The Therapeutic Goods Advertising Code 2021: what practices must know

The 2021 Advertising Code commenced on 1 January 2022, with a transition to 30 June 2022. Here is what it requires of clinic advertising.

1 January 202213 min read

On 1 January 2022 a new Therapeutic Goods Advertising Code came into force. Its formal name is the Therapeutic Goods (Therapeutic Goods Advertising Code) Instrument 2021, and it replaced the Therapeutic Goods Advertising Code (No.2) 2018. Advertisers had a six-month transition period, ending on 30 June 2022, during which they could comply with either Code. From 1 July 2022, only the 2021 Code applied.

The Code sets the minimum requirements for lawfully advertising therapeutic goods to Australian consumers. If your practice promotes any product, from sunscreen and supplements to medical devices and over-the-counter medicines, the Code governs what you can say. Its rules on testimonials and endorsements also matter to every clinic that uses social media, reviews or influencers in any way connected to products.

Status update: the 2021 Code is still the Code in force. It has been amended since commencement, including a narrow change on 20 December 2022 about COVID-19 vaccine advertising and a consequential amendment that commenced on 30 September 2026, which swapped the Code’s references to the old medicine labelling orders (TGO 91 and TGO 92) for the new ones (TGO 115 and TGO 116). Between 9 July and 3 September 2026 the TGA consulted on targeted improvements to the Code. We cover that consultation in a separate article on proposed changes to the Advertising Code.

What changed

The 2021 Code was made under section 42BAA of the Therapeutic Goods Act 1989 and registered on the Federal Register of Legislation on 1 December 2021 as F2021L01661. Section 2 sets commencement at 1 January 2022. Section 6 repeals the 2018 Code.

The TGA announced the new Code on 3 December 2021, after what it described as 18 months of consultation with stakeholders. It said the overarching objective was greater ease of reading, for easier application of the rules.

The transition period

Section 5 of the instrument defines the transition period as beginning on commencement and ending on 30 June 2022. During that window, the 2018 Code continued to apply so that its requirements could be complied with “as an alternative to the requirements specified in Schedule 1”, which is the 2021 Code.

On 8 June 2022 the TGA reminded advertisers that on 1 July 2022 the option of complying with the 2018 Code would no longer apply, and asked them to ensure all advertising, including on social media, was compliant by that date. It announced one exception: while advertisers used up existing hard-copy stock that met the 2018 Code’s mandatory statement requirements, the TGA would take a pragmatic approach and not seek enforcement action, provided the material complied with the 2021 Code in all other respects.

The key changes, according to the TGA

Simpler mandatory statements. Following consumer research, the number of required mandatory statements was reduced.
A new statement for health professional-only products: THIS PRODUCT IS NOT AVAILABLE FOR PURCHASE BY THE GENERAL PUBLIC.
Online sales treated differently. Where goods cannot be physically inspected before purchase, such as in online sales, relevant health warnings must appear in the advertisement at the point of purchase.
Clarified testimonial and endorsement rules. Genuine unpaid testimonials remain allowed, but paid or incentivised testimonials are not, including from influencers. The ban on health professional endorsements extends to former health professionals.
An expanded samples list, adding items such as face masks and gloves, hand sanitisers, certain nicotine replacement therapies and COVID-19 rapid antigen tests.
Prohibited representations moved out of the Code and consolidated in the Therapeutic Goods Regulations 1990.
Expanded “safe and proper use” rules, prohibiting ads that cause undue alarm, fear or distress.

Who it applies to

Section 5 of the Code says it applies to advertisements about therapeutic goods, judged by their likely impact on a reasonable person to whom the ad is directed, and taking into account the total presentation and context of the ad.

That captures practices that advertise products to consumers, pharmacies, brands, and the influencers and agencies who create content about therapeutic goods.

Section 6 lists what the Code does not apply to, including:

advertisements directed exclusively to the health professionals and other persons listed in section 42AA of the Act
public health campaigns conducted, approved or funded by the Commonwealth, a state or territory, or a statutory authority
genuine news broadcast or published by specified media organisations
price-only advertising of certain prescription and pharmacist-only medicines, which is dealt with only by Part 9.

Advertising a health service without referring to any therapeutic good is generally a matter for Ahpra and the National Law, not the Code. Once a service ad promotes a product, the Code and the Act are in play.

What the rules require

The Code is organised into nine parts in Schedule 1. These are the requirements most relevant to practices.

Accuracy and substantiation (section 8)

An ad must be accurate, balanced and not misleading or likely to be misleading, and must “only contain information that is substantiated by the advertiser prior to publication or dissemination.” For goods in the ARTG, an ad must not be inconsistent with the indication or intended purpose accepted for the goods.

