Medicine Status Website Factsheet

Page last updated: 30 November 2022

This factsheet outlines the information available on the Medicine Status Website (MSW) and the timing of its release.

Background

The Medicine Status Website (MSW) has been developed for consumers, in collaboration with consumers and the pharmaceutical industry, to improve the transparency of the Pharmaceutical Benefits Scheme (PBS) listing process.

The main objectives of the MSW include:

  • Centralise the key information available on how to list a medicine on the PBS
  • Enable users to track a medicine’s progress through the PBS listing process
  • Clearly articulate how consumers can contribute to PBAC decision making
  • Increase understanding of the activities involved in the PBS listing process

What information will be published?

The MSW includes information on submissions considered by the PBAC from July 2019 onwards. The MSW does not include information on listing process for vaccines or generic medicines. To obtain information on medicines considered before July 2019, please email the Department of Health and Aged Care (pbs@health.gov.au) or call 1800 020 613.

The MSW summarises the steps involved in the PBS listing process, from when the submission is received for PBAC consideration to when the medicine is available through the PBS. It enables users to track a medicine as it moves through the process.  

A summary of the kind of information available for each step on the MSW is below.

  • Step 1: Submission received for (month/year) PBAC Meeting – the date is the month and year of the PBAC meeting where the submission will be considered.

  • Step 2: Opportunity for consumer comment – the opening and closing dates for consumer comments prior to the PBAC meeting.

  • Step 3: PBAC Meeting – the date of the first day of the 3-day PBAC meeting and confirms the submission was considered by the Committee.

  • Step 4: PBAC outcome published – the outcome of the submission as determined by PBAC. This will display as either:

    • Recommended, deferred or not recommended.

  • Step 4a: Notice of intent submitted – the date the applicant submitted their form to the department to provide formal notice of their intent to proceed or not.

  • Step 5: Lodgement of required documentation – the date the applicant first submitted the required documentation to the department in order to proceed with the PBS listing process.

  • Step 5a: Acceptance of complete documentation – indicates the status of the required documentation. This will display as one of the following options:

    • Accepted, under consideration, not accepted

  • Step 6: Agreement to listing arrangements – the date the required documentation was accepted as complete by the department.

  • Step 6a: Status – indicates the status of the agreement to listing step and will display as one of the following options:

    • In progress or finalised.

  • Step 7: Government processes – the date the terms of listing arrangements between the applicant and the department are finalised and government processes commence.

  • Step 8: Medicine listed on the PBS – the date the medicine is listed on the PBS Schedule and made available to consumers at the subsidised rate.

Detailed descriptions of the activities undertaken in each step are provided in the MSW glossary.

When will information be published?

The MSW will be updated on the first business day of each month*.

It is important to note that the information available on the MSW is not in ‘real time’ and is not automatically linked to other parts of the PBS website. For example, the MSW does not automatically show items on the PBAC agenda at the same time the agenda is made available on the PBS website. However, in general, relevant information that is available on the PBS website will be available on the MSW shortly after.

Steps 4a to Step 7 provide details on the progress of a medicine in the post-PBAC phase of the process. This information was previously not publicly available and is not available anywhere else. The ‘Page last updated’ field at the bottom of each web page shows the date of the last update.

* For information to be included in the monthly updates, the process must have occurred at least five business days before the first of the month.