(a) where immediately before the commencement of this Part, a person or body was under the Pharmaceutical Benefits Act 1947–1952:

an approved pharmaceutical chemist approved in respect of one or more premises;

an approved medical practitioner approved in respect of an area; or

an approved hospital authority approved in respect of one or more hospitals;

that person or body shall be deemed to be an approved pharmacist in respect of those premises, an approved medical practitioner in respect of that area or an approved hospital authority in respect of that hospital or those hospitals under section 90, 92 or 94, as the case requires, and the provisions of this Act apply to and in relation to that person or body accordingly; and

(b) a special arrangement made in pursuance of Pharmaceutical Benefits Act 1947–1952 which was in force immediately before the commencement of this Part shall continue in force as if made in pursuance of section 100.section 15 of the

owned, or was about to own, a business for the supply of pharmaceutical benefits at or from particular premises; and

(b) was purportedly approved under the Pharmaceutical Benefits Act 1947–1952 as an approved pharmaceutical chemist.

if a price agreement is in force in relation to the brand of the pharmaceutical item—the amount in force under the agreement as the amount that is, for the purposes of this Part, taken to be the appropriate maximum price of the brand of the pharmaceutical item; or

if a price determination is in force in relation to the brand of the pharmaceutical item—the amount in force under the determination as the amount that is, for the purposes of this Part, taken to be the appropriate maximum price of the brand of the pharmaceutical item.

approved hospital authority means a hospital authority for the time being approved, or deemed to be approved, under section 94.

approved medical practitioner means a medical practitioner for the time being approved, or deemed to be approved, under section 92.

approved pharmacist means a person for the time being approved under section 90 and includes: a person treated as having been so approved under any provision of a law of the Commonwealth other than section 91 or 91B; and except so far as subsection 90(3) is concerned—a person treated as having been so approved under section 91 or 91B.

a person treated as having been so approved under any provision of a law of the Commonwealth other than section 91 or 91B; and

except so far as subsection 90(3) is concerned—a person treated as having been so approved under section 91 or 91B.

approved supplier means an approved pharmacist, an approved medical practitioner or an approved hospital authority.

authorised midwife means an eligible midwife in relation to whom an approval is in force under section 84AAF.

authorised nurse practitioner means an eligible nurse practitioner in relation to whom an approval is in force under section 84AAJ.

authorised optometrist means an optometrist in relation to whom an approval is in force under section 84AAB.

Authority means the Australian Community Pharmacy Authority established under section 99J.

brand of a pharmaceutical item means:

the trade name under which the person who is or will be the responsible person supplies the pharmaceutical item; or

if there is no trade name—the name of the person who is or will be the responsible person.

Chairperson means the Chairperson of the Tribunal.

child, in relation to a member of a friendly society, means:

a child under the age of 16 years of that member; or

a child of that member who:

has attained the age of 16 years;

is receiving full-time education at a school, college or university;

is wholly or substantially dependent on that member or on the spouse of that member; and

is a person who is to be treated as a child of that member in accordance with the rules of the friendly society.

claimed price means the amount specified in a determination in force under subsection 85B(3).

co-marketed brands has the meaning given by section 84AE.

combination item means a pharmaceutical item that has a drug that contains at least 2 other drugs or medicinal preparations, at least one of which is a listed drug.

combination item has a drug: see subsection 84ABA(2).

Commonwealth officer means:

the Governor-General; or

a Minister; or

a member of the Parliament of the Commonwealth; or

a person who is in the employment of the Commonwealth; or

a person who holds or performs the duties of any office or position established by or under a law of the Commonwealth; or

a member of the Australian Defence Force; or

(h) the Commissioner of the Australian Federal Police, a Deputy Commissioner of the Australian Federal Police, an AFP employee, a special member or a special protective service officer (all within the meaning of the Australian Federal Police Act 1979).

Commonwealth price means:

in relation to a pharmaceutical benefit supplied by an approved pharmacist—the Commonwealth price for the particular quantity or number of units of the pharmaceutical benefit worked out in accordance with a determination in force under paragraph 98B(1)(a); or

in relation to a pharmaceutical benefit supplied by an approved medical practitioner—the Commonwealth price for the particular quantity or number of units of the pharmaceutical benefit worked out in accordance with a determination in force under subsection 98C(1); or

in relation to a pharmaceutical benefit supplied by an approved hospital authority to a patient receiving treatment in or at a hospital in respect of which the authority is approved—the amount of the payment to which the authority is entitled under subsection 99(4) in respect of the supply of the particular quantity or number of units of the pharmaceutical benefit.

communicated means communicated directly or indirectly.

communicated prescription means a prescription that is communicated to an approved pharmacist in the circumstances and manner set out in regulations made for the purposes of paragraph 89(a).

concessional beneficiary means:

(a) a person who is the holder of a pensioner concession card, a seniors health card or a health care card under the Social Security Act 1991; or

a person (other than the holder of the card) whose name is included in a card referred to in paragraph (a); or

a person:

(i) who is an Australian resident within the meaning of the Health Insurance Act 1973; and

(ii) who is eligible for fringe benefits under Veterans’ Entitlements Act 1986; orsection 53A of the

a person who is:

(i) an Australian resident within the meaning of the Health Insurance Act 1973; and

(ii) eligible, under subsection 86(1), (2) or (3) of the Veterans’ Entitlements Act 1986, to be provided with treatment under Part V of the last-mentioned Act; or

a person who is:

(i) an Australian resident within the meaning of the Health Insurance Act 1973; and

(ii) entitled to treatment under Military Rehabilitation and Compensation Act 2004; orsection 284 of the

a person who is:

(i) an Australian resident within the meaning of the Health Insurance Act 1973; and

(ii) the holder of a seniors health card within the meaning of the Veterans’ Entitlements Act 1986.

concessional benefit prescription means a prescription that, in accordance with section 84AA, is a prescription in respect of a concessional beneficiary or of a person who, in relation to the concessional beneficiary, is a dependant within the meaning of subsection (4) or (7).

concession card means a safety net concession card issued under section 84DA and includes an additional concession card, or a replacement concession card, issued under section 84H.

concession card prescription means a prescription that, in accordance with section 84AA, is a prescription for the supply of a pharmaceutical benefit to a person who is a holder of a concession card.

CTS claim means a claim made to the Chief Executive Medicare using the procedures of the Claims Transmission System provided for in section 99AAA.

dependant has the meaning given by subsections (4) and (7).

determined price means the amount specified in a determination in force under subsection 85B(2).

determined quantity of a listed brand of a pharmaceutical item: see subsection 84AK(3).

drug in a combination item means the drug referred to in paragraph 84AB(a) in the application of that paragraph to the pharmaceutical item that is the combination item.

drug in a pharmaceutical item means the drug referred to in paragraph 84AB(a) in the application of that paragraph to the pharmaceutical item.

drug is on F1 has the meaning given by section 84AC.

drug is on F2 has the meaning given by section 84AC.

early supply of a specified pharmaceutical benefit has the meaning given by subsection 84AAA(1).

eligible for increased discounting: see section 87AA.

eligible midwife has the meaning given by section 84AAE.

eligible nurse practitioner has the meaning given by section 84AAI.

entitlement card means a pharmaceutical benefits entitlement card issued under section 84E and includes an additional entitlement card, or a replacement entitlement card, issued under section 84H.

entitlement card prescription means a prescription that, in accordance with section 84AA, is a prescription for the supply of a pharmaceutical benefit to a person who is a holder of an entitlement card.

exempt item means a pharmaceutical item determined by the Minister under section 84AH to be an exempt item.

expiry date, in relation to a medicare number, means:

if the number is recorded on a medicare card that specifies a particular date on which the card expires—that date; and

if the number is recorded on a medicare card that does not specify a particular date on which the card expires but that has recorded on it the month at the end of which the card expires—the last day of that month; and

if the number is not of a kind referred to in paragraph (a) or (b)—such date as the Minister specifies, in writing, in respect of the number.

friendly society body means a body (whether corporate or unincorporate) carrying on business for the benefit of members of a friendly society or friendly societies.

general benefit prescription means a prescription other than: a concessional benefit prescription; or an entitlement card prescription; or a concession card prescription.

a concessional benefit prescription; or

an entitlement card prescription; or

a concession card prescription.

general patient means a person who is an eligible person within the meaning of the Health Insurance Act 1973, but who is not a concessional beneficiary.

general patient charge amount means $25.00.

hospital means premises in which patients are received and lodged for the purpose of hospital treatment.

hospital authority means the governing body of a public hospital or the proprietor of a private hospital.

listed brand of a pharmaceutical item means a brand of the pharmaceutical item in relation to which a determination under subsection 85(6) is in force.

listed drug means a drug or medicinal preparation in relation to which a declaration under subsection 85(2) is in force.

medicare card means:

a card issued by the Chief Executive Medicare and commonly known as a medicare card; or

a card or written authorisation provided to a person that evidences a person’s eligibility for pharmaceutical benefits under:

(i) the scheme known as the Repatriation Pharmaceutical Benefits Scheme established under the Veterans’ Entitlements Act 1986; or

(ii) a scheme that applies under Australian Participants in British Nuclear Tests and British Commonwealth Occupation Force (Treatment) Act 2006; orsection 18 of the

(iii) a scheme that applies under Treatment Benefits (Special Access) Act 2019; orsection 20 of the

any other card that is prescribed for the purposes of this definition.

medicare number means:

in relation to a particular person covered by a medicare card—the particular combination of numbers, or letters and numbers, on the card that is applicable only to that person as a person covered by that card; and

(b) in relation to a person who the Chief Executive Medicare is satisfied is, or is entitled to be treated as, an eligible person within the meaning of the Health Insurance Act 1973 but who is not covered by a medicare card—the particular combination of numbers, or letters and numbers, that would be applicable to that person if that person were covered by a medicare card.

member means a member of the Tribunal, and includes the Chairperson.

nurse practitioner treatment means treatment that the nurse practitioner is authorised (however described) to provide under a law of a State or an internal Territory.

optometrist means a person registered or licensed as an optometrist or optician under a law of a State or an internal Territory that provides for the registration or licensing of optometrists or opticians.

out-patient medication means a drug or medicinal preparation supplied through the out-patient department of a public hospital.

pack quantity of a listed brand of a pharmaceutical item: see subsection 84AK(2).

participating dental practitioner means a dental practitioner in relation to whom an approval is in force under section 84A.

