National Health (IVF Program) Special Arrangement 2025

Administered by Department of Health, Disability and Ageing

Legislation au F2025L01180 In force Legislative Instrument

Legislation content

National Health (IVF Program) Special Arrangement 2025

PB 113 of 2025

made under sections 99 and 100 of the

National Health Act 1953

Compilation No. 2

Compilation date: 1 July 2026

Includes amendments: F2026L00801

About this compilation

This compilation

This is a compilation of the National Health (IVF Program) Special Arrangement 2025 that shows the text of the law as amended and in force on 1 July 2026 (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. The details of amendments made up to, but not commenced at, the compilation date are underlined in the endnotes. Any uncommenced amendments affecting the law are accessible on the Register (www.legislation.gov.au).

Application, saving and transitional provisions

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.

Presentational changes

The Legislation Act 2003 provides for First Parliamentary Counsel to make presentational changes to a compilation. Presentational changes are applied to give a more consistent look and feel to legislation published on the Register, and enable the user to more easily navigate those documents.

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. Any modifications affecting the law are accessible on the Register.

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If a provision of the compiled law has been repealed in accordance with a provision of the law, details are included in the endnotes.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

Division 1—General

1 Name

3 Authority

5 Simplified outline

6 Definitions

Division 2—Special arrangement supplies from hospitals

7 Special arrangement supplies by approved hospital authorities to patients receiving treatment from hospitals

Part 2—Payment for special arrangement supplies of IVF pharmaceutical benefits

Division 1—Supplies by approved hospital authorities for public hospitals

8 Rates of payment for approved hospital authorities for public hospitals

9 Dispensed price for approved hospital authorities for public hospitals

Division 2—Supplies by other approved suppliers

10 Entitlement to, and amount of, payment for approved pharmacists and approved medical practitioners

11 Rates of payment for approved hospital authorities for private hospitals

12 Dispensed price for approved suppliers other than approved hospital authorities for public hospitals

13 Markup for readyprepared pharmaceutical benefits

14 Dispensing fee

Part 3—Supply to CTG registered patients

15 Application of the CTG Special Arrangement—copayment and payment etc.

Part 4—Claims for payment

16 Claims for payment for supply of benefits

Part 5—Application, saving and transitional provisions

Division 1—Provisions relating to this instrument as made

17 Things done under the National Health (IVF Program) Special Arrangement 2015

Schedule 1—IVF pharmaceutical benefits

Endnotes

Endnote 1—About the endnotes

Endnote 2—Abbreviation key

Endnote 3—Legislation history

Endnote 4—Amendment history

Endnote 5—Editorial changes

 

Part 1—Preliminary

Division 1—General

1  Name

 (1) This instrument is the National Health (IVF Program) Special Arrangement 2025.

 (2) This instrument may also be cited as PB 113 of 2025.

3  Authority

  This instrument is made under sections 99 and 100 of the National Health Act 1953.

5  Simplified outline

This instrument makes a special arrangement for, or in relation to, providing that an adequate supply of in vitro fertilisation (IVF) pharmaceutical benefits will be available to persons who are receiving IVF treatment from an accredited ART centre (short for accredited assisted reproductive technology centre).

IVF pharmaceutical benefits can only be supplied in accordance with this instrument on the basis of prescription by a medical practitioner practising for such a centre.

This instrument also deals with payments for supplies of IVF pharmaceutical benefits.

Note: Part VII of the Act, and regulations or other instruments made for the purposes of that Part, have effect subject to this instrument (see subsection 100(3) of the Act).

6  Definitions

Note 1: A number of expressions used in this instrument are defined in the Act, including the following:

(a) hospital;

(b) public hospital.

Note 2: Under subsection 4(1A) of the Act, a word or phrase used in the Act that is defined for the purposes of the Health Insurance Act 1973 has the meaning that it would have if used in that Act. Expressions used in this instrument that take their meaning from that Act include the following:

(a) medical practitioner;

(b) private hospital.

  In this instrument:

accredited ART centre has the same meaning as in Part 2 of the Research Involving Human Embryos Act 2002.

