Therapeutic Goods Administration

What types of complaints can you make?

The TGA looks after the safety, quality, and lawful supply of medicines, medical devices, and other therapeutic goods across Australia. These can include things like prescription medicines, vaccines, vitamins, blood products, bandages, surgical implants, sunscreens, disinfectants, COVID-19 tests, and nicotine vapes.

You can make a complaint to the TGA if you are worried about:

• Side effects or reactions (adverse events): Unexpected or harmful reactions from medicines, vaccines, vitamins, or devices, even if you’re not sure the product caused it.
• Faulty or unsafe devices: Medical devices that don’t work properly, break easily, or seem unsafe, whether or not they caused harm.
• Quality, packaging or labelling problems: Issues such as contamination, broken seals, incorrect dosage information, or unreadable instructions.
• Misleading or unlawful advertising: Ads that exaggerate claims, promote prescription-only products to the public, target children, use scare tactics, or reference serious diseases inappropriately.
• Counterfeit or fake products: Items that look like the real thing but are fake, poorly packaged, or contain the wrong ingredients.
• Illegal supply or import: Medicines or devices being sold or supplied without TGA approval, including unregistered remedies or vapes sold outside pharmacies.
• Unsafe or unlicensed manufacturing: Products being made in unhygienic or unsafe conditions, or by someone without the proper approvals.
• Unlawful sale or import of nicotine vapes: Nicotine vapes sold without a prescription or outside a pharmacy process.

You can report a problem even if:

• You are not sure the product caused the harm.
• The product was bought online, overseas, or informally (e.g. markets, friends, social media).
• The product isn’t listed on the Australian Register of Therapeutic Goods (ARTG).
• You are reporting on behalf of someone else, such as a child, patient, elder, or friend.

The TGA does not cover:

• Concerns about how a doctor, nurse, dentist, pharmacist, or clinic treated you (diagnosis, treatment decisions, communication, or service quality).
• Side effects or harm caused by food, drinks, cosmetics, or household items that are not therapeutic goods.
• Fees, refunds, or business practices of health providers or pharmacies (e.g. billing disputes, poor customer service).
• Complaints that a product “didn’t work for me” unless linked to a safety risk, defect, or breach of law.
• General dissatisfaction with taste, smell, or appearance if the product is safe and lawful.
• Goods that are not legally defined as therapeutic goods (e.g. massage chairs, wellness apps, blue light glasses).
• Workplace policies about medicines or vaccines, unless the complaint is about unlawful supply or safety of the goods themselves.
• Privacy breaches, discrimination, or human rights issues (these are handled by other complaint bodies).
• Goods made and used entirely overseas without targeting Australia.
• Old complaints where the product is no longer on the market, the company has closed, or evidence can no longer be checked.
• Complaints about being refused access under special programs such as the Special Access Scheme (SAS) or Authorised Prescriber Scheme, unless there is a broader safety or compliance problem with the product.

Timing:‍

There are no strict deadlines for making a complaint to the TGA. But it’s best to report problems as soon as possible, because some enforcement actions depend on timing and available evidence.

Discretion:‍

The TGA does not act on every complaint. It decides which issues to investigate based on the level of risk, the evidence available, and whether the problem has already been fixed. Sometimes it may work with a company to bring them into line, and in more serious cases it can issue warnings, order recalls, suspend or cancel products, issue fines, or take court action. Even if the TGA doesn’t act on your individual case, your report still helps them track safety issues and protect the community.

Who can you make a complaint against?