PBS prescriber means:

a medical practitioner; or

a participating dental practitioner; or

an authorised optometrist; or

an authorised midwife; or

an authorised nurse practitioner.

pharmaceutical benefit means the following: (a) if a declaration under subsection 85(2) is in force in relation to a drug or medicinal preparation (the drug) and paragraph (b), (c) and (d) do not apply—the drug; if a determination under subsection 85(3) is in force in relation to a form of the drug and paragraph (c) and (d) do not apply—the drug in that form; if a determination under subsection 85(5) is in force in relation to a manner of administration of that form of the drug and paragraph (d) does not apply—the drug in that form with that manner of administration; if a determination under subsection 85(6) is in force in relation to a brand of a pharmaceutical item that is the drug in that form with that manner of administration—that brand of the drug in that form with that manner of administration. pharmaceutical benefit has a drug: see subsection 84ABA(3).

(a) if a declaration under subsection 85(2) is in force in relation to a drug or medicinal preparation (the drug) and paragraph (b), (c) and (d) do not apply—the drug;

if a determination under subsection 85(3) is in force in relation to a form of the drug and paragraph (c) and (d) do not apply—the drug in that form;

if a determination under subsection 85(5) is in force in relation to a manner of administration of that form of the drug and paragraph (d) does not apply—the drug in that form with that manner of administration;

if a determination under subsection 85(6) is in force in relation to a brand of a pharmaceutical item that is the drug in that form with that manner of administration—that brand of the drug in that form with that manner of administration.

pharmaceutical benefit has a drug: see subsection 84ABA(3).

pharmaceutical item has the meaning given by section 84AB.

pharmaceutical item has a drug: see subsection 84ABA(1).

prescriber bag provisions means the following: section 93 (supplies by medical practitioners); section 93AA (supplies by authorised midwives); section 93AB (supplies by authorised nurse practitioners).

section 93 (supplies by medical practitioners);

section 93AA (supplies by authorised midwives);

section 93AB (supplies by authorised nurse practitioners).

price agreement means an agreement under section 85AD.

price determination means a determination under subsection 85B(2).

pricing quantity of a listed brand of a pharmaceutical item: see subsection 84AK(1).

proportional ex-manufacturer price of a listed brand of a pharmaceutical item: see section 85D.

record form means a pharmaceutical benefits prescription record form, or an out-patient medication prescription record form, issued under section 84D.

refund agreement means an agreement or arrangement under which a payment may be made by or at the direction of a person to another person in the event of the other person being charged an amount in respect of the supply of a pharmaceutical benefit.

relevant entitlement period means:

in the application of this Part before 1 January 1992:

in relation to a pensioner—the period commencing on 1 November 1990 and ending on 31 December 1991; or

in relation to any other person—the year commencing on 1 January 1990 or 1 January 1991; or

in the application of this Part on or after 1 January 1992:

the year commencing on 1 January 1992; or

a succeeding year.

relevant price: see subsection 99ACF(5).

repatriation pharmaceutical benefit means a pharmaceutical benefit within the meaning of: (a) Veterans’ Entitlements Act 1986; orsection 91 of the (b) subsection 4(1) of the Australian Participants in British Nuclear Tests and British Commonwealth Occupation Force (Treatment) Act 2006; or (c) subsection 5(1) of the Treatment Benefits (Special Access) Act 2019.

(a) Veterans’ Entitlements Act 1986; orsection 91 of the

(b) subsection 4(1) of the Australian Participants in British Nuclear Tests and British Commonwealth Occupation Force (Treatment) Act 2006; or

(c) subsection 5(1) of the Treatment Benefits (Special Access) Act 2019.

responsible person for a brand of a pharmaceutical item means the person determined by the Minister under section 84AF to be the responsible person for the brand of the pharmaceutical item.

Schedule equivalent has the meaning given by section 84AJ.

special number, in relation to a particular person who is included within a class of persons identified by the Minister in a determination under subsection 86E(1)—the particular combination of numbers, or letters and numbers, allocated in accordance with a procedure set out in that determination, that is applicable to that person as a person included in that class.

special patient contribution has the meaning given by subsection 85B(5).

State or Territory officer means:

the Governor of a State; or

the Administrator, an Acting Administrator, or a Deputy Administrator, of the Northern Territory; or

a Minister of a State, a Minister for the Australian Capital Territory or a Minister of the Northern Territory; or

a member of the Parliament of a State, a member of the Legislative Assembly for the Australian Capital Territory or a member of the Legislative Assembly of the Northern Territory; or

a person who is in the employment of a State or Territory; or

a person who holds or performs the duties of any office or position established by or under a law of a State or Territory; or

a member of the police force or police service of a State or Territory.

Territory includes an external Territory to which this Act extends.

therapeutic group means a therapeutic group determined by the Minister under section 84AG.

Tribunal means the Pharmaceutical Benefits Remuneration Tribunal established by section 98A.

value for safety net purposes means:

for the supply of a pharmaceutical benefit—the amount prescribed by regulations made for the purposes of subsection 84C(1E); and

for the supply of a repatriation benefit—the amount charged for the supply; and

for the supply of out-patient medication—the applicable amount in relation to the supply.

the agreement was or is renewed on or before the date on which it would, but for that renewal, have expired;

the period of operation of the agreement was or is extended on or before the date on which it would, but for that extension, have expired; or

the rights and obligations under the agreement of the party by or at whose direction payments may be made under the agreement were or are transferred to another person;

the renewal, extension or transfer shall, for the purposes of this Act, be deemed not to have been or to be an entering into a new agreement.

(a) a prescription directs a repeated supply of a pharmaceutical benefit (the specified benefit); and

(b) another pharmaceutical benefit (the supplied benefit) is supplied, on the repeated supply, in accordance with subsection 103(2A);

then, for the purposes of determining whether a repeated supply of the specified benefit has occurred, the supplied benefit is taken to be the repeated supply, upon the prescription, of the specified benefit.

an adoptive child or a stepchild of the person; and

someone who would be the stepchild of the person except that the person is not legally married to the person’s de facto partner; and

(c) someone who is a child of the person within the meaning of the Family Law Act 1975.

the spouse of the person; or

a child under the age of 16 years who is in the custody, care and control of the person or the spouse of the person; or

a person who:

has attained the age of 16 years but is under the age of 25 years; and

is receiving full time education at a school, college or university; and

(iii) is not being paid a disability support pension under the Social Security Act 1991; and

is wholly or substantially dependent on the person or on the spouse of the person.

(a) paragraph (e) of the definition of concessional beneficiary applies to a person (the seniors health card holder); and

(b) no other paragraph of the definition of concessional beneficiary applies to the seniors health card holder;

a person who, apart from this subsection, would be a dependant of the seniors health card holder is taken not to be a dependant of the seniors health card holder.

the relevant person died on that day; or

the concessional beneficiary died on that day;

then, despite that death, the relevant person is taken still to be a dependant of a concessional beneficiary at that time (whether that time is before or after the time of death).

the production to that person or body of a medicare card having on it a medicare number as a number applicable to that particular individual; or

the provision to that person or body of any other information, whether documentary or oral, that indicates a medicare number as a number applicable to that particular individual.

the production to the person or body of a medicare card that indicates the expiry date in relation to that medicare number; or

the provision to the person or body of any other information, whether documentary or oral, that indicates the expiry date in relation to that medicare number.

if the number is not inserted in a CTS claim relating to that prescription—the number in the form in which it appears on the prescription (or in the case of a communicated prescription, the written version of the prescription), at the time when the prescription is sent to the Chief Executive Medicare by an approved supplier with a claim for payment; or

if that number is inserted in a CTS claim relating to the prescription—the number so inserted.

the pharmaceutical item in the pharmaceutical benefit is specified in an instrument under subsection (2); and

the supply of the pharmaceutical benefit is made within the period specified in an instrument under subsection (2) following a previous supply to the person of:

the pharmaceutical benefit; or

another pharmaceutical benefit that has the same pharmaceutical item as the pharmaceutical benefit; or

another pharmaceutical benefit that is Schedule equivalent to the pharmaceutical benefit; and

the supply does not result from a prescription originating from a hospital.

pharmaceutical items for the purposes of paragraph (1)(a); and

periods following previous supply for the purposes of paragraph (1)(b).

the circumstances in which a pharmaceutical benefit that has the pharmaceutical item is supplied; or

any other circumstances in relation to a pharmaceutical benefit that has the pharmaceutical item.

criteria by which applications are to be considered under this section;

conditions to which approvals under this section are subject.

does not, at the time of the suspension or revocation, meet the criteria that would apply if the optometrist were to apply under subsection 84AAB(1) to be an authorised optometrist at that time; or

has breached a condition to which the approval is subject under paragraph 84AAB(3)(b); or

has breached a condition to which an approval would be subject under paragraph 84AAB(3)(b) if the person were to apply under subsection 84AAB(1) to be an authorised optometrist at that time.

be in writing; and

include the Secretary’s reasons for considering the suspension or revocation; and

(c) invite the optometrist to make written submission to the Secretary within the period of 28 days (the submission period) after being given the notice.

decides not to approve an optometrist under section 84AAB; or

suspends or revokes the approval of an optometrist under section 84AAC;

the optometrist may apply, in writing, to the Secretary for reconsideration by the Secretary of the decision.

affirm the decision; or

approve the optometrist.

An approval under paragraph (b) is taken, for the purposes of this Act, to be an approval under section 84AAB.

affirm the suspension or revocation; or

reinstate the approval of the optometrist.

