Shortened forms and definitions
|ATAGI||Australian Technical Advisory Group on Immunisation|
|AUSFTA||Australia – United States Free Trade Agreement|
|department||Australian Government Department of Health|
|DUSC||Drug Utilisation Sub-Committee|
|HTA||health technology assessment|
|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|
The sponsor of a submission seeking listing on the PBS. ‘Sponsor’ is used interchangeably for the following – a pharmaceutical company sponsoring the TGA application or marketing the product in Australia, and an organisation or individual supporting the preparation of a submission. Sponsors are also referred to as responsible persons in the National Health Act 1953 and Regulations in relation to price agreements and listed products.
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.