Consumer Medicine Information (CMI)

In mid-1991 Professor Peter Baume, in his report A Question of Balance: The Future of Drug Evaluation in Australia, recommended that a patient information document be developed for all prescription medicines. The first CMIs for prescription medicines became available in 1993.

In 1995, the legal requirement for CMIs was extended to Pharmacist-Only Medicines (Schedule 3). The TGA’s OTC Medicines Sections may also occasionally require CMI for other OTC products.

All CMIs, regardless of schedule, must be based on and consistent with the Product Information (PI) and must not be promotional.

Pharmacist-Only medicine CMIs must include the information specified in Schedule 13 of the Therapeutic Goods Regulations.

To make sure the information can be easily read and understood, CMI writers are encouraged to:

  • make use of the publication Writing about Medicines for People: Usability Guidelines for Consumer Medicine Information (Usability Guidelines), which provides procedures for setting out, writing, testing, implementing and monitoring CMIs; and
  • use the templates or “core” CMIs that have been developed for some therapeutic categories (see list below).

The CMI Content/Quality Assurance Reference Group was established in 1995 to oversee the provision of advice to sponsors concerning the development of CMIs and to assess CMIs to determine their quality and consistency with the Therapeutic Goods Regulations. Various stakeholder groups are represented on the Reference Group including consumers, doctors, pharmacists, nurses, pharmacologists, industry, CMI writers and communication experts.

The Reference Group can be contacted through its chair, Deborah Monk on (02) 6282 6888 or Project Officer, Mary Emanuel on (02) 9923 9407.

CMI Documents

Consumer Friendly Vocabulary for Medicine Information
Explanatory Note on the Vocabulary
Usability Guidelines
Principles about writing CMIs

The following core CMIs are available:

Analgesics containing codeine

CMIs

PIs

Pseudoephedrine containing products

CMIs

PIs

Guidance

If you require an editable Word version of any of the above Core CMIs, please contact Mary Emanuel on 02 9923 9407.