TGA ends advertising pre-approval for medicines in specified media

From 1 July 2020, medicine ads in print, outdoor and cinema no longer needed TGA pre-approval. The rules stayed; the external check went.

1 July 202011 min read

From 1 July 2020, advertisements for medicines in “specified media” no longer needed pre-approval before they ran. Until then, a medicine ad destined for a magazine, newspaper, catalogue, cinema screen, billboard or public transport display had to be vetted and approved under the Therapeutic Goods Regulations 1990 first. That gate is gone.

For practices, the change is easy to misread. It did not loosen the advertising rules. It removed the external check, and with it the comfort of having someone else sign off. The Therapeutic Goods Administration (TGA) still regulates what an ad says, and the responsibility for getting it right now sits entirely with the advertiser, which includes any clinic that promotes medicines it sells or supplies.

Status update: the end of pre-approval still stands. The advertising code that applied at the time, the Therapeutic Goods Advertising Code (No.2) 2018, was replaced by the Therapeutic Goods Advertising Code 2021 from 1 January 2022, with a transition period to 30 June 2022. We cover that change in our article on the 2021 Advertising Code. The TGA has also published a series of guidance updates since, including on social media advertising and on advertising prescription medicines and health services.

What changed

The TGA announced on 1 July 2020 that medicine ads in television, radio, print media, cinema, billboards or other public displays no longer required pre-approval, “following parliamentary changes to the Therapeutic Goods Act 1989”. The changes came into effect on 1 July 2020.

The TGA’s earlier notice of 13 May 2020 set out what “specified media” covered for the pre-approval scheme:

magazines
newspapers
newsletters
catalogues
cinema advertising
public displays about goods, including posters, billboards and displays in or on public transport.

The legislation requiring pre-approval ended on 30 June 2020. The TGA explained that the change came from a recommendation of the Expert Review of Medicines and Medical Devices Regulation that the pre-approval scheme be stopped in favour of more self-regulation. It also stated that the mandatory pre-approval scheme would not be replaced by any other statutory vetting scheme.

The legislative change itself was made in 2018. A TGA notice published on 10 November 2020, announcing an independent review of the advertising reforms, describes the removal of pre-approval for medicine advertisements in specified media from 1 July 2020 as a government decision “implemented through legislative change in 2018”. The same notice links the broader advertising measures to the Therapeutic Goods Amendment (2017 Measures No.1) Act 2018. That review, led by Ms Rosemary Sinclair AM, was expressly not asked to reconsider the removal of pre-approval.

The wind-down before July 2020

The scheme did not stop overnight. In October 2019 the TGA told complementary medicine advertisers that the Complementary Healthcare Council of Australia would stop accepting new pre-approval applications from 14 November 2019, with alternative arrangements to follow. By June 2020 the TGA was directing applicants with pending applications to Consumer Healthcare Products Australia, and warning that new applications were unlikely to be decided before the scheme ended. The Regulations did not allow refunds of fees paid for pre-approval applications.

Who it applies to

The change affected anyone who advertises medicines to the public in the listed media. In a healthcare setting, that is most relevant if your practice:

sells or promotes over-the-counter medicines, complementary medicines (such as vitamins or supplements) or therapeutic sunscreens
runs a dispensary, a retail area or an online shop that lists medicines
produces printed catalogues, newsletters, posters or shopfront displays that mention specific medicines
works with a pharmacy, supplier or brand on co-branded advertising.

It is worth being clear about what the change did not touch. Prescription-only medicines could not be advertised to the public before 1 July 2020 and still cannot. The end of pre-approval did not open a door for advertising prescription medicines, including the medicines used in cosmetic injectable treatments, weight management or medicinal cannabis. Those restrictions sit in the Act itself and the TGA has continued to enforce them.

Ahpra’s rules on advertising a regulated health service also apply separately to registered practitioners. Those rules were never part of the TGA pre-approval scheme and were not changed by it.

What the rules require

With pre-approval gone, the core obligations are the ones that applied all along. They are now simply unchecked until something goes wrong.

Comply with the Act and the Advertising Code

The TGA’s 1 July 2020 release says ads for therapeutic goods available to consumers are subject to the Act and the Therapeutic Goods Advertising Code, and that the Code sets requirements so that ads are socially responsible and do not mislead or deceive consumers. At the time, that was the 2018 Code. From 1 January 2022 it is the 2021 Code.

Restricted representations still need TGA approval

This is the one piece of prior approval that survived. Advertisers must still obtain approval or permission from the TGA before referring to serious diseases, conditions, ailments or defects in consumer advertising for therapeutic goods. The TGA calls these “restricted representations”. Every TGA notice about the end of pre-approval repeated this point, which tells you how often it is misunderstood.

In practical terms, if a consumer ad for a product mentions a serious condition, you need the TGA’s approval or permission before it runs. A general statement that a product “supports wellbeing” is a very different thing from a claim connected to a serious disease.

Comply with other laws too

The TGA notes that advertisements also need to comply with other relevant laws, giving the Competition and Consumer Act 2010 as an example. That Act contains the Australian Consumer Law, which prohibits misleading or deceptive conduct regardless of whether the TGA rules apply.

Know the enforcement position

The TGA said a broader range of enforcement powers had been put in place to support the self-regulatory approach, and that there are sanctions and penalties for advertising that does not comply with the Act and the Code. Those broadened sanctions came in with the 2018 reforms. The TGA’s enforcement tools include infringement notices, directions or prevention notices, and civil or criminal proceedings. In its November 2025 social media guidance release, the TGA quoted civil penalties of up to $1.65 million per breach for individuals and $16.5 million per breach for corporations.

What it means for your marketing

The biggest practical effect is on workflow. Before July 2020, some advertisers relied on the approval process to catch problems. Now your own review is the only check before publication.

