Making a complaint about the advertising of a therapeutic product

12 March 2014

Advertisements for therapeutic goods (medicines, medical devices and therapeutic devices) directed to consumers must comply with the Therapeutic Goods Advertising Code to ensure that the advertisements are:

  • socially responsible;
  • promote quality use of the products; and
  • do not mislead or deceive consumers.

Copies of this code are available from the ComLaw website.

Approved advertisements

Advertisements for medicines appearing on television or radio, newspapers, consumer magazines, billboards and cinema films are required to be approved before publication.

Advertisements appearing in newspapers and consumer magazines must include the approval number. The approval number is usually in small print and begins with the letters 'ASMI' or 'CHC' followed by a 5-6 digit number and date code.

Approvals are valid for a 2-year period.

The role of the TGA

The TGA is the primary government stakeholder and regulator within the co-regulatory system of advertising for therapeutic goods. The agency is one member of the Therapeutic Goods Advertising Code Council (TGACC) and regularly attends the various complaint handling committees as an observer. In this capacity, the TGA supports the consideration of advertising complaints by these committees, as opposed to initiating its own independent action at the outset. However, where deemed necessary, the TGA will proceed with administrative and/or legal action in order to enforce complaint committee findings and, more broadly, to ensure it underpins the Australian system of advertising controls in the interests of public health and safety.

Industry self-regulation

In addition to the Complaints Resolution Panel (CRP), Australia's system for advertising controls also includes a self regulatory component, comprising voluntary codes of practice with 'built-in' complaint-handling mechanisms. These voluntary codes are administered by the peak therapeutic goods industry associations, including Medicines Australia (for prescription medicines) and the Australian Self Medication Industry (ASMI) and the Complementary Healthcare Council of Australia (CHCA) (for non-prescription medicines).

The respective complaint committees comprise a balance of industry representatives and independent, external representatives (including healthcare professionals, consumer groups and the TGA).

These self regulatory complaint committees primarily consider complaints about 'non-mainstream' advertisements for therapeutic goods e.g. leaflets, flyers, catalogues, brochures, shelf talkers, etc. distributed via letterbox drop, point of sale material, advertisements directed to healthcare professionals, etc.

While requiring compliance with the legislative provisions, the industry codes of practice include additional, 'ethical / industry' requirements which are not necessarily prescribed by law. The complaint committees can impose commercially significant sanctions and government agencies such as the TGA and Australian Competition and Consumer Commission (ACCC) expect industry participants to comply with the findings of these committees.

In the few cases where the complaint committees are unable to achieve a satisfactory outcome, the matter is then referred to the TGA and/or ACCC for consideration of appropriate action under the Therapeutic Goods Act 1989 or the Competition and Consumer Act 2010.

Lodging a complaint

Anyone may lodge a complaint about an advertisement for therapeutic goods and all complaints are treated in confidence unless you consent to the release of your personal details. Anonymous complaints are also accepted.

When lodging a complaint, please include, where possible:

  • the name of the advertiser
  • a copy of the advertisement;
  • the name of the publication and the date published (if applicable); and
  • details of what it is about the advertisement that is unacceptable to you.

Addresses

Complaints must be made in writing, using one of the following addresses.

Complaints about advertisements for medicines or devices appearing in radio, television, consumer magazines, newspapers, billboards, cinema or the Internet may be sent to:

The Executive Officer
Complaints Resolution Panel
PO Box 764
NTH SYDNEY NSW 2059

Complaints about advertisements for complementary medicines (herbal preparations, vitamin or mineral supplements, or homoeopathic preparations) appearing in publications such as leaflets, flyers, brochures, catalogues or letterbox drops may be directed to:

The Secretariat
Complaints Resolution Committee
Complementary Healthcare Council
PO Box 104
DEAKIN WEST ACT 2600

Complaints about advertisements for pharmacy medicines appearing in publications such as trade journals, leaflets, flyers, brochures, catalogues, letterbox drops or as part of a campaign may be sent to:

The Secretariat
ASMI Complaints Panel
PO Box 764
NTH SYDNEY NSW 2059

Alternatively, complaints about advertisements may be sent to:

The Recalls and Advertising Section
Office of Product Review
Therapeutic Goods Administration
PO Box 100
WODEN ACT 2606

Where you provide personal information about yourself, the TGA will use this information to contact you if necessary to ask you about your complaint. Complaints, and the personal information contained within this complaint, may be referred to Australian and/or overseas bodies (referred to above under 'Industry self-regulation') including

  • Government departments and bodies in Australia and overseas who have roles in regulating health, food, therapeutic goods or consumer law.
  • The office administering the National Industrial Chemicals Notification and Assessment Scheme (NICNAS)
  • Law enforcement agencies

to administer the complaint.

For general privacy information, go to Privacy.

More information

Further assistance regarding advertising may be obtained from the Recalls and Advertising Section of the Therapeutic Goods Administration by:

Phone +61 2 6232 8757
Facsimile +61 2 6232 8659
Email tga.advertising@tga.gov.au

Top of page