Safe and proper use (section 9)

An ad must not represent goods, expressly or by implication, as safe or without harm or side effects, effective in all cases or a guaranteed cure, or infallible, unfailing, magical or miraculous. It must not cause, or be likely to cause, undue alarm, fear or distress. It must not delay or discourage people from seeking necessary medical attention or from undertaking treatment prescribed by a medical practitioner, exaggerate efficacy, encourage inappropriate or excessive use, or compare goods in a way that suggests other goods or services are harmful or ineffectual.

Scientific and clinical claims (section 11)

If an ad refers to research, it must identify the researcher, identify the financial sponsor where the advertiser knows or ought reasonably to know it, and give a proper citation so consumers can access the research. Scientific terms must be clearly communicated to the audience.

Children (section 12)

Ads must not be directed to children under 12. Ads may be directed to children aged 12 and over only for goods listed in Annexure 1, and never for goods containing Schedule 2, 3, 4 or 8 substances.

Mandatory statements (Part 4)

Depending on the product, an ad may need one of these statements, prominently displayed or communicated:

ASK YOUR PHARMACIST ABOUT THIS PRODUCT, for goods containing a substance in Schedule 3 and Appendix H of the Poisons Standard (section 15)
THIS PRODUCT IS NOT AVAILABLE FOR PURCHASE BY THE GENERAL PUBLIC, for goods only available through a health professional and advertised to the public (section 16)
ALWAYS FOLLOW THE DIRECTIONS FOR USE, for short form ads such as radio ads of 15 seconds or less, or short text-only ads with no capacity for imagery, but not social media posts (section 17)
ALWAYS READ THE LABEL AND FOLLOW THE DIRECTIONS FOR USE, along with the medicine’s name and one or more accepted indications, for other medicine ads (section 19).

Where an ad directly facilitates the purchase of a medicine that cannot be physically inspected first, such as on a website, social media or an app where a transaction can be completed, it must also include the dosage form, quantity, each active ingredient and any applicable health warnings, either listed or via a link giving direct access to them.

Part 4 does not apply to ads that consist only of the product name, a picture, the price or the point of sale, with no therapeutic claim.

Particular goods (Part 5)

Analgesic ads must carry INCORRECT USE COULD BE HARMFUL.
Complementary medicine ads relying on traditional use evidence must prominently say so.
Sunscreen ads claiming to prevent sunburn or skin cancer must show sunscreen as only one part of sun protection and carry statements about avoiding prolonged high-risk exposure and frequent reapplication.
Weight management ads must promote a healthy energy-controlled diet and physical activity, must not suggest the goods reverse overeating, and must not use images, statistics or testimonials that are not consistent with average expected results.

Testimonials and endorsements (Part 6, section 24)

This is the part that most often catches clinics. A testimonial or endorsement must be consistent with the label, directions for use and accepted indication, and any health benefit mentioned must be typical of what is expected from the goods.

An ad must not contain a testimonial from:

a person engaged in the production, marketing or supply of the goods. The Code’s note says this includes “influencers, direct sellers and other persons who have, or will receive, valuable consideration for making the testimonial”
an immediate family member of such a person, unless the relationship is disclosed
a corporation, or any person or body barred from giving endorsements under section 24(6).

The advertiser must verify both the content of a testimonial and the identity of the person who made it.

Under section 24(6), endorsements must not be given, expressly or by implication, by a government or government authority (unless permitted), a hospital or healthcare facility other than a community pharmacy, employees or contractors of those bodies, a current or former health practitioner, health professional or medical researcher, or anyone who represents themselves as qualified to diagnose, treat or prevent disease. Organisations representing consumers or health practitioners may endorse only if the ad discloses the organisation’s name and whether it received valuable consideration.

Samples and incentives (Part 7)

Samples are allowed only for goods listed in Annexure 2 and never for goods containing Schedule 2, 3, 4 or 8 substances. Ads must not offer personal incentives or commissions to pharmacy assistants or retail salespeople who are not health professionals for recommending or supplying goods.

Restricted representations (Part 8)

Section 28 defines a “serious” form of a disease, condition, ailment or defect, broadly as one that medically requires diagnosis, treatment or supervision by a suitably qualified health practitioner, or for which there is a test requiring medical interpretation. References to serious forms need TGA approval or permission under the Act.

Price information (Part 9)

Prices of registered prescription and certain pharmacist-only medicines may be published only by a retail pharmacy, its agent (including a pharmacy marketing group), or a medical practitioner approved under section 92 of the National Health Act 1953. Price lists cannot run on radio, television, public displays or in cinemas, must contain at least 25 medicines, must be in alphabetical order, and must not steer consumers to a particular medicine.

