Guidance for advertisers
This guidance for advertisers applies to the Therapeutic Goods Advertising Code (No.2) 2018. To assist advertisers with implementation, we have also published guidance material: Complying with the Therapeutic Goods Advertising Code (No. 2) 2018.
This guidance is effective from 1 July 2018, unless otherwise specified.
Sections of this guidance are still under development. We will be adding information to the ARGATG in stages.
This guidance informs advertisers (including sponsors, manufacturers, importers, pharmacists and health professionals) of their responsibilities when advertising therapeutic goods. All advertising of therapeutic goods is subject to the requirements of the Therapeutic Goods Act 1989 (the Act). For those therapeutic goods that can be advertised to the public, advertising must comply with the requirements of the Act and the Therapeutic Goods Advertising Code (the Code).
The Therapeutic Goods Administration (TGA) is responsible for administering the Act and the Code. We have the authority to apply penalties with various consequences for advertisers who do not meet their advertising requirements.
If you are a member of the public and are interested in how therapeutic good advertising is regulated or would like to make a complaint about an advertisement, please see the TGA website: Advertising therapeutic goods.
This guidance provides information to advertisers about:
For additional educational tools and fact sheets to help you understand your advertising requirements, see Advertising therapeutic goods on the TGA website.
This guidance has been developed by TGA and therefore the use of 'we' and 'us' throughout refers to TGA.
All examples provided in this guidance have been compiled to demonstrate the application of the legislation.
See the TGA glossary for definitions relevant to the regulation of therapeutic goods in Australia.
Guidance for advertisers
This guidance for advertisers applies to the Therapeutic Goods Advertising Code (No.2) 2018. To assist advertisers with implementation, we have also published guidance material: Complying with the Therapeutic Goods Advertising Code (No. 2) 2018.
Advertisements for therapeutic goods are subject to the requirements of the Therapeutic Goods Act 1989 (the Act) and the Therapeutic Goods Regulations 1990, the Competition and Consumer Act 2010, and other relevant laws. Advertisements for therapeutic goods directed to the public must also comply with the Therapeutic Goods Advertising Code (the Code).
Section 3 of the Act defines advertise in relation to therapeutic goods to include:
The 'intention' referred to in the definition above is not what you, as the advertiser, intend by releasing the information but rather what the end viewer thinks you intended. If the public or health professional considers that the information promotes the use or supply of the identified goods, then we would consider it an advertisement (see Activities that represent advertising).
The Act:
The purpose of the Code is to ensure that the marketing and advertising of therapeutic goods to the public is conducted in a socially responsible manner that promotes the quality use of therapeutic goods and does not mislead or deceive the public.
On 1 January 2019, the current version of the Code (2015) will be replaced by the 2018 Code.
The 2018 Code contains a number of changes and improvements from the 2015 Code. The 2018 Code aims to:
A consultation on proposed improvements to the Code was held in August 2017.
The Therapeutic Goods Advertising Code 2018 is available on the TGA website, following public consultation on a draft of the 2018 Code.
There is more information on the transition arrangements for the 2018 Code on the TGA website.
Section 42BAA of the Therapeutic Goods Act 1989 (the Act) allows the Minister, or their delegate, to make a code relating to advertisements about therapeutic goods in the form of a legislative instrument.
It is a criminal offence under section 42DM of the Act to advertise a therapeutic good to consumers in a way that does not comply with the Code. Section 42DMA provides for corresponding civil penalties.
When advertising therapeutic goods to the public, you cannot advertise:
You are required to seek permission or approval from TGA before using Restricted representations (representations which refer to serious diseases or conditions) in advertising therapeutic goods to the public.
Section 6 of the Act limits the operation of the Act, and therefore the Code, to
As such, neither the Act, nor the Code, apply to sole traders that operate solely within the state or territory in which they are based. However, advertisers should be aware that the promotion of therapeutic goods online may be considered trade or commerce across state/territory borders and therefore the Act and Code may apply. Sole traders operating solely intrastate should also be aware that some states and territories have adopted the advertising requirements in the Act and the Code.
