Consumer Medicine Information leaflets, or CMI for short, are specially written leaflets that provide information about prescription medicines and pharmacist-only medicines. They are produced in accordance with Commonwealth Government regulations that specify the information they must contain and how they should be presented.
CMIs in Australia contain information that is important to know before and while using a medicine and can help you better understand the medicines you are taking. The pharmaceutical company that makes the medicine writes the CMI: meaning it must be factual and not promotional.
A CMI includes the following information:
Including all of this information can make a CMI quite long but all of it is important. Consumers should be able to follow the headings and subheadings in these medication information sheets, to find out easily what information they need to know. The TGA’s CMI template provides brands with a useful framework of what to include.
If you have any difficulty finding your medicine’s CMI, a pharmacy or doctor can help. They will be able to provide you with a copy or direct you to where you can find it online.
Otherwise, you can generally find your CMI in the following locations:
To find your CMI you can enter the product name, licence details, sponsor details, active ingredients or the ARTG number. CMIs may not be available for every product.
A CMI leaflet is designed to be easy-to-use for the consumer, so you can understand how to safely take a medicine. The leaflet should be reader-friendly, with plain English headings to help you find what you’re looking for.
To make the most of a Consumer Medicine Information leaflet, you can:
The Therapeutic Goods Administration (TGA) regulates labelling and mandates the type of information that has to be included on labels.
For consumers, the label is the single most important source of information about non-prescription medicines and, therefore, it is critical that this information is presented in a way that can be understood and acted on appropriately by the consumer.
The Labelling Code of Practice was developed to provide a set of principles for developing labels with the consumer in mind: consumer-focused principles.
Labels designed using consumer-focused principles help people identify products; differentiate and choose an appropriate medicine for their needs; find and appropriately action instructions for using the medicine safely and effectively; and know where to find further information if they need to know more about their medicine.
For more information about the TGA requirements in relation to medicines labelling, click here.
In relation to medicines, the general term 'packaging' is used to describe the container that immediately covers the medicine as well as the packaging (e.g. carton) in which the medicine is supplied to the consumer.
Various aspects of packaging are regulated by the TGA and other agencies including:
Medicines.org.au - a website that provides consumers and health professionals with free access to a large number of Australian Consumer Medicine Information (CMI) and Product Information (PI) documents;
NPS MedicineWise - for information on medicines, conditions and medical tests.