What it means for your marketing

Website and online shop

If your website sells products, check each product page that allows a purchase for the extra point-of-sale information: dosage form, quantity, active ingredients and health warnings. Check every product claim against the ARTG entry. Remove words such as “safe”, “no side effects”, “guaranteed” or “miracle” wherever they describe a product. If a blog post cites a study to support a product, add the researcher, sponsor and a proper citation.

Google Business Profile and reviews

Reviews that praise a product your clinic sells can become testimonials in your advertising if you republish or promote them. Verify the reviewer and content before using any review in product advertising, and never use a review from staff, family of staff or anyone who received a free product or payment.

Social media and influencers

Paid and gifted influencer testimonials about therapeutic goods are not allowed under the Code. Neither are endorsements from practitioners, current or former. That rules out a clinic doctor or nurse appearing in content endorsing a product, and it rules out hiring a former nurse turned content creator to endorse one. The TGA’s social media guidance, first published on 31 March 2022, applies these rules to posts, comments and hashtags.

Paid ads

Short text ads of 300 characters or fewer with no capacity for imagery are short form ads and need ALWAYS FOLLOW THE DIRECTIONS FOR USE. Social media ads are excluded from that category.

Email, SMS and print

Product promotions in newsletters and texts are advertising, so apply the same checks as for your website. For print, the TGA’s pragmatic approach to old stock covered only mandatory statement differences. Printed claims, testimonials or endorsements that did not meet the 2021 Code needed replacing.

Common mistakes we see

Using practitioner photos or quotes alongside a product in a way that implies the practitioner endorses it.
Sending free products to influencers and then sharing their positive posts as testimonials.
Describing a product as “safe” or “gentle with no side effects”.
Citing “clinically proven” without naming the research or giving a citation.
Product pages with a “buy” button but no active ingredients or health warnings.
Weight-related product promotions without diet and activity statements, or with atypical results.
Assuming any “genuine” testimonial is fine. The verification and eligibility rules still apply.

A practical checklist

Inventory every ad, web page, post and printed item that mentions a therapeutic good.
Confirm none promotes a prescription-only medicine to the public.
Check claims against the ARTG indication and hold your substantiating evidence before publishing.
Remove “safe”, “no side effects”, “guaranteed”, “miracle” and alarming or fear-based language.
Add the correct mandatory statement for each product type and format.
Add dosage form, quantity, ingredients and health warnings to pages where products can be bought.
Remove testimonials from staff, owners, their families, paid or gifted influencers, and anyone else who received valuable consideration.
Remove any current or former practitioner endorsement of a product.
Keep records verifying the identity and content of any testimonial you use.
Add researcher, sponsor and citation details wherever you refer to research.
Check any samples offered appear in Annexure 2 and contain no Schedule 2, 3, 4 or 8 substances.

How this fits with other rules

The Act sits above the Code. Prohibitions such as the ban on advertising prescription-only medicines to the public, and the requirement for approval of restricted representations, are in the Act and Regulations. Prohibited representations were moved from the Code to the Regulations in 2021.

Ahpra and the National Law prohibit testimonials in advertising a regulated health service. That is stricter than the Code, which permits some genuine unpaid testimonials about products. For a registered practitioner, a testimonial that the Code might allow for a product can still breach the National Law if it relates to the clinical aspects of your service.

The Australian Consumer Law requires that influencer relationships and incentivised reviews are disclosed and that reviews are not manipulated. The Code’s ban on paid testimonials goes further for therapeutic goods: disclosure does not make a paid testimonial acceptable.

Frequently asked questions

Can a patient’s unpaid review of a product appear in our advertising?

Under the Code, a genuine testimonial is possible if it meets section 24, including verification of identity and content and a typical health benefit. For registered practitioners, the National Law’s testimonial ban for regulated health services also needs to be considered, so seek advice before using one.

Can our nurse appear in a product video?

Not as an endorser. Section 24(6) prohibits endorsement, expressly or by implication, by a current or former health practitioner or health professional.

What is “valuable consideration”?

The Code does not list every form, but its note says people engaged in marketing or supply include influencers and others who have received or will receive valuable consideration for the testimonial. The TGA’s 2022 social media guide described it as payment of some value, such as money or free product.

Can we show a price list for prescription medicines?

Only if you are a retail pharmacy, a pharmacy’s agent or a medical practitioner approved under section 92 of the National Health Act 1953, and only under the strict Part 9 conditions.

Has the Code changed since 2022?

Yes, through targeted amendments, most recently the labelling-order update of 30 September 2026. Check the current compilation on the Federal Register of Legislation.

Need a hand?

If you promote products alongside services, our TGA advertising compliance review checks your website, social and printed material against the current Code. For teams writing their own content, compliant content and compliance training help you apply both the Code and Ahpra’s rules from the first draft.

This article is general guidance based on the published rules, not legal advice. Final responsibility for advertising sits with the registered practitioner, and complex situations may need independent legal advice.