The advertising requirements in the Act and the Code only apply to the advertising of therapeutic goods, as defined in section 3 of the Act. The advertising of goods that are not therapeutic goods, including foods and goods excluded from the operation of the Act under sections 7 or 7AA, is not subject to the requirements of the Act and the Code. However, some goods, when advertised with therapeutic claims, may be considered therapeutic goods. See advertising interface products and Complementary medicines interface issues for more information.
When preparing to advertise therapeutic goods to the public, you will need to consider other legal requirements as well as those set out in the Act and the Code.
Other relevant laws include:
Depending on a range of factors, including the advertising medium used, there may also be self-regulatory requirements that apply. For example:
The Communications Council has a useful list of advertising codes and regulations that apply in Australia.
The therapeutic goods advertising legislation is grounded in the Quality Use of Medicines (QUM) framework.
Quality Use of Medicines means:
Under the QUM framework, consumers should be able to select management options wisely; choose suitable medicines (if a medicine is considered necessary); and use medicines safely and effectively. Similar considerations apply to medical devices and other therapeutic goods that may be appropriate for self-selection by consumers for use in the care of themselves or their family.
To support the principles of the QUM framework, industry should be able to provide truthful information to potential consumers about the nature and benefits of therapeutic goods. They should be able to do so through responsible advertising, where this will enhance the health outcomes of the Australian people.
In this context, the Code is pivotal to establishing a robust and effective system for regulating advertising of all therapeutic goods to the public. It aids in giving consumers confidence that the claims they read and hear are well-founded, and it should provide a level playing field for industry.
In the event of any inconsistency between the Act or the Code and other policies, the Act and the Code prevail.
The advertising legislation, especially the Code, also draws on concepts used in the World Health Organisation: Ethical Criteria for Medicinal Drug Promotion 1988, namely:
Guidance for advertisers
This guidance for advertisers applies to the Therapeutic Goods Advertising Code (No.2) 2018. To assist advertisers with implementation, we have also published guidance material: Complying with the Therapeutic Goods Advertising Code (No. 2) 2018.
You are not permitted to refer to TGA, use a government logo, or imply that any government body (including a foreign government agency) endorses a therapeutic good in any advertisement to the public.
Do not make reference to government agencies (domestic or foreign), including TGA, in any advertising or promotional material as this potentially implies endorsement by that agency. This includes:
The ARTG contains information about therapeutic goods that can be commercially supplied in Australia.
We encourage you, as the advertiser, to provide the public with a product's ARTG details.
However, you are not permitted to make a broad statement that a therapeutic good is listed, registered, or included in the ARTG, even where factually correct, unless it forms part of a statement of the ARTG number.
You may use terms such as:
You should also be aware of the important differences between TGA classifications for products entered in the ARTG. We classify medicines as registered, assessed listed or listed. It would be inaccurate and misleading to identify a therapeutic good in advertising as a different classification.
Guidance for advertisers
This guidance for advertisers applies to the Therapeutic Goods Advertising Code (No.2) 2018. To assist advertisers with implementation, we have also published guidance material: Complying with the Therapeutic Goods Advertising Code (No. 2) 2018.
The regulation of advertising for different types of therapeutic goods can be quite different. It is important that you understand the specific requirements related to the type of good you are advertising.
Restricted scheduled substances are therapeutic goods containing a pharmacist only medicine (schedule 3), prescription only medicine (schedule 4) or controlled drug (schedule 8) of the Poisons Standard. These substances need a health professional to assess whether the therapeutic good is appropriate and suitable for a patient before they are prescribed.
You cannot advertise restricted scheduled substances to the public. This is prohibited under subsection 42DL(10) of the Act and is not permitted.
There are some exceptions including:
For information on the advertising requirements and restricted scheduled substances see:
For information on advertising medical devices see:
Generally, you cannot advertise biologicals to the public (section 42DL(11) of the Act).