The TGA can look into complaints about the people and companies involved in making, supplying, or advertising therapeutic goods in Australia. This includes:

• Sponsors: The company legally responsible for a therapeutic good in Australia. Sponsors are listed on the Australian Register of Therapeutic Goods (ARTG), and their name is usually on the packaging. If you only know the product name, the TGA can identify the sponsor during its investigation.
• Manufacturers: The factory or facility that physically makes the product. The TGA can act if products are made in unsafe or unhygienic conditions, or if Good Manufacturing Practice (GMP) rules are broken.
• Importers: Businesses or individuals that bring therapeutic goods into Australia. The TGA can act if the goods are unapproved, counterfeit, or brought in illegally.
• Distributors and wholesalers: Companies that supply goods in bulk to pharmacies, clinics, or other retailers. The TGA can act if they knowingly distribute unsafe, unapproved, or illegal products.
• Retailers: Pharmacies, supermarkets, online shops, or platforms like eBay and Amazon that sell products directly to the public. The TGA can act against them for unlawful advertising, supplying unapproved goods, or failing to meet labelling and packaging standards.
• Advertisers: Anyone promoting therapeutic goods, including companies, retailers, social media influencers, bloggers, or individuals. The TGA often acts on complaints about misleading ads, especially online.
• Private individuals: In some cases, if a person sells or advertises therapeutic goods (for example, on social media) without approval, the TGA can investigate them.

You cannot complain about:

• Vets and animal medicine suppliers: The TGA only regulates human therapeutic goods.
• Food and drink companies: The TGA does not regulate regular food or drinks, even if they make health claims.
• Cosmetics and household chemical suppliers (unless marketed as therapeutic): The TGA does not regulate general cosmetics, cleaning products, or chemicals unless they are advertised as treating or preventing a condition.
• Health insurance providers: Complaints about coverage, fees, or claims are not handled by the TGA.
• Healthcare workers (e.g. doctors, nurses, pharmacists): The TGA does not deal with complaints about treatment decisions, diagnoses, or communication.
• Hospitals, clinics, or health services (about treatment or conduct): The TGA may act if they unlawfully supply therapeutic goods, but not if your complaint is about how they provided care or ran their service.
• Wellness products without therapeutic claims: If a product such as a fitness tracker, meditation app, or blue-light glasses does not claim to treat or prevent a condition, the TGA has no power to investigate.

Are you eligible to make a complaint?

Anyone can make a complaint to the TGA. Reports usually come from consumers, family members, carers, healthcare professionals, or the company responsible for the product (the sponsor).

Anonymous complaints: 

You can choose not to give your name. The TGA may give you a pseudonym (a false name) if you prefer to stay anonymous. It can help if you provide your details, as the TGA may need to contact you for more information.‍

No pre-steps required:

You do not need to take any other action before contacting the TGA. However, you should include as much detail as possible about the product, the problem, or the advertisement. Photos or evidence are helpful.‍

No need to resolve it yourself:

You do not need to try fixing the issue directly with the company or retailer. But if you have a side effect or problem with a medicine or device, you should also speak to a healthcare professional.‍

Other organisations may be better placed:

If your issue is about a product that is not a therapeutic good, it may belong with another regulator, such as the ACCC. The TGA will check whether your complaint is something it can look into.‍

Complaints on behalf of others:

You can complain for someone else, or have someone act on your behalf, such as a carer, family member, or healthcare worker. The TGA may ask for written consent if another person is acting for you.‍

No exclusions:‍

There are no restrictions on who can make a complaint, as long as the issue involves a therapeutic good and is within the TGA’s powers. This includes members of the public, health workers, whistleblowers, or anonymous individuals.‍

Free process:

Making a report to the TGA is free. You do not need a lawyer, but you can get legal advice if you want to.

What can this body do to help?

The TGA regulates therapeutic goods to protect the health and safety of Australians. If you make a complaint, the TGA decides what action to take.

Important: The TGA cannot give you personal remedies. It does not provide refunds, replacements, compensation, or dispute resolution services for individuals. Its role is to deal with safety and compliance issues across the community.

