Shortened forms and definitions
|ATAGI||Australian Technical Advisory Group on Immunisation|
|AUSFTA||Australia – United States Free Trade Agreement|
|department||Australian Government Department of Health and Aged Care|
|DUSC||Drug Utilisation Sub-Committee|
|HTA||health technology assessment|
|HTAAP||Health Technology Assessment Access Point|
|MAP||Managed Access Program|
|MBD||Medical Benefits Division|
|MSAC||Medical Services Advisory Committee|
|NIP||National Immunisation Program|
|NPWP||Nutritional Products Working Party|
|OHTA||Office of Health Technology Assessment|
|PBAC||Pharmaceutical Benefits Advisory Committee|
|PBS||Pharmaceutical Benefits Scheme|
|PSD||Public Summary Document|
|RPBS||Repatriation Pharmaceutical Benefits Scheme|
|SPA||special pricing arrangement|
|TAAD||Technology Assessment and Access Division|
|TGA||Therapeutic Goods Administration|
‘Applicant’ refers to the individual or organisation who is responsible for preparing the PBAC submission. The applicant may be a pharmaceutical company responsible for the medicinal product/pharmaceutical item and/or an organisation or individual supporting the preparation of the PBAC submission.
Any day that is not a Saturday or Sunday and is not a national public holiday. If a national public holiday falls on a Saturday or Sunday, and the public holiday is observed by all Australian states and territories on a Monday to Friday in lieu of the day, this day is also considered a national public holiday.
Health Products Portal
The Health Products Portal (HPP) is an online system for each applicant to interact with the department to manage PBAC/PBS processes. The HPP can be accessed via the PBS website, in the ‘for Industry’ section. The HPP is being built and released progressively in phases. The HPP website details which functions are available via the HPP.
Medicine refers to a therapeutic good that is represented to achieve, or is likely to achieve, its principal intended action by pharmacological, chemical, immunological or metabolic means in or on the body of a human. Medicine and drug are interchangeable in this procedure guidance (TGA definition can be viewed on the TGA website). At times Medicine is appropriately read in the context of this guide to include Medicinal Product, or pharmaceutical item.
A product containing a medicine. Medicinal products are also known as pharmaceutical products. The medicinal product is listed on the PBS Schedule. This refers to the brand named product (usually the Trade Product Pack in the Australian Medicines Terminology). Ready prepared Medicinal Products are generally referred to in the National Health Act 1953 as a brand of pharmaceutical item or pharmaceutical benefit.
This is the legal concept of pharmaceutical item, as defined in section 84AB of the National Health Act 1953. It is the the drug, form and manner of administration as set out in the main listing instrument for the PBS (currently known as the National Health (Listing of Pharmaceutical Benefits) Instrument which is located on the Federal Register of Legislation). For example, drugX, tablet 20 mg, oral would be a pharmaceutical item and BrandA of drugX, tablet 20 mg, oral would be a brand of pharmaceutical item.
A responsible person for a brand of a pharmaceutical item is defined in section 84AF of the National Health Act 1953 and stated below.
- 1) The Minister may, by legislative instrument, determine that a person is the responsible person for a brand of a pharmaceutical item if:
- a) the person notified the Minister that the person is or will be the supplier of the brand of the pharmaceutical item to:
- i) wholesalers; or
- ii) in the case of a supply where wholesalers are not involved—approved pharmacists directly; and
- b) the brand of the pharmaceutical item is a listed brand; and
- c) there is no determination in force under this section that another person is the responsible person for:
- i) the brand of the pharmaceutical item; or
- ii) the brand of any other pharmaceutical item.
- 2) The notification referred to in paragraph (1)(a) may be made before or after the commencement of this section.
Submission due day
Submission due day is the date which the Department needs to have received applications for a specified evaluation category for the Committee meeting that is to consider that application. The submission due day for applications in one evaluation category could be different from that for applications in another evaluation category.