A few biologicals are entirely excluded from the therapeutic goods legislation, while others are only excluded on the condition that they are not advertised to the public. If such biologicals were advertised to the public, they would be subject to regulation under the biological framework and the advertising requirements (including offences) would apply.
We have the authority to use various enforcement tools if your advertising does not comply with requirements.
Subject to any jurisdictional limitations, these requirements apply to advertising by any person, including health professionals, professional bodies, media outlets and commercial ventures. The requirements apply to advertising in all forms of media, including:
As biologicals cannot be advertised to the public, the Therapeutic Goods Advertising Code will not generally be relevant.
Services (that do not mention specific therapeutic goods) are permitted to be advertised, see advertising health services.
To advertise services and comply with the therapeutic goods legislation, the advertising should:
An advertisement for a health service that specifies the use of any biological or excluded autologous HCT product associated with that service is not permitted as it would promote the product also.
Testimonials that refer to biologicals or excluded autologous HCT products are likely to be considered advertising and are subject to the same requirements.
Guidance for advertisers
This guidance for advertisers applies to the Therapeutic Goods Advertising Code (No.2) 2018. To assist advertisers with implementation, we have also published guidance material: Complying with the Therapeutic Goods Advertising Code (No. 2) 2018.
Restricted representations (whether made expressly or by implication) can only be used in advertisements for therapeutic goods directed to consumers if TGA has permitted or approved the use of that representation.
A restricted representation is a representation (whether expressly or by implication) in an advertisement that refers to a serious form of a disease, condition, ailment or defect, as defined in the Code. See 'What is a restricted representation?'’ for more information.
The TGA has permitted the use of certain restricted representations by all advertisers of therapeutic goods that meet the characteristics and requirements specified by the TGA. These permitted restricted representations include:/p>
Copies of the written notices of approval or permission for the use of restricted representations are available from the published notices of approved and permitted restricted representations.
Where the TGA has permitted the use of a relevant restricted representation, advertisers do not need to apply for approval to use a restricted representation unless:
If an advertiser wants to use a restricted representation in advertising therapeutic goods to consumers but there is no existing approval or permission, they must seek approval by submitting an application for approval to the TGA.
Approval is not required for advertising that is directed exclusively to healthcare professionals, or generic information about therapeutic goods that is not advertising (as defined in the Act).
Complete an Application for approval to use a restricted representation in advertising.
The TGA can only grant approval for the use of a restricted representation for therapeutic goods that are already entered in (or exempt from inclusion in) the ARTG.
Any proposed restricted representation must be consistent with:
You should prepare your application with reference to the guidance on submitting an application for approval to use a restricted representation and the application checklist.
Guidance for advertisers
This guidance for advertisers applies to the Therapeutic Goods Advertising Code (No.2) 2018. To assist advertisers with implementation, we have also published guidance material: Complying with the Therapeutic Goods Advertising Code (No. 2) 2018.
TGA's approach to compliance is described in the Regulatory Compliance Framework. This framework allows us to escalate actions to achieve compliance, depending on the severity of the non-compliance and your attitude towards compliance.
We have the authority to use various enforcement tools if your advertising does not comply with requirements. We can apply these actions at any time, even if your advertisement was not brought to our attention by a complaint. These actions can have various consequences for you as the advertiser ranging from mild to very serious.
We may take any of the following actions when advertising is found to be non-compliant:
*As of 1 July 2017, the value of a penalty unit is $210. The value of a penalty unit is listed in the Crimes Act 1914.
Guidance for advertisers
This guidance for advertisers applies to the Therapeutic Goods Advertising Code (No.2) 2018. To assist advertisers with implementation, we have also published guidance material: Complying with the Therapeutic Goods Advertising Code (No. 2) 2018.
Not all information released to the public about therapeutic goods is advertising. However, if information you release intends (from the end viewer's point of view) to directly or indirectly promote the use or supply of a therapeutic good then we would likely consider it to be advertising and it must meet legislative requirements as set out in Act and the Code (see Advertising and the Act).
