Health Products Portal

The Health Products Portal (HPP) Terms and Conditions on this webpage reflect the Terms and Conditions within the HPP.

On this page:

• Terms of Use for the Health Products Portal
• Declaration when lodging a submission within the Health Products Portal
• Privacy when using the Department of Health’s Health Products Portal

 Terms of Use for the Health Products Portal

Welcome to the Health Products Portal. As a condition of Your use of the Health Products Portal, You must agree to these Terms of Use.

In these Terms of Use:

1. the terms 'You' and 'Your' refer to the user of the Health Products Portal, and where applicable, also includes a reference to the Organisation and the user's employer where that is not the Organisation.
2. 'General User' means a User who has successfully registered a personal Profile in the Health Product Portal though has not yet been associated with an Organisation Profile. These Users have the ability to register an Organisation Profile or send a request to associate with an Organisation (email is sent to the Organisation Administrator(s) of the registered Organisation Profile). These Users are unable to commence drafting of submissions/applications until they have established an association with an Organisation Profile.
3. 'Health Products Portal' means the electronic platform run by the Department on which Organisations may lodge and manage submissions/applications to the Department relevant to their health products (noting the types of submissions/applications and the relevant products may vary from time to time).
4. 'Intellectual Property Rights' include:
   • all copyright (including rights in relation to phonograms and broadcasts);
   • all rights in relation to inventions, plant varieties, trademarks (including service marks), designs and circuit layouts; and
   • all other rights resulting from intellectual activity in the industrial, scientific, literary or artistic fields.
     
     but do not include:
   • moral rights under Part IX of the Copyright Act 1968 (Cth); or
   • rights in relation to confidential information.
5. 'Material' means any thing:
   • lodged by a User into the Health Products Portal; or
   • communicated by the Department via the Health Products Portal (including receipt confirmations, invoices, requests for further action or response on Your submission/application and all other correspondence or documents provided by the Department via the Health Products Portal), and includes any such thing in which Intellectual Property Rights arise.
6. 'Organisation' means the industry or representative body that undertakes business or transacts with the Department relating to health products with which You are associated.
7. 'Organisation Administrator' is a User who:
   • has registered an Organisation in the Health Products Portal and by default becomes the Organisation Administrator of that Organisation; or
   • has established an association with a registered Organisation in the Health Products Portal (i.e. has been invited by an Organisation Administrator) and has then had their permissions updated to Organisation Administrator by another Organisation Administrator associated with that Organisation; and
     
     who has the ability to:
   • invite Users to associate with the Organisation Profile (i.e. granting access for Users to act on behalf of the Organisation which will also expose those Users to draft information related to submissions/applications created on behalf of that Organisation and Material communicated by the Department to that Organisation);
   • update Users' permissions who have been associated with the Organisation to hold permissions of an Organisation Administrator (i.e. an Organisation Profile can have multiple Organisation Administrators);
   • remove Users' association with the Organisation Profile (which means the removed User can no longer represent that Organisation in the Health Products Portal or view any information drafted/lodged on behalf of that Organisation or Material communicated by the Department to that Organisation);
   • assign draft submissions/applications to an Organisation Agent; and
   • remove an Organisation Agent's access to draft submission/applications or Material communicated by the Department to that Organisation.
8. 'Organisation Agent' means a User assigned to a submission/application by an Organisation Administrator in the Health Products Portal, who may be, for example, an individual officer, employee, contractor or consultant of an Organisation. Once assigned, an Organisation Agent has the ability to act on behalf of that Organisation, though will only be able to see the draft submissions/applications [and Material communicated by the Department to that Organisation] to which they have been granted access (i.e. they cannot see all other draft submissions/applications related to that Organisation for which they have not been granted access). Organisation Agents do not have the ability to delete submissions/applications from within the Health Products Portal, but do have the ability to update and lodge those submissions/applications to which they have been assigned access.
9. 'Organisation General User' means a User who has both registered a personal Profile in the Health Products Portal and established an association with an Organisation Profile. Upon establishing an association with an Organisation in the Health Products Portal, this User can then represent that Organisation in the Health Products Portal and draft/submit submissions/applications to the Department and view Material communicated by the Department to the Organisation. These Users cannot send invitations to other Users to associate with the Organisation (including the ability to assign an Organisation Agent to a submission/application) as this is a function restricted to the role of an Organisation Administrator.
10. 'Profile' means Your online registered account to use the Health Products Portal.
11. 'User' means You or any other individual registered with Health Products Portal Profile, and where the context permits includes a General User, Organisation General User, Organisation Administrator or Organisation Agent. The term 'User' does not include any person acting for or on behalf of the Department, including employees, professional advisers, contractors or agents of the Department.

