Health Products Portal - Frequently Asked Questions

 

Did you know: You can now lodge a New brand or List management service request submission through the Health Products Portal (HPP). For instructions on how to get started, please visit the HPP website.

Page last updated: 9 February 2022

About the HPP

What is the HPP?

What does the HPP do?

Who can use the HPP?

Which web browsers does the HPP support?

I need help using the HPP or have a suggestion for improvement. Who do I contact?
 

Getting started in the HPP

How do I access the HPP?

How do I get a myGovID?

I am getting an error when signing in to the HPP that my email is already in use

What are the different user roles in the HPP?

How can I authorise users to act on behalf of an organisation in the HPP?

How can I act on behalf of the organisation/s I work for, in the HPP?

Can I use AUSkey to access the HPP?

I can’t find my invitation to associate with an organisation or submission within the HPP

Using the HPP

What types of PBS submissions can be made using the HPP?

Do submission due dates or PBAC deadlines change when using the HPP?

What files can I upload into the HPP?

Can I upload large files in the HPP?

How were the data fields in the HPP decided?

How can I delete a draft submission?

Is it okay to have multiple people work on one submission at the same time?

Can I come back to my draft submission later?

Is a responsible person form still required?

If using the HPP for a submission, do I still need to complete the PB11 forms?

What happens after I lodge my submission?

Can I amend my lodged submission?

How do I withdraw my lodged submission?

Will I be notified when I receive correspondence in the HPP?

Can I initiate correspondence?

Will I receive my invoice (cost recovery fees) in the HPP?

Can I pay my invoice (cost recovery fees) in the HPP?
 

PBAC submissions

How do I link an Intent to apply submission to my PBAC submission?

How do I lodge a codependent submission in the HPP?

How do I lodge a submission for a vaccine in the HPP?

What information should I enter for Regulatory details if my submission is regarding a Nutritional Product?

Where do I upload the AMT mapping form?

What should I do if I don't have the pricing information requested by the HPP?
 

New brand submissions

Will the deadlines for my New brand submissions change?

Can I use the HPP to request a listing of new brands that cause a price change?

What attachments do I need if I use the HPP for a New brand submission?

How do I request a biosimilar brand of an existing PBS item in the HPP?
 

List management service request submissions

What is a List management service request?

Will the deadlines for my new brand submissions change?
 

Delete brand(s) submissions

Will the deadlines for deleting my brand(s) change?

Can I use the HPP to delete my product from the PBS?

Notice of intent

How do I link a Notice of intent to a PBAC Submission?

Will I receive my invoice via the HPP?

Can I reuse my Notice of intent to link to a pricing offer package?

Pricing offer package  

How do I link a pricing offer package to a PBAC Submission?

How do I link a Pricing offer package to a Notice of intent?

About the HPP

What is the HPP?

The Health Products Portal (HPP) is a secure and easy to use platform where industry can register once and apply, track, pay and manage pharmaceutical items, including submissions to the Pharmaceutical Benefits Advisory Committee (PBAC).

What does the HPP do?

The HPP supports industry to:

  • Register themselves (using an Australian Government recognised identity – myGovID and self-manage their own profile.
  • Register and manage organisations (including organisation members and agents)
    • Manage Authorised Representatives details
  • Manage and lodge the following:
    • Requests for a Pre-submission Meeting
    • Intents to apply for PBAC submissions (including Committee Secretariat submissions)
    • PBAC Submissions for consideration by the Pharmaceutical Benefits Advisory Committee
    • Notice of intent
    • Pricing offer package
    • New brand submissions
    • List management service requests
    • Requests to Delete brand(s)
  • Receive, initiate and manage correspondence from the Department 
  • View, manage and pay invoices for submissions made via the HPP

Features will be progressively added to the HPP. Details about updates and new features will be published on the Health Products Portal webpage.

Who can use the HPP?

The HPP is available for use by the Pharmaceutical Industry, or its agents. See How do I access the HPP?, for more information.

Which web browsers does the HPP support?

We recommend using the HPP in a recent version of a compatible browser such as Chrome (80+) or Edge.

I need help using the HPP or have a suggestion for improvement. Who do I contact?

