Changes make critical clinical information easier to find
From 2018 you’ll start to see changes to the format of Product Information (PI) documents. You’ll first notice the updated format with new medicines and any medicines where changes to the PI are made.
The changes will bring this important information together at the front of the PI document, helping health professionals quickly and easily locate this information and also aligning with other international regulators.
Under the old format the critical information for health professionals (indications, dosage and administration instructions, contraindications, precautions and adverse events information) has been located after information on the pharmacology and clinical trials of the medicine.
All PIs will be changed to the new format by the end of 2020.
A Product Information document (PI) provides health professionals with a summary of the scientific information relevant to the safe and effective use of a prescription medicine.
PI documents can be found by searching this website or by using the PI search database in eBusiness Services. You can enter the product name, licence details, sponsor details, active ingredient names or the ARTG number to get results. You can also use the TGA's MedSearch app available for Apple and Android devices.
Where available links to product information (PI) pdf documents are provided.
The information in a product information document has been written by the pharmaceutical company responsible for the medicine and has been approved by the TGA. It provides objective information about the quality, safety and effectiveness of the medicine, as demonstrated in the data provided to the TGA by the pharmaceutical company.
This information is intended to assist doctors, pharmacists and other health professionals in prescribing and dispensing medicines. In addition, this information can be used by health professionals in their consultations with patients, so that the patient can be better informed about their medicines.
A PI should contain the following information:
- Name of the medicine
- Composition and pharmaceutical form
- Clinical particulars, including:
- Therapeutic indications
- Dose and method of administration
- Special warning and precautions for use
- Adverse effects
- Pharmacological properties, including:
- Pharmacodynamic properties
- Clinical trials
- Pharmacokinetic properties
- Pharmaceutical properties, including:
- List of excipients
- Special precautions for storage and disposal
- Medicine schedule
- Date(s) of approval and revision
- Further details on the content and format of the product information are detailed in the Form for providing product information (this form will be updated when the new format goes live)
Approximately 90 per cent of registered prescription medicines have PI documents that are available through the TGA website. There are a number of reasons why a PI document may not be available including:
- the medicine is newly registered and the PI document has not yet been lodged
- the medicine is not classed as a registered prescription medicine, for example it may be a listed medicine that is available without a prescription
- the medicine was "grandfathered" onto the ARTG at the time of commencement of the legislation in 1991
- the product contains excipient ingredients only but is still regulated as a "therapeutic good" e.g. water for injection.
If you are looking for a PI document that is not available on the TGA website, contact the sponsor of the medicine directly.