Complying with the restrictions on advertising prescription medicines to the public

Advertising prescription medicines or substances is prohibited under subsections 42DL(10) and 42DLB(7) of the Act, apart from limited circumstances. See when advertising prescription medicines is allowed.

Significant fines, and criminal and civil penalties may apply to contraventions of the Act. This includes in relation to unlawful advertising of prescription medicines to the public. Where unlawful advertising occurs, we will take action in line with our compliance management framework.

Unlawful advertising of prescription medicines may also contravene other criminal and civil penalty provisions under the Act, including:

• using restricted and prohibited representations without permission or approval
• suggesting or implying government endorsements, see the claim 'TGA approved' must not be used in advertising.
• promoting  goods for an “off-label” use, that is, for an indication not entered in the Australian Register of Therapeutic Goods (ARTG)
• failing to comply with the Code.

Prescription medicines must generally be included in the ARTG to be lawfully supplied, unless an exemption, approval or authority applies.

Advertising therapeutic goods that are not included in the ARTG to the public is also prohibited under subsections 42DL(12) and 42DLB(9) of the Act, subject to limited exceptions. For more information, see Advertising legal framework.

To comply with the advertising restrictions in the Act, you should carefully consider the following before disseminating information about, prescription medicines to the public.

Determine if your content is advertising

Not all information communicated to the public about therapeutic goods is advertising.

Under the Act, advertising includes any statement, pictorial representation or design that is intended, directly or indirectly, to promote the use or supply of therapeutic goods is advertising.

Content may be considered advertising where, on its face, it appears to be designed or calculated to promote the supply or use of the relevant goods.

To understand how we assess materials, including contextual and promotional characteristics that may indicate advertising, see Determining if your content is advertising. If content is 'advertising', then the legislative requirements will apply.

For examples, see materials and activities that are likely to be considered advertising prescription medicines.

Remove all references to prescription medicines from your advertising

The prohibition on advertising prescription medicines to the public applies when an advertisement includes a direct or indirect reference to:

• a specific substance in Schedule 3, 4 or 8 of the Poison Standard, or a prescription medicine that, as a matter of fact, contains a substance in Schedule 3, 4 or 8 or where the surrounding context represents that the medicine contains such a substance.
• a colloquial, or an abbreviated name for a medicine, or a class of medicines, that contains a substance included in the relevant schedules (for example, ‘plant-based medicine’, BTX, or ‘the blue pill’), or where the surrounding context implies that it contains such a substance.

An indirect reference, such as ‘plant-based medicine’ or ‘weight loss injection’, is likely to be considered a reference to a prescription medicine when viewed in context. This might be the case even if no specific product, or substance, such as medicinal cannabis or GLP-1 receptor agonists is named.

Table 1 provides examples of direct and indirect references to prescription medicines.

There are limited circumstances in which advertising of prescription medicines is allowed.

Advertising directed exclusively to health professionals

Advertising directed exclusively to health professionals is exempt from the prohibition on advertising prescription medicines. This includes advertising directed to medical practitioners, nurses, purchasing officers, practice managers and other persons mentioned in section 42AA of the Act.

For this exemption to apply, the advertising material must be directed only to health professionals.

Including a disclaimer or caveat, such as advising the consumer to ‘speak with a health practitioner about appropriate treatment options’, does not exempt the material from the advertising restrictions.

For more information, see Advertising to health professionals so consumer rules do not apply.

Advertising must still comply with all other legislative requirements. In particular, it is unlawful to promote ‘off-label’ uses of therapeutic goods even where directed exclusively to health professionals.

Information shared between a health practitioner and their patient

Information given by a health practitioner directly to a patient in the course of treating that patient is not subject to the prohibition on the advertising of prescription medicines.

This allows health practitioners to provide information and advice directly to their patients about treatment options, including prescription medicines, and to explain the benefits and risks of those options.

For more information, see Advertising a health service.

Mass communications to prospective patients or customers that include information about therapeutic goods are unlikely to be exempt from the advertising prohibitions. For more information see direct marketing campaigns.

Advertising authorised or required by government

The prohibition on advertising of prescription medicines does not apply when the advertisement or information is authorised or required by a government or government authority within Australia.

This exception may apply to public health campaigns that are conducted, approved or funded by Commonwealth, state, territory or local governments. These campaigns aim to protect, promote and improve the health and wellbeing of the Australian public.

Advertising permissions and approvals

Public health campaigns that promote the use of prescription medicines are likely to refer to serious forms of disease (for example, vaccine preventable diseases). These are restricted and prohibited representations and must not be used in advertising without our permission or approval.

We publish permissions and approvals for restricted and prohibited representations on our advertising permissions page. For more information, see advertising vaccination services compliantly.

Publication of price lists that comply with the Code

The Code allows for price information for certain prescription medicines to be advertised to the public in the form of a price list, provided certain conditions are met. For more information see Applying the Advertising Code rules: price information.

