Health Products Portal - Terms and Conditions
Page last updated: 11 October 2019
- 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.
- ‘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.
- ‘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).
- ‘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.
- ‘Material’ means any thing:
- lodged by a User into the Health Products Portal; or
- communicated by the Department via the Health Products Portal, and includes any such thing in which Intellectual Property Rights arise.
- ‘Organisation’ means the industry or representative body that undertakes business or transacts with the Department relating to health products with which You are associated.
- ‘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);
- 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);
- assign draft submissions/applications to an Organisation Agent; and
- remove an Organisation Agent’s access to draft submission/applications.
- ‘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 to which they have been granted access (i.e. they cannot see all other draft submissions/applications related to that Organisation). 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.
- ‘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. 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.
- ‘Profile’ means Your online registered account to use the Health Products Portal.
- ‘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.
Authorised use of AUSkey
- only access the Health Products Portal using a valid AUSkey; and
- comply with any terms and conditions applicable to Your use of the AUSkey.
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
- not attempt to undermine the security or integrity of the Health Products Portal;
- 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;
- 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;
- maintain and ensure Your Profile registration and authentication details are true, accurate, current and correct;
- 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
- 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.
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 making an assessment of Your submission/application You lodge in the Health Products Portal.
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:
- 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 Pharmaceutical Benefits Scheme (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.
If You disclose other people’s personal information to the Department via the Health Products Portal, You warrant to the Department that:
- 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
- You have drawn to those people’s attention that collection notice.
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 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.
Declaration when lodging a submission within the HPP
- understand that a copy of the Material lodged in Your submission/application will be available for You to download after lodgement;
- 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;
- 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;
- 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:
- 120MB; and
- You understand that non-compliance with these limits may mean the Department may not be able to accept Your submission/application;
- 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;
- 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.
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) Regulations 2009 (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 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 associate with an organisation (your organisation). Associated users and organisation agents can use the 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 2009.
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 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 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.
- 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 at www.health.gov.au.