A reinstatement under paragraph (b) has effect as if the approval had never been revoked.

is a midwife; and

meets the requirements set out in a determination made under subsection (3).

a requirement to hold particular qualifications in midwifery;

a requirement to have particular experience in midwifery;

a requirement to be credentialled by a particular body.

criteria by which applications are to be considered under this section;

conditions to which approvals under this section are subject.

is not, at the time of the suspension or revocation, an eligible midwife; or

does not, at the time of the suspension or revocation, meet the criteria that would apply if the person were to apply under subsection 84AAF(1) to be an authorised midwife at that time; or

has breached a condition to which the approval is subject under paragraph 84AAF(3)(b); or

has breached a condition to which an approval would be subject under paragraph 84AAF(3)(b) if the person were to apply under subsection 84AAF(1) to be an authorised midwife at that time.

be in writing; and

include the Secretary’s reasons for considering the suspension or revocation; and

(c) invite the person to make written submissions to the Secretary within the period of 28 days (the submission period) after being given the notice.

decides not to approve an eligible midwife under section 84AAF; or

suspends or revokes an approval under section 84AAG;

the person to whom the approval relates may apply, in writing, to the Secretary for reconsideration by the Secretary of the decision.

affirm the decision; or

approve the eligible midwife.

An approval under paragraph (b) is taken, for the purposes of this Act, to be an approval under section 84AAF.

affirm the suspension or revocation; or

reinstate the approval.

A reinstatement under paragraph (b) has effect as if the approval had never been revoked.

is a nurse practitioner; and

meets the requirements (if any) set out in a determination made under subsection (2).

criteria by which applications are to be considered under this section;

conditions to which approvals under this section are subject.

is not, at the time of the suspension or revocation, an eligible nurse practitioner; or

does not, at the time of the suspension or revocation, meet the criteria that would apply if the person were to apply under subsection 84AAJ(1) to be an authorised nurse practitioner at that time; or

has breached a condition to which the approval is subject under paragraph 84AAJ(3)(b); or

has breached a condition to which an approval would be subject under paragraph 84AAJ(3)(b) if the person were to apply under subsection 84AAJ(1) to be an authorised nurse practitioner at that time.

be in writing; and

include the Secretary’s reasons for considering the suspension or revocation; and

(c) invite the person to make written submissions to the Secretary within the period of 28 days (the submission period) after being given the notice.

decides not to approve an eligible nurse practitioner under section 84AAJ; or

suspends or revokes an approval under section 84AAK;

the person to whom the approval relates may apply, in writing, to the Secretary for reconsideration by the Secretary of the decision.

affirm the decision; or

approve the eligible nurse practitioner.

An approval under paragraph (b) is taken, for the purposes of this Act, to be an approval under section 84AAJ.

affirm the suspension or revocation; or

reinstate the approval.

A reinstatement under paragraph (b) has effect as if the approval had never been revoked.

the regulations prescribe that the drug is on F1; and

there is not a determination under section 85AB in force that the drug is on F2.

F2

a determination is in force under subsection (3) that the brands are co-marketed brands of the pharmaceutical item; or

both of the following apply:

the regulations prescribe under subsection (4) that the brands are co-marketed brands of the pharmaceutical item;

there is no determination in force under subsection (3B) that the brands cease to be co-marketed brands of the pharmaceutical item.

Ministerial determination

within 4 months of the first of the co-marketed brands of the co-marketed item being included on the Australian Register of Therapeutic Goods, applications are made to include the other co-marketed brands of the co-marketed item on the Register;

the first determination that is made under subsection 85(6) in relation to a brand of the co-marketed item is made only in relation to the co-marketed brands of the co-marketed item;

each of the co-marketed brands is a listed brand of the co-marketed item;

no other brand is a listed brand of the co-marketed item;

if there is another pharmaceutical item that has the same drug as the co-marketed item:

each of the co-marketed brands is a listed brand of that pharmaceutical item; and

no other brand is a listed brand of that pharmaceutical item.

any of the co-marketed brands is not a listed brand of the co-marketed item; or

another brand is a listed brand of the co-marketed item; or

if there is another pharmaceutical item that has the same drug as the co-marketed item:

any of the co-marketed brands is not a listed brand of that pharmaceutical item; or

another brand is a listed brand of that pharmaceutical item.

any of the co-marketed brands is not a listed brand of the co-marketed item; or

another brand is a listed brand of the co-marketed item; or

if there is another pharmaceutical item that has the same drug as the co-marketed item:

any of the co-marketed brands is not a listed brand of that pharmaceutical item; or

another brand is a listed brand of that pharmaceutical item.

Regulations

the person notified the Minister that the person is or will be the supplier of the brand of the pharmaceutical item to:

wholesalers; or

in the case of a supply where wholesalers are not involved—approved pharmacists directly; and

the brand of the pharmaceutical item is a listed brand; and

there is no determination in force under this section that another person is the responsible person for:

the brand of the pharmaceutical item; or

the brand of any other pharmaceutical item.

one or more therapeutic groups; and

that 2 or more listed drugs are in the same therapeutic group.

either:

section 99ADH has applied to a brand of a pharmaceutical item; or

the price of the brand of the pharmaceutical item is reduced under 99ADHB; and

the Minister has determined, under paragraph (1)(b), that the drug in the pharmaceutical item is in a therapeutic group;

the Minister must, by legislative instrument, vary the determination to remove the drug from that group with effect on the day that section 99ADH applied to the brand of the pharmaceutical item or the price of the brand of the pharmaceutical item was reduced under section 99ADHB.

the person’s spouse;

any dependent child of the person or the person’s spouse.

is under the age of 16 years; or

is a student child.

dependent child, in relation to a person, means:

a child under the age of 16 years who is:

in the custody, care and control of the person; or

where no other person has the custody, care and control of the child—is wholly or substantially in the care and control of the person; or

a student child who is wholly or substantially dependent on the person.

spouse, in relation to a person, means:

a person who is legally married to, and is not living, on a permanent basis, separately and apart from, that person; and

(b) a de facto partner of the person within the meaning of paragraph (a) of the definition of de facto partner in subsection 4(1), who is not living, on a permanent basis, separately and apart from the person;

(c) a de facto partner of the person within the meaning of paragraph (b) of the definition of de facto partner in subsection 4(1).

student child means a person who:

has attained the age of 16 years but has not attained the age of 25 years; and

is receiving full-time education at a school, college or university.

(a) a person who is the spouse of another person (the person’s partner) under paragraph (a) or (b) of the definition is not taken to be living separately and apart from the person’s partner on a permanent basis, if the person is living apart from the person’s partner only because of the illness or infirmity of either or both of them; and

(b) a person who is the spouse of another person (the person’s partner) under paragraph (c) of the definition is not taken to have ceased to live with the person’s partner on a de facto basis, if the person is living apart from the person’s partner only because of the illness or infirmity of either or both of them.

different amounts in respect of a supply of out-patient medication, having regard to the State or Territory in which the hospital supplying the medication is situated; and

different amounts in respect of:

supplies made to concessional beneficiaries and persons who, in relation to concessional beneficiaries, are dependants within the meaning of subsection 84(4) or (7); and

supplies made to holders of a concession card; and

supplies made to general patients other than holders of a concession card.

the total of:

the value for safety net purposes of supplies of pharmaceutical benefits, repatriation pharmaceutical benefits and out-patient medication made to the person during the relevant entitlement period when the person was a concessional beneficiary; and

where the person has, during the relevant entitlement period, been a general patient—the transferred value of supplies of pharmaceutical benefits, repatriation pharmaceutical benefits and out-patient medication made to the person during the period when the person was a general patient;

is not less than the amount of the concessional beneficiary safety net (within the meaning of section 99F);

the total of:

the value for safety net purposes of supplies of pharmaceutical benefits, repatriation pharmaceutical benefits and out-patient medication made to the person and the person’s family during the relevant entitlement period when the person was a concessional beneficiary; and

where the person has, during the relevant entitlement period, been a general patient—the transferred value of supplies of pharmaceutical benefits, repatriation pharmaceutical benefits and out-patient medication made to the person and the person’s family during the period when the person was a general patient;

is not less than the amount of the concessional beneficiary safety net (within the meaning of section 99F).

where the person is a concessional beneficiary at the time of the supply—including the value for safety net purposes of the supply; or

where the person is a general patient at the time of the supply—including the transferred value of the supply;

in the total mentioned in paragraph (1C)(a) or (b) would fulfil that paragraph.

excluding certain components of the amount charged; or

setting a maximum limit on the value.

a person who was, at the time when the person applied for the issue of a concessional card or an entitlement card in respect of that period, a member of the person’s family; or

a person who was, at the time of supply, a member of the person’s family.

(a) a prescription is for the supply of a pharmaceutical benefit or a repatriation pharmaceutical benefit to a person (in this subsection referred to as the patient); and

(b) upon the prescription, a pharmaceutical benefit or repatriation pharmaceutical benefit (the benefit) is given to another person, as agent for the patient, for supply to the patient;

the benefit shall, for the purposes of this section, be taken to have been supplied to the patient upon the prescription.

the pharmaceutical benefit is supplied:

by an approved pharmacist, at or from premises in respect of which the pharmacist is for the time being approved, on presentation of a prescription written by a PBS prescriber in accordance with this Act and the regulations, or, in such circumstances as are prescribed for the purposes of paragraph 89(a), on communication to the pharmacist, in the manner prescribed for the purposes of that paragraph, of a prescription of a PBS prescriber; or

in accordance with section 92 or 94; and

at the time of supply, the person is not a holder of an entitlement card; and

in a case where the supply is made upon a general benefit prescription and the Commonwealth price for the pharmaceutical benefit exceeds the general patient charge amount—the amount received in respect of the supply is equal to the sum of the following:

if the supply is not eligible for increased discounting—the general patient charge amount (less any allowable discount);

if the supply is eligible for increased discounting—the amount charged for the supply under paragraph 87(2)(e);

if an amount may be charged for the supply under subsection 87(2A)—that amount;

any charge for supply at a time outside normal trading hours;

any charge for delivery in accordance with regulations made for the purposes of paragraph 87(4)(b); and

in a case where the supply is made upon a concessional benefit prescription and the Commonwealth price for the pharmaceutical benefit exceeds $4.60—the amount received in respect of the supply is equal to the sum of the following:

$4.60 (less any allowable discount);

if an amount may be charged for the supply under subsection 87(2A)—that amount;

any charge for supply at a time outside normal trading hours;

any charge for delivery in accordance with regulations made for the purposes of paragraph 87(4)(b); and

in a case where the supply is one to which subsection 99(2A), (2AB) or (2B) applies—the amount charged or received in respect of the supply does not exceed the sum of the following:

the price worked out in accordance with a determination in force under subsection (7) for the pharmaceutical benefit;

any amount charged or received by reason only that the supply was made at a time outside normal trading hours;

any amount charged or received in accordance with regulations made for the purposes of paragraph 87(4)(b).

