We are committed to educating advertisers, consumers, health professionals and the therapeutic goods industry to promote voluntary compliance with the import, advertising and supply requirements of the Therapeutic Goods Act 1989. Increased compliance with the Act, optimises public health and safety, and builds community trust in the therapeutic goods regulatory framework.
This plan outlines the compliance education priorities and related activities for 2023. This has been developed in consultation with the Therapeutic Goods Advertising Consultative Committee (TGACC) and may be adjusted as needed in response to demand, emerging trends or compliance matters.
This plan aligns with the Import, Advertising and Supply Compliance Priorities 2022-23 which sets out the TGA’s priority areas for compliance activities. It should be read in conjunction with the Therapeutic Goods Advertising Compliance Education Strategy 2021.
Education priorities
The TGA’s 2023 education priorities are outlined below.
- Communication and education products relating to Import, Advertising and Supply Compliance Priorities 2022-23
- Timely communications on regulatory changes and emerging issues
- Publish information on compliance and enforcement activities for transparency and as a deterrent to non-compliance
- Maintain and enhance fit-for-purpose educational resources on the TGA website and provide training and education opportunities
- Engage with key stakeholders, including members of the TGACC as partners in education and communication activities
- Maintain and enhance an advertising enquiry management function
Education priority 1: Activities related to import, advertising and supply compliance priorities
COVID-19
|
Topic |
Activity |
Details |
|
COVID-19 education pieces |
Consultation and collaboration |
Collaboration with stakeholders to enhance education items about COVID-19 product importation and advertising |
|
COVID-19 vaccines |
Review of the advertising permission expiring December 2022 |
Completed Therapeutic Goods (Restricted Representations - COVID-19 Vaccines) Permission 2022 Updated guidance for Communicating about COVID-19 vaccines |
|
COVID-19 related enforcement actions |
Publish media releases |
Ongoing Information on matters arising from compliance activities See Media releases |
Nicotine vaping products (NVPs)
|
Topic |
Activity |
Details |
|
Information for importers and sponsors |
Update website information |
Update Nicotine vaping products: Information for sponsors, wholesalers and manufacturers to ensure it meets stakeholder requirements |
|
Information for consumers |
Update website information |
Updates will be made to the Nicotine vaping products: Information for consumers to ensure it meets stakeholder requirements |
|
Information for law enforcement |
Prepare fact sheet |
New fact sheet for law enforcement on jurisdictional responsibilities, and NVP regulations |
|
Consumer awareness |
Publish safety alerts |
Ongoing and as required when counterfeit (undeclared nicotine) products are identified See Safety alerts |
|
TBA |
TBA |
Additional education activities may be identified through the compliance plan |
Medicinal cannabis industry compliance
|
Topic |
Activity |
Details |
|
Information for businesses |
Update website information
|
Update Advertising guidance for businesses involved with medicinal cannabis products to ensure it meets stakeholder requirements |
|
Information for law enforcement |
Prepare fact sheet |
Fact sheet for law enforcement on lawful importation, advertising, and supply of medicinal cannabis |
|
TBA |
TBA |
Additional education activities may be identified through the compliance plan |
Performance and image enhancing therapeutic goods
|
Topic |
Activity |
Details |
|
Information for importers and sellers |
Update website information |
Updates to be made to the Performance and image enhancing drugs webpage |
|
TBA |
TBA |
Additional education activities may be identified through the compliance plan |
Therapeutic goods used in beauty and cosmetic dental industry
|
Topic |
Activity |
Details |
|
Information about cosmetics as therapeutic goods |
Publish website information |
Information on the difference between therapeutic goods and cosmetics, and requirements for adverting |
|
Information on compliance and enforcement activities |
Publish media releases |
Ongoing Information on matters arising from compliance and enforcement activities See the Media releases webpage |
|
Information on how to procure products lawfully |
Targeted communication through relevant agencies and peak bodies |
Provide tips and information to health practitioners on ensuring products are included on the ARTG and advertising tips |
|
TBA |
TBA |
Additional education activities may be identified through the compliance plan |
Unapproved therapeutic goods on digital platforms
|
Topic |
Activity |
Details |
|
Weight loss products: Information for consumers |
Publish website information |
Completed |
|
Information for social media advertisers |
Update website information |
Update TGA social media advertising guide to ensure it meets stakeholder requirements |
|
Information for advertisers about advertising laws |
Publish website information |
Reminder to advertisers that it is illegal to advertise therapeutic goods that are not on the ARTG or that are prescription medicines |
|
TBA |
TBA |
Additional education activities may be identified through the compliance plan |
Education priority 2: Activities related to regulatory changes and emerging issues
General advertising
|
Topic |
Activity |
Details |
|
Medical device reforms: information for health professionals |
Prepare website information |
Information on regulations for advertising software-based medical devices |
|
Medical device reforms: information for consumers |
Prepare website information |
