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Advertisers of complementary medicines
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?
|Are seeking a pre-approval decision for a complementary medicine advertisement in print, cinema, billboards or other public displays before early December||
|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.||
|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||
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.:
- 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.
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.