If you require further assistance or have a suggestion for improvement, please email HPP Support.

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Getting started in the HPP

How do I access the HPP?

You can access the HPP, from the HPP webpage. We recommend using the HPP in a recent version of Chrome (80+) or Edge.

An Australian Government recognised identity – myGovID, linked to an organisation in Relationship Authorisation Manager (RAM) is required to access the HPP.

The Australian Business Register provides information on how to get started with myGovID and RAM.

How do I get a myGovID?

myGovID is a whole-of-government secure login for use with participating Australian government online services on behalf of a business.

To acquire a myGovID, or for further information, visit the myGovID website.

I am getting an error when signing in to the HPP that my email is already in use

When signing in to the HPP using your myGovID it is important to select the same organisation in RAM (if this step is applicable). The HPP uses your myGovID and association to an organisation in RAM as a personal/Government authentication check. HPP users then set the organisation they wish to represent within the HPP (after agreeing to the HPP terms and conditions).

If you require further assistance, please email HPP Support.

What are the different user roles in the HPP?

There are three different user role within the HPP:

  • Organisation Administrator – this user can:
  • perform all HPP functions for an organisation, including management of user permissions associated with the organisation
  • view, edit and lodge all information and submissions associated with the organisation.
  • Organisation General User – this user can:
  • perform limited HPP functions for an organisation
  • view, edit and lodge all information and submissions associated with the organisation.
  • Agents – this user can:
  • edit and lodge specific submissions that have been assigned to them, by an Organisation Administrator

For more information on user roles, refer to the Getting started HPP quick reference guide.

How can I authorise users to act on behalf of an organisation in the HPP?

An Organisation Administrator can invite HPP users to act on behalf of an organisation, via the Organisation Profile page. For more information on managing an organisation’s members and agents, refer to the Getting started HPP quick reference guide.

How can I act on behalf of the organisation/s I work for, in the HPP?

To act on behalf of an organisation you must:

For more information on managing invitations, refer to the Getting started HPP quick reference guide.

Can I use AUSkey to access the HPP?

You can no longer access the HPP using an AUSKey as it was officially retired at the end of March 2020. AUSKey was replaced with myGovID and Relationship Authorisation Manager (RAM).

More information on this change can be found on the Australian Business Register website.

I can't find my invitation to associate with an organisation or submission within the HPP

Users who do not have a profile registered in the HPP will not receive an invitation. Ensure the invitation was sent after a HPP profile was created by the person being invited.

For more information on managing invitations, refer to the Getting started Health Products Portal - Quick Reference Guides.

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Using the HPP

What types of PBS submissions can be made using the HPP?

The following submission types are available on HPP:

  • Pre-submission meeting request
  • Intent to apply
  • PBAC submission
  • Notice of intent
  • Pricing offer package
  • New brand of existing PBS item
  • List management service request (price increase request, brand premium)
  • Delete brand(s) submission

The following submission types are not available on HPP, but are planned for future releases:

  • Change of details for a listed brand of a PBS item
  • Lower price offer
  • Notice of intent (pricing offer package)

Do submission due dates or PBAC deadlines change when using the HPP?

There are no changes to the submission due dates or PBAC cycle timeframes with the HPP. For more information please refer to the PBAC calendar

What files can I upload into the HPP?

A complete list of accepted file types can be found in the Using the HPP quick reference guide.

Can I upload large files in the HPP?

Yes, the HPP supports one or many files up to the size of 15GB per upload for PBAC submissions and 50MB per upload for all other submission types. There is no limit of file uploads per submission. More details about uploading files can be found in the HPP quick reference guides.
If you require further assistance uploading a large file, please contact HPP Support.

How were the data fields in the HPP decided?

The data fields in the HPP align with the Procedure guidance for listing medicines on the PBS. The HPP data fields capture the information and additional documents required to prepare a submission.
 For more information, please refer to Procedure guidance for listing medicines on the Pharmaceutical Benefits Scheme.

How can I delete a draft submission?

You can delete a draft submission from the All submissions page. For more information on deleting draft submissions in the HPP, please refer to the Using the HPP quick reference guide.

Is it okay to have multiple people work on one submission at the same time?

