Product Information inserts are no longer required for injectable medicines administered by health professionals

TGA

From 1 September 2023, printed Product Information (PI) inserts won’t be required in the packaging of injectable medicines administered by health professionals. Approved PIs for all these products will still need to be available on our website.

This change only affects injectable products administered by health professionals. This includes nurses, pharmacists and doctors. Vaccines are an example of injectable medicines administered by health professionals.

Injectable products used by patients or their carers will still come with a copy of the PI.

This decision follows public consultation and feedback from stakeholders, including industry and health professionals.

PIs provide scientific information about the safe and effective use of prescription medicines. They are mainly used by healthcare professionals.

Patients, carers and other consumers can access Consumer Medicine Information (CMI) documents. CMIs contain clear information on how to safely use prescription medicines. This includes information on dosage, when a medicine should not be used and any possible side effects.

Read more on our Changes to the Product Information (PI) as a package insert for injectable products page.

/Public Release. View in full here.