Printed and in-clinic material

Posters, window displays, catalogues, newsletters and brochures that promote specific medicines are exactly the media that used to be pre-approved. If your practice or pharmacy produces these, build a written compliance review into the print process. Check product claims against what the product is approved or listed for, check any mandatory statements the Code requires, and check for any reference to a serious condition that would need TGA approval.

Also check co-branded material supplied by a manufacturer or wholesaler. If you display it, you are part of publishing it. Do not assume a supplier’s artwork has been checked by anyone.

Website and online shop

Online advertising was never part of the specified media pre-approval scheme, so for most practices the website workflow does not change. What does change is the mindset. Many practices used print approvals as an informal benchmark for what was acceptable online. Without that reference point, apply the Code directly to product pages, blog posts that mention products, and email newsletters.

Paid ads and outdoor

Billboards, bus shelters, cinema ads and other public displays are squarely within specified media. If you buy outdoor or cinema space to promote a product, the booking will no longer wait on an approval number. That can make campaigns faster to launch, which also makes it easier to launch a non-compliant one. Allow time for your own review before you lock in the booking.

Social media

Social media was not specified media, but the same Act and Code apply to it. The TGA later published dedicated social media guidance, first on 31 March 2022, with a major update on 5 November 2025.

Health service advertising

For most medical, dental and allied health practices, the bulk of your marketing promotes services, not medicines. The end of pre-approval does not change how you promote services. It does remind you that the moment a service ad names or implies a specific therapeutic good, the TGA rules can apply. The TGA later published dedicated guidance on advertising health services, which we cover in a separate article.

Common mistakes we see

Treating “no pre-approval” as “no rules”. The content requirements did not change on 1 July 2020. Only the vetting step went away.
Forgetting restricted representations. References to serious conditions in consumer ads still need TGA approval or permission. This is often missed in brochures and window displays that link a product to a medical condition.
Relying on an old approval. An approval for a past version of an ad does not cover a reworded or redesigned version, and it never covered the same claims in a different channel.
Running supplier material unchecked. Point-of-sale displays and catalogues from brands still need checking against the Code before they go on your walls or shelves.
Assuming prescription medicines are now fair game. They are not. The prohibition on advertising prescription-only medicines to the public is separate and unchanged.
Not keeping records. Without an external approval number, your own records of what was checked, by whom and when are the main evidence of a careful process.

A practical checklist

List every piece of consumer advertising your practice publishes that names a specific medicine or product, across print, outdoor, website, email and social.
Confirm none of it promotes a prescription-only medicine, directly or indirectly.
Check each claim is consistent with what the product is included in the Australian Register of Therapeutic Goods (ARTG) for.
Check any reference to a serious disease, condition, ailment or defect, and confirm you hold TGA approval or permission before publishing.
Check the mandatory statements required by the current Advertising Code are present and prominent.
Review supplier and manufacturer artwork before display, just as you would your own.
Add a sign-off step to your print and media booking process, with a named reviewer.
Keep a simple log of the date, version and reviewer for each ad, plus the evidence that supports each claim.
Subscribe to the TGA’s advertising email list so you hear about guidance updates.
Where an ad is complex or high-risk, consider independent legal or regulatory advice before it runs.

How this fits with other rules

TGA rules govern advertising of therapeutic goods: medicines, medical devices and other regulated products. The end of pre-approval sits within this framework and only affected medicine advertising in specified media.

Ahpra and the National Boards regulate the advertising of regulated health services by registered practitioners under the Health Practitioner Regulation National Law. Those rules, including the ban on testimonials in advertising a regulated health service, apply whether or not any therapeutic good is mentioned. Ahpra’s revised Guidelines for advertising a regulated health service took effect later in 2020, on 14 December 2020, which we cover in a separate article.

The Australian Consumer Law, administered by the ACCC, prohibits misleading or deceptive conduct and false or misleading representations in all advertising. The TGA itself points advertisers to the Competition and Consumer Act 2010.

A single brochure can be subject to all three at once. Meeting one set of rules does not mean you have met the others.

Frequently asked questions

Did the end of pre-approval apply to medical devices?

The TGA’s announcements described the change in terms of medicine advertisements in specified media. Medical device advertising to consumers is still subject to the Act and the Advertising Code. Check the TGA’s guidance for the specific product type you advertise.

Do I still need TGA approval for anything?

Yes. You must obtain approval or permission from the TGA before using restricted representations, meaning references to serious diseases, conditions, ailments or defects, in consumer advertising for therapeutic goods.

Can I now advertise the injectables or prescription medicines we use in the clinic?

No. Advertising prescription-only medicines to the public is prohibited under the Act. The end of pre-approval had no effect on that prohibition. Since 2020 the TGA has issued further guidance making clear that indirect references can also be a problem.

Is there a replacement vetting body I should use?

The TGA stated the mandatory scheme would not be replaced by another statutory vetting scheme. It noted that some businesses offer advisory services, and suggested independent legal advice, a regulatory affairs consultant or an advertising advisory service for advice specific to your advertising.

Who is responsible if an agency designed the ad?

The TGA places the onus on advertisers to ensure ads meet the requirements. Agencies can help, but as the business promoting the product you should review and approve anything published in your name.

Does this change how I advertise my services?

Not directly. Service advertising by registered practitioners is governed by the National Law and Ahpra’s guidelines. It becomes a TGA issue when a service ad also promotes a therapeutic good.

Need a hand?

If your practice sells or promotes products alongside its services, a structured review of your print, outdoor and online material is a sensible first step. Our TGA advertising compliance service checks product advertising against the Act and Code, and our AHPRA compliance audit covers your service advertising under the National Law. If you want your team to run the checks themselves, our compliance training builds a simple pre-publication review into your workflow.

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.