Yes. Multiple people can work on a submission at the same time however, it is recommended that only one person works on a specific submission page at any given time.

Can I come back to my draft submission later?

Yes, you can save a draft submission in the HPP and come back and make any amount of changes. Please note, a draft submission will be removed after 120 days of inactivity. Submission contacts will receive a reminder after 90 days of inactivity on a draft submission.

Is a responsible person form still required?

A responsible person form is no longer required. You can manage Responsible Person and Authorised Representative details in the HPP, via the Organisational Profile. For more information, refer to the Getting started HPP quick reference guide.

The HPP will record who lodged the submission. This can be viewed in the submission PDF.

If using the HPP for a submission, do I still need to complete the PB11 forms?

The HPP collects structured information as part of your submission, which means some forms are no longer required (including PB11, PB11a, PB11b forms, Responsible Person and Part A, B and C of the submission services form). If you would still like to upload these forms as attachments this is available under the Upload Attachments section.

What happens after I lodge my submission?

You can download the submission summary of your lodged submissions from the All submissions page. Submissions will be evaluated in accordance with the current PBAC cycle timeframes.  For more information, please refer to the PBAC calendar

For more information on downloading your submission summary in the HPP, please refer to the Using the HPP quick reference guide.

Can I amend my lodged submission?

You cannot make changes to a submission once it has been lodged in the HPP. If you require further assistance, please email HPP Support.

How do I withdraw my lodged submission?

To withdraw your submission, you will need to notify the relevant area of the Department. You cannot withdraw your submission via the HPP. If you require further assistance, please email HPP Support.

Will I be notified when I receive correspondence in the HPP?

Yes, if you were included as a Submission contact within a submission or have been added as a contact by HPP Support, you will receive an email notification to your nominated email address when a correspondence is sent in the HPP.

To update nominated contacts, please email HPP Support.

Can I initiate correspondence?

Yes, in the correspondence section of the HPP you can create ‘New correspondence’ to send to the Department. For more information please refer to the Using the HPP quick reference guide.

Will I receive my invoice (cost recovery fees) in the HPP?

The Department will send invoices regarding your submission via correspondence in the HPP. For more information please refer to the Using the HPP quick reference guide.

Can I pay my invoice (cost recovery fees) in the HPP?

Yes, some invoices are payable via the HPP, from the Invoices page. Other payment options outside the HPP are also available and are listed on your invoice.
For more information please refer to the Using the HPP quick reference guide.

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PBAC submissions

How do I link an Intent to apply submission to my PBAC submission?

From the All submissions page, start a new PBAC submission. You can then link an Intent to apply that was previously lodged in the HPP. This will pre-populate relevant submission information into your PBAC submission. For more information on the Intent to apply submission and your draft PBAC submission in the HPP, please refer to the Using the HPP quick reference guide.

How do I lodge a codependent submission in the HPP?

Intents to apply for a streamlined or integrated codependent submission can be lodged using the HPP.

For the parts of a streamlined codependent submission that relate to the PBAC, these can be lodged through the HPP. For the parts of your submission that relate to MSAC, these should be lodged using the existing MSAC processes.

Integrated codependent submissions are not yet supported in the HPP. These should be lodged using existing processes.

Please refer to the Procedure guidance for listing medicines on the Pharmaceutical Benefits Scheme for more information on timeframes for codependent submissions.

How do I lodge a submission for a vaccine in the HPP?

Intents to apply for a submission for a vaccine can be lodged using the HPP.

Main submissions to the Australian Technical Advisory Group on Immunisation (ATAGI) are not yet supported in the HPP. These should be lodged using existing processes.

What information should I enter for Regulatory details if my submission is regarding a Nutritional Product

Within your submission select the radio button option ‘Approved’ and note in your ‘Submission purpose’ that TGA approval is not applicable. Ensure to select this option in both your Intent to apply and PBAC submission.  Feedback has been taken into consideration for a future design of the HPP to better accommodate Nutritional Product submissions. 

Where do I upload the AMT mapping form?

You can upload the AMT mapping form to the Product details section or include it in the Other attachments section. The AMT descriptions forms are required to be included with PBAC submissions to the PBAC.

