National Health (Highly Specialised Drugs Program) Special Arrangement 2021

(1) This instrument is the National Health (Highly Specialised Drugs Program) Special Arrangement 2021.

(2) This instrument may also be cited as PB 27 of 2021.

This instrument is made under sections 85, 85A, 88, 99 and 100 of the National Health Act 1953.

This instrument makes a special arrangement for the supply of pharmaceutical benefits that contain highly specialised drugs for the treatment of chronic conditions.

Restrictions apply to the prescribing and supply of these benefits because of their clinical use and other special features.

The prescribing of these benefits is in most cases limited to practitioners who have undertaken particular training or are affiliated with a specialised hospital unit.

The supply of these benefits is restricted to persons who are receiving treatment by medical practitioners and authorised nurse practitioners.

These benefits will be supplied by approved suppliers (public and private hospitals, community pharmacies and certain medical practitioners).

This instrument also deals with payments for supplies of these 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) Chief Executive Medicare;

(b) hospital;

Note 2: Under subsection 4(1A) of the Act, a word or phrase 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 are defined in that Act include the following:

(a) eligible person;

(b) medical practitioner;

(d) specialist.

In this instrument:

accredited prescriber of medication for the treatment of hepatitis B means a medical practitioner, or an authorised nurse practitioner, approved by a State or Territory to prescribe medication for the treatment of hepatitis B in accordance with this instrument.

accredited prescriber of medication for the treatment of hepatitis C means a medical practitioner, or an authorised nurse practitioner, approved by a State or Territory to prescribe medication for the treatment of hepatitis C in accordance with this instrument.

accredited prescriber of medication for the treatment of HIV or AIDS means a medical practitioner, or an authorised nurse practitioner, approved by a State or Territory to prescribe medication for the treatment of HIV or AIDS in accordance with this instrument.

accredited prescriber of medication for the treatment of schizophrenia means a medical practitioner approved by a State or Territory to prescribe medication for the treatment of schizophrenia in accordance with this instrument.

Act means the National Health Act 1953.

affiliated: a specialist is affiliated with a hospital if the specialist is:

(a) a staff specialist of the hospital; or

(b) a visiting or consulting specialist of the hospital.

approved ex‑manufacturer 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, as affected by section 11 of this instrument.

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 Pharmacists Conditions Determination means the National Health (Pharmaceutical Benefits) (Conditions for approved pharmacists) Determination 2017.

approved supplier has the same meaning as in Part VII of the Act, as affected by section 11 of this instrument.

authorised nurse practitioner has the same meaning as in Part VII of the Act.

authorised prescriber has the meaning given by section 7.

CAR drug (short for Complex Authority Required drug) means any of the following highly specialised drugs:

(a) abatacept;

(b) adalimumab;

(d) anifrolumab;

(e) avatrombopag;

(f) azacitidine;

(g) benralizumab;

(h) bosentan;

(i) burosumab;

(j) daunorubicin with cytarabine;

(k) difelikefalin;

(l) dupilumab;

(m) eculizumab;

(n) elexacaftor with tezacaftor and with ivacaftor, and ivacaftor;

(o) eltrombopag;

(p) epoprostenol;

(q) etanercept;

(r) iloprost;

(s) infliximab;

(t) ivacaftor;

(u) lenalidomide;

(v) lumacaftor with ivacaftor;

(w) macitentan;

(x) mepolizumab;

(y) midostaurin;

(z) nusinersen;

(aa) omalizumab;

(bb) onasemnogene abeparvovec;

(cc) pasireotide;

(dd) patisiran;

(ee) pegcetacoplan;

(ff) pegvisomant;

(gg) pomalidomide;

(hh) ravulizumab;

(ii) riociguat;

(jj) risdiplam;

(kk) romiplostim;

(ll) selexipag;

(mm) sildenafil;

(nn) tadalafil;

(oo) teduglutide;

(pp) tezacaftor with ivacaftor and ivacaftor;

(qq) tocilizumab;

(rr) ustekinumab;

(ss) vedolizumab.

circumstances code means the letter “C” followed by a number.

community access medication means any of the following:

(a) medication for the treatment of hepatitis B;

(b) medication for the treatment of HIV or AIDS, other than a pharmaceutical benefit that has the drug:

(i) azithromycin; or

(ii) doxorubicin ‑ pegylated liposomal; or

(iii) rifabutin;

(ba) medication for the treatment of opioid dependence;

(d) lanreotide, if:

(i) the description of its form does not include “Powder for suspension for injection”; and

(ii) it is for continuing treatment;

(e) octreotide, if:

(i) the description of its form includes “Injection (modified release)”; and

(ii) it is for continuing treatment.

CTG registered patient means a patient registered under subsection 10(2) of the CTG Special Arrangement.

CTG Special Arrangement means the National Health (Closing the Gap – PBS Co‑payment Program) Special Arrangement 2016.

CTG supplier has the same meaning as in the CTG Special Arrangement.

dangerous drug has the same meaning as in the Approved Pharmacists Commonwealth Price Determination.

dangerous drug fee has the same meaning as in the Approved Pharmacists Commonwealth Price Determination.

day admitted patient: a person is a day admitted patient of a hospital on a day if, on that day, the person:

(a) is admitted to the hospital (other than through the hospital’s emergency department); and

(b) receives treatment; and

in accordance with a pre‑existing plan for the person’s treatment.

dispensed price:

(a) for a special arrangement supply of an HSD pharmaceutical benefit by an approved hospital authority for a public hospital—has the meaning given by section 29; and

(b) for a special arrangement supply of an HSD pharmaceutical benefit by an approved supplier other than an approved hospital authority for a public hospital—has the meaning given by section 32.

EFC patient has the meaning given by subsection 8(7).

eligible patient has the meaning given by section 8.

General statement for drugs for the treatment of hepatitis C has the same meaning as in the Listing Instrument.

highly specialised drug means a listed drug mentioned in Schedule 1.

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

HSD hospital authority means a hospital authority for which:

(a) an approval under section 94 of the Act, as modified by section 10 of this instrument, is in force; or

(b) an approval mentioned in section 38 of this instrument is in force.

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

listed drug has the same meaning as in Part VII of the Act.

Listing Instrument means the National Health (Listing of Pharmaceutical Benefits) Instrument 2024 (PB 26 of 2024).

medication chart prescription has the same meaning as in the Regulations.

medication for the treatment of hepatitis B means any of the following:

(a) adefovir;

(b) entecavir;

(d) tenofovir.

medication for the treatment of hepatitis C means medication mentioned in the table in clause 3 of the General statement for drugs for the treatment of hepatitis C.

medication for the treatment of HIV or AIDS means any of the following:

(a) abacavir;

(b) abacavir with lamivudine;

(d) atazanavir with cobicistat;

(e) azithromycin;

(f) bictegravir with emtricitabine with tenofovir alafenamide;

(g) cabotegravir;

(h) cabotegravir and rilpivirine;

(i) darunavir;

(j) darunavir with cobicistat;

(k) darunavir with cobicistat, emtricitabine and tenofovir alafenamide;

(l) dolutegravir;

(m) dolutegravir with abacavir and lamivudine;

(n) dolutegravir with lamivudine;

(o) dolutegravir with rilpivirine;

(p) doxorubicin ‑ pegylated liposomal;

(q) emtricitabine with rilpivirine with tenofovir alafenamide;

(r) emtricitabine with tenofovir alafenamide;

(s) etravirine;

(t) ganciclovir;

(u) lamivudine;

(v) lamivudine with zidovudine;

(w) lopinavir with ritonavir;

(x) maraviroc;

(y) nevirapine;

(z) raltegravir;

(aa) rifabutin;

(bb) rilpivirine;

(cc) ritonavir;

(dd) tenofovir;

(ee) tenofovir alafenamide with emtricitabine, elvitegravir and cobicistat;

(ff) tenofovir with emtricitabine;

(gg) tenofovir with emtricitabine and efavirenz;

(hh) valganciclovir;

(ii) zidovudine.

medication for the treatment of opioid dependence means any of the following:

(a) buprenorphine;

(b) buprenorphine with naloxone;

medication for the treatment of schizophrenia means clozapine.

ODT pharmaceutical benefit means an HSD pharmaceutical benefit that has a drug that is a medication for the treatment of opioid dependence.

pack quantity 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.

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

purposes code means the letter “P” followed by a number.

Regulations means the National Health (Pharmaceutical Benefit) Regulations 2017.

residential care service has the same meaning as in the Regulations.

special arrangement supply has the meaning given by sections 13 and 41.

UNAR drug (short for Unrestricted—No Authority Required drug) means any of the following highly specialised drugs:

(a) rituximab.

7 Definition of authorised prescriber

Specialists affiliated with hospitals

(1) A specialist is an authorised prescriber for an HSD pharmaceutical benefit for a patient receiving treatment in, at or from a hospital if the specialist is affiliated with the hospital.

Medical practitioners—with the agreement of specialists

(2) A medical practitioner is an authorised prescriber for an HSD pharmaceutical benefit for a patient receiving treatment in, at or from a hospital if all of the following apply:

(a) the benefit is for continuing treatment for the patient;

(b) the patient’s treatment is being managed by a specialist;

(d) the specialist has agreed to the prescribing of the benefit for the patient by the medical practitioner.

Medical practitioners—if authorised by Commonwealth and State authorities

(3) A medical practitioner is an authorised prescriber for an HSD pharmaceutical benefit for a patient if all of the following apply:

(a) the HSD pharmaceutical benefit is for continuing treatment for the patient;

(b) the medical practitioner is authorised (however described) by an authority of the Commonwealth for the purposes of this provision;

(c) the medical practitioner is authorised (however described) by an authority of the State or Territory in which the hospital is located for the purposes of this provision.

Medical practitioners—medication for the treatment of hepatitis C, lanreotide and octreotide

(4) A medical practitioner is an authorised prescriber for the following HSD pharmaceutical benefits:

(a) a benefit that has a drug that is a medication for the treatment of hepatitis C;

(b) a benefit that has the drug lanreotide, if:

(i) the description of its form does not include “Powder for suspension for injection”; and

(ii) it is for continuing treatment;

(i) the description of its form includes “Injection (modified release)”; and

(ii) it is for continuing treatment.

Accredited prescribers—HSD pharmaceutical benefits for the treatment of hepatitis B, hepatitis C, HIV or AIDS, and schizophrenia

(5) The following table has effect.

Authorised prescribers for certain HSD pharmaceutical benefits
Item	Column 1 The following person …	Column 2 is an authorised prescriber for an HSD pharmaceutical benefit that has a drug that is …
1	An accredited prescriber of medication for the treatment of hepatitis B	a medication for the treatment of hepatitis B.
2	An accredited prescriber of medication for the treatment of hepatitis C	a medication for the treatment of hepatitis C.
3	An accredited prescriber of medication for the treatment of HIV or AIDS	a medication for the treatment of HIV or AIDS.
4	An accredited prescriber of medication for the treatment of schizophrenia	a medication for the treatment of schizophrenia.

Authorised nurse practitioners and medical practitioners—ODT pharmaceutical benefits

(6) Each of the following is an authorised prescriber for an ODT pharmaceutical benefit:

(a) an authorised nurse practitioner;

(b) a medical practitioner.

(7) To avoid doubt, a person is not an authorised prescriber, within the meaning of this instrument, for an HSD pharmaceutical benefit only because the person is authorised in accordance with section 12 of the Listing Instrument to write a prescription for the supply of the pharmaceutical benefit.

Note: A supply of an HSD pharmaceutical benefit is not a special arrangement supply of the benefit unless the supply was prescribed by an authorised prescriber for the benefit (see section 13 of this instrument).

8 Definition of eligible patient

Persons receiving treatment by medical practitioners at or from public hospitals other than as admitted patients

(1) A person is an eligible patient for an HSD pharmaceutical benefit if the person:

(a) is, or is to be treated as, an eligible person; and

(b) is receiving medical treatment by a medical practitioner at or from a public hospital; and

(i) a non‑admitted patient of the hospital; or

(ii) a day admitted patient of the hospital; or

(iii) a patient on discharge from the hospital; and

(d) is not an EFC patient (see subsection (7)) for the benefit.

Persons receiving treatment by authorised nurse practitioners at or from public hospitals other than as admitted patients—medication for the treatment of hepatitis C

(2) A person is an eligible patient for an HSD pharmaceutical benefit that has a drug that is a medication for the treatment of hepatitis C if the person:

(a) is, or is to be treated as, an eligible person; and

(b) is receiving medical treatment by an authorised nurse practitioner at or from a public hospital; and

(i) a non‑admitted patient of the hospital; or

(ii) a day admitted patient of the hospital; or

(iii) a patient on discharge from the hospital.

Persons receiving treatment by medical practitioners in public hospitals as admitted patients—HSD pharmaceutical benefits that contain eculizumab for the treatment of atypical haemolytic uraemic syndrome

(3) A person is an eligible patient for an HSD pharmaceutical benefit that has the drug eculizumab for the treatment of atypical haemolytic uraemic syndrome if the person:

(a) is, or is to be treated as, an eligible person; and

(b) is receiving medical treatment by a medical practitioner in a public hospital; and

Persons receiving treatment by medical practitioners in, at or from private hospitals

(4) A person is an eligible patient for an HSD pharmaceutical benefit if the person:

(a) is, or is to be treated as, an eligible person; and

(b) is receiving medical treatment by a medical practitioner in, at or from a private hospital; and

Persons receiving treatment by authorised nurse practitioners in, at or from private hospitals—medication for the treatment of hepatitis C

(5) A person is an eligible patient for an HSD pharmaceutical benefit that has a drug that is a medication for the treatment of hepatitis C if the person:

(a) is, or is to be treated as, an eligible person; and

(b) is receiving medical treatment by an authorised nurse practitioner in, at or from a private hospital.

Persons receiving HSD pharmaceutical benefits that have drugs that are community access medications

(6) A person is an eligible patient for an HSD pharmaceutical benefit if:

(a) the benefit has a drug that is a community access medication; and

(b) the person is, or is to be treated as, an eligible person.

EFC patient

(7) A person is an EFC patient for an HSD pharmaceutical benefit that has a UNAR drug if the benefit is or will be prescribed to the person:

(a) in accordance with the National Health (Efficient Funding of Chemotherapy) Special Arrangement 2024; or

(b) for the purposes of chemotherapy treatment for cancer.

Division 2—Supplies of HSD pharmaceutical benefits from hospitals

9 Supplies of HSD pharmaceutical benefits by approved hospital authorities to patients receiving treatment from hospitals

(1) In this instrument, and in Part VII of the Act and regulations or other instruments made for the purposes of that Part, a reference to an approved hospital authority supplying pharmaceutical benefits to patients receiving treatment in or at the hospital of which it is the governing body or proprietor includes a reference to the hospital authority supplying HSD pharmaceutical benefits to patients receiving treatment from the hospital.

(2) This section applies in addition to section 94 of the Act.

Division 3—HSD hospital authorities

10 HSD hospital authorities

(1) Section 94 of the Act applies as if that section permitted the Minister to approve a hospital authority for the purpose of its supplying HSD pharmaceutical benefits to patients receiving treatment in, at or from the hospital of which it is the governing body or proprietor if the dispensing of those benefits is performed:

(a) other than at the hospital; and

(b) by or under the direct supervision of a medical practitioner or pharmacist.

(2) Subsection (1) applies despite subsection 94(5) of the Act.

11 References to approved suppliers and approved hospital authorities

In this instrument, and in Part VII of the Act and regulations or other instruments made for the purposes of that Part, a reference to an approved supplier or an approved hospital authority includes a reference to an HSD hospital authority.

12 Numbers allotted to HSD hospital authorities

For the purposes of Part VII of the Act and regulations or other instruments made for the purposes of that Part, a number allotted to an HSD hospital authority under either of the following provisions is taken to have been allotted by the Minister under subsection 16(4) of the Regulations:

(a) subsection 52(3) of the National Health (Highly specialised drugs program) Special Arrangement 2010 (PB 116 of 2010);

(b) subsection 52(3) of the National Health (Highly specialised drugs program for public hospitals) Special Arrangements Instrument 2010 (PB 63 of 2010).

Part 2—Special arrangement supplies of HSD pharmaceutical benefits

Division 1—Preliminary

13 Definition of special arrangement supply

Prescriptions written for public hospital patients

(1) A supply of an HSD pharmaceutical benefit to a person is a special arrangement supply of the benefit if:

(a) the person is an eligible patient for the benefit; and

(b) the benefit is supplied by:

(i) for any benefit—an approved hospital authority for a public hospital; or

(ii) for a benefit that has a CAR drug or UNAR drug—an approved pharmacist; and

(i) when the person was receiving medical treatment in, at or from a public hospital; and

(ii) by an authorised prescriber for the benefit; and

(iii) unless the benefit has a UNAR drug—in circumstances mentioned in Schedule 3 for a circumstances code mentioned in the column headed “Circumstances” in Schedule 1 for the benefit.