(4AA) The supply or repeated supply of a pharmaceutical benefit or repatriation pharmaceutical benefit to a person must not be taken into account for the purposes of this section if it is an early supply of a specified pharmaceutical benefit.

the repatriation pharmaceutical benefit is supplied:

(i) under the scheme established under Veterans’ Entitlements Act 1986; orsection 91 of the

(ii) in accordance with a determination under paragraph 286(1)(c) of the Military Rehabilitation and Compensation Act 2004; or

(iii) under a scheme that applies under Australian Participants in British Nuclear Tests and British Commonwealth Occupation Force (Treatment) Act 2006; orsection 18 of the

(iv) under a scheme that applies under Treatment Benefits (Special Access) Act 2019; andsection 20 of the

at the time of supply the person was not a holder of an entitlement card.

in the case of a pharmaceutical benefit that is a listed brand of a pharmaceutical item—take as a basis the approved ex-manufacturer price or a proportional ex-manufacturer price of the brand of the pharmaceutical item that was in force on the first day of the month of the year in which the supply occurs; and

in the case of other pharmaceutical benefits—take as a basis the basic wholesale price of each ingredient that is applicable on the day on which the supply occurs; and

provide for the addition of such fees and other amounts as are determined by the Tribunal for the purposes of paragraph 98B(2)(c); and

provide for the addition of such other fees and other amounts as are determined by the Minister.

be in accordance with the form approved by the Secretary; and

include the prescribed particulars of the person to whom the form is issued.

is not a holder of an entitlement card.

an approved pharmacist, approved medical practitioner or approved hospital authority supplies a pharmaceutical benefit or repatriation pharmaceutical benefit to a holder of a pharmaceutical benefits prescription record form;

the form is presented at the time of supply; and

the supply is:

a supply of a pharmaceutical benefit to be taken into account under subsection 84C(4) for the purposes of section 84C; or

a supply of a repatriation pharmaceutical benefit to be taken into account, under subsection 84C(4A), for the purposes of section 84C;

the pharmacist, medical practitioner or authority shall record the supply of that pharmaceutical benefit on the form.

the prescribed particulars of the prescription upon which the pharmaceutical benefit or repatriation pharmaceutical benefit is supplied;

the date on which the pharmaceutical benefit or repatriation pharmaceutical benefit is supplied; and

such other particulars in relation to the supply of the pharmaceutical benefit or repatriation pharmaceutical benefit as are prescribed;

and shall be signed by:

in a case where the record is made by an approved pharmacist—the pharmacist;

in a case where the record is made by an approved medical practitioner—the medical practitioner; or

in a case where the record is made by an approved hospital authority—the medical practitioner or pharmacist by or under whose supervision the pharmaceutical benefit or repatriation pharmaceutical benefit is dispensed.

an out-patient medication is supplied to the holder of an out-patient medication prescription record form; and

the form is presented at the time of supply; and

the supply is not excluded under subsection 84C(4B) from being taken into account for the purposes of section 84C;

the medical practitioner or pharmacist by whom, or under whose supervision, the medication is dispensed, or any person authorised under subsection (12) to do so, must record the supply of the medication on the form.

the prescribed particulars of the prescription upon which the medication is supplied; and

the date on which the medication is supplied; and

any other particulars of the supply that are prescribed;

and must be signed by the person making the record.

a person applies, either personally or through the person’s agent, to the Secretary for a safety net concession card in respect of a relevant entitlement period; and

the Secretary is satisfied that the person is eligible to be issued with such a card in respect of that period;

the Secretary must issue a safety net concession card to the person in respect of that period.

a person applies, either personally or through the person’s agent, to an approved pharmacist, approved medical practitioner, approved hospital authority or public hospital authority for a safety net concession card in respect of a relevant entitlement period; and

the pharmacist, medical practitioner or authority is satisfied that the person is eligible to be issued with such a card in respect of that period;

the pharmacist, medical practitioner or authority may issue a safety net concession card to the person in respect of that period.

be in the form approved by the Secretary; and

contain such particulars, and be accompanied by such documents, as are prescribed; and

be signed by the person making the application or by the person’s agent.

the matters contained in the application;

any record form or other document that accompanies the application; and

such other matters as the person considers relevant.

a person applies, either personally or through the person’s agent, to an approved pharmacist, approved medical practitioner, approved hospital authority or public hospital authority for a safety net concession card in respect of a relevant entitlement period; and

the pharmacist, medical practitioner or authority issues such a card to the person in respect of that period;

the pharmacist, medical practitioner or authority must submit the application, and all documents that accompanied the application, to the Secretary by lodging them at a prescribed office within one month (or such longer period as is prescribed) after the day on which the card is issued.

a person applies, either personally or through the person’s agent, to the Secretary for a pharmaceutical benefits entitlement card in respect of a relevant entitlement period; and

the Secretary is satisfied that the person is eligible to be issued with a pharmaceutical benefits entitlement card in respect of that period;

the Secretary shall issue a pharmaceutical benefits entitlement card to the person in respect of that period.

a person applies, either personally or through the person’s agent, to an approved pharmacist, approved medical practitioner, approved hospital authority or public hospital authority for a pharmaceutical benefits entitlement card in respect of a relevant entitlement period; and

the pharmacist, medical practitioner or authority is satisfied that the person is eligible to be issued with a pharmaceutical benefits entitlement card in respect of that period;

the pharmacist, medical practitioner or authority may issue a pharmaceutical benefits entitlement card to the person in respect of that period.

be in accordance with the form approved by the Secretary;

contain such particulars, and be accompanied by such documents, as are prescribed; and

be signed by the person making the application or by the person’s agent.

the matters contained in the application;

any record form or other document that accompanies the application; and

such other matters as the person considers relevant.

a person applies, either personally or through the person’s agent, to an approved pharmacist, approved medical practitioner, approved hospital authority or public hospital authority for a pharmaceutical benefits entitlement card in respect of a relevant entitlement period; and

the pharmacist, medical practitioner or authority issues a pharmaceutical benefits entitlement card to the person in respect of that period;

the pharmacist, medical practitioner or authority shall submit the application, and all relevant documents that accompanied or supported the application, to the Secretary by lodging them at a prescribed office within one month (or such longer period as is prescribed) after the day on which the entitlement card is issued.

the relevant entitlement period in respect of which the card is issued; and

the person to whom the card is issued and each person who is, at the time when the card is issued, a member of the person’s family.

who is or was a holder of a concession card or an entitlement card that has been lost, stolen, damaged or destroyed; or

who is a holder of a concession card or an entitlement card but whose particulars are not included on the card.

(a) a person (in this subsection called the original card holder) has been issued with a concession card, or an entitlement card, in respect of a relevant entitlement period; and

(b) a person (in this subsection referred to as the new family member) becomes, after the issue of the card and during that period, a member of the original card holder’s family;

a replacement concession card or a replacement entitlement card (as the case may be) may, in accordance with the regulations, be issued to the original card holder, being a card that includes particulars of the holders of the original card and of the new family member and, where such a replacement card is issued, each holder of the original card and the new family member shall be taken, from the time when the replacement card is issued, to be a holder of the replacement card.

(a) be made by notice in writing published in the Gazette; and

come into operation on such day as is specified in the determination.

drugs and medicinal preparations that are:

declared by the Minister, by legislative instrument, to be drugs and medicinal preparations to which this Part applies; or

included in a class of drugs and medicinal preparations declared by the Minister, by legislative instrument, to be a class of drugs and medicinal preparations to which this Part applies; and

medicinal preparations composed of:

one or more of the drugs and medicinal preparations referred to in paragraph (a), being a drug or medicinal preparation that is, or drugs and medicinal preparations that are, included in a class of drugs and medicinal preparations declared by the Minister, by legislative instrument, to be a class of drugs and medicinal preparations to which this paragraph applies; and

one or more of such additives as are declared by the Minister, by legislative instrument, to be additives to which this paragraph applies.

Drugs etc. that can only be supplied under the prescriber bag provisions

(2AA) If:

(a) the Minister makes a declaration under subsection (2) in relation to a drug or medicinal preparation (the drug); and

the Pharmaceutical Benefits Advisory Committee has recommended under subsection 101(4AACA) that the drug be supplied only under one or more of the prescriber bag provisions;

then the Minister must, by legislative instrument, declare that the drug can only be supplied under that provision or those provisions.

Drugs etc. that can only be supplied under special arrangements

(a) the Minister makes a declaration under subsection (2) in relation to a drug or medicinal preparation (the drug); and

the Pharmaceutical Benefits Advisory Committee has recommended under subsection 101(4AAD) that the drug be made available only under special arrangements under section 100;

then the Minister must, by legislative instrument, declare that the drug can only be supplied under such special arrangements.

Forms

that a particular pharmaceutical benefit is to be a relevant pharmaceutical benefit for the purposes of section 88A; and

the circumstances in which a prescription for the supply of the pharmaceutical benefit may be written.

