Pamphlet information requirements for all administered injectable products in Australia will change, with physical copies now no longer needed to be provided to patients.
Australia’s Therapeutic Goods Administration (TGA) has long required that administered injectable medicine products include a hard copy of the product information (PI) in the packaging.
For more than 30 years, under the powers of Section 28(2B) of the Therapeutic Goods Act, the TGA has required a printed version of the PI (often referred to as the approved “labelling”) to be available as a package leaflet in the marketing of injectable products.
But, after broad consultation last year, the TGA will drop the requirement for PI to be included in packaging for injectable products administered by healthcare professionals.