Prescriptions written for private hospital patients

(2) A supply of an HSD pharmaceutical benefit to a person is a special arrangement supply of the benefit if:

(a) the person is an eligible patient for the benefit; and

(b) the benefit is supplied by:

(i) an approved hospital authority for a private hospital; or

(ii) an approved pharmacist; and

(i) when the person was receiving medical treatment in, at or from a private hospital; and

(ii) by an authorised prescriber for the benefit; and

(iii) unless the benefit has a UNAR drug—in circumstances mentioned in Schedule 3 for a circumstances code mentioned in the column headed “Circumstances” in Schedule 1 for the benefit.

Community access arrangements

(3) A supply of an HSD pharmaceutical benefit to a person is a special arrangement supply of the benefit if:

(a) the benefit has a drug that is a community access medication; and

(b) the person is an eligible patient for the benefit; and

(d) the benefit is supplied on the basis of a prescription written:

(i) by an authorised prescriber for the benefit; and

(ii) in circumstances mentioned in Schedule 3 for a circumstances code mentioned in the column headed “Circumstances” in Schedule 1 for the benefit.

Division 2—Prescribing of HSD pharmaceutical benefits

15 Prescription circumstances—general (Act s 85(7)(a) and (b))

(1) For the purposes of paragraph 85(7)(a) of the Act, an HSD pharmaceutical benefit, other than a benefit that has a UNAR drug, is a relevant pharmaceutical benefit for the purposes of section 88A of the Act.

(2) For the purposes of paragraph 85(7)(b) of the Act, the circumstances in which a prescription for a special arrangement supply of an HSD pharmaceutical benefit, other than a benefit that has a UNAR drug, may be written are the circumstances mentioned in Schedule 3 to this instrument for a circumstances code mentioned in the column headed “Circumstances” in Schedule 1 to this instrument for the benefit.

(3) This section applies in addition to section 13 of the Listing Instrument.

16 Prescription circumstances—authority required procedures

(1) This section applies to a prescription for a special arrangement supply of an HSD pharmaceutical benefit if the circumstances mentioned in Schedule 3 (if any) in which the prescription is written include:

(a) Compliance with Authority Required procedures; or

(b) Compliance with Written Authority Required procedures.

(2) Section 19 of the Listing Instrument applies to the prescription as if:

(a) a reference to Part 1 of Schedule 4 to that instrument were a reference to Schedule 3 to this instrument; and

(b) a reference to an authorised prescriber were a reference to an authorised prescriber within the meaning of this instrument.

18 When medication chart prescriptions not to be written

HSD pharmaceutical benefits that have CAR drugs or rituximab

(1) Subparagraph 39(a)(ii) of the Regulations does not apply to a prescription for a special arrangement supply of an HSD pharmaceutical benefit that has a CAR drug or rituximab.

Persons receiving treatment in residential care services

(2) Subparagraph 41(1)(a)(i) of the Regulations does not apply to a prescription for a special arrangement supply of an HSD pharmaceutical benefit.

19 Prescriptions not to direct repeated supplies for visitors to Australia

(1) An authorised prescriber for an HSD pharmaceutical benefit must not write a prescription directing a repeated supply of an HSD pharmaceutical benefit to a person who is a visitor to Australia even if the person is, in accordance with section 7 of the Health Insurance Act 1973, to be treated as an eligible person within the meaning of that Act.

(2) This section applies despite section 85A of the Act.

20 Maximum quantity or number of units (Act s 85A(2)(a))

(1) For the purposes of paragraph 85A(2)(a) of the Act, this section sets out the maximum quantity or number of units of the pharmaceutical item in an HSD pharmaceutical benefit that may, in one prescription for a special arrangement supply of the benefit, be directed by an authorised prescriber to be supplied on any one occasion.

Supply for particular purposes

(2) If:

(a) a purposes code is mentioned in the column headed “Purposes” in Schedule 1 to this instrument for the benefit; and

(b) the supply of the benefit is for purposes mentioned in Schedule 3 to this instrument for the purposes code;

the maximum quantity or number of units is the quantity or number of units is mentioned in the column headed “Maximum quantity” in Schedule 1 to this instrument for the benefit and the purposes code.

Supply for all purposes—HSD pharmaceutical benefits not in Schedule 2

(3) If:

(a) a purposes code is not mentioned in the column headed “Purposes” in Schedule 1 to this instrument for the benefit; and

(b) a quantity or number of units is mentioned in the column headed “Maximum quantity” in Schedule 1 to this instrument for the benefit;

the maximum quantity or number of units is that quantity or number of units.

Supply for all purposes—HSD pharmaceutical benefits in Schedule 2

(4) If:

(a) a purposes code is not mentioned in the column headed “Purposes” in Schedule 1 to this instrument for the benefit; and

(b) the words “See Schedule 2” appear in the column headed “Maximum quantity” in Schedule 1 to this instrument for the benefit; and

(c) the prescription is written in circumstances mentioned in Schedule 3 for a circumstances code mentioned in the column headed “Circumstances” in Schedule 2 to this instrument for the benefit;

the maximum quantity or number of units is the quantity or number of units that is applicable under Schedule 2 to this instrument for the benefit and the circumstances code.

Application of this section

(5) To the extent that this section provides for a matter not provided for in the Listing Instrument, this section applies in addition to the Listing Instrument.

(6) To the extent that this section makes a different provision for a matter provided for in the Listing Instrument, this section applies despite the Listing Instrument.

21 Maximum number of repeats (Act s 85A(2)(b))

(1) For the purposes of paragraph 85A(2)(b) of the Act, this section sets out the maximum number of occasions an authorised prescriber may, in one prescription, direct that a special arrangement supply of an HSD pharmaceutical benefit be repeated.

Supply for particular purposes

(2) If:

(a) a purposes code is mentioned in the column headed “Purposes” in Schedule 1 to this instrument for the benefit; and

(b) the supply is for purposes mentioned in Schedule 3 to this instrument for the purposes code;

the maximum number is the number mentioned in the column headed “Maximum repeats” in Schedule 1 to this instrument for the benefit and the purposes code.

Supply for all purposes—HSD pharmaceutical benefits not in Schedule 2

(3) If:

(a) a purposes code is not mentioned in the column headed “Purposes” in Schedule 1 to this instrument for the benefit; and

(b) a number is mentioned in the column headed “Maximum repeats” in Schedule 1 to this instrument for the benefit;

the maximum number is that number.

Supply for all purposes—HSD pharmaceutical benefits in Schedule 2

(4) If:

(a) a purposes code is not mentioned in the column headed “Purposes” in Schedule 1 to this instrument for the benefit; and

(b) the words “See Schedule 2” appear in the column headed “Maximum repeats” in Schedule 1 for the benefit; and

(c) the prescription is written in circumstances mentioned in Schedule 3 for a circumstances code mentioned in the column headed “Circumstances” in Schedule 2 to this instrument for the benefit;

the maximum number is the number that is applicable under Schedule 2 to this instrument for the benefit and the circumstances code.

Application of this section

(5) To the extent that this section provides for a matter not provided for in the Listing Instrument, this section applies in addition to the Listing Instrument.

(6) To the extent that this section makes a different provision for a matter provided for in the Listing Instrument, this section applies despite the Listing Instrument.

22 No variation of application of determination of maximum number of repeats or maximum number or quantity of units—HSD pharmaceutical benefits that have CAR drugs

Section 30 of the Regulations does not apply in relation to a practitioner (within the meaning of section 29 of the Regulations) who has written a prescription for a special arrangement supply of an HSD pharmaceutical benefit that has a CAR drug.

Note: Section 30 of the Regulations allows the Minister to vary the application of a determination under paragraph 85A(2)(a) or (b) of the Act in certain circumstances.

23 Records to be kept—prescriptions for HSD pharmaceutical benefits that have eculizumab for the treatment of atypical haemolytic uraemic syndrome

(1) If an authorised prescriber for an HSD pharmaceutical benefit that has the drug eculizumab for the treatment of atypical haemolytic uraemic syndrome writes a prescription for a special arrangement supply of the benefit, a copy of any clinical records relating to the prescription, including records required to demonstrate that the prescription was written in compliance with the circumstances and purposes determined in relation to the benefit under subsection 85(7) of the Act, must be kept by:

(a) the approved hospital authority for the hospital in, at or from which the eligible patient is receiving treatment; or

(b) if the approved hospital authority is not able to keep the records—the authorised prescriber.

(2) The records must be kept for 2 years after the date the prescription to which the records relate is written.

Division 3—Supplying HSD pharmaceutical benefits

24 Special patient contribution for certain HSD pharmaceutical benefits

(1) This section applies to a special arrangement supply of an HSD pharmaceutical benefit mentioned in the following table.

Special patient contribution for certain HSD pharmaceutical benefits
Item	Drug	Form	Manner of administration	Brand	Pack quantity	Claimed price ($)
1	Lamivudine	Tablet 100 mg	Oral	Zeffix	28	28.09
2	Valaciclovir	Tablet 500 mg (as hydrochloride)	Oral	Valtrex	100	42.70

(2) The special patient contribution for a pack quantity of a listed brand of a pharmaceutical item mentioned in the table is the amount that is the difference between:

(a) the price that would have been the dispensed price for that quantity of the brand of the pharmaceutical item if that dispensed price had been based on the claimed price (within the meaning of Part VII of the Act) mentioned in the table for that quantity; and

(b) the dispensed price for that quantity of the brand of the pharmaceutical item.

(3) This section applies despite subsection 85B(5) of the Act.

25 Conditions for approved pharmacists

Special arrangement supplies of certain HSD pharmaceutical benefits

(1) The Approved Pharmacists Conditions Determination does not apply to the dispensing or supply of an HSD pharmaceutical benefit if:

(a) the manner of administration of the benefit is injection or extracorporeal circulation; and

(b) the benefit does not have a drug that is a community access medication; and

ODT pharmaceutical benefits—special arrangement supplies through agents

(2) If a supply of an ODT pharmaceutical benefit is a special arrangement supply of the benefit mentioned in subsection 26(2) of this instrument, the Approved Pharmacists Conditions Determination applies to the dispensing and supply of the benefit as if paragraph 6(e), subsection 9(1), section 10, paragraphs 14(a) and (b) and section 15 of that Determination were omitted.

ODT pharmaceutical benefits—special arrangement supplies other than through agents

(3) If a supply of an ODT pharmaceutical benefit is a special arrangement supply of the benefit other than a special arrangement supply of the benefit mentioned in subsection 26(2) of this instrument, the Approved Pharmacists Conditions Determination applies to the dispensing and supply of the benefit as if paragraph (c) of the definition of dispensing step in section 5 of that Determination were omitted.

26 Supplies need not be directly to persons

Supplies of HSD pharmaceutical benefits by HSD hospital authorities

(1) An HSD hospital authority may make a special arrangement supply of an HSD pharmaceutical benefit to a person:

(a) other than directly to the person; or

(b) through an agent.

Supplies of ODT pharmaceutical benefits by approved pharmacists and approved hospital authorities

(2) An approved pharmacist or an approved hospital authority may make a special arrangement supply of an ODT pharmaceutical benefit to a person through a person or organisation:

(a) that has premises in a State or Territory; and

(b) that is authorised (however described) by an authority of the State or Territory for the purposes of supplying medication for the treatment of opioid dependence.

Application of this section

(3) This section applies in addition to section 94 of the Act.

27 Repeated supplies of pharmaceutical benefits

Section 51 of the Regulations does not apply to a special arrangement supply of HSD pharmaceutical benefits.

Part 3—Payment for special arrangement supplies of HSD pharmaceutical benefits

Division 1—Supplies by approved hospital authorities for public hospitals

28 Rates of payment for approved hospital authorities for public hospitals (Act s 99(4))

(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 HSD 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 3A in relation to a special arrangement supply of an HSD pharmaceutical benefit to a CTG registered patient by a CTG supplier.

(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 9 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.

29 Dispensed price for approved hospital authorities for public hospitals

(1) The dispensed price for a special arrangement supply of an HSD 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 ex‑manufacturer price or the proportional ex‑manufacturer 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);

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

(ii) the amount calculated in accordance with subsection (2) for the remainder of the quantity that is a broken quantity.

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 ex‑manufacturer price or proportional ex‑manufacturer 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

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

(1) This section applies if:

(a) an approved pharmacist or approved medical practitioner has supplied an HSD pharmaceutical benefit; and

(b) the supply is a special arrangement supply of the benefit.

Note: However, see Part 3A in relation to a special arrangement supply of an HSD pharmaceutical benefit to a CTG registered patient by a CTG supplier.

(2) The approved pharmacist or approved medical practitioner is, 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, 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: Section 87 of the Act limits the amounts that approved pharmacists and approved medical practitioners can charge patients for the supply of pharmaceutical benefits.

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

30A Paragraph 99(3)(b) of the Act does not apply to certain HSD pharmaceutical benefits

Paragraph 99(3)(b) of the Act does not apply to a special arrangement supply of an HSD pharmaceutical benefit if:

(a) the manner of administration of the benefit is injection or extracorporeal circulation; and

(b) the benefit is not a community access medication.

31 Rates of payment for approved hospital authorities for private hospitals (Act s 99(4))

(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 HSD 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 3A in relation to a special arrangement supply of an HSD pharmaceutical benefit to a CTG registered patient by a CTG supplier.

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

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

(1) The dispensed price for a special arrangement supply of an HSD 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 ex‑manufacturer price or the proportional ex‑manufacturer price (as applicable) for each pack quantity; and

(ii) if the benefit is a ready‑prepared pharmaceutical benefit—the mark‑up mentioned in section 33 for each pack quantity, rounded to the nearest cent (rounding 0.5 cents upwards); and

(iii) the dispensing fee for the benefit in accordance with section 34; and

(iv) if the benefit is a ready‑prepared pharmaceutical benefit and a dangerous drug—the dangerous drug 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 dispensing fee for the benefit in accordance with section 34; and

(iii) if the benefit is a ready‑prepared pharmaceutical benefit and a dangerous drug—the dangerous drug fee;

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

(ii) if the benefit is a ready‑prepared pharmaceutical benefit—the mark‑up mentioned in section 33 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 dispensing fee for the benefit in accordance with section 34; and

(v) if the benefit is a ready‑prepared pharmaceutical benefit and a dangerous drug—the dangerous drug 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 ex‑manufacturer price or the proportional ex‑manufacturer price (as applicable) for the pack quantity; and

(ii) if the benefit is a ready‑prepared pharmaceutical benefit—the mark‑up mentioned in section 33 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).

33 Mark‑up for ready‑prepared pharmaceutical benefits

For the purposes of subparagraphs 32(1)(a)(ii), (c)(ii) and (2)(b)(ii), the mark‑up for a pack quantity of an HSD pharmaceutical benefit that is a ready‑prepared pharmaceutical benefit is:

(a) if the pack quantity of the benefit is equal to the maximum quantity of the benefit mentioned in section 20—the amount mentioned in the following table for the approved ex‑manufacturer price (AEMP) or proportional ex‑manufacturer 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 mentioned in section 20:

(i) if the mark‑up 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 mark‑up 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.

Mark‑up for ready‑prepared pharmaceutical benefits
Item	If the AEMP or PEMP (as applicable) for the maximum quantity is …	the mark‑up 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

34 Dispensing fee

(1) For the purposes of subparagraphs 32(1)(a)(iii), (b)(ii) and (c)(iv):

(a) the dispensing fee for the supply of an HSD pharmaceutical benefit is:

(i) if the benefit has a drug mentioned in subsection (2) in the form mentioned in that subsection for the drug—the extemporaneously‑prepared dispensing fee (within the meaning of the Approved Pharmacists Commonwealth Price Determination); or

(ii) if subparagraph (i) does not apply—the ready‑prepared dispensing fee (within the meaning of that Determination); and

(b) if the authorised prescriber who prescribed the benefit, instead of directing a repeated supply of the benefit, directed 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 authorised prescriber directed a repeated supply, the dispensed price for the supply of the benefit includes:

(i) only one dispensing fee; and

(ii) only one dangerous drug fee.

Note: See section 49 of the Regulations for the circumstances in which such a supply may be directed.

(2) For the purpose of subparagraph (1)(a)(i), the drugs and the forms for the drugs are as follows:

(a) mycophenolic acid as a powder for oral suspension containing mycophenolate mofetil 1g per 5 mL, 165mL;

(b) valganciclovir as a powder for oral solution 50mg (as hydrochloride) per mL, 100 mL.

Part 3A—Supply to CTG registered patients by CTG suppliers

34A Application of this Part

This Part applies to a special arrangement supply (the relevant supply) of an HSD pharmaceutical benefit under this Special Arrangement if the relevant supply is made:

(a) to an eligible patient who is a CTG registered patient; and

(b) by an approved supplier who is a CTG supplier.

34B Application of the CTG Special Arrangement—co‑payment and payment etc.

(1) Despite sections 28, 30, 31 and 37 of this Special Arrangement, subsections 11(1), (2), (3), (3E) and (4) (co‑payment reduction etc.) and section 13 (payment by Commonwealth) of the CTG Special Arrangement apply in relation to the relevant supply under this Special Arrangement with the modification set out in subsection (2) of this section.

(2) A reference in the CTG Special Arrangement to a supply of a pharmaceutical benefit under the CTG Special Arrangement is taken to be a reference to the relevant supply under this Special Arrangement.

(3) However, the notes to subsections 11(2) and (3) of the CTG Special Arrangement to not apply in relation to the relevant supply under this Special Arrangement.

