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End of advertising pre-approval scheme: questions and answers

19 June 2020

A: Until 1 July 2020, advertisements for 'designated therapeutic goods' that are to appear in 'specified media' require approval under the Therapeutic Goods Regulations 1990 before they can be published or broadcast. The TGA outsourced the processing of applications for advertising approval to Consumer Healthcare Products Australia until 30 June 2020.

A: The Australian Government has accepted the recommendation of the Review of Medicines and Medical Devices Regulation that the advertising pre-approval scheme be stopped in favour of a more self-regulatory regime.

A: In general terms, 'designated therapeutic goods' are those medicines that are able to be advertised to the public (e.g. complementary medicines). The Therapeutic Goods Regulations 1990 defines 'designated therapeutic goods' as therapeutic goods other than:

  1. therapeutic devices; and
  2. goods included in Schedule 3 to the Poisons Standard that are not included in Appendix H of that standard; and
  3. goods included in Schedule 4 or 8 to the Poisons Standard; and
  4. biologicals.

A: The term 'specified media' is defined in the Therapeutic Goods Act 1989. It encompasses traditional mass media (including magazines, newspapers, free-to-air television and radio broadcasts) as well as cinema films, billboards, advertising on public transport and displays in shopping malls. For the purposes of the advertising pre-approval scheme 'specified media' does not include the internet, email, pay television or other mediums specified in Regulation 5BA of the Therapeutic Goods Regulations 1990.

A: No, from 1 July 2020, there is no legal requirement for advertisers to display this number.

A: No, provided the changes are made after 1 July 2020. Pre-approvals will not be required after 30 June 2020. If the change to the advertisement is made prior to 1 July 2020, and the advertisement will be published or broadcast prior to 1 July 2020, a further pre-approval will be required.

A: Advertisements carrying restricted representations will still require TGA approval after 30 June 2020.

A: You can seek advice from a regulatory affairs consultant, a lawyer who specialises in therapeutic goods, or engage the services of an independent vetting service that assesses the advertising of therapeutic goods for compliance. Your peak body may be able to assist you in locating a suitable advisor.

A: The application will lapse on 1 July 2020 because pre-approvals for medicine advertising will no longer be required.

A: No. Consumer Healthcare Products Australia (CHP Australia) will continue to accept applications for advertising pre-approval until 30 June 2020, in accordance with its contract with the TGA. However, the utility of making an application will diminish as 30 June 2020 approaches and the application will lapse if no decision is made before 1 July 2020.

If an advertiser seeks to have an advertisement approved prior to 30 June 2020 the advertiser should:

High quality applications for compliant advertisements and other straight-forward decisions (e.g. re-approval of an expired approval with no changes) will be given priority and decided quickly. Poorer quality applications may result in refusal or may lapse as time runs out for CHP Australia to make its final decision by 30 June 2020.

A: Yes, the same advertising requirements that applied prior to 1 July 2020 will continue to apply after that date. However, after 30 June 2020, advertisements in specified media for designated therapeutic goods will not need pre-approval before they are published or broadcast.

A: Technically yes. And that is currently the case. There is a small risk that an approval is granted in error or that the ad that is published is different to the ad that was approved. While enforcement action can be taken for breaches of the requirements, the existence of an approval, along with other factors, will be considered in determining the most appropriate approach.

As there will be no need for pre-approval of ads after 30 June 2020, there will be no purpose in reviewing decisions made before 1 July 2020. Additionally, due to the legislative changes, the TGA will not be able to conduct these reviews from 1 July.

A: The personal information you provided to these bodies in the course of lodging a pre-approval application is covered by the Privacy Act 1988 (the Privacy Act). The use of this personal information for purposes other than the processing of a pre-approval application is likely to breach the Privacy Act. For example, Australian Privacy Principle 7 prohibits the use of information for direct marketing purposes. However, advertisers with particular concerns should seek legal advice.

A: Advertisers should seek to inform themselves about their advertising obligations. The TGA provides comprehensive educational and guidance material on its website.

As a minimum, you should:

  • Ensure you are aware of the advertising requirements in the Therapeutic Goods Act 1989 (the Act) and Advertising Code.
  • Make sure you've read the guidance on the TGA Advertising Hub, including the guidance on the Advertising Code.
  • Stay up to date with any new guidance, for example, advertising therapeutic goods in the context of COVID-19.
  • Subscribe to the TGA Advertising email list to be notified of updates, web statements and other important information.
  • If you cannot find the answers you are looking for, you can lodge an inquiry with the TGA online or phone 02 6289 8757 for further information.

A: The TGA does not provide legal advice to advertisers or their representatives. See also question 8.

A: No. The Therapeutic Goods Regulations 1990 does not allow for the refund of fees paid for pre-approval applications that are not finalised before the end of the pre-approval scheme on 1 July 2020. If you are considering a new application you should contact Consumer Healthcare Products Australia.