Consultation: Product Information as a package insert in boxed injectables

Closed 5 Oct 2022

Opened 24 Aug 2022


The Therapeutic Goods Administration (TGA) is requesting 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.

The TGA aims to engage with the Australian public, healthcare professionals, and the industry to collect their views on the usefulness of including the paper PI inside the box of an injectable product.

We note different groups may or may not use included information when provided in hard copy with the product and may be satisfied that it only be accessible online.

We seek your views and feedback on the value of the Product Information (PI) as a package insert in boxed injectables that are administered by a healthcare professional (e.g. vaccines).

Why your views matter

The TGA is requesting feedback to determine if the PI is a necessary package insert in boxed injectables administered by healthcare professionals and ensure that any changes do not result in negative patient outcomes.

You can find details about this consultation and a graphical representation of the information contained in the Product Information (PI) below.


What happens next

The TGA will present the feedback to the Govenment for development of further options and for consideration to shape regulatory reforms and policy, noting that further consultations may be required with more user groups and stakeholders.


  • Anyone from any background


  • Hospitals
  • e-Health
  • Health technology
  • Medicare
  • Legislation
  • Pharmaceutical benefits
  • Rural health services
  • Regulatory policy
  • Immunisation
  • Aboriginal and Torres Strait Islander health
  • Prescription drugs
  • Strategic Policy
  • Policy Development