We consider promotional material to be a form of advertising. Even if the material or the format of advertising can be said to promote the use or supply of relevant goods only in an indirect way, the material or format will still be an 'advertisement'.
Information that is purely factual and balanced and is disseminated for the appropriate use of the goods (for example, consumer medicine information, instructions for use) is unlikely to be considered promotional.
Your information is more likely to be considered promotional if it contains:
When deciding whether your information is an advertisement, we take into consideration the following factors:
Any promotional activity for a therapeutic good is likely to fall under the definition of an advertisement.
Advertisements may be targeted to the masses (for example, a newspaper advertisement for cold relief products), to a specific patient group (for example, an advertisement for blood glucose meters in a magazine for diabetics) or specific individual consumers (for example, a letter to individuals that have bought certain types of products from a retailer in the last 12 months).
Advertising is not limited to a specific type, or types, of media. It can include articles published in journals, magazines and newspapers, displays on posters and notices, photographs, film, broadcast material, video recording, electronic transmissions and material posted on the internet. Point-of-sale materials, leaflets, booklets and other promotional materials that include specific product claims and which are supplied separately from the product may also be advertisements. Words forming part of a soundtrack or video recording are within the definition of to advertise as is the spoken word. Product reviews and even product trade names can constitute advertising.
Depending on the content and the context in which such material is provided to the public, some documents and content may be considered not to be advertisements.
For example:
(A fact sheet providing more information on the differences between advertising and other activities is currently under development.)
The Act and the Code apply to digital communications channels such as social networking sites, blogs and discussion forums when these are used to promote therapeutic goods. Even when these dissemination tools are not used with the conscious intent to promote therapeutic goods, if this is the likely effect of the material on the reasonable consumer, then the material would be subject to the Act and the Code. Website and social media managers should:
The labelling and package leaflet of a product, even if they comply fully with the labelling requirements of the Act, the Regulations, the Devices Regulations and the Labelling Orders, may still be an advertisement. If a label is an advertisement, it needs to comply with the Code (other than those specific sections that have an exemption for labels). This is also the case for Consumer Medicine Information and Patient Information Leaflets (for medical devices).
Guidance for advertisers
We are aware that a member of the public has asked a medical clinic to remove vaccination posters, implying that he is an officer of the TGA. Posters relating to vaccines sanctioned by the Australian Government Department of Health under the National Immunisation Program are permitted by the therapeutic goods advertising requirements.
This guidance for advertisers applies to the Therapeutic Goods Advertising Code (No.2) 2018. To assist advertisers with implementation, we have also published guidance material: Complying with the Therapeutic Goods Advertising Code (No. 2) 2018.
TGA does not regulate the advertising of health services. We do not consider advertisements solely for health services to be advertisements for therapeutic goods.
To ensure that your advertisement for a health service isn't also considered an advertisement for therapeutic goods, do not refer (either directly or indirectly) to any therapeutic goods used in the delivery of the service in the advertisement.
This may be difficult for services that inherently involve therapeutic goods, for example, imaging or vaccination services. Such advertisements will need to comply with the legislative requirements for advertising therapeutic goods as well as any requirements governing the advertising of services.
You should be aware that there are requirements that apply when advertising health services, such as:
Advertisements for extemporaneously compounded medicines must comply with the Act and other relevant laws, including the Health Practitioner Regulation National Law (and applicable advertising and dispensing guidelines), the Australian Consumer Law, and State and Territory Laws. Extemporaneously compounded medicines, although exempt from some parts of the Act, are not exempt from the advertising provisions of the Act.
Generally, it is unlawful to publish or broadcast an advertisement to consumers for an extemporaneously compounded medicine, that refers to a substance (any ingredient of a medicine) or a good containing a substance classified in the Standard for the Uniform Scheduling of Medicines and Poisons (the Poisons Standard) as a pharmacist only medicine (Schedule 3), prescription only medicine (Schedule 4) or controlled drug (Schedule 8) (some exceptions apply).