Act means the National Health Act 1953.

approved exmanufacturer price of a listed brand of a pharmaceutical item has the same meaning as in Part VII of the Act.

approved hospital authority has the same meaning as in Part VII of the Act.

approved medical practitioner has the same meaning as in Part VII of the Act.

approved pharmacist has the same meaning as in Part VII of the Act.

Approved Pharmacists Commonwealth Price Determination means the Commonwealth price (Pharmaceutical benefits supplied by approved pharmacists) Determination 2020.

approved supplier has the same meaning as in Part VII of the Act.

CTG registered patient has the same meaning as in the CTG Special Arrangement.

CTG Special Arrangement means the National Health (Closing the Gap—PBS Copayment Program) Special Arrangement 2026.

dispensed price:

 (a) for the special arrangement supply of an IVF pharmaceutical benefit by an approved hospital authority for a public hospital—has the meaning given by section 9; and

 (b) for the special arrangement supply of an IVF pharmaceutical benefit by any other approved supplier—has the meaning given by section 12.

IVF pharmaceutical benefit means a pharmaceutical benefit mentioned in Schedule 1.

listed brand of a pharmaceutical item has the same meaning as in Part VII of the Act.

maximum quantity: see subsection 13(5).

pack quantity of a listed brand of a pharmaceutical item has the same meaning as in Part VII of the Act.

pharmaceutical benefit has the same meaning as in Part VII of the Act.

pharmaceutical item has the same meaning as in Part VII of the Act.

price to pharmacists has the same meaning as in the Approved Pharmacists Commonwealth Price Determination.

proportional exmanufacturer price of a listed brand of a pharmaceutical item has the same meaning as in Part VII of the Act.

ready‑prepared dispensing fee has the same meaning as in the Approved Pharmacists Commonwealth Price Determination.

readyprepared pharmaceutical benefit has the same meaning as in the National Health (Listing of Pharmaceutical Benefits) Instrument 2024.

RTAC Accredited Unit number means the number by which the Reproductive Technology Accreditation Committee of the Fertility Society of Australia identifies a person or body as being an accredited ART centre.

special arrangement supply: a supply of an IVF pharmaceutical benefit is a special arrangement supply if the benefit is supplied:

 (a) to a person receiving in vitro fertilisation treatment from an accredited ART centre; and

 (b) on the basis of a prescription by a medical practitioner practising for such a centre.

Division 2—Special arrangement supplies from hospitals

7  Special arrangement supplies by approved hospital authorities to patients receiving treatment from hospitals

 (1) Despite section 94 of the Act, a hospital authority approved for the purpose of its supplying pharmaceutical benefits to patients receiving treatment in or at the hospital of which the hospital authority is the governing body or proprietor may also make special arrangement supplies of IVF pharmaceutical benefits to patients receiving treatment from that hospital.

 (2) In the application of Part VII of the Act, and regulations or other instruments made for the purposes of that Part, to special arrangement supplies of IVF pharmaceutical benefits, a reference to a person receiving treatment in or at a hospital is taken to include a reference to a person receiving treatment from the hospital.

Part 2—Payment for special arrangement supplies of IVF pharmaceutical benefits

Division 1—Supplies by approved hospital authorities for public hospitals

8  Rates of payment for approved hospital authorities for public hospitals

 (1) For the purposes of subsection 99(4) of the Act, the amount payable to an approved hospital authority for a public hospital in respect of a special arrangement supply of an IVF pharmaceutical benefit by the authority is the amount, if any, by which the dispensed price for the supply of the benefit exceeds the amount that the hospital authority was entitled to charge under section 87 of the Act in respect of the supply.

Note 1: Section 87 of the Act limits the amounts that approved hospital authorities can charge patients for the supply of pharmaceutical benefits.

Note 2: However, see Part 3 of this instrument in relation to the special arrangement supply of an IVF pharmaceutical benefit to a CTG registered patient.

 (2) This section applies despite the National Health (Commonwealth Price—Pharmaceutical Benefits Supplied By Public Hospitals) Determination 2017 (PB 25 of 2017).

Note: See subsection 99(4) of the Act (read with section 7 of this instrument) for the entitlement of an approved hospital authority to payment for the supply of pharmaceutical benefits to patients receiving treatment in, at or from a hospital in respect of which the authority is approved.