Information on regulations for advertising software-based medical devices |
|
Advertising requirements: information for advertisers |
Website information, webinars and training materials |
Ongoing Information of advertising requirements of therapeutic goods, regulatory changes and emerging issues See Advertising |
Education priority 3: Publish information on compliance and enforcement actions for transparency of compliance activities and as a deterrent to non-compliance
|
Topic |
Activity |
Notes |
|
Import, advertising and supply investigations: information for stakeholders |
Publish outcomes of investigations |
Ongoing Information on completed investigations into import, advertising and supply matters undertaken by the TGA to promote transparency and compliance
|
|
Enforcement actions: information for stakeholders |
Publish media releases |
Ongoing Information on enforcement actions taken by the TGA to promote transparency and compliance See Media releases |
|
Warning statements/safety alerts: information for stakeholders |
Publish media releases/ Safety alerts |
Ongoing as required See Media releases and Safety alerts |
|
Therapeutic Goods Advertising Compliance Annual Report 2022-23 |
Reporting |
The annual report includes an analysis of advertising compliance during the year and promotes transparency by providing information about the TGA's compliance and enforcement work throughout the year |
|
TGA annual reporting |
Reporting |
Information provided as part of the TGA’s annual performance reports |
Education priority 4: Maintain and enhance fit for purpose educational resources, and participate in training and education opportunities
We value stakeholder input and feedback in the preparation of user friendly and relevant guidance. Depending on the topic of the guidance being developed, we may consult with the full or select members of the TGACC, and other impacted or invested stakeholders.
Education campaign
|
Topic |
Activity |
Notes |
|
Education Plan (this document) |
Planning document |
Working document to determine annual education activities to support the Therapeutic Goods Advertising Compliance Education Strategy. TGACC feedback on education requirements continues to inform the plan |
|
Mandatory statements in advertising: Information for consumers |
Education campaign |
To raise awareness of the mandatory statements in advertising and safe behaviours to adopt |
|
Advertising dos and don’ts: information for social media advertisers |
Education campaign |
To inform social media advertisers of the regulations/requirements of advertising therapeutic goods on social media |
Advertising hub improvements
|
Topic |
Activity |
Details |
|
Advertising compliance checklist |
Update checklist |
Update Advertising compliance checklist - consumer advertising |
|
Advertising information for ASX announcements |
Publish website information |
Guidance on advertising requirements and obligations for writing ASX announcements |
|
Advertising ‘decision trees’ |
Update decision trees |
Review the decision trees that enable advertisers to self-assess required compliance with the Act and Code |
|
TGA website |
Web page updates |
Ongoing Update web pages to ensure content is:
|
Development of educational materials to support ongoing advertising compliance
|
Topic |
Activity |
Details |
|
Advertising Code guidance |
Update guidance as required |
Continue to refine guidance to support advertisers to understand the Code requirements |
|
Advertising regulations: eLearning for advertisers |
Determine scope for the development of eLearning modules |
Assess the viability of developing and hosting interactive e-learning modules regarding obligations and responsibility under the Act |
|
Essential oils: information for businesses |
Publish website information |
Provide information regarding the definition and advertising of therapeutic goods |
|
Emerging matters and trends |
Publish website information |
As required Information prepared in response to new or emerging trends relating to advertising, importation and supply regulation |
Stakeholder engagement
|
Topic |
Activity |
Details |
|
TGA stakeholder survey: questions about advertising |
Prepare advertising specific questions to include in annual survey about KPIs. |
Final report typically published in 4th quarter of each year Gain stakeholder input in relation to external view of TGA’s advertising education and compliance programs |
Education and training
|
Topic |
Activity |
Details |
|
Topics as identified |
Education and training |
Educational activities for external audiences to be developed in consultation with stakeholders TGA is often invited to present at different forums on the advertising requirements and its compliance work |
Education priority 5: Engage with key stakeholders, including members of the TGACC, as partners in education and communication activities
|
Activity |
|
When preparing education activities we will ensure that the audience for each activity is identified, that suitable channels of communication are selected and that activities cover a relevant range of topics. Industry membership of the Therapeutic Goods Advertising Consultative Committee (TGACC) reflects representation from key sectors of the therapeutic goods industry. The TGACC will take a pivotal role in helping to guide and shape the education activities for 2022-23, as well as in the distribution of education content and messaging. We will:
|
Education priority 6: Maintain and enhance an advertising enquiry management function
|
Activity |
|
We are committed to maintaining an effective advertising enquiry management function, along with import enquiry management, as part of our ongoing education work. Trends and issues seen through our enquiry management functions will be used to inform our education work. |