Changes to the Product Information (PI) as a package insert for injectable products

From 1 September 2023, injectable products administered by healthcare professionals may not come with a hard copy of the PI in the package of the product.

This change only affects products administered by a healthcare professional, such as a nurse, pharmacist or doctor.

Injectable products not administered by a healthcare professional will still come with a hard copy of the PI in the package of the product. This includes products that are self-administered or administered by a carer.

The approved PI for all these products will still be available on our website.

You can find the PI for any registered medicine by searching for the product using the:

• product name
• active ingredient
• sponsor details
• Australian Register of Therapeutic Goods (ARTG) number.

Why we made this change

We made this decision based on the feedback we received during our Consultation: Product Information as a package insert in boxed injectables. We weighed up the risks and benefits of a paper PI versus the version available on our website.

Accessing the PI online means you are viewing the latest version. A printed PI document included with the product runs the risk of becoming out of date and may be missing recently added safety information.

It is important for healthcare professionals to be aware of any changes because that may make them decide to take extra precautions or in some cases selecting alternate medicines.

Additionally, printing PI documents has an environmental impact since they are typically 10-35 pages long. Including the document with the product can also lead to an increase in the package size.

The electronic PI is accessible through various platforms and devices. It also allows faster access to the required information and improved readability.

What will change

From 1 September 2023, pharmaceutical companies will not be required to add a paper copy of the PI as a package insert for new batches of their injectable products administered by healthcare professionals. The PI will still be accessible online.

Products manufactured before this date that are already in supply will continue to have the PI as a package insert.

There are no changes to the Product Information document.

Product labels may need to be updated. To find out if your product needs updating, please go to the Ensuring compliance after removing the product information insert page.

There are no changes on the Consumer Medicines Information (CMI) document.