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Consumer Medicines Information (CMI) and Product Information (PI)

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About Consumer Medicines Information (CMI)

The Consumer Medicines Information (CMI) is a leaflet that contains information on the safe and effective use of a medicine.

The information has been written by the pharmaceutical company responsible for the medicine. TGA regulations require that CMI must be made available to consumers either in the pack or in another manner that will enable the information to be given to the person to whom the medicines are administered or otherwise dispensed.

A CMI includes:

  • the name of the medicine
  • the active ingredients as well as the inactive ingredients
  • the dosage of the medicine
  • what the medicine is used for and how it works
  • any warnings and precautions, such as when the medicine should not be taken
  • any interaction the medicine might have with food or other medicines
  • how to use the medicine properly
  • side effects
  • what to do in the case of an overdose
  • how to store the medicine properly
  • the sponsor's name and address
  • the date the CMI was last updated

About Product Information (PI)

Product Information (PI) provides health professionals with a summary of the essential scientific information to allow the safe and effective use of a medicine under nearly all circumstances.

As a condition of registration certain medicines, mainly those prescribed by a doctor, are required to have a product information document which provides information relating to the safe and effective use of the medicine, including information regarding the medicine's usefulness and limitations. Product Information documents are agreed with the Therapeutic Goods Administration (TGA) as part of the medicine's approval process before it can be made available in Australia.

The information in these documents assists doctors, pharmacists and other health professionals in prescribing and dispensing medicines and also in their consultations with patients, such as to better educate a patient on the medicine they are being given.

PI should contain the following information:

  • name of the medicine
  • description
  • pharmacology
  • clinical trials
  • indications
  • contraindications
  • precautions
  • adverse effects
  • dosage and administration
  • overdosage
  • presentation and storage conditions
  • name and address of the sponsor
  • poison schedule of the medicine
  • date of approval

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