9  Dispensed price for approved hospital authorities for public hospitals

 (1) The dispensed price for a special arrangement supply of an IVF pharmaceutical benefit by an approved hospital authority for a public hospital is as follows:

 (a) if the quantity of the benefit supplied is equal to a multiple of a pack quantity of the benefit—the sum of the approved exmanufacturer price or the proportional exmanufacturer price (as applicable) for each pack quantity;

 (b) if the quantity of the benefit supplied is less than a pack quantity of the benefit (a broken quantity)—the amount worked out in accordance with subsection (2);

 (c) if neither paragraph (a) or (b) applies to the quantity of the benefit supplied—the sum of:

 (i) the approved exmanufacturer price or the proportional exmanufacturer price (as applicable) for each pack quantity; and

 (ii) the amount worked out in accordance with subsection (2) for the remainder of the quantity supplied that is less than a pack quantity.

Note: No markups may be added to the cost of a pharmaceutical benefit for which payment is claimed by an approved hospital authority for a public hospital.

Broken quantities

 (2) For the purposes of paragraph (1)(b) and subparagraph (1)(c)(ii), the amount for a broken quantity is worked out by:

 (a) dividing the quantity or number of units in the broken quantity by the pack quantity, expressed as a percentage to 2 decimal places; and

 (b) applying that percentage to the approved exmanufacturer price or proportional exmanufacturer price (as applicable) for the pack quantity.

Rounding

 (3) The dispensed price under subsection (1) is rounded to the nearest cent (rounding 0.5 cents upwards).

Division 2—Supplies by other approved suppliers

10  Entitlement to, and amount of, payment for approved pharmacists and approved medical practitioners

 (1) This section applies:

  (a) in relation to an approved pharmacist or an approved medical practitioner who has made a special arrangement supply of an IVF pharmaceutical benefit; and

 (b) subject to section 99AAA of the Act and the conditions determined under section 98C of the Act that are applicable at the time of the supply.

 (2) The approved pharmacist or approved medical practitioner is entitled to be paid by the Commonwealth the amount, if any, by which the dispensed price for the supply of the benefit exceeds the amount that the approved pharmacist or approved medical practitioner was entitled to charge under section 87 of the Act in respect of the supply.

Note 1: Section 87 of the Act limits the amounts that approved pharmacists and approved medical practitioners can charge patients for the supply of pharmaceutical benefits.

Note 2: However, see Part 3 of this instrument in relation to the special arrangement supply of an IVF pharmaceutical benefit to a CTG registered patient.

 (3) This section applies despite subsections 99(2) and (2AA) of the Act.

11  Rates of payment for approved hospital authorities for private hospitals

 (1) For the purposes of subsection 99(4) of the Act, the amount payable to an approved hospital authority for a private hospital in respect of a special arrangement supply of an IVF pharmaceutical benefit by the authority is the amount, if any, by which the dispensed price for the supply of the benefit exceeds the amount that the authority was entitled to charge under section 87 of the Act in respect of the supply.

Note 1: Section 87 of the Act limits the amounts that approved hospital authorities can charge patients for the supply of pharmaceutical benefits.

Note 2: However, see Part 3 of this instrument in relation to the special arrangement supply of an IVF pharmaceutical benefit to a CTG registered patient.

 (2) This section applies despite the National Health (Commonwealth Price ‑ Pharmaceutical benefits supplied by private hospitals) Determination 2020 (PB 99 of 2020).

Note: See subsection 99(4) of the Act (read with section 7 of this instrument) for the entitlement of an approved hospital authority to payment for the supply of pharmaceutical benefits to patients receiving treatment in, at or from a hospital in respect of which the authority is approved.

