The guidance published by the Therapeutic Goods Administration (TGA) on August 2020, gives direction about setting up the summary page for Consumer Medicine Data (CMI) documents. The document is aimed at sponsors of medicines who are catering to the Australian market as well as associated stakeholders.
Sponsors should ensure that medicines that are registered from 1 January 2021 adopt to the relevant CMI template. The new format should be adopted by CMIs of previously registered medicines on or before 30 December 2025. These prerequisites apply to every medicine that requires CMI, including prescription medicines and some non-prescription (over-the-counter) medicines, as set up in Schedules .12 and 13 of the Therapeutic Goods Regulations 1990.
This document will be a companion resource to the previously released guidance documents such as: Using the TGA CMI template – Guidance for sponsors and Consumer Medicine Information (CMI) – How to use the improved CMI template.
This document gives general insights and guidelines pertaining to the new template and effective writing for consumers. The suggestions In this document are in line with the feedback obtained from the consumers during the assessment of the new formats as well through focused discussion with key partner stakeholders as Medicines Australia, the Generic Biosimilar Medicines Association, and the Consumer Healthcare Products Association.
Please refer to https://www.tga.gov.au/resource/creating-cmi-summary-page-guidance-sponsors for further information