking into account whether alternative
options, (both medicinal and non-medicinal), would be more appropriate. This will
address consumer expectations in relation to the supply of a Schedule 3 medicines –
a product request does not automatically result in supply of that product (the issue
of “entitlement”).
Brand awareness: while an essential part of the communication this should be done
in such a way that does not detract from the informative and consultative nature of
the communication.
Preparing pharmacists and pharmacy staff
One of the key elements of the Schedule 3 communications model is the pharmacy support
package. It will be a requirement under the proposed model to ensure that pharmacists are
fully prepared prior to the commencement of consumer-directed communications. These
packages will include:



Comprehensive clinical protocols, guidelines and product information
The protocols will be developed by pharmacists in collaboration with relevant
healthcare practitioners where appropriate
Counselling support to help address the issue of consumers “demanding” a product
by brand name and resisting pharmacist counselling.
Regulatory controls (“checks and balances”)
The existing broad definition of an advertisement in the Therapeutic Goods Act &
Regulations will capture all communications directed to consumers under the proposed
model. Consequently, all existing regulatory controls requirements will provide the
necessary checks and balances to ensure compliance with the requirements for these
communications.
The following controls will apply:
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


The Therapeutic Goods Advertising Code (TGAC): It is envisaged that a specific
section on communications about Pharmacist Only Medicines 3 will be incorporated
in the TGAC to ensure universal application,
Current mandatory pre-approval of advertisements in specified media,
Existing co-and self-regulatory complaints procedures would also apply to the new
model.
Default regulatory position and exceptions
The existing Appendix H arrangements make provision for advertising by exception, i.e.
Schedule 3 medicines are not permitted to be advertised unless an exemption has been
granted.


The proposed model will, instead, become the default regulatory position applicable
to all Schedule 3 medicines, i.e. direct-to-consumer communications about all
Schedule 3 medicines will be permitted unless there are compelling reasons that it
would not be in the public interest.
To ensure public health and safety the model will make provision for exceptions, i.e.
where on a case-by-case basis and based on sound evidence, it would not be in the
public interest to advertise a particular product or substance. Examples include
pseudoephedrine-containing products, codeine containing analgesics and bowelcleansing preparations used prior to surgery or diagnostic investigations.
The model in practice
In the case of currently available Schedule 3 medicines the professional bodies would need
to work with sponsors to ensure that existing clinical protocols are up-to-date and available
to all community pharmacists prior to the commencement of any consumer communication
program.
The same principle will apply to medicines rescheduled from Schedule 4 to Schedule 3 in
future. It will be a requirement that community pharmacists are fully prepared prior to the
commencement of any consumer directed communications.
Summary
The restrictions applying to the advertising of Schedule 3 medicines are an impediment to
realising the full potential of these medicines. Preventing consumer awareness of safe and
efficacious medicines, which are available without a prescription and for which pharmacists
are the gatekeepers, does not make public health sense.
The proposed regulatory model for raising consumer awareness provides a structured and
standardised framework for communicating information in a balanced manner. The goals
are to create disease awareness, emphasise the critical role of the pharmacist and create
product awareness. Public health and safety will be maintained through existing advertising
controls which are robust and comprehensive.
The ultimate outcome of the model will be better-informed consumers.
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Page 16 of 19
Existing controls and arrangements that will accommodate the proposed
model

The existing provisions in the Therapeutic Goods Act are sufficiently broad, to allow
for any matters, including advertising, to be considered by the Secretary, in
particular 52E(1)(f)
52E Secretary to take certain matters into account in exercising powers
(1) In exercising a power under subsection 52D(2), the Secretary must take the following matters
into account (where relevant):
(a) the risks and benefits of the use of a substance;
(b) the purposes for which a substance is to be used and the extent of use of a substance;
(c) the toxicity of a substance;
(d) the dosage, formulation, labelling, packaging and presentation of a substance;
(e) the potential for abuse of a substance;
(f) any other matters that the Secretary considers necessary to protect public health.
(2) In exercising a power under subsection 52D(2), the Secretary must comply with any guidelines
of:
(a) the Australian Health Ministers’ Advisory Council; and
(b) the subcommittee of the Council known as the National Coordinating Committee on Therapeutic
Goods (or any replacement subcommittee);
notified to the Secretary for the purposes of this section.
(3) In exercising a power under subsection 52D(2), the Secretary must have regard to any
recommendations or advice of the Advisory Committee on Medicines Scheduling or the Advisory
Committee on Chemicals Scheduling.
(4) In exercising a power under subsection 52D(2), the Secretary may seek advice from either or
both of the following:
(a) any committee that the Secretary considers appropriate (whether or not the committee is
established under this Act or the regulations);
(b) any person.
(5) Subsections (2) to (4) do not limit the information the Secretary may consider in exercising a
power under subsection 52D(2).