12  Dispensed price for approved suppliers other than approved hospital authorities for public hospitals

 (1) The dispensed price for a special arrangement supply of an IVF pharmaceutical benefit by an approved supplier other than an approved hospital authority for a public hospital is as follows:

 (a) if the quantity of the benefit supplied is equal to a multiple of a pack quantity of the benefit—the sum of:

 (i) the approved exmanufacturer price or the proportional exmanufacturer price (as applicable) for each pack quantity; and

 (ia) if the approved supplier is an approved pharmacist—the wholesale markup for a pack quantity of a readyprepared pharmaceutical benefit worked out in the table in section 11 of the Approved Pharmacists Commonwealth Price Determination for the approved exmanufacturer price or proportional exmanufacturer price (as applicable) for that pack quantity; and

 (ii) if the benefit is a readyprepared pharmaceutical benefit—the markup applicable under section 13 for each pack quantity, rounded to the nearest cent (rounding 0.5 cents upwards); and

 (iii) the readyprepared dispensing fee;

 (b) if the quantity of the benefit supplied is less than a pack quantity of the benefit (a broken quantity)—the sum of:

 (i) the amount worked out in accordance with subsection (2); and

 (ii) the readyprepared dispensing fee;

 (c) if neither paragraph (a) or (b) applies to the quantity of the benefit supplied—the sum of:

 (i) the approved exmanufacturer price or the proportional exmanufacturer price (as applicable) for each pack quantity; and

 (ia) if the approved supplier is an approved pharmacist—the wholesale markup for a pack quantity of a readyprepared pharmaceutical benefit worked out in the table in section 11 of the Approved Pharmacists Commonwealth Price Determination for the approved exmanufacturer price or proportional exmanufacturer price (as applicable) for that pack quantity; and

 (ii) if the benefit is a readyprepared pharmaceutical benefit—the markup applicable under section 13 for each pack quantity, rounded to the nearest cent (rounding 0.5 cents upwards); and

 (iii) the amount worked out in accordance with subsection (2) for the remainder of the quantity that is a broken quantity; and

 (iv) the readyprepared dispensing fee.

Broken quantities

 (2) For the purposes of subparagraphs (1)(b)(i) and (c)(iii), the amount for a broken quantity is worked out by:

 (a) dividing the quantity or number of units in the broken quantity by the pack quantity, expressed as a percentage to 2 decimal places; and

 (b) applying that percentage to the sum of:

 (i) the approved exmanufacturer price or the proportional exmanufacturer price (as applicable) for the pack quantity; and

 (ia) if the approved supplier is an approved pharmacist—the wholesale markup for a pack quantity of a readyprepared pharmaceutical benefit worked out in the table in section 11 of the Approved Pharmacists Commonwealth Price Determination for the approved exmanufacturer price or proportional exmanufacturer price (as applicable) for that pack quantity; and

 (ii) if the benefit is a readyprepared pharmaceutical benefit—the markup applicable under section 13 for the pack quantity, rounded to the nearest cent (rounding 0.5 cents upwards).

Rounding

 (3) The dispensed price under subsection (1) is rounded to the nearest cent (rounding 0.5 cents upwards).

13  Mark‑up for ready‑prepared pharmaceutical benefits

Approved suppliers other than approved pharmacists

 (1) Subsection (2) applies if an approved supplier is not an approved pharmacist.

 (2) For the purposes of subparagraphs 12(1)(a)(ii), (c)(ii) and 12(2)(b)(ii), the markup for a pack quantity of an IVF pharmaceutical benefit that is a readyprepared pharmaceutical benefit is:

 (a) if the pack quantity of the benefit is equal to the maximum quantity of the benefit—the amount mentioned in the following table for the approved exmanufacturer price (AEMP) or proportional exmanufacturer price (PEMP) (as applicable) for that quantity; or

 (b) if the pack quantity of the benefit is less than the maximum quantity of the benefit:

 (i) if the markup mentioned in the following table for the maximum quantity is a monetary amount—that monetary amount reduced proportionately for the relative quantities; or

 (ii) if the markup mentioned in the following table for the maximum quantity is a percentage of the AEMP or PEMP (as applicable)—that percentage of the AEMP or PEMP for the pack quantity.

 

Markup for readyprepared pharmaceutical benefits

Item

If the AEMP or PEMP (as applicable) for the maximum quantity is …

the markup for the maximum quantity is …

1

less than $40

10% of the AEMP or PEMP

2

at least $40 but not more than $100

$4

3

more than $100 but not more than $1,000

4% of the AEMP or PEMP

4

more than $1,000

$40

Approved pharmacists

 (3) Subsection (4) applies if an approved supplier is an approved pharmacist.

