Publishing over-the-counter (OTC) medicine Product Information (PI) and Consumer Medicine Information (CMI)

If your medicine is one that is required to have a Product Information (PI) and Consumer Medicine Information (CMI), you may choose to publish the approved PI and CMI on the TGA website.

Published Consumer Medicine Information and Product Information documents can be accessed by the public via the TGA website.

Requirements for publishing

• The medicine must be one that is required to have a PI. A PI is required where:
  • the medicine is in Schedule 3 of the Poisons Standard, or
  • a PI was specifically requested by the Secretary under 25(1)(da)(ii) of the Act.
• The PI document must have been approved in the approved PI format which commenced on 1 January 2018.
• The CMI must have been produced using the improved CMI template (as first published by the TGA on 20 April 2020).
• Both the PI and CMI must be published. Therefore, unless both the PI and the CMI are in the required format, neither should be published.
• Where a CMI is included as a package insert, any changes to the document must have been approved by the TGA prior to publishing (and prior to supply as a package insert).

How to lodge your approved PI and CMI for publishing

To publish your approved PI and CMI on the TGA website, you need to lodge them via the TGA Business Services (TBS) Portal. To do this, log onto the Portal, select the ‘Documents’ or ‘Lodge Supporting Documents’ tab and select ‘Product Information’ or ‘Consumer Medicine Information’. A user guide is available on the form via the Help button located in the top right corner.

Making changes to already published PI and CMI documents

If you have received approval for changes to a PI that is currently published on the TGA website, you are required to replace the published PI with the newly approved PI using the TGA Business Services Portal. Instructions are included in the user guide, available on the forms via the Help button located in the top right corner. A replacement PI must be lodged within 2 weeks of approval of the changes.

CMIs published on the TGA website must be up-to-date. If your published CMI needs to be updated as a result of approved changes to the PI, the updated CMI must also be lodged via TBS within 2 weeks of approval of the PI.

Where a CMI is included as a pack insert for an OTC medicine, any changes to the CMI will require prior approval by the TGA. On approval, if the previous version is published on the TGA website, the updated CMI must be lodged via TBS within 2 weeks of approval.