Both a medicine and an ingredient used in the manufacture of a medicine is a therapeutic good.
The advertising requirements in Part 5-1 of the Act apply to advertisements that are:
The advertising provisions in Part 5-1 of the Act do not apply to advertisements:
Advertisements for extemporaneously compounded medicines must not refer to any medicine that contains a restricted scheduled substance, even where:
There is an exception, to the offence of advertising a medicine that contains a restricted scheduled substance, for those Schedule 3 substances listed in Appendix H to the current Poisons Standard. Please note that there are certain exemptions from the scheduling requirements which may also apply.
It is an offence to advertise therapeutic goods to the public with references to serious forms of diseases, conditions, ailments or defects without prior authorisation from the TGA. These references are prohibited or restricted representations.
All vaccines for human use are classified as prescription-only medicines (Schedule 4) in the Poisons Standard. You cannot advertise prescription-only medicines to consumers. The only exception to this prohibition is advertising that has been authorised or required by a government or government authority within Australia (subsection 42DL(10) of the Act).
This means that a clinic displaying an advertisement in the form of a National Immunisation Program poster produced by the Australian Government (the Advertisement) that promotes particular vaccines and vaccination would not breach the prohibition.
Advertisers who display such an advertisement must ensure that:
For example:
Public health campaigns relating to vaccination, in addition to referring to prescription-only vaccines, invariably use representations which refer to serious forms of diseases (i.e. vaccine preventable diseases). Such representations are 'restricted representations' which must not be used in advertisements for therapeutic goods prior to approval or permission from the TGA. The TGA has given permission for advertisements that are government public health campaigns, to contain 'restricted representations'.
We do not regulate the advertising of health services but if your advertisement for a vaccination service also promotes the use of a therapeutic good it is considered an advertisement for a therapeutic good which, outside of the context described above, would be likely to contravene the Act.
When advertising vaccination services, avoid using:
Use of any of the above makes advertising of your service to be more likely considered advertising of the vaccine itself and subject to therapeutic goods legislation.
We recommend that advertisements for seasonal influenza vaccination services should inform the public:
High risk groups that are eligible for free influenza vaccines include:
You cannot publish an advertisement to the public about therapeutic goods that contains a statement referring to goods, or substances or preparations containing goods, included in Schedules 3, 4 or 8 of the Poisons Standard (section 42DL(1)(f) of the Act).
The products listed below (and most cosmetic injections) contain substances that are in Schedule 4 of the current Poisons Standard and are therefore regulated as Prescription Only Medicines:
Cosmetic injections are generally administered to temporarily remove/reduce wrinkles and lines on the face, around the eyes, forehead (anti-wrinkle injections and dermal fillers), lips and neck (dermal fillers only) or to improve the appearance of submental fat (deoxycholic acid).
We consider prescription medicines to be high risk products and the patient should be assessed by a medical professional before their use. Health professionals and cosmetic or beauty clinics are not permitted to advertise cosmetic injections (such as those above) to the public.
Some cosmetic injections may be compounded by a pharmacy for an individual patient rather than supplied by a manufacturer as a finished product. The advertising of compounded cosmetic injections that contain prescription-only substances to the public is also prohibited. For more information, see Advertising extemporaneously compounded medicines.
To continue legally promoting your cosmetic service to the public, there are some acceptable general terms that you can use to describe certain cosmetic injections in advertisements.
You cannot make any reference in your advertisement to:
This includes abbreviations of either the ingredient or trade names.
You may use the following acceptable general terms and phrases in your advertising (noting a therapeutic good must not be advertised for an indication or intended purpose that is not accepted in relation to the inclusion of the good on the ARTG):
You may also use other words and phrases with similar meaning, provided that they do not refer to specific products or ingredient names. It is not acceptable to use acronyms, nicknames, abbreviations or hashtags of the medicine's name (or some part thereof), which may be taken by a consumer to be a 'reference' to a specific medicine or substance.