Note: The notes to subsections 11(2) and (3) of the CTG Special Arrangement relate to CTG suppliers making claims for payment under the CTG Special Arrangement. Claims for payment in relation to the relevant supply under this Special Arrangement are instead dealt with under Part 4 of this Special Arrangement.

Part 4—Claims for payment for special arrangement supplies of HSD pharmaceutical benefits

35 Rules for providing information about supplies—definition of under co‑payment data

The National Health (Supply of Pharmaceutical Benefits—Under Co‑payment Data and Claims for Payment) Rules 2022 apply to a special arrangement supply of an HSD pharmaceutical benefit by an approved supplier as if the definition of under co‑payment data in that instrument were replaced with the following definition:

under co‑payment data means information relating to a special arrangement supply of an HSD pharmaceutical benefit by an approved supplier where the amount payable by the Commonwealth is nil because the dispensed price for the supply of the benefit does not exceed the amount that the supplier was entitled to charge under section 87 of the Act in respect of the supply.

35A Claim for payment if an eligible patient is a CTG registered patient

If:

(a) a claim for payment for a special arrangement supply of an HSD pharmaceutical benefit made under the National Health (Supply of Pharmaceutical Benefits—Under Co‑payment Data and Claims for Payment) Rules 2022 is made using the manual system referred to in section 99AAA of the Act; and

(b) the claim is made:

(i) by an approved supplier who is a CTG supplier; and

(ii) in relation to a special arrangement supply of an HSD pharmaceutical benefit to an eligible patient who is a CTG registered patient;

the claim must include an indicator that the eligible patient is a CTG registered patient.

Part 5—Miscellaneous

36 Compliance and audit arrangements

(1) If an approved supplier makes a special arrangement supply of an HSD pharmaceutical benefit, the approved supplier must keep adequate, secure and auditable records of all supplied HSD pharmaceutical benefits for which a claim is made.

(2) The records must be kept in systems that are able to be audited by the Chief Executive Medicare on reasonable notice being given to the approved supplier.

37 Value for safety net purposes for supplies

Supplies by approved hospital authorities

(1) The value for safety net purposes for a special arrangement supply of an HSD pharmaceutical benefit to a person by an approved hospital authority is the amount paid by the person for the supply of the benefit that is equivalent to the amount chargeable under subsection 87(5) of the Act for the supply of the benefit less the amount chargeable under that subsection because of subsection 87(2A) of the Act.

Note: However, see Part 3A in relation to a special arrangement supply of an HSD pharmaceutical benefit to a CTG registered patient by a CTG supplier.

Supplies by approved pharmacists and approved medical practitioners

(2) The value for safety net purposes for a special arrangement supply of an HSD pharmaceutical benefit to a person by an approved pharmacist or approved medical practitioner is the amount paid by the person for the supply of the benefit that is equivalent to the amount chargeable under section 87 of the Act for the supply of the benefit less the amount chargeable under subsection 87(2A) of the Act.

Note: However, see Part 3A in relation to a special arrangement supply of an HSD pharmaceutical benefit to a CTG registered patient by a CTG supplier.

Application of this section

(3) This section applies despite regulation 17A of the Regulations.

Part 6—Application, saving and transitional provisions

Division 1—Provisions relating to this instrument as made

38 HSD hospital authorities

Despite the repeal of the National Health (Highly specialised drugs program) Special Arrangement 2010 (PB 116 of 2010):

(a) an approval that was in force under subsection 52(2) of that instrument immediately before 1 April 2021; and

(b) an approval that was continued in force under section 53 of that instrument as if it were an approval under subsection 52(2) of that instrument, and was in force immediately before 1 April 2021;

continues in force as if it were an approval under section 94 of the Act, as modified by section 10 of this instrument.

Division 2—Provisions relating to the National Health Legislation Amendment (Opioid Dependence Treatment and Maximum Dispensed Quantities) Instrument 2023

39 Purpose of this Division

This Division makes provision in relation to certain pre‑commencement prescriptions for the purpose of the application of Part VII of the Act, and regulations and other instruments made for the purposes of that Part, to those prescriptions.

40 Definitions

In this Division:

Claims Rules means the National Health (Supply of Pharmaceutical Benefits—Under Co‑payment Data and Claims for Payment) Rules 2022.

pre‑commencement benefit: see section 50.

pre‑commencement prescription: a prescription is a pre‑commencement prescription if:

(a) the prescription was written:

(i) before 1 July 2023; and

(ii) by an authorised nurse practitioner or a medical practitioner; and

(iii) for the supply to a person of a drug that is a medication for the treatment of opioid dependence; and

(iv) in the circumstance that the prescription was for the treatment of opiate dependence, including for detoxification (withdrawal) and maintenance of withdrawal; and

(b) immediately before 1 July 2023, a pre‑commencement benefit could have been supplied to the person on the basis of the prescription.

41 Definition of special arrangement supply

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

(a) on or after 1 July 2023; and

(b) to a person who is, or is to be treated as, an eligible person; and

(d) on the basis of a pre‑commencement prescription (as affected by this Division, if applicable); and

(e) in accordance with this Division.

42 Prescriptions directing supply for dispensing over time

(1) This section applies if a pre‑commencement prescription directed the supply of a specified quantity or number of units (whether expressed as a total or as a dose) to be dispensed over a specified period of time (the directed dispensing period).

Deemed variation of application of determination of maximum number or quantity of units

(2) If the specified quantity or number of units, or the quantity or number of units required for the doses over the directed dispensing period, is more than the maximum quantity or number of units mentioned in Schedule 1 for the pharmaceutical benefit to be supplied on the basis of the prescription:

(a) the application of the determination of the maximum quantity or number of units under paragraph 85A(2)(a) of the Act for the benefit is taken to have been varied under section 30 of the Regulations; and

(b) the prescription is taken to have been authorised in accordance with subsection 30(4) of the Regulations; and

(c) the number P2023OD is taken to have been allotted to, and marked on, the prescription as mentioned in subsection 30(5) of the Regulations.

Deemed modification of prescription—remaining period of up to 28 days

(3) If, when the prescription is first presented to an approved supplier on or after 1 July 2023, the period remaining in the directed dispensing period (the remaining period) is not more than 28 days, the prescription is taken to direct the supply on one occasion of the total quantity or number of units required for the remaining period.

Deemed modification of prescription—remaining period of 29 to 55 days

(4) If, when the prescription is first presented to an approved supplier on or after 1 July 2023, the remaining period is more than 28 days but not more than 55 days, the prescription is taken to direct the supply on one occasion of the total quantity or number of units required for 28 days.

Deemed modification of prescription—remaining period of 56 to 83 days

(5) If, when the prescription is first presented to an approved supplier on or after 1 July 2023, the remaining period is more than 55 days but not more than 83 days, the prescription is taken to direct:

(a) the supply on any one occasion of the total quantity or number of units required for 28 days; and

(b) that the supply be repeated once.

Deemed modification of prescription—remaining period of 84 days or more

(6) If, when the prescription is first presented to an approved supplier on or after 1 July 2023, the remaining period is 84 days or more, the prescription is taken to direct:

(a) the supply on any one occasion of the total quantity or number of units required for 28 days; and

(b) that the supply be repeated twice.

43 Prescriptions directing supply of buprenorphine for injection

(1) This section applies if:

(a) a pre‑commencement prescription is for the supply of the drug buprenorphine with the manner of administration injection (the medication); and

(b) the prescription directed the supply of a specified quantity or number of units of the medication (the directed quantity) that is more than the quantity of the medication mentioned in subsection (2) (the standard quantity for the medication).

(2) For the purposes of paragraph (1)(b), the standard quantity for the medication is:

(a) if the brand of the medication is Buvidal Weekly—4; or

(b) if the brand of the medication is Buvidal Monthly or Sublocade—1.

Deemed modification of prescription—remaining quantity of not more than standard quantity

(3) If, when the prescription is first presented to an approved supplier on or after 1 July 2023, the quantity or number of units of the medication that remains to be supplied (the remaining quantity) is not more than the standard quantity for the medication, the prescription is taken to direct the supply on one occasion of the remaining quantity.

Deemed modification of prescription—remaining quantity of more than standard quantity but less than twice standard quantity

(4) If, when the prescription is first presented to an approved supplier on or after 1 July 2023, the remaining quantity is more than the standard quantity for the medication but is less than twice the standard quantity for the medication, the prescription is taken to direct the supply on one occasion of the standard quantity for the medication.

Deemed modification of prescription—remaining quantity of more than twice standard quantity but less than 3 times standard quantity

(5) If, when the prescription is first presented to an approved supplier on or after 1 July 2023, the remaining quantity is more than twice the standard quantity for the medication but is less than 3 times the standard quantity for the medication, the prescription is taken to direct:

(a) the supply on any one occasion of the standard quantity for the medication; and

(b) that the supply be repeated once.

Deemed modification of prescription—remaining quantity of 3 times standard quantity or more

(6) If, when the prescription is first presented to an approved supplier on or after 1 July 2023, the remaining quantity is 3 times the standard quantity for the medication or more, the prescription is taken to direct:

(a) the supply on any one occasion of the standard quantity for the medication; and

(b) that the supply be repeated twice.

44 Prescriptions directing supply of methadone

(1) This section applies if a pre‑commencement prescription is for the supply of the drug methadone.

(2) On the basis of the prescription, the person for whom the prescription was written is entitled to receive, and an approved supplier may supply to the person, any ODT pharmaceutical benefit that has the drug methadone.

(3) This section applies despite section 89 and paragraph 103(2)(a) of the Act.

45 First supply on or after 1 July 2023 deemed to be supply on first presentation

If the first supply of an ODT pharmaceutical benefit by an approved supplier on the basis of a pre‑commencement prescription on or after 1 July 2023 is not a supply of that benefit on first presentation of the prescription, it is taken to be a supply of that benefit on first presentation of the prescription.

46 Supply on first presentation of prescription (Regulations s 44)

Subparagraphs 44(2)(a)(i) and (3)(a)(i) of the Regulations do not apply to a special arrangement supply of an ODT pharmaceutical benefit on the basis of a pre‑commencement prescription.

47 Repeat authorisations (Regulations s 52)

(1) Section 52 of the Regulations applies to the supply of an ODT pharmaceutical benefit on the basis of a pre‑commencement prescription to which subsection 42(5) or (6) or 43(5) or (6) of this instrument applies as if the benefit were supplied in the circumstances set out in subsection 52(2) of the Regulations.

(2) Subsection 52(3) of the Regulations applies in relation to a pre‑commencement prescription as if the prescription had been authorised in accordance with authority required procedures that are part of the circumstances determined by the Minister under paragraph 85(7)(b) of the Act for the pharmaceutical benefit to be supplied on the basis of the prescription.

48 Prescriptions written in electronic form—additional procedures for giving information (Claims Rules s 7) and keeping documents

Additional procedures for giving information

(1) Section 7 of the Claims Rules applies in relation to a pre‑commencement prescription written in electronic form as if a reference in that section to the prescription were a reference to a print‑out of the prescription.

Keeping print‑outs of prescriptions

(2) If an approved supplier supplies a pharmaceutical benefit on the basis of a pre‑commencement prescription written in electronic form, the approved supplier must keep a print‑out of the prescription for at least 2 years from the date the pharmaceutical benefit was supplied by the approved supplier.

49 Information to be given using Claims Transmission System (Claims Rules Sch 1)

General

(1) The table in clause 1 of Schedule 1 to the Claims Rules applies to a pre‑commencement prescription as follows:

(a) as if, for the purposes of item 2 of the table, the Authority Prescription Number for the prescription were 00000641;

(b) as if, for the purposes of item 8 of the table, the prescription were signed on 1 July 2023;

(c) if the authorised nurse practitioner or medical practitioner who wrote the prescription did not write their PBS prescriber number on the prescription—as if, for the purposes of item 28 of the table, that number were written on the prescription;

(d) if the authorised nurse practitioner or medical practitioner who wrote the prescription did not write their prescriber ID on the prescription—as if, for the purposes of item 31 of the table, that number were written on the prescription;

(e) if the prescription was written in electronic form—as if, for the purposes of item 32 of the table, the prescription were a paper‑based prescription;

(f) as if, for the purposes of item 40 of the table, the authorised nurse practitioner or medical practitioner who wrote the prescription had written on the prescription:

(i) the words “Streamlined Authority Code”; and

(ii) the relevant streamlined authority code included in any circumstances mentioned in an item of the table in Part 1 of Schedule 4 to the Listing Instrument for the writing of a prescription for a pharmaceutical benefit for the treatment of opioid dependence.

Pre‑commencement prescriptions written in electronic form

(2) Clause 2 of Schedule 1 to the Claims Rules does not apply to a pre‑commencement prescription written in electronic form.

50 Pre‑commencement benefits

Each pharmaceutical benefit specified in the following table is a pre‑commencement benefit.

Pre‑commencement benefits
Item	Listed drug	Form	Manner of administration	Brand
1	Buprenorphine	Injection (modified release) 8 mg in 0.16 mL pre‑filled syringe	Injection	Buvidal Weekly
2	Buprenorphine	Injection (modified release) 16 mg in 0.32 mL pre‑filled syringe	Injection	Buvidal Weekly
3	Buprenorphine	Injection (modified release) 24 mg in 0.48 mL pre‑filled syringe	Injection	Buvidal Weekly
4	Buprenorphine	Injection (modified release) 32 mg in 0.64 mL pre‑filled syringe	Injection	Buvidal Weekly
5	Buprenorphine	Injection (modified release) 64 mg in 0.18 mL pre‑filled syringe	Injection	Buvidal Monthly
6	Buprenorphine	Injection (modified release) 96 mg in 0.27 mL pre‑filled syringe	Injection	Buvidal Monthly
7	Buprenorphine	Injection (modified release) 128 mg in 0.36 mL pre‑filled syringe	Injection	Buvidal Monthly
8	Buprenorphine	Injection (modified release) 160 mg in 0.45 mL pre‑filled syringe	Injection	Buvidal Monthly
9	Buprenorphine	Injection (modified release) 100 mg in 0.50 mL pre‑filled syringe	Injection	Sublocade
10	Buprenorphine	Injection (modified release) 300 mg in 1.50 mL pre‑filled syringe	Injection	Sublocade
11	Buprenorphine	Tablet (sublingual) 400 micrograms (as hydrochloride)	Sublingual	Subutex
12	Buprenorphine	Tablet (sublingual) 2 mg (as hydrochloride)	Sublingual	Subutex
13	Buprenorphine	Tablet (sublingual) 8 mg (as hydrochloride)	Sublingual	Subutex
14	Buprenorphine with naloxone	Film (soluble) 2 mg (as hydrochloride)‑0.5 mg (as hydrochloride)	Sublingual	Suboxone Film 2/0.5
15	Buprenorphine with naloxone	Film (soluble) 8 mg (as hydrochloride)‑2 mg (as hydrochloride)	Sublingual	Suboxone Film 8/2
16	Methadone	Oral liquid containing methadone hydrochloride 25 mg per 5 mL, 200 mL	Oral	Biodone Forte
17	Methadone	Oral liquid containing methadone hydrochloride 25 mg per 5 mL, 200 mL	Oral	Aspen Methadone Syrup
18	Methadone	Oral liquid containing methadone hydrochloride 25 mg per 5 mL, 1 L	Oral	Biodone Forte
19	Methadone	Oral liquid containing methadone hydrochloride 25 mg per 5 mL, 1 L	Oral	Aspen Methadone Syrup

Note: The drugs mentioned in the table were declared by the Minister under subsection 85(2) of the Act, and the forms, manners of administration and brands mentioned in the table were determined by the Minister under subsections 85(3), (5) and (6) of the Act respectively—see the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012) as in force before 1 July 2023.

Schedule 1—HSD pharmaceutical benefits and related information

Note: See the definitions of highly specialised drug and HSD pharmaceutical benefit in section 6, and sections 13, 15, 20 and 21.

1 Highly specialised drugs and HSD pharmaceutical benefits

(1) Each listed drug specified in the following table is a highly specialised drug.

(2) Each pharmaceutical benefit specified in the following table is an HSD pharmaceutical benefit.

(3) The following table also specifies circumstances, purposes, maximum quantities and maximum repeats for HSD pharmaceutical benefits.

Note: The drugs mentioned in the table have been declared by the Minister under subsection 85(2) of the Act. The forms, manners of administration and brands mentioned in the table have been determined by the Minister under subsections 85(3), (5) and (6) of the Act respectively.