Publishing price information outside of these limited exceptions may amount to unlawful advertising. See price information below.

These guidelines outline the factors that may cause content to be treated as advertising the use or supply of prescription medicines.

The examples provided are not exhaustive. They are intended to help businesses understand the legislative requirements. They can be applied across all industry sectors that publish or communicate content about prescription medicines. The examples are relevant to all forms of media and communication.

For more information on how to assess whether your content or activities are advertising, see determine whether your content is advertising.

Referring to prescription medicines through a business name or logo

Businesses that supply prescription medicines, or provide health services that involve prescription medicines, must take care to ensure that their business name or logo does not promote a prescription medicine.

A business name that directly or indirectly refers to a prescription medicine may be considered advertising if it suggests that the business provides services involving prescribing, supply or use of that medicine.

The prohibition on advertising prescription medicines also extends to pictorial representations. A business logo that includes a graphic or other image, whether realistic, stylised or cartoon, that depicts a prescription medicine and suggests its availability at the business may be considered advertising for that medicine.

Example

A clinic specialising in the treatment of pain associated with musculoskeletal disease includes ‘Medicinal Cannabis Clinic’ in its name.

Reason why this is non-compliant

In this context, the business name itself promotes the use or supply of a prescription medicine (medicinal cannabis).

Example

A company with the term ‘Dispensary’ in its name includes a stylised cannabis leaf beside their company name on its shop front and website.

Reason why this is non-compliant

The combination of the term ‘Dispensary’ with the cannabis leaf suggests that the company dispenses medicinal cannabis. This likely amounts to promoting the supply of medicinal cannabis.

Example

A men’s health company logo features a stylised image of a blue pill commonly associated with prescription medicines for the treatment of erectile dysfunction.

Reason why this is non-compliant

Depending on the context, this may, amount to prohibited advertising of a prescription medicine if the blue pill logo can be seen as encouraging its use or supply.

Promoting health services that supply or prescribe prescription medicines

When advertising health services, businesses must not directly or indirectly promote prescription medicines.

References to prescription medicines, or a class of prescription medicines, when promoting a health service may result in the content becoming prohibited advertising of those medicines.

Specific examples of activities and materials that are likely to be advertising of prescription medicines are provided below.

For guidance on how to advertise a health service without unlawfully advertising therapeutic goods used in the delivery of that service, see Advertising a health service.

The advertising of health services may be subject to requirements under Australian Consumer Law and the Health Practitioner Regulation National Law. For more information see Ahpra’s Guidelines for advertising a regulated health service.

Promoting prescribing services or consultations for specific prescription medicines

Materials that promote a health service (including via telehealth) as a way to obtain specific prescription medicines are likely to amount to unlawful advertising for those medicines. This includes advertising that indicates that a health service:

‘Before and after’ photos

Health service providers are not prohibited under the Act from using ‘before’ and ‘after’ photos to advertise their health service.

However, if it is expressly or implicitly suggested that the ‘after’ photo is due to the administration of a prescription medicine, this is likely to amount to advertising that medicine, in contravention of the Act.

Pharmacies promoting availability, or that certain medicines can be dispensed on prescription

It is unlawful for a business, such as a pharmacy, to promote the supply of specific (that is, named) prescription medicines or a specific class of prescription medicines (for example medicinal cannabis), such as by stating they:

• can fill prescriptions for, or
• dispense particular products.

This includes advertising displayed in public areas of a health service, including waiting rooms or reception areas, foyers, elevators or retail spaces.

Examples include, but are not limited to:

• leaflets, posters, displays, brochures and other promotional materials that are supplied separately from the product
• advertorials and infomercials, including those shown on television
• in-store and window signage.

Advertising for general dispensing services, such as offering ‘cheaper prescriptions’’, ‘click and collect prescriptions’, are not considered advertising for therapeutic goods unless they promote specific prescription medicines or classes of medicines.

We have published advertising permissions to allow pharmacies to advertise vaccination services. For more information, see advertising vaccination services compliantly.

Example

A prescription diabetes medicine is in short supply. A pharmacy displays a poster in its shopfront and includes information on its website and social media that it has the medicine in stock, its available strengths (for example 10mg, 20mg) and dosage instructions.

Reason why this is non-compliant

These materials, in the context of a community pharmacy, promote the supply of a specific prescription medicine.

Example

A pain clinic displays a sign in its window stating, ‘ask us about medicinal cannabis for your pain today’.

Reason why this is non-compliant

The sign, in the context of a pain clinic, is likely to be unlawful advertising of medicinal cannabis.

Promoting prescription medicines for the treatment of specific health conditions

A statement, pictorial representation or design that promotes the use of specific prescription medicines to treat specific medical conditions is likely to be an advertisement for those medicines.