 (4) For the purposes of subparagraphs 12(1)(a)(ii), (c)(ii) and 12(2)(b)(ii), the markup for a pack quantity of a readyprepared pharmaceutical benefit is:

 (a) if the pack quantity of the benefit is equal to the maximum quantity of the benefit—the amount mentioned in the following table for the price to pharmacists (PTP) for that quantity; or

 (b) if the pack quantity of the benefit is less than the maximum quantity of the benefit:

 (i) if the markup mentioned in the following table for the maximum quantity is a monetary amount—that monetary amount reduced proportionately for the relative quantities; or

 (ii) if the markup mentioned in the following table for the maximum quantity is a percentage of the price to pharmacists—that percentage of the price to pharmacists for the pack quantity.

 

Markup for readyprepared pharmaceutical benefits

Item

If the PTP for the maximum quantity is …

the markup for the PTP is …

1

less than $40

10% of the PTP

2

at least $40 but not more than $100

$4

3

more than $100 but not more than $1,000

4% of the PTP

4

more than $1,000

$40

Note: See the definition of price to pharmacists in section 6.

 (5)  For the purposes of this section, the maximum quantity of a readyprepared pharmaceutical benefit having a pharmaceutical item is the maximum number of units of the pharmaceutical item that may, in one prescription, be directed to be supplied on any one occasion, as determined for the item under paragraph 85A(2)(a) of the Act.

Note: The National Health (Listing of Pharmaceutical Benefits) Instrument 2024, as in force on 1 October 2025, contains the determination of the maximum quantity of a readyprepared pharmaceutical benefit having a pharmaceutical item.

14  Dispensing fee

  If a medical practitioner practising for an accredited ART centre:

 (a) prescribes an IVF pharmaceutical benefit to a person receiving in vitro fertilisation treatment from the centre; and

 (b) instead of directing a repeated supply of the benefit, directs the supply on one occasion of a quantity or number of units of the benefit, not exceeding the total quantity or number of units that could be prescribed if the medical practitioner directed a repeated supply;

the dispensed price for the supply of the benefit includes only one dispensing fee.

Note: See section 49 of the National Health (Pharmaceutical Benefits) Regulations 2017 for the circumstances in which such a supply may be directed.

Part 3—Supply to CTG registered patients

 

15  Application of the CTG Special Arrangement—co‑payment and payment etc.

 (1) This section applies to a special arrangement supply of an IVF pharmaceutical benefit to a CTG registered patient.

 (2) Despite section 87 of the Act and sections 8, 10 and 11 of this instrument, subsections 10(1), (2), (3) and (10) (copayment reduction etc.), section 11 (value for safety net purposes) and section 12 (payment by Commonwealth) of the CTG Special Arrangement apply in relation to the special arrangement supply with the modification set out in subsection (3) of this section.

 (3) A reference in the CTG Special Arrangement to:

 (a) a special arrangement supply (within the meaning of the CTG Special Arrangement) of a pharmaceutical benefit is taken to be a reference to the special arrangement supply mentioned in subsection (1); and

 (b) a CTG supplier is taken to be a reference to the approved supplier who made the special arrangement supply mentioned in subsection (1).

 (4) However, the notes to subsections 10(2) and (3) of the CTG Special Arrangement do not apply in relation to the special arrangement supply mentioned in subsection (1).

Note: The notes to subsections 10(2) and (3) of the CTG Special Arrangement relate to suppliers making claims for payment under the CTG Special Arrangement. Claims for payment in relation to the special arrangement supply mentioned in subsection (1) are instead dealt with under section 16 of this instrument.

Part 4—Claims for payment

 

16  Claims for payment for supply of benefits

 (1) A claim for payment of an amount to which an approved supplier is entitled in respect of the special arrangement supply of an IVF pharmaceutical benefit must include:

 (a) the RTAC Accredited Unit number for the accredited ART centre for which the medical practitioner who prescribed the supply of the IVF pharmaceutical benefit was practising; and

 (b) an indicator that the supply was made to a CTG registered patient, if the claim is made:

 (i) in respect of a supply made to such a patient; and

 (ii) using the manual system referred to in section 99AAA of the Act.

