Lodge an application form

What you need to know

Lodging an online application form is the first step of the MSAC application process. The process to seek any regulatory approvals can happen at the same time.

If you need advice before you apply, find out how to get support from our secretariat.

If your application is found suitable, our secretariat will publish documents (redacted) related to your application on this website. This includes the application summary. Our secretariat will make the final decision on what is redacted in these documents.

After lodging, you can withdraw your application at any time during the MSAC process.

• Medicare Benefits Schedule (MBS) funding applications – statement of clinical relevance

  If you are applying for Medicare Benefits Schedule (MBS) funding, you will need a statement of clinical relevance.

• PBAC codependent applications – how your application will progress

  You will first need to complete the MSAC application form if your codependent application is for both:

  • Pharmaceutical Benefits Schedule (PBS) funding for a medicine
  • Medicare Benefits Schedule (MBS) funding for an investigative or therapeutic service.

  The form will ask whether the service relies on a Pharmaceutical Benefits Schedule (PBS) listing. This lets us know your application also needs consideration by the Pharmaceutical Benefits Advisory Committee (PBAC).

  Our secretariat and the PBAC secretariat will use the information in the form to decide how to progress your application.

  Find out more about:

  • codependent applications PBAC also considers
  • how our secretariat manages PBAC codependent applications.
• High cost, highly specialised therapy (HST) applications – mandatory briefing before you apply

  If your application is for a potential HST, you must provide a briefing for Australian and state and territory health officials 4 to 8 weeks before you apply.

  Please contact our secretariat as soon as possible if you are considering lodging an application for a potential HST.

• Radiopharmaceutical applications

  If your application is for a radiopharmaceutical, you must refer to the framework for the MSAC assessment of radiopharmaceuticals. Depending on the regulatory status of the radiopharmaceutical, you may need to provide extra information with your application form.

  If you do not provide the information we need about the composition and supply of the radiopharmaceutical, it may delay your application.

What you need to do

1. Check the deadlines

You can lodge an application at any time, but the pre-assessment phase will not start until after the next deadline. See the key dates for applicants for upcoming deadlines.

2. Access the HPP

You will need to access the Health Products Portal (HPP) to lodge your application form. If you haven’t already:

1. create a myGovID – this is a digital identity that is recognised by the Australian Government
2. link your digital identity to your organisation
3. sign into the HPP with your myGovID.

For detailed steps, see how to access the HPP.

3. Complete the application form

You will need to complete the online form in the HPP.

Sign in to the HPP

Get tips on how to create a new application in the HPP.

For re-applications, you can make a copy of and edit a previously submitted form. See how to re-lodge a previous application in the HPP.

If you have any technical issues with the form, contact HPP support.

The form will require you to:

• select the relevant form option – either:
  • MBS eligible service or technology (for MBS funding applications)
  • other service or technology (for funding through other programs)
• upload at least one completed PICO set template for the service or technology
• enter other information directly into the form, including:
  • details of your clinical experts
  • regulatory information
  • for MBS funding applications, your proposed MBS item descriptor and fee.

4. Lodge the application form

Before you lodge, make sure you have:

• completed all relevant sections in full
• attached supporting documents including at least one completed PICO set document template
• for MBS funding applications, included a statement of clinical relevance and the proposed MBS item descriptor and fee.

Our secretariat will not accept your application if there is information missing.

Lodging an application form does not guarantee your application will progress through the MSAC process. It must first go through the suitability stage.

5. Download a record

After you lodge an application form, the HPP will automatically create a PDF that:

• contains all the data you entered into the online form
• includes the file names of all the documents you uploaded as part of your application.

You can download the PDF for your records. To see the format of the PDF, refer to the application record examples.

6. Manage your application

Go to HPP user support for guidance on withdrawing a lodgement and managing contact details.

If you receive updates on any regulatory approvals for your service or technology, let our secretariat know through HPP correspondence.

Next steps

The next step is the suitability check stage in the pre-assessment phase.

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