HSD pharmaceutical benefits and related information
Listed drug	Form	Manner of administration	Brand	Circumstances	Purposes	Maximum quantity	Maximum repeats
Abacavir	Oral solution 20 mg (as sulfate) per mL, 240 mL	Oral	Ziagen	C13920		8	5
	Tablet 300 mg (as sulfate)	Oral	Ziagen	C4454 C4512		120	5
Abacavir with Lamivudine	Tablet containing abacavir 600 mg (as sulfate) with lamivudine 300 mg	Oral	ABACAVIR/LAMIVUDINE 600/300 SUN	C4527 C4528		60	5
			Abacavir/ Lamivudine Mylan	C4527 C4528		60	5
			Abacavir/Lamivudine Viatris	C4527 C4528		60	5
			Kivexa	C4527 C4528		60	5
Abatacept	Powder for I.V. infusion 250 mg	Injection	Orencia	C14488 C14507 C14519 C14523 C14524 C14555 C14604 C14617		See Schedule 2	See Schedule 2
Adalimumab	Injection 20 mg in 0.2 mL pre‑filled syringe	Injection	Humira	C12120 C14061 C14063 C14064 C14107 C14136		See Schedule 2	See Schedule 2
	Injection 20 mg in 0.4 mL pre‑filled syringe	Injection	Abrilada	C12120 C14061 C14063 C14064 C14107 C14136		See Schedule 2	See Schedule 2
			Amgevita	C12120 C14061 C14063 C14064 C14107 C14136		See Schedule 2	See Schedule 2
	Injection 40 mg in 0.4 mL pre‑filled pen	Injection	Adalicip	C12120 C14061 C14063 C14064 C14107 C14136		See Schedule 2	See Schedule 2
			Humira	C12120 C14061 C14063 C14064 C14107 C14136		See Schedule 2	See Schedule 2
			Yuflyma	C12120 C14061 C14063 C14064 C14107 C14136		See Schedule 2	See Schedule 2
	Injection 40 mg in 0.4 mL pre‑filled syringe	Injection	Adalicip	C12120 C14061 C14063 C14064 C14107 C14136		See Schedule 2	See Schedule 2
			Humira	C12120 C14061 C14063 C14064 C14107 C14136		See Schedule 2	See Schedule 2
			Yuflyma	C12120 C14061 C14063 C14064 C14107 C14136		See Schedule 2	See Schedule 2
	Injection 40 mg in 0.8 mL pre‑filled pen	Injection	Abrilada	C12120 C14061 C14063 C14064 C14107 C14136		See Schedule 2	See Schedule 2
			Amgevita	C12120 C14061 C14063 C14064 C14107 C14136		See Schedule 2	See Schedule 2
			Hadlima	C12120 C14061 C14063 C14064 C14107 C14136		See Schedule 2	See Schedule 2
			Hyrimoz	C12120 C14061 C14063 C14064 C14107 C14136		See Schedule 2	See Schedule 2
			Idacio	C12120 C14061 C14063 C14064 C14107 C14136		See Schedule 2	See Schedule 2
	Injection 40 mg in 0.8 mL pre‑filled syringe	Injection	Abrilada	C12120 C14061 C14063 C14064 C14107 C14136		See Schedule 2	See Schedule 2
			Amgevita	C12120 C14061 C14063 C14064 C14107 C14136		See Schedule 2	See Schedule 2
			Hadlima	C12120 C14061 C14063 C14064 C14107 C14136		See Schedule 2	See Schedule 2
			Hyrimoz	C12120 C14061 C14063 C14064 C14107 C14136		See Schedule 2	See Schedule 2
			Idacio	C12120 C14061 C14063 C14064 C14107 C14136		See Schedule 2	See Schedule 2
Adefovir	Tablet containing adefovir dipivoxil 10 mg	Oral	APO‑Adefovir	C4490 C4510		60	5
	Tablet containing adefovir dipivoxil 10 mg (S19A)	Oral	Adefovir Dipivoxil Tablets 10 mg (SigmaPharm Laboratories)	C4490 C4510		60	5
Alemtuzumab	Solution concentrate for I.V. infusion 12 mg in 1.2 mL	Injection	Lemtrada	C6847 C7714 C9589 C9636	P6847 P9589	3	0
				C6847 C7714 C9589 C9636	P7714 P9636	5	0
Ambrisentan	Tablet 5 mg	Oral	Ambrisentan Viatris	C11229 C13496 C13497 C13499 C13500 C13575 C13576 C13582		See Schedule 2	See Schedule 2
			Cipla Ambrisentan	C11229 C13496 C13497 C13499 C13500 C13575 C13576 C13582		See Schedule 2	See Schedule 2
			PULMORIS	C11229 C13496 C13497 C13499 C13500 C13575 C13576 C13582		See Schedule 2	See Schedule 2
			Volibris	C11229 C13496 C13497 C13499 C13500 C13575 C13576 C13582		See Schedule 2	See Schedule 2
	Tablet 10 mg	Oral	Ambrisentan Viatris	C11229 C13496 C13497 C13499 C13500 C13575 C13576 C13582		See Schedule 2	See Schedule 2
			Cipla Ambrisentan	C11229 C13496 C13497 C13499 C13500 C13575 C13576 C13582		See Schedule 2	See Schedule 2
			PULMORIS	C11229 C13496 C13497 C13499 C13500 C13575 C13576 C13582		See Schedule 2	See Schedule 2
			Volibris	C11229 C13496 C13497 C13499 C13500 C13575 C13576 C13582		See Schedule 2	See Schedule 2
Anakinra	Injection 100 mg in 0.67 mL single use pre‑filled syringe	Injection	Kineret	C5450		28	5
Anifrolumab	Solution concentrate for I.V. infusion 300 mg in 2 mL	Injection	Saphnelo	C15387 C15388 C15426		See Schedule 2	See Schedule 2
Apomorphine	Injection containing apomorphine hydrochloride hemihydrate 50 mg in 5 mL	Injection	Movapo	C11385 C11445		180	5
	Injection containing apomorphine hydrochloride hemihydrate 100 mg in 20 mL	Injection	Apomine Solution for Infusion	C10830 C10863		90	5
	Solution for subcutaneous infusion containing apomorphine hydrochloride hemihydrate 50 mg in 10 mL pre‑filled syringe	Injection	Movapo PFS	C11385 C11445		180	5
	Solution for subcutaneous injection containing apomorphine hydrochloride 30 mg in 3 mL pre‑filled pen	Injection	Apomine Intermittent	C10830 C10863		100	5
			Movapo Pen	C10830 C10863		100	5
Atazanavir	Capsule 200 mg (as sulfate)	Oral	Reyataz	C4454 C4512		120	5
	Capsule 300 mg (as sulfate)	Oral	Reyataz	C4454 C4512		60	5
Atazanavir with cobicistat	Tablet containing 300 mg atazanavir and 150 mg cobicistat	Oral	Evotaz	C4454 C4512		60	5
Avatrombopag	Tablet 20 mg	Oral	Doptelet	C14054 C14130 C15340 C15375		See Schedule 2	See Schedule 2
Azacitidine	Powder for injection 100 mg	Injection	Azacitidine Accord	C12439 C12983 C12986 C13010 C13011 C13012 C13015 C13029		See Schedule 2	See Schedule 2
			Azacitidine Dr.Reddy's	C12439 C12983 C12986 C13010 C13011 C13012 C13015 C13029		See Schedule 2	See Schedule 2
			AZACITIDINE EUGIA	C12439 C12983 C12986 C13010 C13011 C13012 C13015 C13029		See Schedule 2	See Schedule 2
			Azacitidine Juno	C12439 C12983 C12986 C13010 C13011 C13012 C13015 C13029		See Schedule 2	See Schedule 2
			Azacitidine MSN	C12439 C12983 C12986 C13010 C13011 C13012 C13015 C13029		See Schedule 2	See Schedule 2
			Azacitidine Sandoz	C12439 C12983 C12986 C13010 C13011 C13012 C13015 C13029		See Schedule 2	See Schedule 2
			Azacitidine‑Teva	C12439 C12983 C12986 C13010 C13011 C13012 C13015 C13029		See Schedule 2	See Schedule 2
Azithromycin	Tablet 600 mg (as dihydrate)	Oral	Zithromax	C6356 C9604		16	5
Baclofen	Intrathecal injection 10 mg in 5 mL	Injection	Bacthecal	C6911 C6925 C6939 C6940 C9488 C9489 C9524 C9637		10	0
			Lioresal Intrathecal	C6911 C6925 C6939 C6940 C9488 C9489 C9524 C9637		10	0
			Sintetica Baclofen Intrathecal	C6911 C6925 C6939 C6940 C9488 C9489 C9524 C9637		10	0
	Intrathecal injection 40 mg in 20 mL	Injection	Sintetica Baclofen Intrathecal	C7134 C7148 C7152 C7153 C9525 C9562 C9606 C9638		2	0
Benralizumab	Injection 30 mg in 1 mL single dose pre‑filled pen	Injection	Fasenra Pen	C15353 C15376 C15383 C15444		See Schedule 2	See Schedule 2
Bictegravir with emtricitabine with tenofovir alafenamide	Tablet containing bictegravir 50 mg with emtricitabine 200 mg with tenofovir alafenamide 25 mg	Oral	Biktarvy	C4470 C4522		60	5
Bosentan	Tablet 62.5 mg (as monohydrate)	Oral	Bosentan APO	C11229 C12425 C13495 C13496 C13497 C13499 C13571 C13582 C13632		See Schedule 2	See Schedule 2
			BOSENTAN DR.REDDY’S	C11229 C12425 C13495 C13496 C13497 C13499 C13571 C13582 C13632		See Schedule 2	See Schedule 2
			Bosentan Mylan	C11229 C12425 C13495 C13496 C13497 C13499 C13571 C13582 C13632		See Schedule 2	See Schedule 2
			Bosentan RBX	C11229 C12425 C13495 C13496 C13497 C13499 C13571 C13582 C13632		See Schedule 2	See Schedule 2
			BOSLEER	C11229 C12425 C13495 C13496 C13497 C13499 C13571 C13582 C13632		See Schedule 2	See Schedule 2
	Tablet 125 mg (as monohydrate)	Oral	Bosentan APO	C11229 C13495 C13496 C13497 C13499 C13571 C13582 C13632		See Schedule 2	See Schedule 2
			BOSENTAN DR.REDDY’S	C11229 C13495 C13496 C13497 C13499 C13571 C13582 C13632		See Schedule 2	See Schedule 2
			Bosentan GH	C11229 C13495 C13496 C13497 C13499 C13571 C13582 C13632		See Schedule 2	See Schedule 2
			Bosentan Mylan	C11229 C13495 C13496 C13497 C13499 C13571 C13582 C13632		See Schedule 2	See Schedule 2
			Bosentan RBX	C11229 C13495 C13496 C13497 C13499 C13571 C13582 C13632		See Schedule 2	See Schedule 2
			BOSLEER	C11229 C13495 C13496 C13497 C13499 C13571 C13582 C13632		See Schedule 2	See Schedule 2
Buprenorphine	Injection (modified release) 8 mg in 0.16 mL pre‑filled syringe	Injection	Buvidal Weekly	C15385		4	5
	Injection (modified release) 16 mg in 0.32 mL pre‑filled syringe	Injection	Buvidal Weekly	C15385		4	5
	Injection (modified release) 24 mg in 0.48 mL pre‑filled syringe	Injection	Buvidal Weekly	C15385		4	5
	Injection (modified release) 32 mg in 0.64 mL pre‑filled syringe	Injection	Buvidal Weekly	C15385		4	5
	Injection (modified release) 64 mg in 0.18 mL pre‑filled syringe	Injection	Buvidal Monthly	C15356		1	5
	Injection (modified release) 96 mg in 0.27 mL pre‑filled syringe	Injection	Buvidal Monthly	C15356		1	5
	Injection (modified release) 100 mg in 0.5 mL pre‑filled syringe	Injection	Sublocade	C15439		1	5
	Injection (modified release) 128 mg in 0.36 mL pre‑filled syringe	Injection	Buvidal Monthly	C15356		1	5
	Injection (modified release) 160 mg in 0.45 mL pre‑filled syringe	Injection	Buvidal Monthly	C15356		1	5
	Injection (modified release) 300 mg in 1.5 mL pre‑filled syringe	Injection	Sublocade	C15439		1	5
	Tablet (sublingual) 400 micrograms (as hydrochloride)	Sublingual	Subutex	C15355		28	5
	Tablet (sublingual) 2 mg (as hydrochloride)	Sublingual	Subutex	C15355		84	5
	Tablet (sublingual) 8 mg (as hydrochloride)	Sublingual	Subutex	C15355		112	5
Buprenorphine with naloxone	Film (soluble) 2 mg (as hydrochloride)‑0.5 mg (as hydrochloride)	Sublingual	Suboxone Film 2/0.5	C15355		84	5
	Film (soluble) 8 mg (as hydrochloride)‑2 mg (as hydrochloride)	Sublingual	Suboxone Film 8/2	C15355		112	5
Burosumab	Solution for injection 10 mg in 1 mL	Injection	Crysvita	C13330 C13377		See Schedule 2	See Schedule 2
	Solution for injection 20 mg in 1 mL	Injection	Crysvita	C13330 C13377		See Schedule 2	See Schedule 2
	Solution for injection 30 mg in 1 mL	Injection	Crysvita	C13330 C13377		See Schedule 2	See Schedule 2
Cabotegravir	Tablet 30 mg	Oral	Vocabria	C12619		30	0
Cabotegravir and rilpivirine	Pack containing 1 vial cabotegravir 600 mg in 3 mL and 1 vial rilpivirine 900 mg in 3 mL	Injection	Cabenuva	C12636		1	5
Ciclosporin	Capsule 10 mg	Oral	Neoral 10	C6631 C6638 C6643 C6660 C9694 C9695 C9742 C9764 C15360 C15361		120	5
	Capsule 25 mg	Oral	APO‑Ciclosporin	C6631 C6638 C6643 C6660 C9694 C9695 C9742 C9764 C15360 C15361		120	5
			CICLOSPORIN-WGR	C6631 C6638 C6643 C6660 C9694 C9695 C9742 C9764 C15360 C15361		120	5
			Cyclosporin Sandoz	C6631 C6638 C6643 C6660 C9694 C9695 C9742 C9764 C15360 C15361		120	5
			Neoral 25	C6631 C6638 C6643 C6660 C9694 C9695 C9742 C9764 C15360 C15361		120	5
	Capsule 50 mg	Oral	APO‑Ciclosporin	C6631 C6638 C6643 C6660 C9694 C9695 C9742 C9764 C15360 C15361		120	5
			CICLOSPORIN-WGR	C6631 C6638 C6643 C6660 C9694 C9695 C9742 C9764 C15360 C15361		120	5
			Cyclosporin Sandoz	C6631 C6638 C6643 C6660 C9694 C9695 C9742 C9764 C15360 C15361		120	5
			Neoral 50	C6631 C6638 C6643 C6660 C9694 C9695 C9742 C9764 C15360 C15361		120	5
	Capsule 100 mg	Oral	APO‑Ciclosporin	C6631 C6638 C6643 C6660 C9694 C9695 C9742 C9764 C15360 C15361		120	5
			CICLOSPORIN-WGR	C6631 C6638 C6643 C6660 C9694 C9695 C9742 C9764 C15360 C15361		120	5
			Cyclosporin Sandoz	C6631 C6638 C6643 C6660 C9694 C9695 C9742 C9764 C15360 C15361		120	5
			Neoral 100	C6631 C6638 C6643 C6660 C9694 C9695 C9742 C9764 C15360 C15361		120	5
	Oral liquid 100 mg per mL, 50 mL	Oral	Neoral	C6631 C6638 C6643 C6660 C9694 C9695 C9742 C9764 C15360 C15361		4	5
	Solution concentrate for I.V. infusion 50 mg in 1 mL	Injection	Sandimmun	C6628 C9831		10	0
Cinacalcet	Tablet 30 mg (as hydrochloride)	Oral	Cinacalcet Viatris	C10063 C10067 C10073		56	5
			Pharmacor Cinacalcet	C10063 C10067 C10073		56	5
	Tablet 60 mg (as hydrochloride)	Oral	Cinacalcet Viatris	C10063 C10067 C10073		56	5
			Pharmacor Cinacalcet	C10063 C10067 C10073		56	5
	Tablet 90 mg (as hydrochloride)	Oral	Cinacalcet Viatris	C10063 C10067 C10073		56	5
			Pharmacor Cinacalcet	C10063 C10067 C10073		56	5
Clozapine	Oral liquid 50 mg per mL, 100 mL	Oral	Clopine Suspension	C4998 C5015 C9490		1	0
			Versacloz	C4998 C5015 C9490		1	0
	Tablet 25 mg	Oral	Clopine 25	C4998 C5015 C9490		200	0
			Clozaril 25	C4998 C5015 C9490		200	0
			Clozitor	C4998 C5015 C9490		200	0
	Tablet 50 mg	Oral	Clopine 50	C4998 C5015 C9490		200	0
			Clozitor	C4998 C5015 C9490		200	0
	Tablet 100 mg	Oral	Clopine 100	C4998 C5015 C9490		200	0
			Clozaril 100	C4998 C5015 C9490		200	0
			Clozitor	C4998 C5015 C9490		200	0
	Tablet 200 mg	Oral	Clopine 200	C4998 C5015 C9490		200	0
			Clozitor	C4998 C5015 C9490		200	0
Darbepoetin alfa	Injection 10 micrograms in 0.4 mL pre‑filled syringe	Injection	Aranesp	C6294 C9688		8	5