The Commonwealth of Australia as represented by the Department of Health (the 'Department') may at its discretion update these Terms of Use. The Department will provide notice of any update to these Terms of Use where it considers it feasible to do so.

By continuing to use the Health Products Portal, You accept the Terms of Use as they apply from time to time and acknowledge that You have an ongoing need to access the Health Products Portal. Your acceptance of these Terms of Use is not affected by any statement to the contrary, or any restriction, exclusion or additional terms or conditions of use set out in any submission/application submitted by You, and You agree that such statements, restrictions, exclusions, and additional terms or conditions have no legal effect.

Failure to comply with these Terms of Use may, at any time, result in Your Profile being suspended or terminated.

Communications from the Department via the Health Products Portal

The Department may communicate with Your Organisation regarding Your submissions/applications or actions resulting from the Department's assessment of Your submissions/applications via the Health Products Portal. This may include corresponding with You regarding:

1. the assessment of Your submissions/applications, including seeking clarification of any Material submitted; and
2. any action or proposed action under law relating to Your submissions/applications (including the proposed form of a document or instrument to be made under a law).

Your Obligations

Authorised use of myGovID

You must:

1. only access the Health Products Portal using a valid myGovID; and
2. comply with any terms and conditions applicable to Your use of the myGovID.

Confirmation of identity

You confirm that Your individual identification details submitted on the Health Products Portal registration page are true and correct and that You are not misrepresenting Your identity or registering on behalf of any other individual.

Lawful and appropriate use of Health Products Portal

You must:

1. only use the Health Products Portal for Your own lawful purposes, in accordance with these Terms of Use or any other conditions notified by the Department on the Health Products Portal, and in a manner that does not infringe the Intellectual Property Rights of, or restrict or inhibit the use of the Health Products Portal by, any third party;
2. not attempt to undermine the security or integrity of the Health Products Portal;
3. not attempt to gain unauthorised access to any Materials other than those submitted by You, or to which You have been given express permission by the Department;
4. immediately notify the Department of any unauthorised use of Your Profile or any other breach of security and take all other actions that the Department reasonably deems necessary to maintain or enhance the security of the Health Products Portal;
5. maintain and ensure Your Profile registration and authentication details are true, accurate, current and correct;
6. not use, or misuse the Health Products Portal in any way which may disrupt or impair the functionality of the Health Products Portal or other systems used for the Health Products Portal; and
7. not transmit, or input via the Health Products Portal, any:
   • harmful code or malware;
   • unlawful, defamatory, obscene, offensive or scandalous Material, or any Material that constitutes or encourages conduct that would contravene any law or which may harass or cause distress or inconvenience to any person; or
   • Material in violation of any Intellectual Property Rights or any laws that You do not have the right to use or transmit or input into the Health Products Portal.

Any Material (including attachments) submitted to the Health Products Portal that does not comply with these conditions may either be destroyed by the Department in its absolute discretion or their contents may not be considered or assessed for the purposes of the National Health Act 1953 (Cth). It is Your responsibility to ensure that any files uploaded comply with these conditions.

You acknowledge that Your access to, and use of, the Health Products Portal is subject to applicable Commonwealth legislation (including the Crimes Act 1914 (Cth), the  Criminal Code Act 1995 (Cth), the Privacy Act 1988 (Cth), the Health Insurance Act 1973 (Cth) and the National Health Act 1953 (Cth)), and that penalties may apply for misuse of information obtained from the Health Products Portal or disclosure of information contrary to law.

Your use of the Health Products Portal will be logged for the purpose of security and usage monitoring.

Intellectual Property

You are granted the right to access and use the Health Products Portal by the Department for the purposes of lodging Your submissions/applications and as otherwise expressly permitted in these Terms of Use.

Materials on the Health Products Portal may be protected by Intellectual Property Rights. You must not use any Material on the Health Products Portal for a purpose for which You do not have express permission from the Intellectual Property Rights owner. If You have any doubt as to Your right to use the Material, please contact its owner. The Department is not liable if You breach an owner's Intellectual Property Rights.

You grant (or will procure) a royalty-free, non-exclusive, non-transferrable licence (including a right of sub-licence) for the Department to use and reproduce the information and Material included in the submission/application solely for the purpose of the efficient operation of the Pharmaceutical Benefits Scheme (PBS).

You acknowledge and agree that the licence granted above does not limit or exclude any rights that the Department is entitled to exercise at law in relation to the Material.

