Pharmaceutical Benefits Scheme (PBS)

Guarantee of Supply

This page contains information on the guarantee of supply provisions.

From 1 August 2007, responsible persons listing a new brand of an F2 medicine on the PBS (PBS Formularies), and responsible persons for existing brands that offer a price reduction, will be required to guarantee the supply of these brands. The guarantee of supply period will be up to 24 months, or until another bioequivalent or biosimilar medicine lists on the PBS or becomes available at a lower price.

The guarantee of supply provisions will deter suppliers from entering the Australian market without a viable business model able to support their long term participation in the market. Interruptions to supply are disruptive for patients, prescribers and pharmacists. The provisions also ensure that the government has as much notice as possible about supply failures so that the impact on patients, prescribers and pharmacists can be minimised. The Guarantee of Supply requirements and sanctions for failing to comply with the requirements are set out in Division 3C of Part VII of the National Health Act 1953.

PDF printable version of PBS Reform Fact Sheet (PDF 39 KB)

Pharmaceutical Benefits Scheme (PBS): Guarantee of Supply Form Notification under Section 99AEG of the National Health Act 1953 (PDF 41 KB)

If you are having difficulty downloading the PDF document(s), please email pbdwebmaster@health.gov.au for an alternative version or a copy to be sent to you.