Pharmaceutical benefits that can only be supplied under the prescriber bag provisions

a particular pharmaceutical benefit (other than a pharmaceutical benefit that has a drug covered by subsection (2A)) can only be supplied under special arrangements under section 100; or

one or more of the circumstances in which a prescription for the supply of a pharmaceutical benefit may be written under paragraph (7)(b) are circumstances in which the benefit can only be supplied under special arrangements under section 100.

Brand or pharmaceutical item that is biosimilar or bioequivalent to listed item is taken to have the same drug

(a) a listed brand of a pharmaceutical item (the listed brand) has a drug; and

another brand of the pharmaceutical item, or a brand of another pharmaceutical item, is biosimilar or bioequivalent to the listed brand;

then, for the purposes of this Part, the other brand or pharmaceutical item is taken to have the same drug as the listed brand.

epoetin lambda;

epoetin alfa.

Alternative names or terminology

more than one name is recognised for the same listed drug; or

more than one description is recognised for the same form of a listed drug; or

more than one description is recognised for the same manner of administration of a form of a listed drug.

(a) the Minister makes a declaration under subsection 85(2AA) declaring that a drug or medicinal preparation (the drug) can only be supplied under one or more (but not all) of the prescriber bag provisions (the drug prescriber bag provision); and

(b) the Minister makes a determination under subsection 85(7A) determining that a pharmaceutical benefit that has the drug can only be supplied under a different prescriber bag provision or different prescriber bag provisions (the pharmaceutical benefit prescriber bag provision);

then the pharmaceutical benefit can only be supplied under this Part under the drug prescriber bag provision and the pharmaceutical benefit prescriber bag provision.

determine the maximum quantity or number of units of:

if the pharmaceutical benefit has a pharmaceutical item—the pharmaceutical item; or

in any other case—the pharmaceutical benefit;

that may, in one prescription, be directed to be supplied on any one occasion, either for all purposes or for particular purposes; and

determine the maximum number of occasions on which the supply of the pharmaceutical benefit may, in one prescription, be directed to be repeated, either for all purposes or for particular purposes; and

determine the manner of administration that may, in a prescription, be directed to be used in relation to the pharmaceutical benefit.

there are no brands of pharmaceutical items that:

have the drug; and

are bioequivalent or biosimilar; and

are listed brands of the pharmaceutical items on any day in the relevant period;

there are no brands of pharmaceutical items that:

have another listed drug that is in the same therapeutic group as the drug; and

are bioequivalent or biosimilar; and

are listed brands of the pharmaceutical items on any day in the relevant period;

the drug was not on F2 on the day before the determination under subsection (1) comes into force.

both:

subsection 99ACB(3A) or (3B) applies to the brand of the pharmaceutical item that has the drug; and

there is not another brand of the pharmaceutical item that has the drug that is a listed brand; or

both:

subsection 99ACB(3A) or (3B) applies to the brand of the pharmaceutical item that has the drug; and

the drug is not on F2; or

both:

subsection 99ACB(3B) applies to the brand of the pharmaceutical item that has the drug; and

the tenth anniversary of the drug in the pharmaceutical item being on F1 has not occurred.

the drug is in a combination item; and

there are no brands of combination items that:

have the drug; and

are bioequivalent or biosimilar; and

are listed brands of the combination items on any day in the relevant period.

the day before the day the determination under subsection (1) comes into force; and

the day the determination under subsection (1) comes into force.

the person is not yet the responsible person; or

the item is not yet a pharmaceutical item; or

the quantity or number of units of the item is not yet a pricing quantity; or

the brand is not yet a listed brand.

However, those matters must be satisfied at the time the amount referred to in subsection (1) comes into force.

the price that would have been the Commonwealth price for that quantity or number of units of the brand of the pharmaceutical item if that Commonwealth price had been based on the claimed price for that quantity or number of units; and

the Commonwealth price for that quantity or number of units of the brand of the pharmaceutical item.

in a case where a price agreement is in force in relation to the brand of the pharmaceutical item—the amount in force under the agreement as the amount that is, for the purposes of this Part, taken to be the appropriate maximum price of the brand of the pharmaceutical item is taken to be reduced by the reduction amount or the reduction percentage, as the case requires; or

in a case where a price determination is in force in relation to the brand of the pharmaceutical item—the amount in force under the determination as the amount that is, for the purposes of this Part, taken to be the appropriate maximum price of the brand of the pharmaceutical item is taken to be reduced by the reduction amount or the reduction percentage, as the case requires.

in a case where a price agreement is in force in relation to the brand of the pharmaceutical item—the amount in force under the agreement as the amount that is, for the purposes of this Part, taken to be the appropriate maximum price of the brand of the pharmaceutical item is taken to be increased by the increase amount or the increase percentage, as the case requires; or

in a case where a price determination is in force in relation to the brand of the pharmaceutical item—the amount in force under the determination as the amount that is, for the purposes of this Part, taken to be the appropriate maximum price of the brand of the pharmaceutical item is taken to be increased by the increase amount or the increase percentage, as the case requires.

one or more pharmaceutical items;

pharmaceutical benefits within the meaning of:

this Act; or

(ii) the Australian Participants in British Nuclear Tests and British Commonwealth Occupation Force (Treatment) Act 2006; or

(iii) the Military Rehabilitation and Compensation Act 2004; or

(iiia) the Treatment Benefits (Special Access) Act 2019; or

(iv) Veterans’ Entitlements Act 1986.Part VA of the

reimbursing the Commonwealth in relation to the provision of pharmaceutical benefits in circumstances set out in the deed;

providing the Commonwealth with information in relation to pharmaceutical benefits.

Existing deeds to be covered by this section

(a) is, or is to be treated as, an eligible person within the meaning of the Health Insurance Act 1973; and

is receiving:

medical treatment by a medical practitioner; or

dental treatment by a participating dental practitioner; or

optometrical treatment by an authorised optometrist; or

midwifery treatment by an authorised midwife; or

nurse practitioner treatment by an authorised nurse practitioner;

is entitled to receive pharmaceutical benefits under this Part without the payment or provision of money or other consideration other than a charge made in accordance with section 87.

Residency

a person working outside Australia as a Commonwealth officer; or

a person working outside Australia as a State or Territory officer; or

the spouse, or a dependent child, of a person covered by paragraph (a) or (b) if the spouse or child is outside Australia accompanying that person.

Definitions

an approved supplier is presented with a prescription for the supply of a pharmaceutical benefit to a person; and

the person presenting the prescription claims to be, or to be the agent of, the person to whom the prescription relates; and

the person presenting the prescription does not request that the drug or medicinal preparation to which the prescription relates not be supplied as a pharmaceutical benefit;

the approved supplier may request the person presenting the prescription to provide to the approved supplier a medicare number applicable to the person to whom the prescription relates and the expiry date in relation to the number.

Inclusion of medicare number in a prescription does not prevent later request

the prescription already contains a medicare number as a number applicable to the person to whom the prescription relates; or

the approved supplier’s records already contain such a number (whether with or without the expiry date in relation to that number) recorded and retained in accordance with section 86D.

Approved supplier’s powers if medicare number is provided

if the prescription has already been endorsed with a medicare number as such a number, check the number so provided or included against the endorsed number and:

confirm that they are the same; or

if they are not the same and the approved supplier considers the number so provided or included more reliable than the endorsed number—alter the endorsed number to the number so provided or included or insert the number so provided or included in the CTS claim relating to the prescription, noting the discrepancy; or

if they are not the same and the approved supplier considers the endorsed number more reliable than the number so provided or included—disregard the number so provided or included and, if making a CTS claim, insert the endorsed number in the CTS claim relating to that prescription; and

if the prescription has not already been endorsed with a medicare number as such a number:

endorse the prescription with the medicare number so provided or included as a number applicable to the person; or

insert the number so provided or included in the CTS claim relating to that prescription; and

if the approved supplier has also been provided with, or has, in the approved supplier’s records, the expiry date in relation to the medicare number ultimately supplied to the Chief Executive Medicare—confirm that the supply of a pharmaceutical benefit authorised by the prescription is not being sought after the expiry date.

Approved supplier’s powers in respect of prescription (other than communicated prescription) covering person included in class determined under subsection 86E(1)

the prescription for the supply of a pharmaceutical benefit that is presented to the approved supplier does not contain a medicare number as a number applicable to the person to whom the prescription relates; and

despite a request under subsection (1), a medicare number is not provided to the approved supplier as such a number; and

a medicare number is not retained in the approved supplier’s records in accordance with section 86D as such a number; and

the approved supplier is satisfied that the person to whom the prescription relates is included within a class of persons identified by the Minister under subsection 86E(1);

the approved supplier may:

endorse on the prescription the special number applicable to the person as a member of that class; or

insert that number in the CTS claim relating to that prescription.

Approved supplier’s powers in respect of written version of communicated prescription not containing medicare number

a prescription for the supply of a pharmaceutical benefit is not presented to an approved supplier as described in subsection (1) but is communicated to the approved supplier in circumstances set out in regulations made for the purposes of paragraph 89(a); and

the approved supplier later receives a written version of the prescription that does not contain a medicare number as a number applicable to the person to whom the prescription relates;

the approved supplier may, after the written version of the prescription is received, endorse on the written version, or insert in the CTS claim relating to the prescription:

if a medicare number is already retained in the approved supplier’s records in accordance with section 86D as a number applicable to the person to whom the prescription relates—that medicare number; or

if a medicare number is not so retained as a number applicable to the person to whom the prescription relates—the special number applicable to the person under subsection 86E(1) as a person in respect of whom a prescription has been so communicated.

an approved supplier is presented, on or after 1 January 2001, with a prescription for the supply of a pharmaceutical benefit to a person; and

the pharmaceutical benefit is one in respect of the supply of which the approved supplier would, but for the operation of subsection 99AAAB(2), be entitled to receive a payment under subsection 99(2) or (4) or 99AAAA(2); and

the person presenting the prescription claims to be, or to be the agent of, the person to whom the prescription relates; and

the person presenting the prescription does not request that the drug or medicinal preparation to which the prescription relates not be supplied as a pharmaceutical benefit;

the approved supplier must, if:

the prescription does not contain a medicare number as a number applicable to the person to whom the prescription relates; and

the approved supplier’s records do not already contain a medicare number as such a number (whether with or without the expiry date in relation to that number) recorded and retained in accordance with section 86D;

request the person presenting the prescription to provide to the approved supplier a medicare number applicable to the person to whom the prescription relates and the expiry date in relation to that number.

