Consultation: Product Information as a package insert in boxed injectables

This consultation is now closed. You can read about the outcome on our Changes to the Product Information (PI) as a package insert for injectable products page. 

About this consultation

Through this public consultation, the TGA sought feedback on the current usage of the information included with boxed injectables and whether the requirement to include a paper Product Information (PI) as a package insert in boxed injectables is still relevant for those administered by healthcare professionals.

In Australia, the PI is required to be provided both in the box of injectables and also as an electronic document available on the TGA website. The PI provides healthcare professionals with a summary of the scientific information about the safe and effective use of a prescription medicine.

More information on the consultation and a summary of the responses is available on the TGA consultation hub.

What we are doing next

We are using the feedback received to develop options for regulatory reforms and policy for further consideration, noting that further consultations with internal and external stakeholders may be required to help shape options. Implementation of some options may require government approval (regulatory change) and/or parliamentary approval (legislative change). We will present these to the Government for consideration and we will continue to share progress and updates with our stakeholders on this page.

All recent TGA consultations can be found at the TGA consultation hub.