You may also have obligations under the Competition and Consumer Act 2010 and state and territory fair trading/consumer affairs legislation.
Guidance for advertisers
This guidance for advertisers applies to the Therapeutic Goods Advertising Code (No.2) 2018. To assist advertisers with implementation, we have also published guidance material: Complying with the Therapeutic Goods Advertising Code (No. 2) 2018.
We are currently developing this guidance.
Guidance for advertisers
This guidance for advertisers applies to the Therapeutic Goods Advertising Code (No.2) 2018. To assist advertisers with implementation, we have also published guidance material: Complying with the Therapeutic Goods Advertising Code (No. 2) 2018.
We recognise that there can be a regulatory 'interface', or potential overlap, between certain foods, medicines, devices, cosmetics and consumer goods. Products at this interface may seem very similar, but can be regulated differently.
We describe examples of three such interfaces below:
Sometimes it isn't clear whether a product for oral consumption is a therapeutic good or a food. The potential overlap between certain foods and medicines is referred to as the food-medicine interface.
Generally, if your product is covered by a food standard, or is traditionally used as a food in the form that it is presented, it is regulated as a food. If your product is not a food, it is likely to be considered a therapeutic good.
TGA has developed a Food-Medicine Interface Guidance Tool (FMIGT) in consultation with Food Standards Australia and New Zealand (FSANZ) and Australian state and territory agencies. This tool helps you determine how your product is regulated. Use this guidance and the FMIGT to determine whether your product is a food or a therapeutic good.
Making therapeutic claims, statements or indications for a product that you intend to market as a food, might lead a consumer to think the product is for therapeutic use. This could result in your product being regulated as a therapeutic good.
A probiotic is a product containing live bacteria that is taken orally to restore the body's beneficial bacteria. Probiotics are presented as ready-to-eat yoghurt or milk products, in powders for mixing in food and drink, or in gelatine capsules. Probiotics are often positioned at the food-medicine interface.
Probiotic products that are clearly covered by a food standard, or that are traditionally used as foods in Australia or New Zealand in the form they are presented in, are regulated as foods.
For example, yoghurt and yoghurt drinks are covered by Food Standard 2.5.3 for fermented milk products. Accompanying general level health claims for such products would be limited to lactose digestion covered by the nutrition, health and related claims set out in Food Standard 1.2.7. High level health claims need to be separately approved by FSANZ.
A probiotic that is not covered by a food standard or that is not traditionally used as a food in Australia or New Zealand, however, is not automatically considered a therapeutic good.
If the product is accompanied by a therapeutic claim, statement or instructions for use, it may meet the definition of a therapeutic good because:
For example, a sachet of probiotic powder might be marketed as a food but other factors such as claims about its health benefits, warning statements or a dosage regime may lead consumers to believe it is a therapeutic good.
If you decide to market your product as a therapeutic good, it will be regulated as one. If the product is manufactured overseas, we must approve your products manufacturing before it can be imported and released for supply in Australia.
These kinds of products are often regulated as complementary medicines and listed on the ARTG. If you have suitable supporting evidence, listed therapeutic goods can make low-level therapeutic claims on the product label and in your advertising, in line with the Code.
If you would like your probiotic product to be regulated as a food rather than a therapeutic good, consider how you market and present it to consumers.
Contact a regulatory affairs consultant or your state or territory food authority for further information, or see the following useful links:
Most cosmetic products are generally not considered therapeutic goods, as they tend not to be for a therapeutic use and we do not regulate them. However, a cosmetic may be a therapeutic good, depending on its ingredients, route of administration and if therapeutic claims are made on the product label or in advertising. Products for topical use (including for use on teeth or the oral mucosa) may be regulated as a cosmetic or a therapeutic good depending on the type of product and the claims made.
