PBS Forms

Page last updated: 11 May 2022

Accessibility

The documents on this page may not be accessible. If you need assistance please email the PBS Web team.

The Health Products Portal (HPP) is the approved method for lodging submissions for listing medicines on the PBS.

From 1 April 2021 the following services must also be made using the HPP:

  • Application for a New brand or new oral form of existing PBS items
  • Application to delete a product from the PBS
  • Management of manufacturer details
  • Management of Authorised Representative details

For instructions on how to get started, please visit the HPP website

This page contains forms that may be required by the Department of Health to list a medicine on the Pharmaceutical Benefits Scheme. Forms relating to processing claims, paying benefits, or PBS stationery order forms can be found on the Services Australia website.

  

Application Form for Pre-submission Services (Pre-submission Meeting Request Form)

You can now submit your Application Form for Pre-submission Services online via the Health Products Portal (HPP). More information on the HPP including registering, sign in, FAQs, Reference Guides and Terms and Conditions can be found on the Health Products Portal pages.

The Pre-submission Meeting Briefing Paper and the Pre-submission Meeting Outcomes template is to be completed and submitted to the Pre-submission Meetings Team. For more information, please refer to the Procedure Guidance and Cost Recovery Administrative Guidelines.

  

Application Form for Submission Services

You can now submit all Submission Services forms via the Health Products Portal (HPP). From 1 April 2021, Applications for a New Brand or new oral form of existing pharmaceutical item must be made via the HPP. This form can still be used for listing section 19A medicines in accordance with the guidance provided by the Department.

Part C (Application for New Brand or new oral form of existing pharmaceutical item) of this application form is to be completed and submitted to the Information Management Team. For more information, please refer to the Procedure Guidance and Cost Recovery Administrative Guidelines.

 

Facilitated Resolution Pathway Workshop

The Facilitated Resolution Pathway Workshop Briefing Paper and the Facilitated Resolution Pathway Workshop Outcomes template are to be completed and submitted to the department via the HPP. More information on the HPP including registering, sign in, FAQs, Reference Guides and Terms and Conditions can be found on the Health Products Portal pages.

  

Application Form for Pricing Services

Part A (Notice of Intent for Pricing) and Part B (Pricing Application) of this application form are to be completed and submitted to PBS Pricing. For more information, please refer to the Procedure Guidance and Cost Recovery Administrative Guidelines.

  

Application for List Management Services

You can now submit List management service request submissions via the Health Products Portal (HPP). The HPP collects structured information as part of your submission, which means this form is no longer required.

This application is to be completed and submitted to the department for the following list management services that involve either a price increase or Ministerial Discretion:

  • Ministerial Discretion not to apply a Statutory Price Reduction request
  • Price increase requests
  • Brand Premium requests
  • New item recognised as a new preparation request.

For more information, please refer to the Procedure Guidance and Cost Recovery Administrative Guidelines.

  

Application to list a Drug or Medicinal Preparation as a Pharmaceutical Benefit (PB11)

You can now submit all PBAC submissions via the Health Products Portal (HPP). The HPP collects structured information as part of your submission, which means this form is no longer required.
This form can still be used as part of a Pricing Offer Package (pricing application).

This application is to be completed and submitted to the Pharmaceutical Benefits Advisory Committee (PBAC) secretariat. For more information, please refer to the PBAC guidelines.

 

Request for Approved Ex-Manufacturer Price (PB11a)

You can now submit List management service requests, New brand or new oral form and PBAC submissions via the Health Products Portal (HPP). The HPP collects structured information as part of your submission, which means this form is no longer required. This form can still be used for other application types including Pricing Offer Packages (pricing applications) and changes to the Responsible Person (RP) for a PBS product.

The PB11a is a form that sponsors need to submit to reflect the listing price sought for their product on the Pharmaceutical Benefits Scheme (PBS) or when requesting a price or related alteration for a product already listed on the PBS.

The PB11a form has been updated to reflect the new legislation changes commencing 1 October 2012.

For any questions relating to completion of the PB11a form, please email the Pricing Section, Pharmaceutical Evaluation Branch.

A new PB11a form is required for the purpose of a new price agreement where the Responsible Person changes their details including:

  • the registered company name and ABN
  • Brand names for which they are the Responsible Person
  • Responsible Person

 

Cost Information (PB11b)

Page last updated: 11 May 2022

You can now submit List management service requests, New brand or new oral form and PBAC submissions via the Health products Portal (HPP). To get started, please visit the HPP website. The HPP collects structured information as part of your submission, which means this form is no longer required.
This form can still be used for other application types, including Pricing Offer Packages (pricing applications) and section 19A medicines, in accordance with the guidance provided by the Department.

Submit the PB11b form to the PBAC Secretariat at the time of making a PBAC submission, or to apply for a price increase for a product already listed on the PBS, submit to the Pricing Section.

 

Guarantee of Supply

This form is to be used when a Responsible Person  wishes to advise a failure to supply a brand of an item listed on the PBS, or a belief that a failure to supply is likely to occur.

Please email the completed form to PBS Listings.

 

Responsible Person

From 1 April 2021, you must update your Responsible Person details via the Health Products Portal (HPP). The Organisation Profile in the HPP stores this information, which means this form is no longer required.
This form can still be used for other application types including changing the Responsible Person (RP) for a listed PBS product. For more information on this application type, please see this FAQ on the PBS website.

This form confirms with the Department of Health those brands of items on the PBS a particular Responsible Person will be supplying.

Please email the completed Responsible Person form to PBS Listings.

  

Australian Medicines Terminology (AMT) descriptions for PBS Listings

Submissions to the PBAC should include the following form, if the submission includes a new medicine that is not currently listed in the Australian Medicines Terminology (AMT).