20 April 2020 - The Therapeutic Goods Regulations 1990 have been amended to support improved Consumer Medicine Information.
The reforms establish new templates for prescription medicines and non-prescription medicines, which outline minimum requirements and exemptions to requirements where applicable.
Newly registered medicines must produce their Consumer Medicine Information using the new template from 1 January 2021 and all previously registered medicines will be required to adopt the new format by 30 December 2025. While the reforms include a significant transition period, the TGA will be working with industry stakeholders to encourage sponsors to adopt the new format earlier for the benefit of consumers.