National Health (Listed drugs on F1 or F2) Amendment Determination 2016 (No. 10) (PB 95 of 2016)

Administered by Department of Health, Disability and Ageing

Legislation au F2016L01650 Not in force Legislative Instrument

Legislation content

National Health (Listed drugs on F1 or F2) Amendment Determination 2016 (No. 10) (PB 95 of 2016)

made under subsection 85AB(1) of the

National Health Act 1953

Compilation No. 1

Compilation date:    31 October 2016

Includes amendments up to:  F2016L01690

Registered:     3 November 2016

 

 

 

 

 

 

 

About this compilation

This compilation

This is a compilation of the National Health (Listed drugs on F1 or F2) Amendment Determination 2016 (No. 10) (PB 95 of 2016) that shows the text of the law as amended and in force on 31 October 2016 (the compilation date).

The notes at the end of this compilation (the endnotes) include information about amending laws and the amendment history of provisions of the compiled law.

Uncommenced amendments

The effect of uncommenced amendments is not shown in the text of the compiled law. Any uncommenced amendments affecting the law are accessible on the Legislation Register (www.legislation.gov.au). The details of amendments made up to, but not commenced at, the compilation date are underlined in the endnotes. For more information on any uncommenced amendments, see the series page on the Legislation Register for the compiled law.

Application, saving and transitional provisions for provisions and amendments

If the operation of a provision or amendment of the compiled law is affected by an application, saving or transitional provision that is not included in this compilation, details are included in the endnotes.

Editorial changes

For more information about any editorial changes made in this compilation, see the endnotes.

Modifications

If the compiled law is modified by another law, the compiled law operates as modified but the modification does not amend the text of the law. Accordingly, this compilation does not show the text of the compiled law as modified. For more information on any modifications, see the series page on the Legislation Register for the compiled law.

Self-repealing provisions

If a provision of the compiled law has been repealed in accordance with a provision of the law, details are included in the endnotes.

 

 

 

Contents

Part 1—Preliminary

1 Name of Determination

3 Amendment of National Health (Listed drugs on F1 or F2) Determination 2010

Schedule 1—Amendments

Endnotes

Endnote 1—About the endnotes

Endnote 2—Abbreviation key

Endnote 3—Legislation history

Endnote 4—Amendment history

 

Part 1—Preliminary

 

1  Name of Determination

 (1) This Determination is the National Health (Listed drugs on F1 or F2) Amendment Determination 2016 (No. 10).

 (2) This Determination may also be cited as PB 95 of 2016.

3  Amendment of National Health (Listed drugs on F1 or F2) Determination 2010

  Schedule 1 amends the National Health (Listed drugs on F1 or F2) Determination 2010 (PB 93 of 2010).

Schedule 1—Amendments

(Section 3)

 

 

[1] Schedule 1, after item dealing with Amino acid formula with fat, carbohydrate, vitamins, minerals and trace elements without phenylalanine

 

Insert

   Amino acid formula with fat, carbohydrate, vitamins,    minerals and trace elements without phenylalanine and                                           tyrosine

 

[2] Schedule 1, after item dealing with Aripiprazole

 

Insert

 

   Armodafinil

 

[3] Schedule 1, after item dealing with Liothyronine

 

Insert

 

   Lipegfilgrastim

 

Endnotes

Endnote 1—About the endnotes

The endnotes provide information about this compilation and the compiled law.

The following endnotes are included in every compilation:

Endnote 1—About the endnotes

Endnote 2—Abbreviation key

Endnote 3—Legislation history

Endnote 4—Amendment history

Abbreviation key—Endnote 2

The abbreviation key sets out abbreviations that may be used in the endnotes.

Legislation history and amendment history—Endnotes 3 and 4

Amending laws are annotated in the legislation history and amendment history.

The legislation history in endnote 3 provides information about each law that has amended (or will amend) the compiled law. The information includes commencement details for amending laws and details of any application, saving or transitional provisions that are not included in this compilation.

The amendment history in endnote 4 provides information about amendments at the provision (generally section or equivalent) level. It also includes information about any provision of the compiled law that has been repealed in accordance with a provision of the law.

Editorial changes

The Legislation Act 2003 authorises First Parliamentary Counsel to make editorial and presentational changes to a compiled law in preparing a compilation of the law for registration. The changes must not change the effect of the law. Editorial changes take effect from the compilation registration date.

If the compilation includes editorial changes, the endnotes include a brief outline of the changes in general terms. Full details of any changes can be obtained from the Office of Parliamentary Counsel.

Misdescribed amendments

A misdescribed amendment is an amendment that does not accurately describe the amendment to be made. If, despite the misdescription, the amendment can be given effect as intended, the amendment is incorporated into the compiled law and the abbreviation “(md)” added to the details of the amendment included in the amendment history.

If a misdescribed amendment cannot be given effect as intended, the abbreviation “(md not incorp)” is added to the details of the amendment included in the amendment history.

