Pre-clearance

Australia ／ TGA

Use of a restricted representation, that is one referring to a serious form of a disease, condition, ailment or defect, requires prior approval by the Secretary, who must approve it if satisfied the representation is accurate, balanced and not misleading, and who is taken to have approved it if no written notice is given within 60 days of the application.

重篤な疾患等に言及する制限表示（restricted representation）を用いるには事前に長官の承認が必要で、長官は表示が正確かつ均衡で誤認を与えないと認める場合に承認しなければならず、申請から60日以内に書面通知がなければ承認したものとみなされる。

statuteTherapeutic Goods Act 1989, sections 42DF and 42DG (Compilation No. 86)checked 2026-09-23

Note
Advertising Code section 28 defines when a form of disease is 'serious'. Whether a general pre-approval requirement for consumer advertisements in specified media still exists was NOT verified because tga.gov.au was unreachable from this environment throughout the task; no statement is made here either way.

The same topic elsewhere

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