Inclusion of medicare number in a prescription does not prevent later request

the prescription presented to the approved supplier already contains a medicare number as a number applicable to the person to whom the prescription relates; or

the approved supplier’s records already contain a medicare number as such a number (whether with or without the expiry date in relation to that number) recorded and retained in accordance with section 86D;

the approved supplier may request the person presenting the prescription to provide to the approved supplier a medicare number applicable to the person to whom the prescription relates and the expiry date in relation to that number.

Approved supplier’s obligations in relation to medicare number provided

a medicare number is provided to the approved supplier as a number applicable to the person to whom the prescription relates following a request under subsection (1) or is included as such a number in the approved supplier’s records in accordance with section 86D; and

the prescription has not already been endorsed with a medicare number as a number applicable to the person to whom the prescription relates;

the approved supplier must:

endorse the prescription with the medicare number so provided or included; or

insert the number so provided or included in the CTS claim relating to the prescription.

If medicare number is provided, approved supplier may check prescription endorsed by practitioner

a medicare number applicable to the person to whom the prescription relates is provided to the approved supplier following a request under subsection (2) or is included in the approved supplier’s records in accordance with section 86D; and

the prescription has already been endorsed with a medicare number as a number applicable to the person to whom the prescription relates;

the approved supplier may check the number so provided or included against the endorsed number and:

confirm that they are the same; or

if they are not the same and the approved supplier considers the number so provided or included more reliable than the endorsed number:

alter the endorsed number to the number so provided or included; or

insert the number so provided or included in the CTS claim relating to the prescription, noting the discrepancy; or

if they are not the same and the approved supplier considers the endorsed number more reliable than the number so provided or included—disregard the number so provided or included and, if making a CTS claim, insert the endorsed number in the CTS claim relating to that prescription.

Approved supplier may check to ensure that supply not being sought after relevant expiry date

the prescription for the supply of a pharmaceutical benefit that is presented to the approved supplier does not contain a medicare number as a number applicable to the person to whom the prescription relates; and

despite a request under subsection (1), a medicare number is not provided to the approved supplier as such a number; and

a medicare number is not retained in the approved supplier’s records in accordance with section 86D as such a number; and

the approved supplier is satisfied that the person to whom the prescription relates is included within a class of persons identified by the Minister in a determination under subsection 86E(1);

the approved supplier must:

endorse on the prescription the special number applicable to the person as a member of that class; or

insert that special number in the CTS claim relating to the prescription.

Requirement in respect of written version of communicated prescription not containing medicare number

a prescription for the supply of a pharmaceutical benefit is not presented to an approved supplier as described in subsection (1) but is communicated to the approved supplier in circumstances set out in regulations made for the purposes of paragraph 89(a); and

the pharmaceutical benefit is one in respect of the supply of which the approved supplier would, but for the operation of subsection 99AAAB(2), be entitled to receive a payment under subsection 99(2) or (4) or 99AAAA(2); and

the approved supplier later receives a written version of the prescription that does not contain a medicare number as a number applicable to the person to whom the prescription relates;

the approved supplier must, after the written version of the prescription is received, endorse on the written version, or insert in the CTS claim relating to the prescription:

if a medicare number is already retained in the approved supplier’s records in accordance with section 86D as a number applicable to the person to whom the prescription relates—that medicare number; or

if a medicare number is not so retained as a number applicable to the person to whom the prescription relates—the special number applicable to the person under subsection 86E(1) as a person in respect of whom a prescription has been so communicated.

an approved supplier is provided with a medicare number as a number applicable to a person (whether with or without the expiry date in relation to that number) either:

as a result of a request under section 86B or 86C; or

to facilitate the supply of pharmaceutical benefits at a later time or times; and

the approved supplier is satisfied that the person providing the number, or number and date, is:

the person in respect of whom the number was provided; or

the legal guardian of that person; or

another person who, in accordance with a determination made by the Minister under subsection (5), is capable of giving an authorisation under this subsection;

the approved supplier may, with the authorisation of the person providing the number, or number and date, undertake the permitted recording and retention activities in relation to that number, or number and date.

Supplier may record and retain medicare numbers and expiry dates supplied by PBS prescribers in respect of communicated prescriptions

a prescription for the supply of a pharmaceutical benefit is communicated to an approved supplier in circumstances set out in regulations made for the purposes of paragraph 89(a); and

at the time the prescription is communicated, the PBS prescriber communicating the prescription informs the approved supplier of a medicare number as a number applicable to the person to whom the prescription relates (whether with or without the expiry date in relation to that number);

the approved supplier may undertake the permitted recording and retention activities in relation to that number, or number and date.

Persons not obliged to authorise recording and retention of particulars

that the record of those numbers, or numbers and dates, is protected, by such security safeguards as it is reasonable in the circumstances to take, against loss, against unauthorised access, use, modification or disclosure, and against other misuse; and

if it is necessary for access to the record of those numbers, or numbers and dates, to be given to a person in connection with the provision of services to the approved supplier—that everything reasonably within the power of the approved supplier is done to prevent unauthorised use or disclosure of information contained in that record.

Determinations are legislative instruments

to record and retain that number, or that number and date, in the approved supplier’s records in relation to that person; or

if the approved supplier has already recorded and retained either or both of those particulars in relation to that person by virtue of a previous operation of this section—to check the accuracy and completeness of the recorded particulars in respect of that person and, if the recorded particulars are inaccurate or incomplete, to modify those particulars appropriately.

persons who are not legally competent;

(b) persons requiring drugs or medicinal preparations in an emergency, including an emergency to which a national emergency declaration (within the meaning of the National Emergency Declaration Act 2020) relates;

foreign persons:

(i) who are entitled to be treated as eligible persons within the meaning of the Health Insurance Act 1973 under section 7 of that Act; and

who are able to produce evidence, of a kind specified in the determination, to prove that entitlement;

persons in respect of whom a prescription is communicated in circumstances set out in regulations made for the purposes of paragraph 89(a).

Determinations may set out particulars of which suppliers must be satisfied

the particular matters in respect of which an approved supplier must be satisfied before being satisfied that a person is included within a particular class determined under that subsection; and

the procedure to be followed by the approved supplier in establishing such matters.

Determinations under subsection (1) must establish procedure for allocation of special numbers

upon:

a concessional benefit prescription; or

an entitlement card prescription where the supply is an early supply of a specified pharmaceutical benefit; or

a concession card prescription (other than where the supply is an early supply of a specified pharmaceutical benefit);

charge the person to whom the pharmaceutical benefit is supplied $4.60 (less any allowable discount); or

upon a general benefit prescription if, during the relevant entitlement period in which the supply is made, the person supplied is eligible to be issued with a concession card—charge the person $4.60 (less any allowable discount); or

upon a general benefit prescription (other than one relating to a supply to which paragraph (b) applies), or a concession card prescription (where the supply is an early supply of a specified pharmaceutical benefit)—charge the person to whom the pharmaceutical benefit is supplied either:

in any case—the general patient charge amount; or

if the supply is eligible for increased discounting—an amount that is less than the general patient charge amount, but greater than nil.

(2AAAA) For a supply other than an early supply, the allowable discount is an amount of not more than $1.

(2AAA) Paragraph (2)(b) does not apply to an early supply of a specified pharmaceutical benefit.

a holder of a concession card; or

a holder of an entitlement card; or

a concessional beneficiary; or

a person who is a dependant of a concessional beneficiary within the meaning of subsection 84(4) or (7); or

a general patient;

unless the pharmacist, medical practitioner or authority is satisfied that the person is entitled to receive the benefit on those terms.

a holder of a concession card; or

a holder of an entitlement card; or

a concessional beneficiary; or

a person who is a dependant of a concessional beneficiary within the meaning of subsection 84(4) or (7); or

a general patient;

unless the person produces evidence (whether by way of the production of a card or evidence of identity or otherwise) to the pharmacist, medical practitioner or authority that the person is entitled to receive the benefit on those terms.

by an approved pharmacist or an approved medical practitioner in respect of the supply of a pharmaceutical benefit by delivery at or to a place other than premises in respect of which the approved pharmacist is approved, or premises at which the approved medical practitioner carries on practice, as the case may be.

the patient is the holder of an entitlement card; and

the supply is not an early supply of a specified pharmaceutical benefit.

an approved supplier did not supply a pharmaceutical benefit to a person on terms that are appropriate for the supply of a benefit to:

the holder of a concession card or entitlement card; or

a concessional beneficiary; or

a person who is a dependant of a concessional beneficiary within the meaning of subsection 84(4) or (7);

because the supplier was not satisfied that the person was entitled to receive the benefit on those terms; and

the Secretary is satisfied that the person was entitled at the time to receive the benefit on those terms;

the person is entitled to be paid by the Commonwealth an amount equal to the difference between:

the amount payable for the supply of the benefit on those terms; and

an amount equal to:

if the supply of the benefit is one to which subsection 99(2A), (2AB) or (2B) applies—the Commonwealth price for the supply of the benefit; or

in any other case—the amount that the person was charged under section 87.

an approved supplier did not supply the benefit to the person on those terms because the supplier was not satisfied that the person was entitled to receive the benefit on those terms; and

the Secretary is satisfied that the person was entitled at the time to receive the benefit on those terms.

under this Act an approved supplier charged a person an amount in respect of a supply of a pharmaceutical benefit; and

at the time of the supply, the person was eligible to be issued with a concession card or an entitlement card but was not the holder of such a card.