The NCCTG Scheduling Policy Framework for Medicines and Chemicals will remain
relevant and adequate except for an amendment to Appendix H (see 9.3 below)
Legislative & other amendments required to implement the model
Amendments to the Therapeutic Goods Act


Replace “Schedule 3” under Section 42DL(1)(f) and 42DL(2)(c) with “Appendix H”.
Delete Section 42DL(3)(b)
42DL Advertising offences
(1) A person must not publish or broadcast an advertisement about therapeutic goods:
(a) that contains a prohibited representation (whether in express terms or by necessary
implication) about those goods; or
Page 17 of 19
(b) that does not contain a required representation about those goods; or
(c) that contains a restricted representation, about those goods, the use of which has not been
approved under subsection 42DF(1) or permitted under subsection 42DK(1); or
(d) that is in contravention of a notice referred to in section 42DKB that was given to the
person; or
(e) that contains:
(i) a reference to the Act other than in a statement of the registration number, listing
number or device number of the goods; or
(ii) a statement suggesting or implying the goods have been recommended or approved
by or on behalf of a government or government authority (including a foreign
government or foreign government authority), other than a statement of their
availability as a pharmaceutical benefit or a statement authorised or required by a
government or government authority (including a foreign government or foreign
government authority); or
(f) that contains a statement referring to goods, or substances or preparations containing
goods, included in Appendix H, Schedule3, 4 or 8 to the current Poisons Standard, other
than a statement authorised or required by a government or government authority
(including a foreign government or foreign government authority); or
(fa) that contains a statement referring to a biological, other than a statement authorised or
required by a government or government authority (including a foreign government or
foreign government authority); or
(g) that are not entered in the Register; or
(h) if the goods are therapeutic goods, or come within a class of therapeutic goods, that:
(i) are exempt goods or exempt devices prescribed in the regulations for the purposes of
this provision; or
(ii) have been approved under subsection 19(1) or section 41HB of this Act for
importation into, exportation from, or supply within, Australia.
Penalty: 60 penalty units.
(2) For the purposes of an offence against subsection (1), strict liability applies to the following
physical elements:
(a) that the use of a restricted representation, as referred to in paragraph (1)(c), has not been
approved under subsection 42DF(1) or permitted under subsection 42DK(1);
(b) that the notice referred to in paragraph (1)(d) is a notice referred to in section 42DKB;
(c) that goods, substances or preparations referred to in paragraph (1)(f) are included in
Appendix H, Schedule 3, 4 or 8 to the current Poisons Standard;
(d) that the therapeutic goods, or class of therapeutic goods, referred to in paragraph (1)(h):
(i) are exempt goods or exempt devices prescribed in the regulations made for the
purposes of subparagraph (1)(h)(i); or
(ii) have been approved under subsection 19(1) or section 41HB of the Act for
importation into, exportation from or supply within, Australia.
(3) It is a defence to a prosecution under subsection (1) if:
(a) in relation to an advertisement mentioned in paragraph (1)(a) or (f)—the advertisement is
made by, or on behalf of, the Commonwealth; and
(b) in relation to an advertisement mentioned in paragraph (1)(f)—the goods, substances or
preparations are mentioned in Appendix H of the current Poisons Standard; and
(c) in relation to goods mentioned in paragraph (1)(g)—the goods are exempt goods or
exempt devices other than goods of a kind mentioned in paragraph (1)(h).
Page 18 of 19
Amendments to the SUSMP (the Poisons Standard)

Modify Appendix H in the Poisons Standard to include goods, substances or
preparations included in Schedule 3 which are not permitted to be advertised.
Amendments the NCCTG Scheduling Policy Framework for Medicines and
Chemicals


Amend Appendix H – Schedule 3 medicines permitted to be advertised to become a
negative list, and
Delete the reference to the NCCTG Guidelines.
Appendix H – Schedule 3 medicines not permitted to be advertised
The decision-maker should make their determination after taking into account matters set the NCCTG
Guidelines for brand advertising of substances included in Schedule 3 of the Standard for Uniform Scheduling
of Drugs and Poisons (SUSDP) (November 2000). (Note: A review of advertising arrangements for therapeutic
goods is under consideration. Until this review has been finalised, Appendix H will be retained in the Poisons
Standard.)
Amendments to the Schedule 3 Advertising Guidelines

Delete the Guidelines for brand advertising of substances included in Schedule 3 of
the Poisons Standard 15 November 2000
Amendments to the Therapeutic Goods Advertising Code (TGAC)

Delete 6.3(e) under Section 6 - Minimum requirements:
(e)
or, in the case of Schedule 3 therapeutic goods listed in Appendix H of the Standard for
the Uniform Scheduling of Drugs and Poisons, words to the effect of YOUR PHARMACIST’S ADVICE IS REQUIRED;

(4)
Insert a new clauses under Section 7 - Special Categories:
Schedule 3 medicines:
Advertisements for therapeutic goods in Schedule 3 of the Poisons Standard must contain the following
components:
(a) a list of the symptoms and/or condition(s) for which the Schedule 3 medicine is indicated;
and
(b) a statement that mandatory assessment by a pharmacist will be required to determine the
suitability of the medicine for a particular consumer; and
(c) only the brand name of the product as it appears on the ARTG. No other promotional
messages or claims may be included.
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