What should I do if I don't have the pricing information requested by the HPP?

Contact HPP Support with your specific question(s) regarding how to complete pricing information in the HPP.

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New brand submissions

Will the deadlines for my new brand submissions change?

There will be no changes to the usual deadlines for publication in the Schedule. For more information please refer to the Summary of deadlines for PBS monthly listing and pricing process.

Can I use the HPP to request a listing of new brands that cause a price change?

Yes, you can use the HPP New brand submission to request to list a new brand which causes a price change. Please note, the different deadlines still apply to these products. For more information please refer to the Summary of deadlines for PBS monthly listing and pricing process.

What attachments do I need if I use the HPP for a new brand submission?

The HPP requires the Product Information and the TGA bioequivalence statement within the ‘Brand details’ section. The HPP collects structured information as part of your submission, which means some forms are no longer required (including the Responsible person form, PB11a form and Part C of the submission services form).

How do I request to list a biosimilar brand of an existing PBS item in the HPP?

Please complete a PBAC submission in the HPP, for biosimilar listings / new biosimilar brands of an existing pharmaceutical item. For further information, please visit the PBS FAQs.

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List management service request submissions

What is a list management service request?

The following request can be made via the List management service request submission in the HPP:

  • Add or request to change a Special Payment Contribution (e.g. Brand premium)
  • Price increase request
  • Ministerial Discretion not to apply Statutory Price Reductions
  • Request to remove a Special Payment Contribution (e.g. Brand premium)

For more information please refer to the PBS pricing webpage.

Will the deadlines for my list management submissions change?

There will be no changes to the usual deadlines for publication in the Schedule. For more information please refer to the Summary of deadlines for PBS monthly listing and pricing process.

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Delete brand(s) submissions

Will the deadlines for deleting my brand(s) change?

There will be no changes to the usual deadlines for publication in the Schedule. For more information please refer to the PBAC calendar.  It is preferred that, if possible, up to three months advance notice of the deletion be given in the Schedule. The usual deadlines for publication in the Schedule apply.

Can I use the HPP to delete my product from the PBS?

Yes, you can lodge a Delete brand(s) submission via the HPP where your product is:

  • one of several brands of an item listed in the Schedule of Pharmaceutical Benefits (the Schedule), or 
  • the only brand of an item listed in the Schedule. For further information about deleting your product and consideration timeframes, please visit the PBS FAQs

*If your product is one of several brands of an item listed for prescribing in the Schedule please complete a single Delete brand submission in the HPP, including all requested deletions, unless they have different effective dates then there should be a submission per effective date. If you are requesting item and brand deletions at the same time, these should be separate submissions. 

Notice of intent

How do I link a Notice of intent to a PBAC Submission?

From the All submissions page, start a new Notice of intent submission. The first question will allow you to link the Notice of Intent to a previously lodged PBAC submission in the HPP. This will pre-populate relevant submission information into your Notice of intent submission. For more information on the Notice of intent in the HPP, please refer to the Using the HPP quick reference guide

Will I receive my invoice via the HPP?

Invoices related to a Notice of Intent will be accessible via the HPP.

Can I reuse my Notice of intent to link to a pricing offer package?

Yes, you can use a single Notice of intent to link to multiple Pricing offer packages. This differs from PBAC submissions where you can only link an Intent to apply once. 

Pricing offer package

How do I link a Pricing offer package to a PBAC submission?

From the All submissions page, start a new Pricing offer package. The first question will allow you to link the Pricing offer package to a previously lodged Notice of Intent submission in the HPP. If you select ‘No’ you will be given the option to link the Pricing offer package to an urgent public health need or a previously lodged PBAC submission in the HPP. This will pre-populate relevant submission information into your Pricing offer package. For more information on the Notice of intent in the HPP, please refer to the Using the HPP quick reference guide

How do I link a Pricing offer package to a Notice of intent?

From the All submissions page, start a new Pricing offer package. The first question will allow you to link the Pricing offer package to a previously lodged Notice of Intent submission in the HPP. This will pre-populate relevant submission information into your Pricing offer package. For more information on the Notice of intent in the HPP, please refer to the Using the HPP quick reference guide

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See Also

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