that the failure to issue a concession card or entitlement card was not caused by some wilful action of the person; and

that in the circumstances the person should be treated as if:

the person had been at the time when the pharmaceutical benefit was supplied the holder of a concession card or entitlement card; and

the prescription upon which the pharmaceutical benefit had been supplied were a concession card prescription or entitlement card prescription (as the case may be);

the person is entitled to be paid by the Commonwealth an amount equal to any amount paid by the person that would not have been payable if the pharmaceutical benefit had been supplied on a concession card prescription or an entitlement card prescription (as the case may be).

a listed brand of the pharmaceutical item in the pharmaceutical benefit; or

the manner of administration of the pharmaceutical item in the pharmaceutical benefit.

by a medical practitioner otherwise than in relation to the medical treatment of a person requiring that pharmaceutical benefit; or

by a participating dental practitioner otherwise than in relation to the dental treatment of a person requiring that pharmaceutical benefit; or

by an authorised optometrist otherwise than in relation to the optometrical treatment of a person requiring that pharmaceutical benefit; or

by an authorised midwife otherwise than in relation to the midwifery treatment of a person requiring that pharmaceutical benefit; or

by an authorised nurse practitioner otherwise than in relation to the nurse practitioner treatment by the authorised nurse practitioner of a person requiring that pharmaceutical benefit.

request the provision of a medicare number applicable to the person and of the expiry date in relation to that number; and

if a medicare number (whether with or without the expiry date in relation to that number):

is so provided as a number applicable to the person; or

is retained as such a number in the PBS prescriber’s records in accordance with section 88AA;

endorse the medicare number on a prescription written for that person (including, in the case of a communicated prescription, a subsequent written version of that communicated prescription).

the person in respect of whom the number was provided; or

the legal guardian of that person; or

another person identified in a determination made by the Minister under section 86D or 88AA as capable of authorising the recording and retention of such number or number and date;

authorises the PBS prescriber to inform the approved supplier of that number, or number and date.

to provide a medicare number, or a medicare number and the expiry date in relation to that number, to a PBS prescriber; or

to authorise such a PBS prescriber to inform an approved supplier of such a number, or number and date, in the circumstances described in subsection 86D(2).

there be supplied on one occasion a quantity or number of units of:

if the pharmaceutical benefit has a pharmaceutical item—the pharmaceutical item; or

in any other case—the pharmaceutical benefit;

in excess of the maximum quantity or number of units (if any) applicable under a determination of the Minister under subsection 85A(2); or

the pharmaceutical benefit is to be administered in a manner other than the manner (if any) applicable under a determination of the Minister under subsection 85A(2).

if the pharmaceutical benefit has a pharmaceutical item—the pharmaceutical item; or

in any other case—the pharmaceutical benefit;

not exceeding the total quantity or number of units that could be prescribed if the medical practitioner directed a repeated supply.

if the pharmaceutical benefit has a pharmaceutical item—the pharmaceutical item; or

in any other case—the pharmaceutical benefit;

not exceeding the total quantity or number of units that could be prescribed if the person directed a repeated supply.

the regulations prescribe either or both of the following:

circumstances in which the person may make such a direction;

conditions on the making of such a direction; and

the direction is made in those circumstances and in accordance with those conditions.

(a) the supply of a pharmaceutical benefit (the first benefit) and another pharmaceutical benefit (the second benefit) is directed; and

the second benefit is:

Schedule equivalent to the first benefit; or

if the first benefit is a listed brand of a pharmaceutical item—another listed brand of the pharmaceutical item;

then the prescription is taken to direct the repeated supply of the first benefit.

a PBS prescriber is provided with a medicare number as a number applicable to a person (whether with or without the expiry date in relation to that number) either:

as a result of a request under subsection 88(3A); or

to facilitate the writing of a prescription for the supply of pharmaceutical benefits at a later time or times; and

the PBS prescriber is satisfied that the person providing the number, or number and date, is:

the person in respect of whom the number was provided; or

the legal guardian of that person; or

another person who, in accordance with a determination made by the Minister under subsection (4), is capable of giving an authorisation under this subsection;

the PBS prescriber may, with the authorisation of the person providing the number, or number and date:

record and retain that number, or number and date, in the PBS prescriber’s records; or

if the PBS prescriber has already recorded and retained either or both of those particulars by virtue of a previous operation of this section—check the accuracy and completeness of the recorded particulars and, if the recorded particulars are inaccurate or incomplete, appropriately modify those particulars.

that the record of those numbers, or numbers and dates, is protected, by such security safeguards as it is reasonable in the circumstances to take, against loss, against unauthorised access, use, modification or disclosure, and against other misuse; and

that if it is necessary for access to the record of those numbers, or numbers and dates, to be given to a person in connection with the provision of services to the PBS prescriber, everything reasonably within the power of the PBS prescriber is done to prevent unauthorised use or disclosure of information contained in that record.

the pharmaceutical benefit is covered by an instrument made under subsection (3); and

the supply is made in accordance with conditions that are specified in an instrument made under subsection (3).

a person had presented the pharmacist with a prescription that:

had been written by a PBS prescriber in accordance with this Act and the regulations; and

did not contain a medicare number; and

a reference in this Part to a prescription for the supply of a pharmaceutical benefit to a person who is a holder of a concession card or an entitlement card included a reference to a supply made in accordance with subsection (1) to a person who is a holder of a concession card or an entitlement card on the day of the supply; and

the following provisions were omitted:

subsection 84(2A) and paragraph 84(10)(a);

section 84AA;

subparagraph 86B(3)(b)(i) and paragraph 86B(4)(e);

paragraphs 86C(3)(c) and (6)(e);

paragraph 92A(1)(ca); and

(d) the words “, in accordance with concessional benefit prescription, concession card prescription and entitlement card prescription in subsection 84(1) were omitted.section 84AA,” in the definitions of

the pharmaceutical benefits that may be supplied by an approved pharmacist without a prescription; and

the conditions that must be satisfied when making a supply of those pharmaceutical benefits.

cause a written report to be prepared of a review of this section no more than two years from the commencement of the section; and

cause a copy of the report to be laid before each House of the Parliament within six months of the commencement of the review.

the sale of the pharmacy; or

the acquisition, following the death of a person who was the owner or one of the owners of the pharmacy, of that person’s interest in the business of the pharmacy; or

a change in the constitution of a partnership that owned the pharmacy;

if the pharmacy is to continue to operate at the same premises.

(3AB) In subsections (3AA) and (3AE):

pharmacy means a business in the course of the carrying on of which pharmaceutical benefits are supplied.

(3AC) For the purposes of paragraph (3AA)(b), if a person who is the owner or one of the owners of the business of a pharmacy dies, another person will be taken to have acquired the interest of the deceased person only after:

a grant of probate of the will, or letters of administration of the estate, of the owner who has died, by a court of a State or Territory having jurisdiction in relation to the owner; and

the transfer to that other person of that interest.

(3AD) Despite the grant of that probate or those letters of administration being taken to have had effect from the date of death of the owner, any permission to supply pharmaceutical benefits at particular premises that is granted under section 91 in respect of:

a period preceding that grant of probate or those letters of administration; or

a period following that grant of probate or those letters of administration and preceding the subsequent transfer of the business;

is unaffected.

(3AE) Subsection (3A) does not apply to an application for an approval if:

(a) the application arises out of an expansion or contraction of particular premises (the original premises) at which a pharmacy is situated; and

the expanded or contracted premises occupy any of the space occupied by the original premises.

(3AF) However, the Secretary may, at his or her discretion, refer to the Authority an application referred to in subsection (3AE).

the pharmacist would be unable to supply pharmaceutical benefits at the premises; or

the premises would not be accessible by members of the public for the purpose of receiving pharmaceutical benefits at times that, in the opinion of the Secretary, are reasonable.

before 18 December 1990, was granted an approval to supply pharmaceutical benefits at or from particular premises; and

supplied pharmaceutical benefits on or before 18 December 1990 from other premises without the Secretary having granted approval under subsection (3) in respect of those other premises;

is to be taken to have been granted in respect of those other premises, or whichever of those premises was the premises from which the pharmacist last supplied pharmaceutical benefits before 18 December 1990, an approval under subsection (3).

(a) the approval referred to in paragraph (5A)(a) was not in force immediately before the commencement of Health and Community Services Legislation Amendment Bill (No. 2) 1993; orsection 20 of the

the pharmacist is not permitted, under the law of the State or Territory in which the premises referred to in paragraph (5A)(b) are situated, to carry on business at those premises.

the application was made on or after 1 July 2006; and

the decision was made on the basis that the application did not comply with the requirements of the relevant rules determined by the Minister under section 99L.

the Secretary’s decision will result in a community being left without reasonable access to pharmaceutical benefits supplied by an approved pharmacist; and

it is in the public interest to approve the pharmacist.

on request by the pharmacist made under section 90B; and

by the Minister personally.

a reference to a decision of the Secretary includes a reference to a decision of the Secretary that has been affirmed by a decision of the Administrative Review Tribunal or an order of a federal court; and

a reference to a decision of the Administrative Review Tribunal includes a reference to a decision of the Administrative Review Tribunal that has been affirmed by an order of a federal court.

within 30 days after the pharmacist is notified of the Secretary’s decision; or

if the pharmacist has applied to the Administrative Review Tribunal for review of the Secretary’s decision—within 30 days after:

the pharmacist is given a copy of the Administrative Review Tribunal’s decision affirming the Secretary’s decision; or

the application has been discontinued, withdrawn or dismissed; or

if the pharmacist has sought an order from a federal court in respect of the Secretary’s decision or a decision of the Administrative Review Tribunal affirming the Secretary’s decision—within 30 days after:

the court has made an order affirming the Secretary’s decision or the Administrative Review Tribunal’s decision, as the case requires; or

the court proceeding has been discontinued, withdrawn or dismissed.

