Need help with your Consumer Medicine Information (CMI)?

A CMI writer can help with the transition to the new CMI template

Aussie Pharma has until December 2025 to transition to the new Consumer Medicine Information (CMI) template, including a one-page summary. 

With this new template, medicine sponsors now have a great opportunity to update and improve the content of their CMI. With better CMI design and content, everybody involved in the use of medicines benefits: doctor, pharmacist, sponsor and—most importantly—the consumer. 

Outsourcing the reformatting and content improvement of your CMIs to an expert can ensure you produce quality CMI. And it will likely save you time and money.     

A picture of the side effects section in a Consumer Medicine Information pack insert, under a magnifying glass

Benefits of using a dedicated CMI writer

  • Improve quality and consistency of your CMIs

  • Save time. You can implement more quickly, allowing your staff to focus on other critical projects 

  • Usability testing of CMI can be time consuming and expensive. Outsourcing this to an experienced CMI writer is affordable and can be very cost-effective

  • Putting the patient first. Improving the content with an experienced CMI writer will further improve the usability of the CMI

About Sally Bathgate:

  • Experienced CMI writer with nearly a decade in Regulatory Affairs at Novartis

  • Former member of QARG (Quality Assurance Reference Group) and EDWG (Electronic Distribution Working Group)

  • Familiar with the history of CMI, the regulatory requirements, and CMI writing guidelines (past and current)

  • Experience in usability testing of CMI

  • Using best-practice in patient-facing medical communications

A picture of a medical writer working with a patient to improve CMI through user testing. The medical writer is blond, with short hair and she wears glasses.

Still not sure if you need a CMI writer? You have options

1.     CMI review

You may wish to complete the new CMI and summaries in-house. However, you may want to check that your new CMI are internally and externally consistent. I can review your company’s CMI for quality and consistency and suggest areas for improvement.

2.     Summaries only

Your company may wish to import current CMI content into the new format. I can provide the one-page summary for newly completed CMI, compliant with the guidelines.

3.     Full CMI formatting and update: one-page summary and new format

Working with the template provided by the TGA (or Guildlink where applicable) I can rewrite your CMI in accordance with the guidelines.

4.     Usability testing of new CMIs

The new CMI template has been developed using an iterative process of usability testing and improvement. I can provide this same service, following the methodology from Writing about medicines for people: usability guidelines for Consumer Medicine Information. 3rd ed. I can test and report on the usability of your new CMI and summaries. 

Please get in touch to discuss how I can help you best with your CMI revisions. Act now, before I’m booked up!