Depending on the seriousness of the problem, the TGA may:

• Take no further action: If the issue is low risk, lacks evidence, or is outside its powers. Your report is still recorded and may be used to spot patterns in future.
• Refer the matter to another body: If the complaint is better handled elsewhere (e.g. Food Standards Australia New Zealand, AHPRA, the Australian Pesticides and Veterinary Medicines Authority), the TGA can pass it on.
• Issue a warning letter: Telling a company, retailer, or advertiser what rules they have broken, what must be fixed, and what will happen if they don’t comply.
• Suspend a product or licence: Temporarily stopping a product being sold or a company being allowed to make or import goods, until safety issues are fixed.
• Cancel a product or licence: Removing a product from the official register or cancelling a company’s licence to manufacture or import. Cancelled goods can also be seized or recalled.
• Recall products: Removing or correcting unsafe goods (for example, if they are contaminated, mislabelled, or defective). This can be voluntary (by the company) or ordered by the TGA.
• Direct advertisers to correct or remove ads: The TGA can order companies or individuals to stop misleading ads, take them down, issue corrections, or prevent future ads from being published.
• Issue fines (infringement notices): Financial penalties can reach more than $13,000 for individuals and $66,000 for companies per breach. Multiple fines can be issued.
• Accept enforceable undertakings: Formal agreements where a company promises to take corrective action. If broken, the TGA can go to the Federal Court to enforce it.
• Seek injunctions: Federal Court orders to make a company or person stop breaking the law or comply with the rules.
• Apply for civil penalties: For serious breaches, the TGA can go to the Federal Court to seek large fines (over $1 million for corporations), declarations of breach, or corrective orders.
• Refer for criminal prosecution: The most serious cases (e.g. knowingly supplying fake or unapproved goods, or causing major harm) may be prosecuted by the Commonwealth Director of Public Prosecutions. Penalties can include up to 7 years in prison and fines over $1.3 million.

How to prepare your complaint:

To make a complaint to the TGA, you should give clear details about the product or issue and include any evidence you have. This helps the TGA investigate quickly.

What to include:

• Your details: First and last name, email, and phone number. You can report anonymously or use a pseudonym, but providing your details helps if the TGA needs more information.
• Product details: Name of the product, sponsor or manufacturer (often on the packaging), batch or serial numbers, expiry dates, and where and when you bought it.
• Respondent’s details: The company or person involved (e.g. manufacturer, sponsor, retailer, advertiser, distributor) with any contact details you know.
• What happened: Explain clearly what the issue is. For example, the side effect, product defect, or advertisement you are concerned about. Include when and where it occurred, whether you needed medical treatment, and what that treatment was.
• Evidence: Attach photos, documents, or copies of the advertisement to support your complaint. The TGA’s online forms allow you to upload these.

What not to include:‍

Do not provide false or misleading information. If you are unsure about a detail (e.g. exact dates), say so in your report.

Lodging your complaint and next steps:

Where to lodge:‍

All reports should be lodged in writing through the TGA’s online portal. There are different forms depending on the issue:

• Medicine or vaccine side effects (adverse events), click here
• Medicine or vaccine product quality, packaging, or labelling issues, click here
• Medical device side effects or faults, click here
• Counterfeit products or other breaches of the law, click here
• Misleading or unlawful advertising, click here

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After you lodge a complaint:

• Acknowledgement: You will get a confirmation message from the TGA’s system.
• Assessment: The TGA checks whether your complaint is something it can act on. If you provided your contact details, it may ask you for more information.
• Closing a matter: If the issue is low risk or already being managed, the TGA may close the complaint but still keep it on record. Your report can still help identify future problems.
• Investigations: The TGA investigates complaints that raise safety concerns, involve repeat breaches, or come from multiple reports about the same product. Your report (without your name or contact details) may be shared with the product sponsor or manufacturer.
• Outcomes: Depending on the findings, the TGA may:
  • recall or cancel the product
  • restrict who can buy it
  • require warnings or labelling changes
  • require the sponsor to carry out further research
• Safety alerts: If the TGA identifies a wider concern, it may publish a public safety warning about the product.

More information:

Refer to the factsheet provided below for more information.