This includes, but is not limited to:

• listing medical conditions or medical categories that may benefit from treatment with particular medicines
• using statements suggesting that the online prescription service can prescribe or supply specific medicines for certain medical conditions
• providing a catalogue of prescription medicines available for the treatment of particular medical conditions
• listing medical conditions with the prescription medicines approved to treatment them
• providing a form or facility that allows consumers to select from a list of medical conditions, or to check their eligibility for a prescription medicine, for example a survey, questionnaire, checklist or symptom checker
• providing an interactive or automated system such as a chatbot that suggests a prescription can be issued for certain medical conditions based on automated responses.

Promoting prescription medicines for the treatment of specific health conditions risks breaching other aspects of the advertising legislation, including the use of restricted or prohibited representations without prior permission or approval from us.

Example

A telehealth clinic’s website allows users to choose a medical condition from a dropdown menu. After selecting a condition, the user is taken to a page displaying a catalogue of prescription medicines associated with that condition. The page includes search and filter options to find specific medicines and features a prominent “Request Appointment” button.

Reason why this is non-compliant

By presenting a list of prescription medicines tailored to a medical condition, the website is promoting the use and supply of those medicines.

The website may also breach other aspects of the advertising legislation, including the prohibition on using restricted and prohibited representations without permission or approval.

Treatment involving the use of prescription medicines should only be discussed with a patient during a consultation with a health practitioner where appropriate treatment options can be explored. For more information, see information shared between a health practitioner and their patient.

Brand and disease awareness campaigns

Businesses should carefully consider whether brand or disease awareness campaigns they manage or deliver, promote the use or supply of prescription medicines.

For detailed information and examples to help identify when brand and disease awareness campaigns advertise therapeutic goods, see Advertising requirements for disease education activities.

Direct marketing campaigns

Mass communications about a prescription medicine, such emails or text messages, or communications delivered at public events (for example webinars) are unlikely to be exempt from the advertising rules. This is because they are not information shared between a health practitioner and their patient during treatment.

These types of mass communications can amount to unlawful advertising.

Example

A cosmetic clinic emails former patients with information about cosmetic injectable products available at the clinic.

The email includes information about different treatments options, including various prescription-only injectable products, their benefits and prices.

The clinic encourages patients to book a treatment or a consultation to discuss these options further.

Reason why this is non-compliant

This advertises prescription cosmetic injectables, which is prohibited.

Although the information is sent by a clinic to former patients, it is not provided in the course of treatment and is therefore not exempt from the advertising restrictions.

Referencing (linking to) third-party information about prescription medicines

Businesses should carefully consider whether additional or third-party materials associated with information they disseminate refer to a prescription medicine. This includes, for example:

• linking to third party materials, such as websites, articles, research papers or opinion pieces. Where the linked third party material promotes the use or supply of a specific prescription medicine.
• ‘sharing’ or ‘re-sharing’ social media posts and testimonials.

Where such links or shared content are included in the material provided by a business (for example a website or social media page), this may risk the business’s material being considered an advertisement for a prescription medicine.

Example

A website for a telehealth service includes links to blog posts and journal articles that promote the benefits of medicinal cannabis.

The linked material contains detailed testimonials and research papers endorsing the use of medicinal cannabis for the treatment of chronic pain.

The website also encourages users to book a treatment or a consultation to discuss pain management options.

Reason why this is non-compliant

The link to the third-party information, when viewed in the context of the references to treatment or consultations for pain management options on the website, are likely to promote medicinal cannabis.

As a result, the website may be considered unlawful advertising of a prescription medicine.

Using testimonials or endorsements

Using testimonials and endorsements about a prescription medicine is likely to be advertising of that medicine and is therefore unlawful.

In addition, the Code prohibits endorsements or testimonials about therapeutic goods given by certain individuals and organisations, including health practitioners.

For more information see Testimonials and endorsements in advertising.

The use of testimonials in advertising for health services is not permitted under the Health Practitioner Regulation National Law.

Ahpra’s Guidelines for advertising a regulated health service explain this prohibition, including what constitutes a testimonial under the National Law. This applies to all registered health professionals.

Social media posts, pages, groups and influencers

Business owners and social media account holders, including influencers, are responsible for the content of social media pages created or managed by them. This includes websites, social media channels, blog posts and discussion forums.

Content that can be viewed by the public must not promote the use or supply of prescription medicines.

For detailed information and examples to help identify when social media activities advertise therapeutic goods, see advertising therapeutic goods on social media.

Company announcements

Companies may be required to release information to the public about prescription medicines to meet their continuous disclosure obligations under the Corporations Act 2001. We have published guidance on Complying with advertising rules for therapeutic goods when making an ASX announcement, which explains how to meet these obligations without unlawfully advertising prescription medicines.

Compliance with the Medicines Australia Code of Conduct

When prescription-only medicines are registered in the ARTG, it is a condition of registration that any promotional activities comply with the Medicines Australia (MA) Code of Conduct.

Non-compliance with the conditions of registration may have serious penalties under the Act, including possible cancellation of the medicine’s registration.

1. Appendix H lists medicines included in Schedule 3 that are permitted to be advertised to the public.