 (2) This section has effect in addition to section 99AAA of the Act.

Part 5—Application, saving and transitional provisions

Division 1—Provisions relating to this instrument as made

17  Things done under the National Health (IVF Program) Special Arrangement 2015

 (1) If:

 (a) a thing was done for a particular purpose under the National Health (IVF Program) Special Arrangement 2015 as in force immediately before that instrument was repealed; and

 (b) the thing could be done for that particular purpose under this instrument;

the thing has effect for the purposes of this instrument as if it had been done for that particular purpose under this instrument.

 (2) Without limiting subsection (1), a reference in that subsection to a thing being done includes a reference to a supply of pharmaceutical benefits or claim for payment being made.

Schedule 1—IVF pharmaceutical benefits

Note: See the definition of IVF pharmaceutical benefit in section 6.

 

 

Listed Drug

Form

Manner of Administration

Brand

Cetrorelix

Powder for injection 250 micrograms (as acetate) with diluent

Injection

Cetrotide

Choriogonadotropin alfa

Solution for injection 250 micrograms in 0.5 mL prefilled pen

Injection

Ovidrel

Choriogonadotropin alfa

Solution for injection 250 micrograms in 0.5 mL prefilled syringe (S19A)

Injection

Ovidrel (USA)

Chorionic gonadotrophin

Injection set containing powder for injection 1,500 units, 3 and solvent 1 mL, 3 (s19A)

Injection

Brevactid 1500 I.E

Chorionic gonadotrophin

Powder for injection 5,000 units with solvent (s19A)