	Injection 20 micrograms in 0.5 mL pre‑filled injection pen	Injection	Aranesp SureClick	C6294 C9688		8	5
	Injection 20 micrograms in 0.5 mL pre‑filled syringe	Injection	Aranesp	C6294 C9688		8	5
	Injection 30 micrograms in 0.3 mL pre‑filled syringe	Injection	Aranesp	C6294 C9688		8	5
	Injection 40 micrograms in 0.4 mL pre‑filled injection pen	Injection	Aranesp SureClick	C6294 C9688		8	5
	Injection 40 micrograms in 0.4 mL pre‑filled syringe	Injection	Aranesp	C6294 C9688		8	5
	Injection 50 micrograms in 0.5 mL pre‑filled syringe	Injection	Aranesp	C6294 C9688		8	5
	Injection 60 micrograms in 0.3 mL pre‑filled injection pen	Injection	Aranesp SureClick	C6294 C9688		8	5
	Injection 60 micrograms in 0.3 mL pre‑filled syringe	Injection	Aranesp	C6294 C9688		8	5
	Injection 80 micrograms in 0.4 mL pre‑filled injection pen	Injection	Aranesp SureClick	C6294 C9688		8	5
	Injection 80 micrograms in 0.4 mL pre‑filled syringe	Injection	Aranesp	C6294 C9688		8	5
	Injection 100 micrograms in 0.5 mL pre‑filled injection pen	Injection	Aranesp SureClick	C6294 C9688		8	5
	Injection 100 micrograms in 0.5 mL pre‑filled syringe	Injection	Aranesp	C6294 C9688		8	5
	Injection 150 micrograms in 0.3 mL pre‑filled injection pen	Injection	Aranesp SureClick	C6294 C9688		8	5
	Injection 150 micrograms in 0.3 mL pre‑filled syringe	Injection	Aranesp	C6294 C9688		8	5
Darunavir	Tablet 600 mg	Oral	Darunavir Juno	C5094		120	5
	Tablet 600 mg (as ethanolate)	Oral	Prezista	C5094		120	5
	Tablet 800 mg	Oral	Darunavir Juno	C4313		60	5
	Tablet 800mg (as ethanolate)	Oral	Prezista	C4313		60	5
Darunavir with cobicistat	Tablet containing darunavir 800mg with cobicistat 150 mg	Oral	Prezcobix	C6377 C6413 C6428		60	5
Darunavir with cobicistat, emtricitabine and tenofovir alafenamide	Tablet containing darunavir 800 mg with cobicistat 150 mg, emtricitabine 200 mg and tenofovir alafenamide 10 mg	Oral	Symtuza	C10317 C10324		60	5
Daunorubicin with cytarabine	Powder for I.V. infusion containing daunorubicin 44 mg (as hydrochloride) and cytarabine 100 mg	Injection	Vyxeos	C15390 C15413		See Schedule 2	See Schedule 2
Deferasirox	Tablet 90 mg	Oral	Deferasirox ARX	C7374 C7375 C7385 C8326 C8328 C8329 C9222 C9258 C9302	P7385 P8326 P8328 P8329 P9222 P9258 P9302	180	2
			Deferasirox Sandoz	C7374 C7375 C7385 C8326 C8328 C8329 C9222 C9258 C9302	P7385 P8326 P8328 P8329 P9222 P9258 P9302	180	2
			DEFERASIROX‑TEVA	C7374 C7375 C7385 C8326 C8328 C8329 C9222 C9258 C9302	P7385 P8326 P8328 P8329 P9222 P9258 P9302	180	2
			Eferas	C7374 C7375 C7385 C8326 C8328 C8329 C9222 C9258 C9302	P7385 P8326 P8328 P8329 P9222 P9258 P9302	180	2
			Jadenu	C7374 C7375 C7385 C8326 C8328 C8329 C9222 C9258 C9302	P7385 P8326 P8328 P8329 P9222 P9258 P9302	180	2
			Pharmacor Deferasirox FC	C7374 C7375 C7385 C8326 C8328 C8329 C9222 C9258 C9302	P7385 P8326 P8328 P8329 P9222 P9258 P9302	180	2
			Deferasirox ARX	C7374 C7375 C7385 C8326 C8328 C8329 C9222 C9258 C9302	P7374 P7375	180	5
			Deferasirox Sandoz	C7374 C7375 C7385 C8326 C8328 C8329 C9222 C9258 C9302	P7374 P7375	180	5
			DEFERASIROX‑TEVA	C7374 C7375 C7385 C8326 C8328 C8329 C9222 C9258 C9302	P7374 P7375	180	5
			Eferas	C7374 C7375 C7385 C8326 C8328 C8329 C9222 C9258 C9302	P7374 P7375	180	5
			Jadenu	C7374 C7375 C7385 C8326 C8328 C8329 C9222 C9258 C9302	P7374 P7375	180	5
			Pharmacor Deferasirox FC	C7374 C7375 C7385 C8326 C8328 C8329 C9222 C9258 C9302	P7374 P7375	180	5
	Tablet 180 mg	Oral	Deferasirox ARX	C7374 C7375 C7385 C8326 C8328 C8329 C9222 C9258 C9302	P7385 P8326 P8328 P8329 P9222 P9258 P9302	180	2
			Deferasirox Sandoz	C7374 C7375 C7385 C8326 C8328 C8329 C9222 C9258 C9302	P7385 P8326 P8328 P8329 P9222 P9258 P9302	180	2
			DEFERASIROX‑TEVA	C7374 C7375 C7385 C8326 C8328 C8329 C9222 C9258 C9302	P7385 P8326 P8328 P8329 P9222 P9258 P9302	180	2
			Eferas	C7374 C7375 C7385 C8326 C8328 C8329 C9222 C9258 C9302	P7385 P8326 P8328 P8329 P9222 P9258 P9302	180	2
			Jadenu	C7374 C7375 C7385 C8326 C8328 C8329 C9222 C9258 C9302	P7385 P8326 P8328 P8329 P9222 P9258 P9302	180	2
			Pharmacor Deferasirox FC	C7374 C7375 C7385 C8326 C8328 C8329 C9222 C9258 C9302	P7385 P8326 P8328 P8329 P9222 P9258 P9302	180	2
			Deferasirox ARX	C7374 C7375 C7385 C8326 C8328 C8329 C9222 C9258 C9302	P7374 P7375	180	5
			Deferasirox Sandoz	C7374 C7375 C7385 C8326 C8328 C8329 C9222 C9258 C9302	P7374 P7375	180	5
			DEFERASIROX‑TEVA	C7374 C7375 C7385 C8326 C8328 C8329 C9222 C9258 C9302	P7374 P7375	180	5
			Eferas	C7374 C7375 C7385 C8326 C8328 C8329 C9222 C9258 C9302	P7374 P7375	180	5
			Jadenu	C7374 C7375 C7385 C8326 C8328 C8329 C9222 C9258 C9302	P7374 P7375	180	5
			Pharmacor Deferasirox FC	C7374 C7375 C7385 C8326 C8328 C8329 C9222 C9258 C9302	P7374 P7375	180	5
	Tablet 360 mg	Oral	Deferasirox ARX	C7374 C7375 C7385 C8326 C8328 C8329 C9222 C9258 C9302	P7385 P8326 P8328 P8329 P9222 P9258 P9302	180	2
			Deferasirox Sandoz	C7374 C7375 C7385 C8326 C8328 C8329 C9222 C9258 C9302	P7385 P8326 P8328 P8329 P9222 P9258 P9302	180	2
			DEFERASIROX‑TEVA	C7374 C7375 C7385 C8326 C8328 C8329 C9222 C9258 C9302	P7385 P8326 P8328 P8329 P9222 P9258 P9302	180	2
			Eferas	C7374 C7375 C7385 C8326 C8328 C8329 C9222 C9258 C9302	P7385 P8326 P8328 P8329 P9222 P9258 P9302	180	2
			Jadenu	C7374 C7375 C7385 C8326 C8328 C8329 C9222 C9258 C9302	P7385 P8326 P8328 P8329 P9222 P9258 P9302	180	2
			Pharmacor Deferasirox FC	C7374 C7375 C7385 C8326 C8328 C8329 C9222 C9258 C9302	P7385 P8326 P8328 P8329 P9222 P9258 P9302	180	2
			Deferasirox ARX	C7374 C7375 C7385 C8326 C8328 C8329 C9222 C9258 C9302	P7374 P7375	180	5
			Deferasirox Sandoz	C7374 C7375 C7385 C8326 C8328 C8329 C9222 C9258 C9302	P7374 P7375	180	5
			DEFERASIROX‑TEVA	C7374 C7375 C7385 C8326 C8328 C8329 C9222 C9258 C9302	P7374 P7375	180	5
			Eferas	C7374 C7375 C7385 C8326 C8328 C8329 C9222 C9258 C9302	P7374 P7375	180	5
			Jadenu	C7374 C7375 C7385 C8326 C8328 C8329 C9222 C9258 C9302	P7374 P7375	180	5
			Pharmacor Deferasirox FC	C7374 C7375 C7385 C8326 C8328 C8329 C9222 C9258 C9302	P7374 P7375	180	5
	Tablet, dispersible, 125 mg	Oral	Deferasirox Juno	C7374 C7375 C7385 C8326 C8328 C8329 C9222 C9258 C9302	P7385 P8326 P8328 P8329 P9222 P9258 P9302	168	2
			Pharmacor Deferasirox	C7374 C7375 C7385 C8326 C8328 C8329 C9222 C9258 C9302	P7385 P8326 P8328 P8329 P9222 P9258 P9302	168	2
			Deferasirox Juno	C7374 C7375 C7385 C8326 C8328 C8329 C9222 C9258 C9302	P7374 P7375	168	5
			Pharmacor Deferasirox	C7374 C7375 C7385 C8326 C8328 C8329 C9222 C9258 C9302	P7374 P7375	168	5
	Tablet, dispersible, 250 mg	Oral	Deferasirox Juno	C7374 C7375 C7385 C8326 C8328 C8329 C9222 C9258 C9302	P7385 P8326 P8328 P8329 P9222 P9258 P9302	168	2
			Pharmacor Deferasirox	C7374 C7375 C7385 C8326 C8328 C8329 C9222 C9258 C9302	P7385 P8326 P8328 P8329 P9222 P9258 P9302	168	2
			Deferasirox Juno	C7374 C7375 C7385 C8326 C8328 C8329 C9222 C9258 C9302	P7374 P7375	168	5
			Pharmacor Deferasirox	C7374 C7375 C7385 C8326 C8328 C8329 C9222 C9258 C9302	P7374 P7375	168	5
	Tablet, dispersible, 500 mg	Oral	Deferasirox Juno	C7374 C7375 C7385 C8326 C8328 C8329 C9222 C9258 C9302	P7385 P8326 P8328 P8329 P9222 P9258 P9302	168	2
			Pharmacor Deferasirox	C7374 C7375 C7385 C8326 C8328 C8329 C9222 C9258 C9302	P7385 P8326 P8328 P8329 P9222 P9258 P9302	168	2
			Deferasirox Juno	C7374 C7375 C7385 C8326 C8328 C8329 C9222 C9258 C9302	P7374 P7375	168	5
			Pharmacor Deferasirox	C7374 C7375 C7385 C8326 C8328 C8329 C9222 C9258 C9302	P7374 P7375	168	5
Deferiprone	Oral solution 100 mg per mL, 250 mL	Oral	Ferriprox	C6403 C6448 C9228 C9286		5	5
	Tablet 500 mg	Oral	Ferriprox	C6403 C6448 C9228 C9286		300	5
	Tablet 1000 mg	Oral	Ferriprox	C6403 C6448 C9590 C9623		300	5
Desferrioxamine	Powder for injection containing desferrioxamine mesilate 500 mg	Injection	DBL Desferrioxamine Mesilate	C6394 C9696		400	5
	Powder for injection containing desferrioxamine mesilate 2 g	Injection	DBL Desferrioxamine Mesilate	C6394 C9696		60	5
Difelikefalin	Solution for I.V. injection 50 micrograms (as acetate) in 1 mL	Injection	Korsuva	C15171 C15211 C15227		See Schedule 2	See Schedule 2
Dolutegravir	Tablet 50mg (as sodium)	Oral	Tivicay	C4454 C4512		60	5
Dolutegravir with abacavir and lamivudine	Tablet containing dolutegravir 50 mg with abacavir 600 mg and lamivudine 300 mg	Oral	Triumeq	C9981 C10116		60	5
Dolutegravir with lamivudine	Tablet containing dolutegravir 50 mg (as sodium) with lamivudine 300 mg	Oral	Dovato	C9987 C11066		60	5
Dolutegravir with rilpivirine	Tablet containing dolutegravir 50 mg (as sodium) with rilpivirine 25 mg (as hydrochloride)	Oral	Juluca	C8214 C8226		60	5
Dornase Alfa	Solution for inhalation 2.5 mg (2,500 units) in 2.5 mL	Inhalation	Pulmozyme	C5634 C5635 C5740 C9591 C9592 C9624		60	5
Doxorubicin ‑ Pegylated Liposomal	Suspension for I.V. infusion containing pegylated liposomal doxorubicin hydrochloride 20 mg in 10 mL	Injection	Caelyx	C6234 C6274 C9223 C9287		4	5
			Liposomal Doxorubicin SUN	C6234 C6274 C9223 C9287		4	5
Dupilumab	Injection 200 mg in 1.14 mL single dose pre‑filled syringe	Injection	Dupixent	C15341 C15348 C15433		See Schedule 2	See Schedule 2
	Injection 300 mg in 2 mL single dose pre‑filled syringe	Injection	Dupixent	C15348 C15424 C15425		See Schedule 2	See Schedule 2
Eculizumab	Solution concentrate for I.V. infusion 300 mg in 30 mL	Injection	Soliris	C13458 C13459 C13464 C13560 C13660 C13661 C13684 C13845 C13857 C14750 C14753 C14754 C14781 C14792 C14793 C14799 C14805		See Schedule 2	See Schedule 2
Elexacaftor with tezacaftor and with ivacaftor, and ivacaftor	Pack containing 28 sachets containing granules elexacaftor 80 mg with tezacaftor 40 mg and with ivacaftor 60 mg and 28 sachets containing granules ivacaftor 59.5 mg	Oral	Trikafta	C15482 C15511		See Schedule 2	See Schedule 2
	Pack containing 28 sachets containing granules elexacaftor 100 mg with tezacaftor 50 mg and with ivacaftor 75 mg and 28 sachets containing granules ivacaftor 75 mg	Oral	Trikafta	C15482 C15511		See Schedule 2	See Schedule 2
	Pack containing 56 tablets elexacaftor 50 mg with tezacaftor 25 mg and with ivacaftor 37.5 mg and 28 tablets ivacaftor 75 mg	Oral	Trikafta	C13932 C13991		See Schedule 2	See Schedule 2
	Pack containing 56 tablets elexacaftor 100 mg with tezacaftor 50 mg and with ivacaftor 75 mg and 28 tablets ivacaftor 150 mg	Oral	Trikafta	C13962 C13980		See Schedule 2	See Schedule 2
Eltrombopag	Tablet 25 mg (as olamine)	Oral	Revolade	C13327 C14126 C14127 C14129 C15173 C15174 C15191 C15192		See Schedule 2	See Schedule 2
	Tablet 50 mg (as olamine)	Oral	Revolade	C13327 C14126 C14127 C14129 C15173 C15174 C15191 C15192		See Schedule 2	See Schedule 2
Emtricitabine with rilpivirine with tenofovir alafenamide	Tablet containing emtricitabine 200 mg with rilpivirine 25 mg with tenofovir alafenamide 25 mg	Oral	Odefsey	C4470 C4522		60	5
Emtricitabine with tenofovir alafenamide	Tablet containing emtricitabine 200 mg with tenofovir alafenamide 10 mg	Oral	Descovy	C4454 C4512		60	5
	Tablet containing emtricitabine 200 mg with tenofovir alafenamide 25 mg	Oral	Descovy	C4454 C4512		60	5
Entecavir	Tablet 0.5 mg (as monohydrate)	Oral	ENTAC	C4993 C5036		60	5
			ENTECAVIR APO	C4993 C5036		60	5
			Entecavir GH	C4993 C5036		60	5
			Entecavir Mylan	C4993 C5036		60	5
			ENTECAVIR RBX	C4993 C5036		60	5
			Entecavir Sandoz	C4993 C5036		60	5
			Entecavir Viatris	C4993 C5036		60	5
			ENTECAVIR-WGR	C4993 C5036		60	5
			ENTECLUDE	C4993 C5036		60	5
	Tablet 1 mg (as monohydrate)	Oral	ENTECAVIR APO	C5037 C5044		60	5
			Entecavir Mylan	C5037 C5044		60	5
			ENTECAVIR RBX	C5037 C5044		60	5
			Entecavir Sandoz	C5037 C5044		60	5
			Entecavir Viatris	C5037 C5044		60	5
			ENTECAVIR-WGR	C5037 C5044		60	5
			ENTECLUDE	C5037 C5044		60	5
Epoetin Alfa	Injection 1,000 units in 0.5 mL pre‑filled syringe	Injection	Eprex 1000	C6294 C9688		12	5
	Injection 2,000 units in 0.5 mL pre‑filled syringe	Injection	Eprex 2000	C6294 C9688		12	5
	Injection 3,000 units in 0.3 mL pre‑filled syringe	Injection	Eprex 3000	C6294 C9688		12	5
	Injection 4,000 units in 0.4 mL pre‑filled syringe	Injection	Eprex 4000	C6294 C9688		12	5
	Injection 5,000 units in 0.5 mL pre‑filled syringe	Injection	Eprex 5000	C6294 C9688		12	5
	Injection 6,000 units in 0.6 mL pre‑filled syringe	Injection	Eprex 6000	C6294 C9688		12	5
	Injection 8,000 units in 0.8 mL pre‑filled syringe	Injection	Eprex 8000	C6294 C9688		12	5
	Injection 10,000 units in 1 mL pre‑filled syringe	Injection	Eprex 10000	C6294 C9688		12	5
	Injection 20,000 units in 0.5 mL pre‑filled syringe	Injection	Eprex 20,000	C6294 C9688		12	5
	Injection 40,000 units in 1 mL pre‑filled syringe	Injection	Eprex 40,000	C6294 C9688		2	5