Generally, a product for topical use that is covered by the Therapeutic Goods (Excluded Goods) Determination 2018 (the Determination) will be regulated as a cosmetic. The Determination, which was made under section 7AA of the Act, declares a number of products not to be therapeutic goods provided those goods (to the extent that they are therapeutic goods) are exported, imported or supplied in a manner that is consistent with the terms of their exclusion under the Determination, or advertised or presented for supply in a particular way. Additionally, the Therapeutic Goods (Declared Goods) Order 2019 made under section 7 of the Act declares that products labelled or promoted for cosmetic purposes when promoted for oral consumption are, for the purposes of the Act, therapeutic goods.
The National Industrial Chemicals Notification and Assessment Scheme (NICNAS) regulates the ingredients in cosmetic products under the Industrial Chemicals (Notification and Assessment) Act 1989. Further information on the regulation of cosmetic ingredients is available from NICNAS.
Claims on cosmetic labels are regulated by the Australian Competition and Consumer Commission.
We are currently developing this guidance.
Guidance for advertisers
This guidance for advertisers applies to the Therapeutic Goods Advertising Code (No.2) 2018. To assist advertisers with implementation, we have also published guidance material: Complying with the Therapeutic Goods Advertising Code (No. 2) 2018.
Effective handling of reports enables advertisers of therapeutic goods to comply with legislative requirements, be socially responsible and assist in delivering good health outcomes. Reports about advertising are currently considered by us or one of a number of industry associations depending on the advertiser, type of product and the medium in which the advertisement appeared.
Anyone may lodge a report about a non-compliant advertisement for therapeutic goods.
To report an advertisement, please use our online form.
If you require support to complete this form, please call 1800 020 653.
When a report is lodged, the following details should be included where possible:
See commonly recorded breaches of the Act and the Code as a guide.
You can find more information about how we may use personal information received in a report on the Privacy page of the TGA website.
Guidance for advertisers
This guidance for advertisers applies to the Therapeutic Goods Advertising Code (No.2) 2018. To assist advertisers with implementation, we have also published guidance material: Complying with the Therapeutic Goods Advertising Code (No. 2) 2018.
Please see our dedicated Advertising therapeutic goods section of the TGA website for details on upcoming webinars and roadshows to assist you in understanding your advertising responsibilities and being compliant with current legislation.
If you are new to therapeutic goods regulation and wish to advertise your product in Australia, you may also benefit from attending our training on advertising and making claims for therapeutic goods.
Guidance for advertisers
This guidance for advertisers applies to the Therapeutic Goods Advertising Code (No.2) 2018. To assist advertisers with implementation, we have also published guidance material: Complying with the Therapeutic Goods Advertising Code (No. 2) 2018.
Version | Description of change | Author | Effective date |
---|---|---|---|
V1.0 | Original publication | Advertising compliance section and Regulatory guidance team | June 2018 |
V2.0 |
Additional information about:
Some minor editorial changes have also been made |
Advertising compliance section and Regulatory guidance team | July 2018 |
V2.1 | Minor editorial changes to reflect the making of the Therapeutic Goods Advertising Code (No.2) 2018 (the Code) and the inclusion of the Pricing Information Code of Practice at Schedule 4 of the Code from 1 January 2019. | Advertising Education and Assurance Section | November 2018 |
V2.2 | Updated Advertising vaccination services and vaccines | Advertising Education and Assurance Section | November 2019 |
V2.3 | Changes to the information about advertising pre-approvals | Advertising Education and Assurance Section | November 2019 |
V2.4 | Updated Cosmetic medicine interface | Advertising Education and Assurance Section | December 2019 |
V2.5 | Changes to reflect the requirement for advertising pre-approval in specified media ending on 30 June 2020 | Advertising Education and Assurance Section | July 2020 |
V2.6 | Initial changes for complaints handling process improvements | Advertising Education and Assurance Section | August 2020 |
V2.7 | Changes to restricted representation guidance, including reference to approval checklist | Advertising Education and Assurance Section | October 2020 |
V2.8 | Updated section on reporting non-compliant advertisements | Advertising Education and Assurance Section | October 2020 |