Look out…the new CMI templates are finally here
TGA’s updated CMI templates and guidance is finally live on their website!
No new or additional content is required in the new templates. The intent was to revise the format to promote safe and effective use by improving the ease of identification and comprehension of information.
- Introduction of an easy to understand, one-page CMI summary for critical information about the safe and effective use of the medicine. This is optional for Non-Prescription (OTC) medicines or for any medicines where the CMI is enclosed as a pack insert.
- Separate templates for Prescription and Non-Prescription medicines, with the notable difference of having the summary page optional for the latter.
- Presentation of side effects in tabular format, categorised into Less serious/Common and Serious/Rare, with side effects grouped by their effect on the body (e.g. bleeding related) and what to do for each type of side effect. This new format helps patients quickly identify serious side effects requiring immediate action.
- Listing of active ingredient, excipients and potential allergens in a table for easy scanning.
- Reference to the use of external hyperlinks (e.g. instructional videos / diagrams for device use) to enhance understanding.
When do I need to implement the new templates by?
The new templates take effect from 1 January 2021 for newly registered medicines. All previously registered medicines must be in the revised format by 30 December 2025.
Ready to download the updated templates? Click here.
If you have questions about how to navigate the use of standards and managing test programs, please reach out. We have a staff of consultants with extensive expertise. Whether it’s a TGA application, a strategy for MDR transition, a US presubmission or 510(k) filing, or specific help with regulatory documents (e.g. Clinical Evaluation Reports), or an update of your quality system to gain MDSAP. We understand you need a commercial approach which delivers viable options. Contact us to discuss your needs and how we can help. You can drop us an email [email protected] or call 1 888-271-5063 (US toll free) ♦ +61 2 9906 2984 (Sydney)
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