Injection

Choriomon 5000 I.E

Corifollitropin alfa

Solution for injection 100 micrograms in 0.5 mL single dose prefilled syringe

Injection

Elonva

Corifollitropin alfa

Solution for injection 150 micrograms in 0.5 mL single dose prefilled syringe

Injection

Elonva

Follitropin alfa

Injection 75 I.U. in 0.125 mL prefilled pen

Injection

Bemfola

Follitropin alfa

Injection 150 I.U. in 0.25 mL prefilled pen

Injection

Bemfola

Follitropin alfa

Injection 225 I.U. in 0.375 mL prefilled pen

Injection

Bemfola

Follitropin alfa

Injection 300 I.U. in 0.5 mL multidose cartridge

Injection

Gonalf Pen

Follitropin alfa

Injection 300 I.U. in 0.5 mL multidose cartridge

Injection

Ovaleap

Follitropin alfa

Injection 300 I.U. in 0.5 mL prefilled pen

Injection

Bemfola

Follitropin alfa

Injection 450 I.U. in 0.75 mL multidose cartridge

Injection

Gonalf Pen

Follitropin alfa

Injection 450 I.U. in 0.75 mL multidose cartridge

Injection

Ovaleap

Follitropin alfa

Injection 450 I.U. in 0.75 mL prefilled pen

Injection

Bemfola

Follitropin alfa

Injection 900 I.U. in 1.5 mL multidose cartridge

Injection

Gonalf Pen

Follitropin alfa

Injection 900 I.U. in 1.5 mL multidose cartridge

Injection

Ovaleap

Follitropin alfa with lutropin alfa

Injection 900 I.U. 450 I.U. in 1.44 mL multidose cartridge

Injection

Pergoveris

Follitropin beta

Solution for injection 300 I.U. in 0.36 mL multidose cartridge

Injection

Puregon 300 IU/0.36 mL

Follitropin beta

Solution for injection 600 I.U. in 0.72 mL multidose cartridge

Injection

Puregon 600 IU/0.72 mL

Follitropin beta

Solution for injection 900 I.U. in 1.08 mL multidose cartridge

Injection

Puregon 900 IU/1.08 mL

Follitropin delta

Injection 12 micrograms in 0.36 mL prefilled multidose pen

Injection

Rekovelle

Follitropin delta

Injection 36 micrograms in 1.08 mL prefilled multidose pen

Injection

Rekovelle

Follitropin delta

Injection 72 micrograms in 2.16 mL prefilled multidose pen

Injection

Rekovelle

Ganirelix

Injection 250 micrograms (as acetate) in 0.5 mL prefilled syringe

Injection

ARX Ganirelix

Ganirelix

Injection 250 micrograms (as acetate) in 0.5 mL prefilled syringe

Injection

Ganirelix Lupin

Ganirelix

Injection 250 micrograms (as acetate) in 0.5 mL prefilled syringe

Injection

GANIRELIX SUN

Ganirelix

Injection 250 micrograms (as acetate) in 0.5 mL prefilled syringe

Injection

Ganirelix Theramex

Ganirelix

Injection 250 micrograms (as acetate) in 0.5 mL prefilled syringe

Injection

Orgalutran

Human menopausal gonadotrophin

Powder for injection 600 I.U. with solvent

Injection

Menopur 600

Human menopausal gonadotrophin

Powder for injection 1,200 I.U. with solvent

Injection

Menopur 1200

Lutropin alfa

Powder for injection 75 I.U. with solvent

Injection

Luveris

Nafarelin

Nasal spray (pump pack) 200 micrograms (as acetate) per dose, 60 doses

Nasal

Synarel

Progesterone

Capsule 200 mg

Vaginal

Progesterone BNM 200

Progesterone

Capsule 200 mg

Vaginal

Utrogestan

Progesterone

Pessary 100 mg

Vaginal

Oripro

Progesterone

Pessary 200 mg

Vaginal

Oripro

Progesterone

Vaginal gel (prolonged release) 90 mg in single dose prefilled applicator

Vaginal

Crinone 8%

Progesterone

Vaginal tablet 100 mg

Vaginal

Endometrin

Triptorelin

Injection 100 micrograms (as acetate) in 1 mL prefilled syringe

Injection

Decapeptyl

Note: Each listed drug mentioned in the table has been declared by the Minister under subsection 85(2) of the Act. The form, manner of administration and brand mentioned in the table have been determined by the Minister under subsections 85(3), (5) and (6) of the Act respectively.

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 how an amendment is to be made. If, despite the misdescription, the amendment can be given effect as intended, then the misdescribed amendment can be incorporated through an editorial change made under section 15V of the Legislation Act 2003.

If a misdescribed amendment cannot be given effect as intended, the amendment is not incorporated and “(md not incorp)” is added to the amendment history.

 

Endnote 2—Abbreviation key

 

ad = added or inserted

orig = original

am = amended

p = page(s)

amdt = amendment

para = paragraph(s)/subparagraph(s)

C[x] = Compilation No. x

/subsubparagraph(s)

ch = Chapter(s)

pres = present

cl = clause(s)

prev = previous

cont. = continued

(prev…) = previously

def = definition(s)

pt = Part(s)

Dict = Dictionary

r = regulation(s)/Court rule(s)

disallowed = disallowed by Parliament

reloc = relocated

div = Division(s)

renum = renumbered

ed = editorial change

rep = repealed

exp = expires/expired or ceases/ceased to have

rs = repealed and substituted

effect

s = section(s)/subsection(s)

gaz = gazette

/rule(s)/subrule(s)/order(s)/suborder(s)

LA = Legislation Act 2003

sch = Schedule(s)

LIA = Legislative Instruments Act 2003

SLI = Select Legislative Instrument

(md) = misdescribed amendment can be given

SR = Statutory Rules

effect

sub ch = SubChapter(s)

(md not incorp) = misdescribed amendment

sub div = Subdivision(s)

cannot be given effect

sub pt = Subpart(s)

mod = modified/modification

underlining = whole or part not

No. = Number(s)

commenced or to be commenced

Ord = Ordinance

 

 

Endnote 3—Legislation history

 

Name

Registration

Commencement

Application, saving and transitional provisions

National Health (IVF Program) Special Arrangement 2025 (PB 113 of 2025)

25 Sept 2025 (F2025L01180)

1 Oct 2025 (s 2(1) item 1)

 

National Health Legislation (Closing the Gap—PBS Co-payment Program) (Repeal and Consequential Amendments) Instrument 2026 (PB 28 of 2026)