Epoetin Beta	Injection 2,000 units in 0.3 mL pre‑filled syringe	Injection	NeoRecormon	C6294 C9688		12	5
	Injection 3,000 units in 0.3 mL pre‑filled syringe	Injection	NeoRecormon	C6294 C9688		12	5
	Injection 4,000 units in 0.3 mL pre‑filled syringe	Injection	NeoRecormon	C6294 C9688		12	5
	Injection 5,000 units in 0.3 mL pre‑filled syringe	Injection	NeoRecormon	C6294 C9688		12	5
	Injection 6,000 units in 0.3 mL pre‑filled syringe	Injection	NeoRecormon	C6294 C9688		12	5
	Injection 10,000 units in 0.6 mL pre‑filled syringe	Injection	NeoRecormon	C6294 C9688		12	5
Epoetin lambda	Injection 1,000 units in 0.5 mL pre‑filled syringe	Injection	Novicrit	C6294 C9688		12	5
	Injection 2,000 units in 1 mL pre‑filled syringe	Injection	Novicrit	C6294 C9688		12	5
	Injection 3,000 units in 0.3 mL pre‑filled syringe	Injection	Novicrit	C6294 C9688		12	5
	Injection 4,000 units in 0.4 mL pre‑filled syringe	Injection	Novicrit	C6294 C9688		12	5
	Injection 5,000 units in 0.5 mL pre‑filled syringe	Injection	Novicrit	C6294 C9688		12	5
	Injection 6,000 units in 0.6 mL pre‑filled syringe	Injection	Novicrit	C6294 C9688		12	5
	Injection 8,000 units in 0.8 mL pre‑filled syringe	Injection	Novicrit	C6294 C9688		12	5
	Injection 10,000 units in 1 mL pre‑filled syringe	Injection	Novicrit	C6294 C9688		12	5
Epoprostenol	Powder for I.V. infusion 500 micrograms (as sodium)	Injection	Veletri	C13491 C13505 C13506 C13510 C13512 C13577 C13634		See Schedule 2	See Schedule 2
	Powder for I.V. infusion 500 micrograms (as sodium) with 2 vials diluent 50 mL	Injection	Flolan	C13491 C13505 C13506 C13510 C13512 C13577 C13634		See Schedule 2	See Schedule 2
	Powder for I.V. infusion 1.5 mg (as sodium)	Injection	Veletri	C13491 C13505 C13506 C13510 C13512 C13577 C13634		See Schedule 2	See Schedule 2
	Powder for I.V. infusion 1.5 mg (as sodium) with 2 vials diluent 50 mL	Injection	Flolan	C13491 C13505 C13506 C13510 C13512 C13577 C13634		See Schedule 2	See Schedule 2
Etanercept	Injection 50 mg in 1 mL single use auto‑injector, 4	Injection	Enbrel	C9417 C14068 C14070 C14071 C14154 C14155		See Schedule 2	See Schedule 2
	Injections 50 mg in 1 mL single use pre‑filled syringes, 4	Injection	Enbrel	C9417 C14068 C14070 C14071 C14154 C14155		See Schedule 2	See Schedule 2
	Injection set containing 4 vials powder for injection 25 mg and 4 pre‑filled syringes solvent 1 mL	Injection	Enbrel	C9417 C14068 C14070 C14071 C14154 C14155		See Schedule 2	See Schedule 2
Etravirine	Tablet 200 mg	Oral	Intelence	C5014		120	5
Everolimus	Tablet 0.25 mg	Oral	Certican	C5554 C5795 C9691 C9693		120	5
			Everocan	C5554 C5795 C9691 C9693		120	5
	Tablet 0.5 mg	Oral	Certican	C5554 C5795 C9691 C9693		120	5
			Everocan	C5554 C5795 C9691 C9693		120	5
	Tablet 0.75 mg	Oral	Certican	C5554 C5795 C9691 C9693		240	5
			Everocan	C5554 C5795 C9691 C9693		240	5
	Tablet 1 mg	Oral	Certican	C5554 C5795 C9691 C9693		240	5
			Everocan	C5554 C5795 C9691 C9693		240	5
Filgrastim	Injection 120 micrograms in 0.2 mL single‑use pre‑filled syringe	Injection	Nivestim	C6621 C6640 C6653 C6654 C6655 C6679 C6680 C7822 C7843 C8667 C8668 C8669 C8670 C8671 C8672 C8673 C8674 C8696		20	11
	Injection 300 micrograms in 0.5 mL single‑use pre‑filled syringe	Injection	Nivestim	C6621 C6640 C6653 C6654 C6655 C6679 C6680 C7822 C7843 C8667 C8668 C8669 C8670 C8671 C8672 C8673 C8674 C8696		20	11
			Zarzio	C6621 C6640 C6653 C6654 C6655 C6679 C6680 C7822 C7843 C8667 C8668 C8669 C8670 C8671 C8672 C8673 C8674 C8696		20	11
	Injection 480 micrograms in 0.5 mL single‑use pre‑filled syringe	Injection	Nivestim	C6621 C6640 C6653 C6654 C6655 C6679 C6680 C7822 C7843 C8667 C8668 C8669 C8670 C8671 C8672 C8673 C8674 C8696		20	11
			Zarzio	C6621 C6640 C6653 C6654 C6655 C6679 C6680 C7822 C7843 C8667 C8668 C8669 C8670 C8671 C8672 C8673 C8674 C8696		20	11
Ganciclovir	Powder for I.V. infusion 500 mg (as sodium)	Injection	Cymevene	C5000 C15782 C15784 C15800 C15814		10	1
			GANCICLOVIR SXP	C5000 C15782 C15784 C15800 C15814		10	1
Glecaprevir with pibrentasvir	Tablet containing 100 mg glecaprevir with 40 mg pibrentasvir	Oral	Maviret	C7593 C7615 C10268	P7593	84	1
				C7593 C7615 C10268	P7615	84	2
				C7593 C7615 C10268	P10268	84	3
Iloprost	Solution for inhalation 20 micrograms (as trometamol) in 2 mL	Inhalation	Ventavis	C13491 C13505 C13506 C13510 C13577 C13631 C13634		See Schedule 2	See Schedule 2
Infliximab	Powder for I.V. infusion 100 mg	Injection	Inflectra	C4524 C7777 C8296 C8844 C8881 C8883 C8940 C8941 C8962 C9065 C9067 C9068 C9111 C9188 C9472 C9559 C9584 C9602 C9632 C9668 C9669 C9677 C9719 C9721 C9732 C9751 C9754 C9775 C9779 C9783 C9787 C9803 C11158 C12003 C12025 C12042 C12043 C12049 C12051 C12059 C12063 C12069 C12074 C12313 C13518 C13526 C13584 C13586 C13587 C13639 C13640 C13641 C13691 C13692 C13702 C13719 C14359 C14360 C14502 C14504 C14505 C14507 C14544 C14546 C14547 C14548 C14585 C14597 C14615 C14623 C14638 C14667 C14683 C14689 C14701 C14705 C14707 C14716 C14718 C14723 C14724 C14737		See Schedule 2	See Schedule 2
			Remicade	C4524 C7777 C8296 C8881 C8883 C8941 C8962 C9065 C9067 C9068 C9111 C9559 C9632 C9669 C9677 C9719 C9721 C9751 C9754 C9779 C9783 C9803 C11158 C12003 C12025 C12043 C12049 C12059 C12063 C12313 C13518 C13526 C13584 C13586 C13587 C13639 C13640 C13641 C13691 C13692 C13702 C13719 C14359 C14360 C14504 C14505 C14507 C14546 C14547 C14548 C14597 C14615 C14667 C14705 C14716 C14718 C14724 C14737		See Schedule 2	See Schedule 2
			Renflexis	C4524 C7777 C8296 C8844 C8881 C8883 C8940 C8941 C8962 C9065 C9067 C9068 C9111 C9188 C9472 C9559 C9584 C9602 C9632 C9668 C9669 C9677 C9719 C9721 C9732 C9751 C9754 C9775 C9779 C9783 C9787 C9803 C11158 C12003 C12025 C12042 C12043 C12049 C12051 C12059 C12063 C12069 C12074 C12313 C13518 C13526 C13584 C13586 C13587 C13639 C13640 C13641 C13691 C13692 C13702 C13719 C14359 C14360 C14502 C14504 C14505 C14507 C14544 C14546 C14547 C14548 C14585 C14597 C14615 C14623 C14638 C14667 C14683 C14689 C14701 C14705 C14707 C14716 C14718 C14723 C14724 C14737		See Schedule 2	See Schedule 2
Interferon Gamma‑1b	Injection 2,000,000 I.U. in 0.5 mL	Injection	Imukin	C6222 C9639		12	11
Ivacaftor	Sachet containing granules 25 mg	Oral	Kalydeco	C15251 C15252 C15253 C15255		See Schedule 2	See Schedule 2
	Sachet containing granules 50 mg	Oral	Kalydeco	C15251 C15252 C15253 C15255		See Schedule 2	See Schedule 2
	Sachet containing granules 75 mg	Oral	Kalydeco	C15251 C15252 C15253 C15255		See Schedule 2	See Schedule 2
	Tablet 150 mg	Oral	Kalydeco	C15251 C15252 C15253 C15255		See Schedule 2	See Schedule 2
Lamivudine	Oral solution 10 mg per mL, 240 mL	Oral	3TC	C4454 C4512		8	5
	Tablet 100 mg	Oral	Zeffix	C4993 C5036		56	5
			Zetlam	C4993 C5036		56	5
	Tablet 150 mg	Oral	3TC	C4454 C4512		120	5
			Lamivudine Alphapharm	C4454 C4512		120	5
	Tablet 300 mg	Oral	3TC	C4454 C4512		60	5
			Lamivudine Alphapharm	C4454 C4512		60	5
Lamivudine with Zidovudine	Tablet 150 mg‑300 mg	Oral	Combivir	C4454 C4512		120	5
			Lamivudine/Zidovudine Viatris 150/300	C4454 C4512		120	5
Lanreotide	Injection 60 mg (as acetate) in single dose pre‑filled syringe	Injection	Mytolac	C4575 C7025 C7509 C7532 C9260 C9261		2	5
			Somatuline Autogel	C4575 C7025 C7509 C7532 C9260 C9261		2	5
	Injection 90 mg (as acetate) in single dose pre‑filled syringe	Injection	Mytolac	C4575 C7025 C7509 C7532 C9260 C9261		2	5
			Somatuline Autogel	C4575 C7025 C7509 C7532 C9260 C9261		2	5
	Injection 120 mg (as acetate) in single dose pre‑filled syringe	Injection	Mytolac	C4575 C7025 C7509 C7532 C9260 C9261 C10061 C10075 C10077		2	5
			Somatuline Autogel	C4575 C7025 C7509 C7532 C9260 C9261 C10061 C10075 C10077		2	5
Lanthanum	Tablet, chewable, 500 mg (as carbonate hydrate)	Oral	Fosrenol	C5530 C9762		180	5
	Tablet, chewable, 750 mg (as carbonate hydrate)	Oral	Fosrenol	C5530 C9762		180	5
	Tablet, chewable, 1000 mg (as carbonate hydrate)	Oral	Fosrenol	C5530 C9762		180	5
Lenalidomide	Capsule 5 mg	Oral	Cipla Lenalidomide	C13782 C13785 C13786 C13787 C13791 C13801 C13803 C13804 C13805 C13810 C13811 C13812 C13813 C14362		See Schedule 2	See Schedule 2
			Lenalide	C13782 C13785 C13786 C13787 C13791 C13801 C13803 C13804 C13805 C13810 C13811 C13812 C13813 C14362		See Schedule 2	See Schedule 2
			Lenalidomide Dr.Reddy's	C13782 C13785 C13786 C13787 C13791 C13801 C13803 C13804 C13805 C13810 C13811 C13812 C13813 C14362		See Schedule 2	See Schedule 2
			Lenalidomide Sandoz	C13782 C13785 C13786 C13787 C13791 C13801 C13803 C13804 C13805 C13810 C13811 C13812 C13813 C14362		See Schedule 2	See Schedule 2
			Lenalidomide‑Teva	C13782 C13785 C13786 C13787 C13791 C13801 C13803 C13804 C13805 C13810 C13811 C13812 C13813 C14362		See Schedule 2	See Schedule 2
			Lenalidomide Viatris	C13782 C13785 C13786 C13787 C13791 C13801 C13803 C13804 C13805 C13810 C13811 C13812 C13813 C14362		See Schedule 2	See Schedule 2
			Revlimid	C13782 C13785 C13786 C13787 C13791 C13801 C13803 C13804 C13805 C13810 C13811 C13812 C13813 C14362		See Schedule 2	See Schedule 2
	Capsule 10 mg	Oral	Cipla Lenalidomide	C13782 C13785 C13786 C13787 C13791 C13801 C13803 C13804 C13805 C13810 C13811 C13812 C13813 C14362		See Schedule 2	See Schedule 2
			Lenalide	C13782 C13785 C13786 C13787 C13791 C13801 C13803 C13804 C13805 C13810 C13811 C13812 C13813 C14362		See Schedule 2	See Schedule 2
			Lenalidomide Dr.Reddy's	C13782 C13785 C13786 C13787 C13791 C13801 C13803 C13804 C13805 C13810 C13811 C13812 C13813 C14362		See Schedule 2	See Schedule 2
			Lenalidomide Sandoz	C13782 C13785 C13786 C13787 C13791 C13801 C13803 C13804 C13805 C13810 C13811 C13812 C13813 C14362		See Schedule 2	See Schedule 2
			Lenalidomide‑Teva	C13782 C13785 C13786 C13787 C13791 C13801 C13803 C13804 C13805 C13810 C13811 C13812 C13813 C14362		See Schedule 2	See Schedule 2
			Lenalidomide Viatris	C13782 C13785 C13786 C13787 C13791 C13801 C13803 C13804 C13805 C13810 C13811 C13812 C13813 C14362		See Schedule 2	See Schedule 2
			Revlimid	C13782 C13785 C13786 C13787 C13791 C13801 C13803 C13804 C13805 C13810 C13811 C13812 C13813 C14362		See Schedule 2	See Schedule 2
	Capsule 15 mg	Oral	Cipla Lenalidomide	C13782 C13785 C13786 C13787 C13791 C13803 C13804 C13805 C13811 C13812 C13813 C14362		See Schedule 2	See Schedule 2
			Lenalide	C13782 C13785 C13786 C13787 C13791 C13803 C13804 C13805 C13811 C13812 C13813 C14362		See Schedule 2	See Schedule 2
			Lenalidomide Dr.Reddy's	C13782 C13785 C13786 C13787 C13791 C13803 C13804 C13805 C13811 C13812 C13813 C14362		See Schedule 2	See Schedule 2
			Lenalidomide Sandoz	C13782 C13785 C13786 C13787 C13791 C13803 C13804 C13805 C13811 C13812 C13813 C14362		See Schedule 2	See Schedule 2
			Lenalidomide‑Teva	C13782 C13785 C13786 C13787 C13791 C13803 C13804 C13805 C13811 C13812 C13813 C14362		See Schedule 2	See Schedule 2
			Lenalidomide Viatris	C13782 C13785 C13786 C13787 C13791 C13801 C13803 C13804 C13805 C13810 C13811 C13812 C13813 C14362		See Schedule 2	See Schedule 2
			Revlimid	C13782 C13785 C13786 C13787 C13791 C13803 C13804 C13805 C13811 C13812 C13813 C14362		See Schedule 2	See Schedule 2
	Capsule 25 mg	Oral	Cipla Lenalidomide	C13782 C13785 C13786 C13787 C13803 C13805 C13811 C13812 C13813 C14362		See Schedule 2	See Schedule 2
			Lenalide	C13782 C13785 C13786 C13787 C13803 C13805 C13811 C13812 C13813 C14362		See Schedule 2	See Schedule 2
			Lenalidomide Dr.Reddy's	C13782 C13785 C13786 C13787 C13803 C13805 C13811 C13812 C13813 C14362		See Schedule 2	See Schedule 2
			Lenalidomide Sandoz	C13782 C13785 C13786 C13787 C13803 C13805 C13811 C13812 C13813 C14362		See Schedule 2	See Schedule 2
			Lenalidomide‑Teva	C13782 C13785 C13786 C13787 C13803 C13805 C13811 C13812 C13813 C14362		See Schedule 2	See Schedule 2
			Lenalidomide Viatris	C13782 C13785 C13786 C13787 C13791 C13801 C13803 C13804 C13805 C13810 C13811 C13812 C13813 C14362		See Schedule 2	See Schedule 2
			Revlimid	C13782 C13785 C13786 C13787 C13803 C13805 C13811 C13812 C13813 C14362		See Schedule 2	See Schedule 2
Levodopa with carbidopa	Intestinal gel containing levodopa 20 mg with carbidopa monohydrate 5 mg per mL, 100 mL	Intra‑ intestinal	Duodopa	C10138 C10161 C10363 C10375	P10138 P10161	28	5
				C10138 C10161 C10363 C10375	P10363 P10375	56	5
Lipegfilgrastim	Injection 6 mg in 0.6 mL single use pre‑filled syringe	Injection	Lonquex	C7822 C7843 C9224 C9322		1	11
Lopinavir with ritonavir	Oral liquid 400 mg‑100 mg per 5 mL, 60 mL	Oral	Kaletra	C4454 C4512		10	5
	Tablet 200 mg‑50 mg	Oral	Kaletra	C4454 C4512		240	5
Lumacaftor with ivacaftor	Sachet containing granules, lumacaftor 75 mg and ivacaftor 94 mg	Oral	Orkambi	C14757 C14765		See Schedule 2	See Schedule 2