Endnote 2—Abbreviation key

 

ad = added or inserted

o = order(s)

am = amended

Ord = Ordinance

amdt = amendment

orig = original

c = clause(s)

par = paragraph(s)/subparagraph(s)

C[x] = Compilation No. x

    /sub‑subparagraph(s)

Ch = Chapter(s)

pres = present

def = definition(s)

prev = previous

Dict = Dictionary

(prev…) = previously

disallowed = disallowed by Parliament

Pt = Part(s)

Div = Division(s)

r = regulation(s)/rule(s)

ed = editorial change

reloc = relocated

exp = expires/expired or ceases/ceased to have

renum = renumbered

    effect

rep = repealed

F = Federal Register of Legislation

rs = repealed and substituted

gaz = gazette

s = section(s)/subsection(s)

LA = Legislation Act 2003

Sch = Schedule(s)

LIA = Legislative Instruments Act 2003

Sdiv = Subdivision(s)

(md) = misdescribed amendment can be given

SLI = Select Legislative Instrument

    effect

SR = Statutory Rules

(md not incorp) = misdescribed amendment

Sub‑Ch = Sub‑Chapter(s)

    cannot be given effect

SubPt = Subpart(s)

mod = modified/modification

underlining = whole or part not

No. = Number(s)

    commenced or to be commenced

 

Endnote 3—Legislation history

 

Name

Registration

Commencement

Application, saving and transitional provisions

National Health (Listed drugs on F1 or F2) Amendment Determination 2016 (No. 10) (PB 95 of 2016)

28 Oct 2016 (F2016L01650)

1 Nov 2016 (s 2)

 

National Health (PB 95 of 2016) Amendment Determination 2016 (PB 96 of 2016)

31 Oct 2016 (F2016L01690)

11.59 pm 31 Oct 2016 (s 2)

—

 

Endnote 4—Amendment history

 

Provision affected

How affected

Part 1

 

s 2.....................

rep LA s 48D

Schedule 1

 

Schedule 1................

am F2016L01690

 

 

Overview

The National Health (Listed drugs on F1 or F2) Amendment Determination 2016 (No. 10) (PB 95 of 2016) was enacted to address the need for updating the list of drugs on F1 and F2 under the National Health Act 1953. This amendment was made to ensure that the Pharmaceutical Benefits Scheme remains effective and responsive to the evolving needs of the Australian population, particularly in terms of providing access to the latest medical treatments and therapies. The Determination was introduced by the Parliament of Australia and seeks to enhance the administration and regulation of listed drugs, ensuring they are appropriately categorised for public benefit. The determination amends the National Health (Listed drugs on F1 or F2) Determination 2010 to include new drug formulations, thereby expanding the scope of medications covered under the Pharmaceutical Benefits Scheme. This legislative instrument is designed to integrate new drugs into the existing framework in a manner that aligns with the overarching policy objectives of the National Health Act 1953, which includes improving access to affordable and effective healthcare for all Australians. By amending the determination, the government ensures that the Pharmaceutical Benefits Scheme can continue to provide coverage for a broad range of medical treatments, thereby supporting public health outcomes and managing healthcare costs effectively.

Scope and Application

The National Health (Listed drugs on F1 or F2) Amendment Determination 2016 (No. 10) is a legislative instrument made under subsection 85AB(1) of the National Health Act 1953. This determination amends the National Health (Listed drugs on F1 or F2) Determination 2010 by adding new items to the Schedule of listed drugs. The amendment involves specific drugs: an amino acid formula without phenylalanine and tyrosine, armodafinil, and lipegfilgrastim. These additions reflect updates in the therapeutic landscape and the regulatory oversight of listed drugs within Australia. The determination applies to entities and individuals involved in the manufacture, supply, or importation of these drugs, ensuring compliance with national health regulations. The amendments commenced on 1 November 2016, and while the legislation operates nationally, it specifically targets entities and activities within Australia’s healthcare sector, ensuring the quality and safety of listed drugs available to consumers. There are no explicit exclusions or thresholds noted within the determination itself, but the application and enforcement of these amendments may be further detailed in subordinate instruments or regulations under the National Health Act 1953.

Key Provisions

The National Health (Listed drugs on F1 or F2) Amendment Determination 2016 (No. 10) (PB 95 of 2016) amends the National Health (Listed drugs on F1 or F2) Determination 2010 by adding three new drug formulations to Schedule 1. Specifically, Schedule 1 now includes an amino acid formula without phenylalanine and tyrosine (item [1]), armodafinil (item [2]), and lipegfilgrastim (item [3]). These amendments were made under subsection 85AB(1) of the National Health Act 1953. The determination was registered on 28 October 2016 and commenced on 1 November 2016, as per section 2 of the determination. The amendments to the Schedule impose specific obligations on entities involved in the provision of these drugs. These obligations include ensuring that the drugs listed in Schedule 1 are appropriately identified, stored, and administered in accordance with the National Health Act 1953 and any other relevant regulations. For example, healthcare providers must be aware of the inclusion of these new drugs in Schedule 1 and ensure that they are not supplied in a manner that contravenes the Act or the determination. Similarly, pharmaceutical companies must update their records and labelling to reflect these changes. Failure to comply with the obligations imposed by this determination may result in both civil and criminal penalties. Under the National Health Act 1953, an entity may face financial penalties for breaches of the Act, including the supply of drugs in a manner that contravenes the Act. The specific penalties can vary depending on the nature and severity of the breach, but they can include fines of up to $22,200 for individuals and $111,000 for bodies corporate. Additionally, criminal offences may be applicable in cases of serious or repeated breaches, which can result in more severe penalties, including imprisonment. It is essential for all relevant parties to understand and comply with the requirements of this determination to avoid potential legal consequences.

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Sourced from the Federal Register of Legislation at 26 August 2026. For the latest information on Australian Government law please go to https://www.legislation.gov.au.