6 Mar 2026 (F2026L00220)

sch 2 (items 24-28): 1 Apr 2026 (s 2(1) item 1)

National Health (IVF Program) Special Arrangement Amendment (April Update) Instrument 2026 (PB 37 of 2026)

31 Mar 2026 (F2026L00409)

1 Apr 2026 (s 2(1) item 1)

National Health Legislation Special Arrangement Amendment (Wholesale Mark-up) Instrument 2026 (PB 57 of 2026)

26 June 2026 (F2026L00801)

sch 1 (items 14-22): 1 July 2026 (s 2(1) item 1)

 

Endnote 4—Amendment history

 

Provision affected

How affected

Part 1

 

Division 1

 

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

rep LA s 48D

s 4.....................

rep LA s 48C

s 6.....................

am F2026L00220; F2026L00801

Part 2

 

Division 2

 

s 12....................

am F2026L00801

 

ed C2

s 13....................

rs F2026L00801

Part 3

 

s 15....................

am F2026L00220

Schedule 1

 

Schedule 1................

am F2026L00409

Schedule 2................

rep LA s 48C

 

Endnote 5—Editorial changes

In preparing this compilation for registration, the following kinds of editorial change(s) were made under the Legislation Act 2003.

Subparagraph 12(1)(a)(ia)

Kind of editorial change

Give effect to the misdescribed amendment as intended and numbering or renumbering of provisions

Details of editorial change

Schedule 1 item 19 of the National Health Legislation Special Arrangement Amendment (Wholesale Markup) Instrument 2026 (PB 57 of 2026) provides as follows:

19  At the end of subparagraph 12(1)(a)(i)

Add “if the approved supplier is an approved pharmacist—the wholesale markup for a pack quantity of a readyprepared pharmaceutical benefit worked out in the table in section 11 of the Approved Pharmacists Commonwealth Price Determination for the approved exmanufacturer price or proportional exmanufacturer price (as applicable) for that pack quantity; and”.

This amendment results in the text being added at the end of subparagraph 12(1)(a)(i), rather than as a separate subparagraph.

This compilation was editorially changed by inserting the text as subparagraph (ia), to correct the numbering and give effect to the misdescribed amendment as intended.

Subparagraph 12(1)(c)(ia)

Kind of editorial change

Give effect to the misdescribed amendment as intended and numbering or renumbering of provisions

Details of editorial change

Schedule 1 item 20 of the National Health Legislation Special Arrangement Amendment (Wholesale Markup) Instrument 2026 (PB 57 of 2026) provides as follows:

20  At the end of subparagraph 12(1)(c)(i)

Add “if the approved supplier is an approved pharmacist—the wholesale markup for a pack quantity of a readyprepared pharmaceutical benefit worked out in the table in section 11 of the Approved Pharmacists Commonwealth Price Determination for the approved exmanufacturer price or proportional exmanufacturer price (as applicable) for that pack quantity; and”.

This amendment results in the text being added at the end of subparagraph 12(1)(c)(i), rather than as a separate subparagraph.

This compilation was editorially changed by inserting the text as subparagraph (ia), to correct the numbering and give effect to the misdescribed amendment as intended.

Subparagraph 12(2)(b)(ia)

Kind of editorial change

Give effect to the misdescribed amendment as intended and numbering or renumbering of provisions

Details of editorial change

Schedule 1 item 21 of the National Health Legislation Special Arrangement Amendment (Wholesale Markup) Instrument 2026 (PB 57 of 2026) provides as follows:

21  At the end of subparagraph 12(2)(b)(i)

Add “if the approved supplier is an approved pharmacist—the wholesale markup for a pack quantity of a readyprepared pharmaceutical benefit worked out in the table in section 11 of the Approved Pharmacists Commonwealth Price Determination for the approved exmanufacturer price or proportional exmanufacturer price (as applicable) for that pack quantity; and”.

This amendment results in the text being added at the end of subparagraph 12(2)(b)(i), rather than as a separate subparagraph.

This compilation was editorially changed by inserting the text as subparagraph (ia), to correct the numbering and give effect to the misdescribed amendment as intended.

 

Interactions

Authorises

All Versions

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.