Australian regulatory authority, the Therapeutic Goods Administration (TGA), has published new Guidance on advertising restrictions for prescription-only medicines (POMs).
The regulator states that the guidance is intended to help individuals and businesses comply with Australia’s regulatory requirements. The TGA notes that unlawful advertising of POMs may include the use of restricted or prohibited representations without approval; with restricted representations including disease and condition, and prohibited representations featuring sexually transmitted diseases, neoplastic diseases and mental illness. Other unlawful advertisement includes implying Government endorsement through claims such as “TGA approved” and promoting products for off-label uses not included in the Australian Register of Therapeutic Goods.
The Guidance also reiterates that advertising POMs or substances is prohibited under subsections 42DL(10) and 42DLB(7) of the Act, except in limited circumstances, including advertising directed exclusively to healthcare professionals, information shared by a healthcare professional with a patient or advertising authorised or required by the Government. The TGA further advises businesses to assess whether content constitutes advertising and to remove references to POMs from advertising materials to avoid unlawful promotion.