Indemnification, liability and termination

You remain solely responsible for complying with all applicable laws in connection to Your use of the Health Products Portal. It is Your responsibility to check that storage of, transfer and access to the Materials You transmit or input via the Health Products Portal will comply with all laws applicable to You.

You indemnify the Department for any loss or expense incurred by the Department in dealing with any claim against it, including legal costs and expenses on a solicitor/own client basis and the cost of time spent, resources used or disbursements paid by the Department, arising from either:

1. a breach by You of these Terms of Use; or
2. an act or omission involving fault on Your part in connection with these Terms of Use.

Your liability to indemnify the Department under these Terms of Use will be reduced proportionately to the extent that any negligent or other tortious act or omission of the Department contributed to the relevant loss or damage.

If You:

1. breach any of these Terms of Use or conditions posted by the Department on the Health Products Portal; or
2. engage in misleading, deceptive, fraudulent, immoral or illegal conduct,

the Department may, without limiting its rights, terminate Your access to the Health Products Portal or suspend for any period of time Your use of the Health Products Portal. The Department reserves the right to pursue legal action.

Collection of Your personal information and privacy obligations

The Department may collect, use and disclose personal information about You or about third parties that You input or transmit via the Health Products Portal for the purpose of administering the Health Products Portal.

The Department will handle the personal information in accordance with the Privacy Act 1988 (Cth) and the Australian Privacy Principles.

Collection notice for Registration stage

Your personal information is protected by law, including the Privacy Act 1988 (Cth) and the Australian Privacy Principles, and is being collected by the Department for the purposes of Your Organisation applying to list a medicine on the PBS (PBS application).

If You do not provide this information, Your Organisation will be unable to lodge and manage a PBS application.

Personal information about You collected by the Health Products Portal may be disclosed to other Users associated with Your Organisation, including Organisation Agents.

You can get more information about the way in which the Department will manage Your personal information, including the Department's privacy policy, see  Privacy when using the Department of Health's Health Products Portal (HPP) .

If You disclose other people's personal information to the Department via the Health Products Portal, You warrant to the Department that:

1. the people to whom the personal information relates have consented to the Department collecting, using and disclosing their personal information as described in the Department's collection notice, see  Privacy when using the Department of Health's Health Products Portal (HPP) ; and
2. You have drawn to those people's attention that collection notice.

Disclaimers

You agree that Your use of the Health Products Portal is entirely at Your own risk, and You have made Your own assessment on the risk of use of the Health Products Portal and any Materials on the Health Products Portal.

You accept and agree that You are authorised and responsible for any submissions/applications made to the Health Products Portal using Your Profile. The Department is not liable or legally responsible for any of the submissions/applications You make using Your Profile.

The Department may at any time change the content, including removal of any Materials held in the Health Products Portal at its discretion and without notice.

You agree that Material You transmit or input via the Health Products Portal may be accessed by other Users who are permitted access to the Material by the Department for the purposes of processing submissions/applications, or operating and administering the Health Products Portal. You are responsible for all risks relating to access by Users to Material You transmit or input via the Health Products Portal before using the Health Products Portal.

The Materials communicated or made available to You on the Health Products Portal may include information relating to third parties which has been made available to You for a specific purpose with the consent of that third party. Penalties may apply for misuse or unauthorised disclosure of this information.

The Materials on the Health Products Portal may include the views or recommendations of third parties and do not necessarily reflect the views of the Australian Government or indicate a commitment to a particular course of action.

The Department gives no warranty in connection with the Health Products Portal and its Materials and cannot guarantee that the use of the Health Products Portal and its Materials will not breach Intellectual Property Rights, will be uninterrupted or error free that defects will be corrected, or that the Health Products Portal is free of harmful code.

To the maximum extent permitted by law, the Department excludes all liability and responsibility to You (or any other person) for any loss (including loss of information, data, profits and savings) or damage resulting, directly or indirectly, in connection from Your (or any other person's) use of or reliance on, the Health Products Portal or its Materials.

Where connection to a system or website outside the Department's control compromises the objectives of the Health Products Portal, the Department may sever links to that website or system.

The Health Products Portal is hosted in a cloud environment and has been designed to meet relevant requirements under the Australian Government Protective Security Policy Framework and the Information Security Manual. However, You acknowledge that the Department does not give any representation or warranty that the Health Products Portal or any underlying environment or platform is secure or meets a particular security standard.

You accept that any information provided to You or Your Organisation about the progress of any application, through the Health Products Portal, may be subject to change. Any such information provided to You or Your Organisation remains confidential and must not be disclosed by You or Your Organisation.