	Sachet containing granules, lumacaftor 100 mg and ivacaftor 125 mg	Oral	Orkambi	C14757 C14765		See Schedule 2	See Schedule 2
	Sachet containing granules, lumacaftor 150 mg and ivacaftor 188 mg	Oral	Orkambi	C14757 C14765		See Schedule 2	See Schedule 2
	Tablet containing lumacaftor 100 mg with ivacaftor 125 mg	Oral	Orkambi	C14783 C14784		See Schedule 2	See Schedule 2
	Tablet containing lumacaftor 200 mg with ivacaftor 125 mg	Oral	Orkambi	C14785 C14796		See Schedule 2	See Schedule 2
Macitentan	Tablet 10 mg	Oral	Opsumit	C11229 C13496 C13497 C13499 C13500 C13575 C13576 C13582		See Schedule 2	See Schedule 2
Mannitol	Pack containing 280 capsules containing powder for inhalation 40 mg and 2 inhalers	Inhalation by mouth	Bronchitol	C7362 C7367 C9527 C9593		4	5
Maraviroc	Tablet 150 mg	Oral	Celsentri	C5008		120	5
	Tablet 300 mg	Oral	Celsentri	C5008		120	5
Mepolizumab	Injection 100 mg in 1 mL single dose pre‑filled pen	Injection	Nucala	C13865 C13890 C15344 C15353 C15376 C15400		See Schedule 2	See Schedule 2
	Powder for injection 100 mg	Injection	Nucala	C15344 C15353 C15376 C15400		See Schedule 2	See Schedule 2
Methadone	Oral liquid containing methadone hydrochloride 25 mg per 5 mL in 1 L bottle, 1 mL	Oral	Aspen Methadone Syrup	C15358		840	5
			Biodone Forte	C15358		840	5
	Oral liquid containing methadone hydrochloride 25 mg per 5 mL in 200 mL bottle, 1 mL	Oral	Aspen Methadone Syrup	C15358		840	5
			Biodone Forte	C15358		840	5
Methoxsalen	Solution for blood fraction 20 microgram per mL, 10 mL	Extracorporeal Circulation	Uvadex	C10971 C10985 C10988 C10989 C12531 C12546 C12567 C12579	P10988 P10989	1	5
				C10971 C10985 C10988 C10989 C12531 C12546 C12567 C12579	P12531 P12567	2	0
				C10971 C10985 C10988 C10989 C12531 C12546 C12567 C12579	P10971 P10985	2	6
				C10971 C10985 C10988 C10989 C12531 C12546 C12567 C12579	P12546 P12579	12	1
Methoxy polyethylene glycol‑epoetin beta	Injection 30 micrograms in 0.3 mL pre‑filled syringe	Injection	Mircera	C6294 C9688		2	5
	Injection 50 micrograms in 0.3 mL pre‑filled syringe	Injection	Mircera	C6294 C9688		2	5
	Injection 75 micrograms in 0.3 mL pre‑filled syringe	Injection	Mircera	C6294 C9688		2	5
	Injection 100 micrograms in 0.3 mL pre‑filled syringe	Injection	Mircera	C6294 C9688		2	5
	Injection 120 micrograms in 0.3 mL pre‑filled syringe	Injection	Mircera	C6294 C9688		2	5
	Injection 200 micrograms in 0.3 mL pre‑filled syringe	Injection	Mircera	C6294 C9688		2	5
	Injection 360 micrograms in 0.6 mL pre‑filled syringe	Injection	Mircera	C6294 C9688		2	5
Midostaurin	Capsule 25 mg	Oral	Rydapt	C11699 C13001 C13013		See Schedule 2	See Schedule 2
Mycophenolic acid	Capsule containing mycophenolate mofetil 250 mg	Oral	APO‑Mycophenolate	C5600 C5653 C9689 C9690		600	5
			Ceptolate	C5600 C5653 C9689 C9690		600	5
			Mycophenolate Sandoz	C5600 C5653 C9689 C9690		600	5
			Pharmacor Mycophenolate 250	C5600 C5653 C9689 C9690		600	5
	Powder for oral suspension containing mycophenolate mofetil 1 g per 5 mL, 165 mL	Oral	CellCept	C5554 C5795 C9691 C9693		2	5
			Pharmacor Mycophenolate	C5554 C5795 C9691 C9693		2	5
	Tablet containing mycophenolate mofetil 500 mg	Oral	ARX-MYCOPHENOLATE	C5554 C5795 C9691 C9693		300	5
			Ceptolate	C5554 C5795 C9691 C9693		300	5
			MycoCept	C5554 C5795 C9691 C9693		300	5
			Mycophenolate APOTEX	C5554 C5795 C9691 C9693		300	5
			Mycophenolate GH	C5554 C5795 C9691 C9693		300	5
			Mycophenolate Sandoz	C5554 C5795 C9691 C9693		300	5
			Pharmacor Mycophenolate 500	C5554 C5795 C9691 C9693		300	5
	Tablet (enteric coated) containing mycophenolate sodium equivalent to 180 mg mycophenolic acid	Oral	Mycophenolic Acid ARX	C4084 C4095 C9692 C9809		240	5
			Myfortic	C4084 C4095 C9692 C9809		240	5
	Tablet (enteric coated) containing mycophenolate sodium equivalent to 360 mg mycophenolic acid	Oral	Mycophenolic Acid ARX	C4084 C4095 C9692 C9809		240	5
			MYCOTEX	C4084 C4095 C9692 C9809		240	5
			Myfortic	C4084 C4095 C9692 C9809		240	5
Natalizumab	Injection 150 mg in 1 mL single dose pre-filled syringe	Injection	Tysabri	C13625 C13718		2	5
	Solution concentrate for I.V. infusion 300 mg in 15 mL	Injection	Tysabri	C13625 C13718		1	5
Nevirapine	Oral suspension 50 mg (as hemihydrate) per 5 mL, 240 mL	Oral	Viramune	C4454 C4512		10	5
	Tablet 200 mg	Oral	Nevirapine Alphapharm	C4454 C4512		120	5
			Nevirapine Viatris	C4454 C4512		120	5
	Tablet 400 mg (extended release)	Oral	Viramune XR	C4454 C4526		60	5
Nivolumab with relatlimab	Solution concentrate for I.V. infusion containing 240 mg nivolumab and 80 mg relatlimab in 20 mL	Injection	Opdualag	C14812 C14815 C14819 C14829	P14812 P14819	2	8
				C14812 C14815 C14819 C14829	P14815 P14829	2	11
Nusinersen	Solution for injection 12 mg in 5 mL	Injection	Spinraza	C12672 C12676 C13222 C13270 C14370 C14421 C14433 C14459 C15066 C15069 C15112 C15116		See Schedule 2	See Schedule 2
Ocrelizumab	Solution concentrate for I.V. infusion 300 mg in 10 mL	Injection	Ocrevus	C7386 C7699 C9523 C9635		2	0
Octreotide	Injection 50 micrograms (as acetate) in 1 mL	Injection	Octreotide GH	C6369 C6390 C8165 C9232 C9233 C9289		90	11
			Octreotide (SUN)	C6369 C6390 C8165 C9232 C9233 C9289		90	11
			Sandostatin 0.05	C6369 C6390 C8165 C9232 C9233 C9289		90	11
	Injection 50 micrograms (as acetate) in 1 mL (S19A)	Injection	Octreotide Acetate Omega (Canada)	C6369 C6390 C8165 C9232 C9233 C9289		90	11
	Injection 100 micrograms (as acetate) in 1 mL	Injection	Octreotide GH	C6369 C6390 C8165 C9232 C9233 C9289		90	11
			Octreotide (SUN)	C6369 C6390 C8165 C9232 C9233 C9289		90	11
			Sandostatin 0.1	C6369 C6390 C8165 C9232 C9233 C9289		90	11
	Injection 100 micrograms (as acetate) in 1 mL (S19A)	Injection	Octreotide Acetate Omega (Canada)	C6369 C6390 C8165 C9232 C9233 C9289		90	11
	Injection 500 micrograms (as acetate) in 1 mL	Injection	Octreotide Acetate Omega (Canada)	C6369 C6390 C8165 C9232 C9233 C9289		90	11
			Octreotide GH	C6369 C6390 C8165 C9232 C9233 C9289		90	11
			Octreotide (SUN)	C6369 C6390 C8165 C9232 C9233 C9289		90	11
			Sandostatin 0.5	C6369 C6390 C8165 C9232 C9233 C9289		90	11
	Injection (modified release) 10 mg (as acetate), vial and diluent syringe	Injection	Octreotide Depot	C5901 C5906 C8161 C8197 C8198 C8208 C9262 C9288 C9313		2	5
			Sandostatin LAR	C5901 C5906 C8161 C8197 C8198 C8208 C9262 C9288 C9313		2	5
	Injection (modified release) 20 mg (as acetate), vial and diluent syringe	Injection	Octreotide Depot	C5901 C5906 C8161 C8197 C8198 C8208 C9262 C9288 C9313		2	5
			Sandostatin LAR	C5901 C5906 C8161 C8197 C8198 C8208 C9262 C9288 C9313		2	5
	Injection (modified release) 30 mg (as acetate), vial and diluent syringe	Injection	Octreotide Depot	C5901 C5906 C8161 C8197 C8198 C8208 C9262 C9288 C9313 C10061 C10075 C10077		2	5
			Sandostatin LAR	C5901 C5906 C8161 C8197 C8198 C8208 C9262 C9288 C9313 C10061 C10075 C10077		2	5
Omalizumab	Injection 75 mg in 0.5 mL single dose pre‑filled syringe	Injection	Xolair	C15346 C15347 C15350 C15352 C15376 C15401 C15403		See Schedule 2	See Schedule 2
	Injection 150 mg in 1 mL single dose pre‑filled syringe	Injection	Xolair	C7046 C7055 C15346 C15347 C15350 C15352 C15376 C15401 C15403		See Schedule 2	See Schedule 2
Onasemnogene abeparvovec	Pack containing 1 vial solution for I.V. infusion 20 trillion vector genomes per mL, 5.5 mL and 2 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL	Injection	Zolgensma	C12639 C14468 C15458 C15460		See Schedule 2	See Schedule 2
	Pack containing 1 vial solution for I.V. infusion 20 trillion vector genomes per mL, 5.5 mL and 3 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL	Injection	Zolgensma	C12639 C14468 C15458 C15460		See Schedule 2	See Schedule 2
	Pack containing 1 vial solution for I.V. infusion 20 trillion vector genomes per mL, 5.5 mL and 4 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL	Injection	Zolgensma	C12639 C14468 C15458 C15460		See Schedule 2	See Schedule 2
	Pack containing 1 vial solution for I.V. infusion 20 trillion vector genomes per mL, 5.5 mL and 5 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL	Injection	Zolgensma	C12639 C14468 C15458 C15460		See Schedule 2	See Schedule 2
	Pack containing 1 vial solution for I.V. infusion 20 trillion vector genomes per mL, 5.5 mL and 6 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL	Injection	Zolgensma	C12639 C14468 C15458 C15460		See Schedule 2	See Schedule 2
	Pack containing 1 vial solution for I.V. infusion 20 trillion vector genomes per mL, 5.5 mL and 7 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL	Injection	Zolgensma	C12639 C14468 C15458 C15460		See Schedule 2	See Schedule 2
	Pack containing 1 vial solution for I.V. infusion 20 trillion vector genomes per mL, 5.5 mL and 8 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL	Injection	Zolgensma	C12639 C14468 C15458 C15460		See Schedule 2	See Schedule 2
	Pack containing 2 vials solution for I.V. infusion 20 trillion vector genomes per mL, 5.5 mL and 1 vial solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL	Injection	Zolgensma	C12639 C14468 C15458 C15460		See Schedule 2	See Schedule 2
	Pack containing 2 vials solution for I.V. infusion 20 trillion vector genomes per mL, 5.5 mL and 2 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL	Injection	Zolgensma	C12639 C14468 C15458 C15460		See Schedule 2	See Schedule 2
	Pack containing 2 vials solution for I.V. infusion 20 trillion vector genomes per mL, 5.5 mL and 3 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL	Injection	Zolgensma	C12639 C14468 C15458 C15460		See Schedule 2	See Schedule 2
	Pack containing 2 vials solution for I.V. infusion 20 trillion vector genomes per mL, 5.5 mL and 4 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL	Injection	Zolgensma	C12639 C14468 C15458 C15460		See Schedule 2	See Schedule 2
	Pack containing 2 vials solution for I.V. infusion 20 trillion vector genomes per mL, 5.5 mL and 5 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL	Injection	Zolgensma	C12639 C14468 C15458 C15460		See Schedule 2	See Schedule 2
	Pack containing 2 vials solution for I.V. infusion 20 trillion vector genomes per mL, 5.5 mL and 6 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL	Injection	Zolgensma	C12639 C14468 C15458 C15460		See Schedule 2	See Schedule 2
	Pack containing 2 vials solution for I.V. infusion 20 trillion vector genomes per mL, 5.5 mL and 7 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL	Injection	Zolgensma	C12639 C14468 C15458 C15460		See Schedule 2	See Schedule 2
	Pack containing 2 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL	Injection	Zolgensma	C12639 C14468 C15458 C15460		See Schedule 2	See Schedule 2
	Pack containing 3 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL	Injection	Zolgensma	C12639 C14468 C15458 C15460		See Schedule 2	See Schedule 2
	Pack containing 4 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL	Injection	Zolgensma	C12639 C14468 C15458 C15460		See Schedule 2	See Schedule 2
	Pack containing 5 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL	Injection	Zolgensma	C12639 C14468 C15458 C15460		See Schedule 2	See Schedule 2
	Pack containing 6 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL	Injection	Zolgensma	C12639 C14468 C15458 C15460		See Schedule 2	See Schedule 2
	Pack containing 7 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL	Injection	Zolgensma	C12639 C14468 C15458 C15460		See Schedule 2	See Schedule 2
	Pack containing 8 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL	Injection	Zolgensma	C12639 C14468 C15458 C15460		See Schedule 2	See Schedule 2
	Pack containing 9 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL	Injection	Zolgensma	C12639 C14468 C15458 C15460		See Schedule 2	See Schedule 2
Pamidronic Acid	Concentrated injection containing pamidronate disodium 15 mg in 5 mL	Injection	Pamisol	C4433 C9234		4	2
	Concentrated injection containing pamidronate disodium 30 mg in 10 mL	Injection	Pamisol	C4433 C9234		2	2
	Concentrated injection containing pamidronate disodium 60 mg in 10 mL	Injection	Pamisol	C4433 C9234		1	2
	Concentrated injection containing pamidronate disodium 90 mg in 10 mL	Injection	Pamisol	C4433 C5218 C5291 C9234 C9315 C9335		1	11
Pasireotide	Injection (modified release) 20 mg (as embonate), vial and diluent syringe	Injection	Signifor LAR	C9088 C9089		See Schedule 2	See Schedule 2
	Injection (modified release) 40 mg (as embonate), vial and diluent syringe	Injection	Signifor LAR	C9088 C9089		See Schedule 2	See Schedule 2
	Injection (modified release) 60 mg (as embonate), vial and diluent syringe	Injection	Signifor LAR	C9088 C9089		See Schedule 2	See Schedule 2
