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Advertisers of complementary medicines

29 October 2019

Do you advertise to the public using print media, cinema, billboards or other public displays?

You need to know about changes coming to advertising pre-approvals.

In the lead up to the abolition of the therapeutic goods advertising pre-approval requirements in June 2020, the Complementary Healthcare Council of Australia (CHC) will cease accepting applications for pre-approval in November 2019:

  • from 14 November 2019, CHC will not accept any new applications for advertising pre-approval
  • the TGA is making alternate arrangements for preapproval services for these types of advertisements until 30 June
  • applications received by CHC before 14 November 2019 will be processed and decided, with final decisions for all applications to be made by 27 January 2020.

The TGA is working on alternate arrangements to replace CHC's services. We cannot announce these until the Government has approved the alternate arrangements and made any necessary changes to the Therapeutic Goods Regulations 1990 (the Regulations). We expect the new arrangements will start by late November or early December 2019 at the latest.

For applications that must be submitted between 14 November 2019 and the commencement of the new arrangements, these may be submitted to the TGA. These will be forwarded to the new service provider once the new arrangements start.

Application fees will not change from those already published on the website.

Applicants should note that the CHC will be closed for the Christmas Holidays from 21 December 2019 to 5 January 2020.

What do advertisers need to do?

If you... Then...
Are seeking a pre-approval decision for a complementary medicine advertisement in print, cinema, billboards or other public displays before early December
  • Lodge your application with CHC as soon as possible.
  • High quality applications for compliant advertisements and other straight-forward decisions (e.g. re-approval of an expired approval with no changes to the advertisement) will be given priority and decided quickly.
  • Poorer applications may end in refusals as time runs out for CHC to make its final decisions in January.
  • After 20 January 2020, decisions on applications with CHC will be made on the information available at the time of the decision. This will include refusal where the requirements for approval have not been satisfied. Applicants will still have the right to request a review of the decision (Regulations 5M and 5P).
  • Don't book your advertising space until you receive an approval.
  • Subscribe to the TGA Advertising email list to be notified of the alternate arrangements for your future applications.
Are considering applying between 14 November and the start of the new arrangements (late November/early December) • We strongly recommend that you wait for the start of the new arrangements.
  • If you must apply between 14 November and the start of new arrangements, you can lodge your application with the TGA via email to advertising.preapproval@tga.gov.au.
  • Your application will be held and forwarded for consideration under the new arrangements.
  • Ensure you use the current application form. Note that this will change at the start of the new arrangements.
Are considering an advertisement that will need pre-approval but you don't need to apply before the start of the new arrangements
Have lodged a pre-approval application with CHC before 14 November 2019
  • Applications received prior to 14 November 2019 will be considered and a decision made by CHC.
  • No extensions will be granted beyond 6 January 2020.
  • Ensure all correspondence with CHC has been finalised by 20 January 2020.
  • Make sure you have paid all invoices for these applications before 27 January 2020. Failure to pay these fees will be grounds for refusal of the applications if not received in time.
  • You should subscribe to the TGA Advertising email list to be notified of the new arrangements for any future applications.

Timing of applications

The applicant should allow sufficient time for a decision when applying for advertising pre-approval. The legislation allows up to 60 days for the delegate to make a decision on an application (with the possibility of further extension by agreement between the applicant and the delegate making the decision). The actual time taken to make a decision depends on the complexity and compliance of the advertisement, in combination with the quality of the information provided with the application. Negotiations over content and presentation of the advertisement, provision of additional information by applicants and the need to revise the advertisement will all add to the time it takes to make a decision. Advertisers must factor in sufficient time for this consideration before committing themselves to commercial arrangements for the publication or broadcast of the advertisement.

Please note that the 60-day clock starts from the day of lodgement with any delegate, whether CHC or TGA.

Types of media affected

CHC only processes applications for complementary medicines that are to appear in:

  • Mainstream media - i.e.:
    • Magazines
    • Newspapers
    • Newsletters
    • Catalogues
  • Cinema advertising
  • Public displays about goods, including posters, billboards and displays in or on public transport

This change does not affect:

  • complementary medicines advertising for broadcast media (i.e. free-to-air television or radio), or
  • advertising of medicines other than complementary medicines in all specified media.

Applications for pre-approval of advertising in these mediums can continue to be lodged with Consumer Healthcare Products Australia (CHP Australia, previously ASMI) as usual.

Further information

Once finalised, the alternate arrangements will be published on the TGA website and we will issue an email alert to subscribers on the TGA Update and TGA Advertising email lists.

Please lodge any queries in relation to this information via the TGA Advertising online query form.