You accept that any information provided to You or Your Organisation about the market share information of a third party with the consent of that third party may only be used for the purpose of calculating and verifying reimbursement amounts under a risk share arrangement. Any such information provided to You or Your Organisation remains confidential and must not be disclosed by You or Your Organisation.

General

These Terms of Use are governed by the laws of the Australian Capital Territory, Australia, and You agree to submit to the exclusive jurisdiction of the courts of the Australian Capital Territory.

If any of these Terms of Use are held to be invalid, unenforceable or illegal for any reason, the remaining Terms of Use will continue in full force.

If either party waives any breach of these Terms of Use, this will not constitute a waiver of any other breach. No waiver will be effective unless made in writing.

Declaration when lodging a submission within the Health Products Portal

The below Declaration text is applicable when lodging one of the following submissions in the HPP:

• Pre-submission meeting request
• Intent to apply
• PBAC Submission
• Delete brand(s)

Declaration

You warrant that You, Your Organisation, and Your submission/application have complied and will continue to comply with the Terms of Use for the Health Products Portal as well as the additional conditions set out below.

You:

1. warrant that:
   • to the best of Your knowledge, the information contained in Your submission/application is true and accurate and that no other information that is relevant is known to You. Information that is relevant is that which may contradict or bring into doubt information given in the application or otherwise influence the PBAC’s consideration of the effectiveness, cost or safety of the medicine in comparison with other treatments;
   • if at any time after the submission/application is made and even after a pharmaceutical benefit is listed on the PBS You or Your Organisation  become aware of any information which may, if known at the time of the PBAC’s assessment, have negatively impacted the PBAC’s assessment of the effectiveness, cost or safety of the medicine in comparison with other treatments (that is the information is adverse to the value proposition of the medicine), that information will be provided to the Department;
2. understand that a copy of the Material lodged in Your submission/application will be available for You to download after lodgement;
3. will ensure that Your submission/application or draft submission/application does not include any personal information for the purposes of the Privacy Act 1988 (Cth) other than the name and contact details of the primary contact and other nominated contacts for Your submission/application for which You have obtained consent to provide;
4. understand that, if any other personal information is included in attachments in support of Your submission/application, the personal information must be provided with the consent of the individual, and evidence of consent must be provided to the Department upon request;
5. warrant that:
   • to the best of Your knowledge, the information contained in Your submission/application is true and accurate;
   • Your submission/application complies with the following file size upload limits:
   • 15GB; and
   • You understand that non-compliance with these limits may mean the Department may not be able to accept Your submission/application;
6. accept and agree that You are responsible for any submissions/applications made to the Health Products Portal by Your Organisation. The Department is not liable or legally responsible for any of the submissions/applications You make using Your Profile. Your Organisation retains ownership of the submission/application and its contents;
7. acknowledge that, if You make a submission/application for an Organisation without quoting an ABN, the Organisation may be requested to provide an ABN or it may be required to register for an ABN to progress consideration of the submission/application.

Submission/application fees

You acknowledge that if You lodge an submission/application, Your Organisation may be required to pay fees in accordance with the National Health Act 1953 (Cth) and the National Health (Pharmaceuticals and Vaccines – Cost Recovery) Amendment (Fees) Regulations 2022 (Cth). There may be consequences if any fees are not paid.

The following link directs You to information regarding the fees applicable to submissions/applications.

 

The below Declaration text is applicable when lodging one of the following submissions in the HPP:

• List management service request
• New brand

Declaration

You warrant that You, Your Organisation, and Your submission/application have complied and will continue to comply with the  Terms of Use for the Health Products Portal as well as the additional conditions set out below.

You:

1. understand that a copy of the Material lodged in Your submission/application will be available for You to download after lodgement;
2. will ensure that Your submission/application or draft submission/application does not include any personal information for the purposes of the Privacy Act 1988 (Cth) other than the name and contact details of the primary contact and other nominated contacts for Your submission/application for which You have obtained consent to provide;
3. understand that, if any other personal information is included in attachments in support of Your submission/application, the personal information must be provided with the consent of the individual, and evidence of consent must be provided to the Department upon request;
4. declare that:
   • to the best of Your knowledge, the information contained in Your submission/application is true and accurate and that no other information that is relevant to the listing of the health product is known to you;
   • Your submission/application complies with the following file size upload limits:
   • 50MB; and
   • You understand that non-compliance with these limits may mean the Department may not be able to accept Your submission/application;
5. accept and agree that You are responsible for any submissions/applications made to the Health Products Portal by Your Organisation. The Department is not liable or legally responsible for any of the submissions/applications You make using Your Profile. Your Organisation retains ownership of the submission/application and its contents;
6. acknowledge that, if You make a submission/application for an Organisation without quoting an ABN, the Organisation may be requested to provide an ABN or it may be required to register for an ABN to progress consideration of the submission/application.
7. accept and agree that Your Organisation is the Responsible Person within the meaning of the National Health Act 1953 (Cth) and will be the supplier of the brands of pharmaceutical items to wholesalers or, in the case where wholesalers are not involved, to approved pharmacists directly, in accordance with the obligations imposed on Responsible Persons under that Act.
8. accept and agree that Your authority to act on behalf of Your Organisation extends to all of the obligations imposed on Responsible Persons under the National Health Act 1953 (Cth) (including in relation to price negotiation and agreements, price disclosure, guarantee of supply and change of Responsible Person details).
9. accept and agree that, where a Summary of Changes (SoC) is provided to You 'under embargo' for any additions or changes to health products for Your Organisation, You:
   • will not publicly release this information before the effective date of the Schedule of Pharmaceutical Benefits;
   • may undertake limited distribution of this information to finalise materials to allow availability and prescribing of the product on the effective listing date.
10. accept and agree that 'under embargo' requirements also extend to any general correspondence between You and the Department pertaining to health products. Any persons this information is released to must also follow the 'under embargo' requirements.
11. acknowledge that the price specified in the 'Price for Agreement or Determination' for all proposed listings contained in Your submission/application is an offer only and will be used by the Minister to consider making a price agreement under the National Health Act 1953 (Cth), the decision on which will be communicated to Your Organisation separately.
12. accept and agree that sufficient stock of the health product to meet demand will be available to allow for delivery to PBS dispensers (e.g. pharmacies, hospitals or other dispensers) in time for the effective listing date.

Submission/application fees

You acknowledge that if You lodge an submission/application, Your Organisation may be required to pay fees in accordance with the National Health Act 1953 (Cth) and the National Health (Pharmaceuticals and Vaccines – Cost Recovery) Amendment (Fees) Regulations 2022 (Cth). There may be consequences if any fees are not paid.

The following link directs You to information regarding the fees applicable to submissions/applications.
http://www.pbs.gov.au/info/industry/listing/elements/fees-and-charges

Privacy when using the Department of Health's Health Products Portal

The Australian Government Department of Health (Department) is bound by the Privacy Act 1988 and the Australian Privacy Principles (APPs).

The Department is collecting this personal information about You to create a Health Products Portal (Portal) User Profile and to associate You with an Organisation (Your Organisation). Associated Users and Organisation Agents can use the Health Products Portal to apply on behalf of an Organisation to list a medicine on the  Pharmaceutical Benefits Scheme ( PBS application).

The Department may also collect Your personal information from another person, with Your prior consent, as part of:

• registering an Organisation;
• inviting You to associate with an Organisation;
• nominating You as a contact person in a submission/application;
• appointing You as an Organisation Agent; and/or
• managing Your roles and permissions for an Organisation.

If Your Organisation applies to list a medicine on the PBS, the collection of personal information, including the name and contact details of Your Organisation’s responsible person is required by the National Health (Pharmaceuticals and Vaccines — Cost Recovery) Regulations 2022 .

If You do not provide information to enable the creation of a User Profile,  Organisation registration, Organisation association or submission/application, Your  Organisation will be unable to lodge and manage a PBS application. 

Where You are associated with an Organisation, the Department may disclose personal information about You related to Your use of the Health Products Portal to other Users associated with the Organisation, including the Organisation Agent. This includes disclosure of Your name and email address, and details of submissions/applications that You are currently drafting or have previously made.

Upon request, the Department may disclose to Your Organisation’s Administrator information in audit logs relating to Your use of the Health Products Portal connected with the Organisation.

The Department is unlikely to disclose Your personal information to overseas recipients. If Your Organisation or Organisation Agent is based overseas, the Department will only disclose Your personal information to these bodies with Your express consent.

The Department has an APP privacy policy. You can obtain a copy of the APP privacy policy by contacting the Department using the contact details set out at the end of this notice.  The APP privacy policy contains information about:

• how You may access the personal information the Department holds about You and how You can seek correction of it; and
• how You may complain about a breach of
• the APPs; or
• a registered APP code that binds the Department; and
• how the Department will deal with such a complaint.

You can contact the Department by telephone on (02) 6289 1555 or freecall 1800 020 103 or by using the online enquiries form on the  Health website.