(a) the pharmacist makes an application under Administrative Review Tribunal Act 2024 for the President of the Administrative Review Tribunal to refer a decision on review of the Secretary’s decision to the guidance and appeals panel for review; andsection 123 of the

the President refuses the application;

the pharmacist may make a request under subsection (1) within 30 days of the day on which the pharmacist is notified of the refusal under Administrative Review Tribunal Act 2024.section 129 of the

the Secretary’s decision is the subject of a proceeding before the Administrative Review Tribunal or a federal court; and

the proceeding has not been discontinued, withdrawn or dismissed, or otherwise finally determined.

the Minister may, by notice in writing given to the pharmacist, require the pharmacist to provide such further information, or produce such further documents, to the Minister as the Minister specifies, within the period specified in the notice; and

the Minister may give a notice in writing to any other person:

advising the person of the request; and

inviting the person to provide comments on, or information or documents relevant to, the request within the period specified in the notice.

the Minister gives a notice to a pharmacist under paragraph (1)(a); and

the pharmacist does not provide the information specified in the notice or produce the documents specified in the notice within the period specified in the notice;

the Minister may treat the request as having been withdrawn.

is only required to consider comments, information or documents provided by the person during the period specified in the notice; and

if the person does not provide any comments, information or documents within that period—is not required to take any further action to obtain such comments, information or documents.

a person is an approved pharmacist in respect of a pharmacy at particular premises; and

the approved pharmacist dies at any time on or after the commencement of this section; and

another person claims to be:

the executor, or one of the executors, of the will of the deceased pharmacist in respect of which probate has been granted; or

the executor, or one of the executors, of the will of the deceased pharmacist although probate has not yet been granted; or

a person, or one of the persons, to whom the administration of the estate of the deceased pharmacist has been granted; or

a person, or one of the persons, intending to apply for administration of the estate of the deceased pharmacist; and

that other person applies to the Secretary for permission to supply pharmaceutical benefits at those premises;

the Secretary may, if the Secretary reasonably believes that the applicant is, or on the grant of probate of the will or letters of administration of the estate is likely to be, such an executor or administrator, grant the applicant permission to supply such pharmaceutical benefits at those premises.

must be made in writing in a form approved by the Secretary; and

must be made as soon as reasonably practicable after the death of the pharmacist who previously supplied such pharmaceutical benefits at those premises; and

must be accompanied by documentary evidence relating to:

the identity of the applicant; and

the nature of the applicant’s claim to be a person referred to in a subparagraph of paragraph 91(1)(c);

of a kind determined by the Secretary under subsection (3).

the person granted that permission is to be treated for all purposes of this Act as if the person is, and, since the referral day in relation to the permission, had been, approved under section 90 as an approved pharmacist in relation to the pharmacy at those premises; and

any supply of pharmaceutical benefits at or from those premises by a pharmacist who is not an approved pharmacist after the referral day in relation to the permission and before the grant of that permission is to be treated as if it had been a supply of those pharmaceutical benefits by the person to whom the permission is granted; and

references in this Act to an approval granted under section 90 include references to an approval treated as having been granted under section 90 by paragraph (a); and

the conditions to which an approval granted under the Minister’s determination for the purposes of paragraph 92A(1)(f)) apply also to an approval that is treated as having been granted under section 90 by paragraph (a); andsection 90 is subject (including any condition that is imposed by means of

the rights conferred and obligations imposed on an approved pharmacist apply to that person in his or her activities as such an approved pharmacist.

unless paragraph (b) applies—the day following the date of death of the deceased pharmacist to whom the application for permission related; or

if there has been a prior permission granted under this section in relation to the premises to which the permission relates—the day following the date the prior permission was revoked.

probate of the will, or administration of the estate, of a deceased approved pharmacist is granted; and

the person granted a permission under subsection (1) in relation to the supply of pharmaceutical benefits at premises where that pharmacist carried on business is not, or is not included among persons who are, granted that probate or administration;

he or she must, as soon as he or she becomes aware of that fact, notify the Secretary in writing of that fact.

probate of the will, or administration of the estate, of a deceased approved pharmacist is granted; and

the person granted a permission under subsection (1) is not, or is not included among persons who are, granted that probate or administration;

the Secretary must, by notice in writing given to the person granted that permission, revoke the permission.

because of a disaster or exceptional circumstances relating to the affected premises:

the approved pharmacist is unable to supply pharmaceutical benefits at the affected premises; or

the affected premises are not accessible by members of the public for the purpose of receiving pharmaceutical benefits; and

the alternative premises are in substantially the same locality as the affected premises.

the approved pharmacist is unable to supply pharmaceutical benefits at the alternative premises; or

the alternative premises are not accessible by members of the public for the purpose of receiving pharmaceutical benefits at times that, in the opinion of the Secretary, are reasonable.

Application requirements

be in writing and in a form approved by the Secretary (if any); and

unless the Secretary otherwise allows, be made:

as soon as reasonably practicable after the condition in paragraph (1)(a) is first met in relation to the affected premises; and

before the end of the period of 14 days beginning on the day the approved pharmacist starts supplying pharmaceutical benefits at or from the alternative premises; and

be accompanied by documentary evidence, of a kind determined under paragraph (11)(e) (if any), demonstrating that:

paragraphs (1)(a) and (b) are satisfied for the application; and

paragraphs (2)(a) and (b) are not satisfied for the application.

Secretary may require further information or documents

the approved pharmacist is to be treated for all purposes of this Act (except section 92 and subsection 98(4)) as if the approved pharmacist were, during the temporary supply period, approved under section 90 as an approved pharmacist in relation to the alternative premises; and

references in this Act to an approval granted under section 90 include references to an approval treated as having been granted under section 90 by paragraph (a) of this subsection; and

the conditions to which an approval granted under the Minister’s determination for the purposes of paragraph 92A(1)(f)) also apply to an approval that is treated as having been granted under section 90 by paragraph (a) of this subsection; andsection 90 is subject (including any condition that is imposed by means of

in addition to supplying pharmaceutical benefits at the alternative premises during the temporary supply period, the approved pharmacist may also supply pharmaceutical benefits from the alternative premises during that period.

Meaning of temporary supply period

the end of the following period beginning on the day after the condition in paragraph (1)(a) is first met in relation to the affected premises:

6 months (unless subparagraph (ii) or (iii) applies);

a shorter period specified in the notice of the Secretary’s decision granting the permission;

if the Secretary, by written notice given to the approved pharmacist before the end of the period that would otherwise apply under subparagraph (i) or (ii) or this subparagraph, extends that period by a further specified period—that period as so extended;

when the approved pharmacist supplies pharmaceutical benefits, after the beginning of the temporary supply period, at or from:

the affected premises; or

premises (other than the alternative premises or premises for which the pharmacist is approved under the Secretary is satisfied are in substantially the same locality as the affected premises;section 90) that

when an approval is granted to the approved pharmacist under section 90 in respect of the alternative premises;

when the approved pharmacist’s approval for the affected premises is cancelled under section 98;

when the permission is revoked under subsection (9) of this section.

Revoking permission

both:

the approved pharmacist is able to supply pharmaceutical benefits at the affected premises; and

the affected premises are accessible by members of the public for the purpose of receiving pharmaceutical benefits; or

the approved pharmacist is unable to supply pharmaceutical benefits at the alternative premises; or

the alternative premises are not accessible by members of the public for the purpose of receiving pharmaceutical benefits at times that, in the opinion of the Secretary, are reasonable; or

it is in the public interest to do so.

Effect of certain State and Territory laws

matters to which the Secretary may, must or must not have regard for the purposes of making a decision for the purposes of this section;

events that are taken to be, or not to be, disasters for the purposes of paragraph (1)(a);

circumstances that are taken to be, or not to be, exceptional circumstances for the purposes of paragraph (1)(a);

circumstances in which premises are taken to be, or not to be, in substantially the same locality as other premises for the purposes of paragraph (1)(b) or subparagraph (8)(b)(ii);

kinds of documentary evidence for the purposes of paragraph (3)(c).

an approval under section 90 in respect of particular premises covers one individual and the individual is bankrupt; and

(b) the trustee (the applicant) of the estate of the bankrupt individual makes an application to the Secretary for permission to supply pharmaceutical benefits at those premises;

the Secretary must grant, or refuse to grant, the applicant permission to supply pharmaceutical benefits at those premises.

Approved pharmacist is a partnership and partners are bankrupt

an approval under section 90 in respect of particular premises covers a partnership that consists only of individuals and each of the partners is bankrupt; and

either:

(i) if the same person is the trustee of the estate of each of the bankrupt partners—the trustee (the applicant) makes an application to the Secretary for permission to supply pharmaceutical benefits at those premises; or

(ii) otherwise—the trustees (the applicant) of the estates of the bankrupt partners make a joint application to the Secretary for permission to supply pharmaceutical benefits at those premises;

the Secretary must grant, or refuse to grant, the applicant permission to supply pharmaceutical benefits at those premises.

External administrator in relation to pharmacy

an approval under section 90 is in force in respect of particular premises; and

there is an external administrator in relation to the pharmacy situated at those premises; and

(c) the external administrator (the applicant) makes an application to the Secretary for permission to supply pharmaceutical benefits at those premises;

the Secretary must grant, or refuse to grant, the applicant permission to supply pharmaceutical benefits at those premises.

Application requirements

be in writing and in a form approved by the Secretary; and

unless the Secretary otherwise allows, be made before the end of the period of 10 business days beginning on:

for an application under subsection (1)—the day the trustee became the trustee of the estate of the bankrupt individual; or

for an application under subsection (2)—the first day on which there was a trustee of the estate of each bankrupt partner; or

for an application under subsection (3)—the day the applicant became the external administrator; and

be accompanied by documentary evidence that:

for an application under subsection (1) or (2)—there is a trustee of the estate of the bankrupt individual or of the estate of each bankrupt partner; or

for an application under subsection (3)—there is an external administrator in relation to the pharmacy; and

be accompanied by a statement setting out:

whether, at the time of the application, the pharmacy situated at the premises is operating at the premises; and

if the pharmacy is not operating at the premises—the day the pharmacy ceased operating and the day of the proposed resumption of operation; and

the grounds on which the applicant considers the pharmacy can continue or resume operating at the premises.

Secretary may require further information or documents