Advertising therapeutic goods
Advertisements for therapeutic goods can be presented in several forms, including:
- medical journals
Certain advertisements directed at consumers require approval prior to broadcast or publication.
Advertising to consumers is permitted for the majority of medicines available for over the counter sale, while advertising prescription-only and certain pharmacist-only medicines to the general public is prohibited. (However, government-controlled public health campaigns that have been approved by Health Ministers are exempt from this prohibition).
The advertising of therapeutic goods to consumers and health practitioners is controlled by a combination of statutory measures administered by the TGA and self-regulation through Codes of Practice administered by the relevant therapeutic goods industry associations.
Advertisements for therapeutic goods in Australia are subject to the requirements of the Therapeutic Goods Act 1989 and Regulations, the Competition and Consumer Act 2010 and other relevant laws. Advertisements for therapeutic goods directed to consumers must also comply with the Therapeutic Goods Advertising Code.
The purpose of these requirements is to protect public health by promoting the safe use of therapeutic goods, ensuring that they are honestly promoted as to their benefits, uses and effects.
Further information, on Australia's co-regulatory system of advertising for therapeutic goods, including details of the Therapeutic Goods Advertising Code Council (TGACC), the Complaints Resolution Panel and the Complaints Register, may be obtained from the TGACC Internet site.
Regulation of advertising
- Regulation of therapeutic goods advertising in Australia
Advertisements for therapeutic goods are subject to the requirements of the Therapeutic Goods Act and Regulations, the Trade Practices Act and other relevant laws.
- Australian Regulatory Guidelines for Advertising Therapeutic Goods (ARGATG)
Guidance for advertisers
- Therapeutic goods advertising code
Links to and information about the Therapeutic Goods Advertising Code
- Restricted representations
A restricted representation is any reference expressly or by implication, to a disease, condition, ailment or defect specified in Table 1, Appendix 6 of the Therapeutic Goods Advertising Code
- Advertising and endorsements
Information for advertisers about misrepresenting products as TGA/government approved.
- Advertising medicines to consumers
Controls are placed on the advertising of therapeutic goods - medicines and medical devices to ensure advertisements are socially responsible, truthful, appropriate and not misleading.
- Advertising prescription medicines to health professionals
Advertising registered prescription medicines to consumers is not permitted, but advertising is permitted to healthcare professionals within the scope of the legislation
- Schedule 1 of the Therapeutic Goods Regulations explained
This fact sheet addresses misunderstandings about the aims of the Therapeutic Goods Act and Regulations, and their effect on the ability of complementary healthcare professionals obtaining access to therapeutic goods and related advertising material.
- Schedule 1 certificates
The TGA Advertising Unit often receives requests for Schedule 1 Certificates also referred to as Certificates of Exemption
- Changes to advertising for medicines containing codeine
Important information for pharmacists, sponsors, broadcasters and publishers on the changes to advertising requirements that will occur on 1 February 2018 for medicines containing codeine
- Preparing education materials and advertising for pain relief products
Guidance for sponsors and advertisers, in the context of the up-scheduling of codeine, on preparing education materials and advertising for pharmacy assistants and consumers about pain relief products
- Advertising health services with schedule 3, schedule 4 or schedule 8 medicines
Information for health professionals to consider when advertising health services that involve therapeutic goods containing schedule 3, schedule 4 or schedule 8 substances
- Advertising extemporaneously compounded medicines
The advertising of extemporaneously compounded medicines to consumers is regulated under the therapeutic goods legislation
- Advertising of vaccination services
Information for immunisation service providers regarding the advertising of vaccination services, including seasonal influenza vaccination services
- Advertising cosmetic injections
A brochure containing information on advertising cosmetic injections and complying with therapeutic goods legislation
- Advertising cosmetic services that include schedule 4 substances
Points for medical practitioners and cosmetic / beauty therapists to consider when advertising cosmetic services that involve therapeutic goods containing Schedule 4 substances
- Price information code of practice
The Price Information Code of Practice sets out the conditions for the publication of prices of medicines listed in Schedules 3, 4 and 8 of the Poisons Standard
- Schedule 3 advertising guidelines
Guidelines describing the process for determining whether a substance in Schedule 3 of the Poisons Standard may be advertised
Medical devices and in vitro diagnostic devices
- Advertising health services with medical devices
Information for health practitioners and health professionals to consider when advertising health services that involve medical devices (including in vitro diagnostic devices)
Complaints about advertising
Complaints about advertisements directed to consumers in specific media (such as newspapers, magazines, the Internet, radio and television) are considered by the Complaints Resolution Panel. The Therapeutic Goods Advertising Code Council makes recommendations about the advertising requirements and any changes to the Code.
- Making a complaint about the advertising of a therapeutic product
Anyone may lodge a complaint about an advertisement for therapeutic goods and all complaints are treated in confidence. Anonymous complaints are also accepted.
- Investigations of advertising complaints
The TGA's policy is to publish the outcome of certain investigations into complaints about advertising which have been referred by the Complaints Resolution Panel
- Consumer guide to commonly noted advertising breaches
Summary of commonly recorded breaches of the therapeutic goods advertising requirements
- Application for approval of advertising for medicines
This form is for applying for the approval of advertisements in 'specified media' to which Division 2 of Part 2 of the Therapeutic Goods Regulations applies
- Application for approval to use a restricted representation in advertising
Form to apply for approval to use a restricted representation in advertising
Regulatory decisions & notices about advertising
- Human placenta ingestion
19 January 2018: Potential health risks and legal implications for placenta consumption
- Decisions in relation to complaints about advertisements
Outcomes of investigations into complaints about therapeutic goods advertising directed to consumers which have been referred to the TGA by the Complaints Resolution Panel for follow-up action
- Notices of approved & permitted restricted representations
Notices of advertising exemptions
- Decisions to withdraw medicines advertising approval
Decisions to withdraw approval for advertisements for medicines appearing in specified media
- Reforms to the therapeutic goods advertising framework
13 March 2018 Starting in March 2018 there will be a number of changes to the regulatory framework for the advertising of therapeutic goods
- Simplified and improved arrangements for handling therapeutic goods advertising complaints
7 July 2017 From 1 July 2018, the TGA will assume responsibility for receiving and considering all complaints about therapeutic goods advertisements directed to the public under a simplified complaints system
- Advertising reforms: Questions and answers
7 July 2017 Questions and answers regarding the advertising reforms
- Advertising therapeutic goods (closed consultations & reviews)
Links to closed TGA consultations and reviews about the regulation of advertising
Contact details for enquiries about advertising therapeutic goods
If your enquiry is not about advertising therapeutic goods, please see: Contact the TGA
Users who are deaf or have a hearing or speech impairment can call through the National Relay Service:
|Fax||+61 2 6232 8426|
|Post||Advertising Compliance Unit
Regulatory Practice, Education and Compliance Branch
Therapeutic Goods Administration
PO Box 100
Woden ACT 2606, Australia
|Therapeutic Goods Administration
136 Narrabundah Lane
Symonston ACT 2609