Patisiran	Solution concentrate for I.V. infusion 10 mg in 5 mL	Injection	Onpattro	C15453 C15478 C15501		See Schedule 2	See Schedule 2
Pegcetacoplan	Solution for subcutaneous infusion 1,080 mg in 20 mL	Injection	Empaveli	C13616 C13655 C13710 C13743		See Schedule 2	See Schedule 2
Pegfilgrastim	Injection 6 mg in 0.6 mL single use pre‑filled syringe	Injection	Pelgraz	C7822 C7843 C9235 C9303		1	11
			Ziextenzo	C7822 C7843 C9235 C9303		1	11
Peginterferon alfa‑2a	Injection 135 micrograms in 0.5 mL single use pre‑filled syringe	Injection	Pegasys	C5004 C9603		8	5
	Injection 180 micrograms in 0.5 mL single use pre‑filled syringe	Injection	Pegasys	C5004 C9603		8	5
Pegvisomant	Injection set containing powder for injection 10 mg, 30 and diluent, 30	Injection	Somavert	C7087 C9041		See Schedule 2	See Schedule 2
	Injection set containing powder for injection 15 mg, 30 and diluent, 30	Injection	Somavert	C7087 C9041		See Schedule 2	See Schedule 2
	Injection set containing powder for injection 20 mg, 1 and diluent, 1	Injection	Somavert	C9041		See Schedule 2	See Schedule 2
	Injection set containing powder for injection 20 mg, 30 and diluent, 30	Injection	Somavert	C7087 C9041		See Schedule 2	See Schedule 2
Plerixafor	Injection 24 mg in 1.2 mL	Injection	Mozobil	C4549 C9329		1	1
			Plerixafor ARX	C4549 C9329		1	1
			PLERIXAFOR EUGIA	C4549 C9329		1	1
Pomalidomide	Capsule 1 mg	Oral	Pomolide	C13746 C13755 C13757 C13768		See Schedule 2	See Schedule 2
			Pomalidomide Sandoz	C13746 C13755		See Schedule 2	See Schedule 2
	Capsule 2 mg	Oral	Pomolide	C13746 C13755 C13757 C13768		See Schedule 2	See Schedule 2
			Pomalidomide Sandoz	C13746 C13755		See Schedule 2	See Schedule 2
	Capsule 3 mg	Oral	Pomalidomide Sandoz	C13746 C13755 C13757 C13768		See Schedule 2	See Schedule 2
			Pomalyst	C13746 C13755 C13757 C13768		See Schedule 2	See Schedule 2
			Pomolide	C13746 C13755 C13757 C13768		See Schedule 2	See Schedule 2
	Capsule 4 mg	Oral	Pomalidomide Sandoz	C13746 C13755 C13757 C13768		See Schedule 2	See Schedule 2
			Pomalyst	C13746 C13755 C13757 C13768		See Schedule 2	See Schedule 2
			Pomolide	C13746 C13755 C13757 C13768		See Schedule 2	See Schedule 2
Raltegravir	Tablet 400 mg (as potassium)	Oral	Isentress	C4454 C4512		120	5
	Tablet 600 mg (as potassium)	Oral	Isentress HD	C4454 C4512		120	5
Ravulizumab	Solution concentrate for I.V. infusion 300 mg in 3 mL	Injection	Ultomiris	C13459 C14476 C14477 C14530 C14531 C14565 C14586 C14744 C14746 C14747 C14748 C14749 C14780 C14791 C14797		See Schedule 2	See Schedule 2
	Solution concentrate for I.V. infusion 1,100 mg in 11 mL	Injection	Ultomiris	C13459 C14476 C14477 C14530 C14531 C14565 C14586 C14744 C14746 C14747 C14748 C14749 C14780 C14791 C14797		See Schedule 2	See Schedule 2
Ribavirin	Tablet 200 mg	Oral	Ibavyr	C5957		200	2
Rifabutin	Capsule 150 mg	Oral	Mycobutin	C6350 C6356 C9560 C9622		120	5
Rilpivirine	Tablet 25 mg (as hydrochloride)	Oral	Edurant	C4454 C4512		60	5
Riociguat	Tablet 500 micrograms	Oral	Adempas	C13502 C13514 C13515 C15271 C15272 C15274		See Schedule 2	See Schedule 2
	Tablet 1 mg	Oral	Adempas	C13502 C13514 C13515 C15271 C15272 C15274		See Schedule 2	See Schedule 2
	Tablet 1.5 mg	Oral	Adempas	C13502 C13514 C13515 C15271 C15272 C15274		See Schedule 2	See Schedule 2
	Tablet 2 mg	Oral	Adempas	C13502 C13514 C13515 C15271 C15272 C15274		See Schedule 2	See Schedule 2
	Tablet 2.5 mg	Oral	Adempas	C13502 C13514 C13515 C15271 C15272 C15274		See Schedule 2	See Schedule 2
Risdiplam	Powder for oral solution 750 micrograms per mL, 80 mL	Oral	Evrysdi	C14368 C14372 C14392 C14408 C14420 C14435 C14458 C15095		See Schedule 2	See Schedule 2
Ritonavir	Tablet 100 mg	Oral	Norvir	C4454 C4512		720	5
Rituximab	Solution for I.V. infusion 100 mg in 10 mL	Injection	Riximyo			6	0
			Ruxience			6	0
			Truxima			6	0
	Solution for I.V. infusion 500 mg in 50 mL	Injection	Riximyo			2	1
			Ruxience			2	1
			Truxima			2	1
Romiplostim	Powder for injection 375 micrograms	Injection	Nplate	C13396 C14098 C14099 C14149		See Schedule 2	See Schedule 2
	Powder for injection 625 micrograms	Injection	Nplate	C13396 C14098 C14099 C14149		See Schedule 2	See Schedule 2
Ruxolitinib	Tablet 5 mg	Oral	Jakavi	C13876 C13892 C13907 C13911	P13907 P13911	56	0
				C13876 C13892 C13907 C13911	P13876 P13892	56	5
	Tablet 10 mg	Oral	Jakavi	C13876 C13892 C13907 C13911	P13907 P13911	56	0
				C13876 C13892 C13907 C13911	P13876 P13892	56	5
Selexipag	Tablet 200 micrograms	Oral	Uptravi	C11193 C11195 C11261		See Schedule 2	See Schedule 2
	Tablet 400 micrograms	Oral	Uptravi	C11193 C11195		See Schedule 2	See Schedule 2
	Tablet 600 micrograms	Oral	Uptravi	C11193 C11195		See Schedule 2	See Schedule 2
	Tablet 800 micrograms	Oral	Uptravi	C11193 C11195 C11261		See Schedule 2	See Schedule 2
	Tablet 1 mg	Oral	Uptravi	C11193 C11195		See Schedule 2	See Schedule 2
	Tablet 1.2 mg	Oral	Uptravi	C11193 C11195		See Schedule 2	See Schedule 2
	Tablet 1.4 mg	Oral	Uptravi	C11193 C11195		See Schedule 2	See Schedule 2
	Tablet 1.6 mg	Oral	Uptravi	C11193 C11195		See Schedule 2	See Schedule 2
Selinexor	Tablet 20 mg	Oral	Xpovio	C14021 C14023 C14024 C14031 C14039 C14045	P14021 P14045	16	2
				C14021 C14023 C14024 C14031 C14039 C14045	P14023 P14024	20	2
				C14021 C14023 C14024 C14031 C14039 C14045	P14031 P14039	32	2
Sevelamer	Tablet containing sevelamer carbonate 800 mg	Oral	ARX-SEVELAMER	C5530 C9762		360	5
			Sevelamer Apotex	C5530 C9762		360	5
			Sevelamer Lupin	C5530 C9762		360	5
	Tablet containing sevelamer hydrochloride 800 mg	Oral	Renagel	C5530 C9762		360	5
Sildenafil	Tablet 20 mg (as citrate)	Oral	Revatio	C11229 C13482 C13484 C13569 C13570 C13572 C13573 C13629		See Schedule 2	See Schedule 2
			SILDATIO PHT	C11229 C13482 C13484 C13569 C13570 C13572 C13573 C13629		See Schedule 2	See Schedule 2
			Sildenafil PHT APOTEX	C11229 C13482 C13484 C13569 C13570 C13572 C13573 C13629		See Schedule 2	See Schedule 2
			Sildenafil Sandoz PHT 20	C11229 C13482 C13484 C13569 C13570 C13572 C13573 C13629		See Schedule 2	See Schedule 2
Siltuximab	Powder for injection 100 mg	Injection	Sylvant	C12585 C12594		2	4
	Powder for injection 400 mg	Injection	Sylvant	C12585 C12594		2	4
Sirolimus	Oral solution 1 mg per mL, 60 mL	Oral	Rapamune	C5795 C9914		2	5
	Tablet 0.5 mg	Oral	Rapamune	C5795 C9914		200	5
	Tablet 1 mg	Oral	Rapamune	C5795 C9914		200	5
	Tablet 2 mg	Oral	Rapamune	C5795 C9914		200	5
Sofosbuvir with velpatasvir	Tablet containing 400 mg sofosbuvir with 100 mg velpatasvir	Oral	Epclusa	C5969		28	2
Sofosbuvir with velpatasvir and voxilaprevir	Tablet containing 400 mg sofosbuvir with 100 mg velpatasvir and 100 mg voxilaprevir	Oral	Vosevi	C10248		28	2
Sucroferric oxyhydroxide	Tablet, chewable, 2.5 g (equivalent to 500 mg iron)	Oral	Velphoro	C5530 C9762		180	5
Tacrolimus	Capsule 0.5 mg	Oral	Pacrolim	C5569 C9697		200	5
			Pharmacor Tacrolimus 0.5	C5569 C9697		200	5
			Prograf	C5569 C9697		200	5
			Tacrograf	C5569 C9697		200	5
			Tacrolimus Sandoz	C5569 C9697		200	5
	Capsule 0.5 mg (once daily prolonged release)	Oral	ADVAGRAF XL	C5569 C9697		60	5
			Tacrolimus XR Sandoz	C5569 C9697		60	5
	Capsule 0.75 mg	Oral	Tacrolimus Sandoz	C5569 C9697		200	5
	Capsule 1 mg	Oral	Pacrolim	C5569 C9697		200	5
			Pharmacor Tacrolimus 1	C5569 C9697		200	5
			Prograf	C5569 C9697		200	5
			Tacrograf	C5569 C9697		200	5
			Tacrolimus Sandoz	C5569 C9697		200	5
	Capsule 1 mg (once daily prolonged release)	Oral	ADVAGRAF XL	C5569 C9697		120	5
			Tacrolimus XR Sandoz	C5569 C9697		120	5
	Capsule 2 mg	Oral	Tacrolimus Sandoz	C5569 C9697		200	5
	Capsule 3 mg (once daily prolonged release)	Oral	ADVAGRAF XL	C5569 C9697		100	3
			Tacrolimus XR Sandoz	C5569 C9697		100	3
	Capsule 5 mg	Oral	Pharmacor Tacrolimus 5	C5569 C9697		100	5
			Prograf	C5569 C9697		100	5
			Tacrograf	C5569 C9697		100	5
			Tacrolimus Sandoz	C5569 C9697		100	5
	Capsule 5 mg (once daily prolonged release)	Oral	ADVAGRAF XL	C5569 C9697		60	5
			Tacrolimus XR Sandoz	C5569 C9697		60	5
Tadalafil	Tablet 20 mg	Oral	Adcirca	C11229 C13482 C13569 C13570 C13572 C13573 C15508 C15515		See Schedule 2	See Schedule 2
			Tadalca	C11229 C13482 C13569 C13570 C13572 C13573 C15508 C15515		See Schedule 2	See Schedule 2
			TADALIS 20	C11229 C13482 C13569 C13570 C13572 C13573 C15508 C15515		See Schedule 2	See Schedule 2
			Tadalis 20	C15463 C15464 C15486 C15494 C15495 C15505 C15513 C15525		See Schedule 2	See Schedule 2
Teduglutide	Powder for injection 5 mg with diluent	Injection	Revestive	C11999 C14534 C14632		See Schedule 2	See Schedule 2
Tenofovir	Tablet containing tenofovir disoproxil fumarate 300 mg	Oral	Tenofovir APOTEX	C6980 C6982 C6983 C6984 C6992 C6998 C10362	P10362	60	2
			TENOFOVIR ARX	C6980 C6982 C6983 C6984 C6992 C6998 C10362	P10362	60	2
			Tenofovir Sandoz	C6980 C6982 C6983 C6984 C6992 C6998 C10362	P10362	60	2
			Viread	C6980 C6982 C6983 C6984 C6992 C6998 C10362	P10362	60	2
			Tenofovir APOTEX	C6980 C6982 C6983 C6984 C6992 C6998 C10362	P6980 P6982 P6983 P6984 P6992 P6998	60	5
			TENOFOVIR ARX	C6980 C6982 C6983 C6984 C6992 C6998 C10362	P6980 P6982 P6983 P6984 P6992 P6998	60	5
			Tenofovir Sandoz	C6980 C6982 C6983 C6984 C6992 C6998 C10362	P6980 P6982 P6983 P6984 P6992 P6998	60	5
			Viread	C6980 C6982 C6983 C6984 C6992 C6998 C10362	P6980 P6982 P6983 P6984 P6992 P6998	60	5
	Tablet containing tenofovir disoproxil maleate 300 mg	Oral	Tenofovir Disoproxil Mylan	C6980 C6982 C6983 C6984 C6992 C6998 C10362	P10362	60	2
			Tenofovir Disoproxil Viatris	C6980 C6982 C6983 C6984 C6992 C6998 C10362	P10362	60	2
			Tenofovir Disoproxil Mylan	C6980 C6982 C6983 C6984 C6992 C6998 C10362	P6980 P6982 P6983 P6984 P6992 P6998	60	5
			Tenofovir Disoproxil Viatris	C6980 C6982 C6983 C6984 C6992 C6998 C10362	P6980 P6982 P6983 P6984 P6992 P6998	60	5
	Tablet containing tenofovir disoproxil phosphate 291 mg	Oral	Tenofovir GH	C6980 C6982 C6983 C6984 C6992 C6998 C10362	P10362	60	2
				C6980 C6982 C6983 C6984 C6992 C6998 C10362	P6980 P6982 P6983 P6984 P6992 P6998	60	5
Tenofovir alafenamide with emtricitabine, elvitegravir and cobicistat	Tablet containing tenofovir alafenamide 10 mg with emtricitabine 200 mg, elvitegravir 150 mg and cobicistat 150 mg	Oral	Genvoya	C4470 C4522		60	5
Tenofovir with emtricitabine	Tablet containing tenofovir disoproxil fumarate 300 mg with emtricitabine 200 mg	Oral	CIPLA TENOFOVIR + EMTRICITABINE 300/200	C6985 C6986		60	5
			Tenofovir/Emtricitabine 300/200 APOTEX	C6985 C6986		60	5
			TENOFOVIR/EMTRICITABINE 300/200 ARX	C6985 C6986		60	5
	Tablet containing tenofovir disoproxil maleate 300 mg with emtricitabine 200 mg	Oral	Tenofovir Disoproxil Emtricitabine Viatris 300/200	C6985 C6986		60	5
	Tablet containing tenofovir disoproxil phosphate 291 mg with emtricitabine 200 mg	Oral	Tenofovir EMT GH	C6985 C6986		60	5
	Tablet containing tenofovir disoproxil succinate 301 mg with emtricitabine 200 mg	Oral	Tenofovir/Emtricitabine Sandoz 301/200	C6985 C6986		60	5
Tenofovir with emtricitabine and efavirenz	Tablet containing tenofovir disoproxil maleate 300 mg with emtricitabine 200 mg and efavirenz 600 mg	Oral	Tenofovir Disoproxil Emtricitabine Efavirenz Viatris 300/200/600	C4470 C4522		60	5
Tezacaftor with ivacaftor and ivacaftor	Pack containing 28 tablets tezacaftor 100 mg with ivacaftor 150 mg and 28 tablets ivacaftor 150 mg	Oral	Symdeko	C12609 C12614 C12630 C12635		See Schedule 2	See Schedule 2
Thalidomide	Capsule 50 mg	Oral	Thalomid	C5914 C9290		112	0
	Capsule 100 mg	Oral	Thalomid	C5914 C9290		56	0
Tocilizumab	Concentrate for injection 80 mg in 4 mL	Injection	Actemra	C9380 C9386 C9407 C9417 C9494 C9495 C10570 C12163 C12436 C12450 C12451 C14082 C14083 C14085 C14091 C14093 C14145 C14148 C14162 C14164 C14179 C14485 C14487 C14488 C14489 C14491 C14507 C14538 C14621		See Schedule 2	See Schedule 2
	Concentrate for injection 200 mg in 10 mL	Injection	Actemra	C9380 C9386 C9407 C9417 C9494 C9495 C10570 C12163 C12436 C12450 C12451 C14082 C14083 C14085 C14091 C14093 C14145 C14148 C14162 C14164 C14179 C14485 C14487 C14488 C14489 C14491 C14507 C14538 C14621		See Schedule 2	See Schedule 2
	Concentrate for injection 400 mg in 20 mL	Injection	Actemra	C9380 C9386 C9407 C9417 C9494 C9495 C10570 C12163 C12436 C12450 C12451 C14082 C14083 C14085 C14091 C14093 C14145 C14148 C14162 C14164 C14179 C14485 C14487 C14488 C14489 C14491 C14507 C14538 C14621		See Schedule 2	See Schedule 2
Ustekinumab	Solution for I.V. infusion 130 mg in 26 mL	Injection	Stelara	C9655 C9656 C9710 C13975 C13976 C14010 C14758 C14787 C14801		See Schedule 2	See Schedule 2
Valaciclovir	Tablet 500 mg (as hydrochloride)	Oral	APX Valaciclovir	C5975 C9267		500	2