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SR 1960 No. 17 Regulations as amended, taking into account amendments up to National Health (Pharmaceutical Benefits) Amendment (Price Disclosure) Regulation 2014
Principal Regulations; Repeals the former National Health (Pharmaceutical Benefits) Regulations.
Administered by: Health
Registered 04 Jun 2014
Start Date 03 Jun 2014
End Date 31 Mar 2015
Date of repeal 01 Apr 2017
Repealed by National Health (Pharmaceutical Benefits) Regulations 2017

Commonwealth Coat of Arms

National Health (Pharmaceutical Benefits) Regulations 1960

Statutory Rules No. 17, 1960 as amended

made under the

National Health Act 1953

Compilation start date:                     3 June 2014

Includes amendments up to:            SLI No. 60, 2014

About this compilation

This compilation

This is a compilation of the National Health (Pharmaceutical Benefits) Regulations 1960 as in force on 3 June 2014. It includes any commenced amendment affecting the legislation to that date.

This compilation was prepared on 3 June 2014.

The notes at the end of this compilation (the endnotes) include information about amending laws and the amendment history of each amended provision.

Uncommenced amendments

The effect of uncommenced amendments is not reflected in the text of the compiled law but the text of the amendments is included in the endnotes.

Application, saving and transitional provisions for provisions and amendments

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

Modifications

If a provision of the compiled law is affected by a modification that is in force, details are included in the endnotes.

Provisions ceasing to have effect

If a provision of the compiled law has expired or otherwise ceased to have effect in accordance with a provision of the law, details are included in the endnotes.

  

  

  


Contents

Part 1—Preliminary                                                                                                             1

Division 1.1—Interpretation                                                                                     1

1............................ Name of Regulations.......................................................... 1

2............................ Commencement.................................................................. 1

3............................ Repeal and saving............................................................... 1

4............................ Transitional......................................................................... 2

5............................ Interpretation....................................................................... 2

Division 1.2—Application of Regulations to electronic prescriptions and electronic orders     10

5A......................... Preparing electronic prescriptions..................................... 10

5B.......................... Date when a prescription is written or a pharmaceutical benefit is prescribed          10

5C.......................... Requirement to give information in writing...................... 10

5D......................... Requirement to give a prescription.................................... 11

5E.......................... Approval of kinds of electronic communications.............. 11

5F.......................... Approval of information technology requirements........... 12

Part 2—Approvals under Part VII of the Act                                                   14

8............................ Application for approval to be in approved form.............. 14

8AA...................... Application for approval as authorised optometrist, authorised midwife or authorised nurse practitioner.......................................................................................... 14

8A......................... Numbering of approvals................................................... 14

9............................ Certain requirements to be met after cancellation etc of approval             15

Part 2A—Co‑marketed brands                                                                                   16

9AAC.................... Co‑marketed brands.......................................................... 16

Part 2BSafety net concession cards                                                                     17

9AA...................... Safety net concession card................................................ 17

9AB....................... Additional concession cards............................................. 18

9AC....................... Replacement concession cards.......................................... 19

9AD...................... Refusal to issue additional or replacement concession cards 20

9AE....................... Review of decisions.......................................................... 21

9AF....................... Prescribed offices............................................................. 21

Part 2C—Pharmaceutical benefits entitlement cards                                    22

9A......................... Pharmaceutical benefits prescription record forms............ 22

9B.......................... Pharmaceutical benefits entitlement card........................... 23

9BA....................... Prescribed offices............................................................. 24

9C.......................... Additional entitlement cards.............................................. 24

9D......................... Replacement entitlement cards.......................................... 26

9E.......................... Refusal to issue additional or replacement entitlement cards 27

9F.......................... Review of decisions.......................................................... 28

Part 3—Pharmaceutical benefits                                                                                29

13.......................... Variation of application of determination of maximum number of repeats or maximum number or quantity of units.................................................................................. 29

Part 4—Supply of pharmaceutical benefits by particular PBS prescribers          33

14.......................... Meaning of practitioner.................................................... 33

15.......................... Prescriber bag supplies—practitioners on ships............... 33

16.......................... Prescriber bag supplies—obtaining benefits by practitioners 33

17.......................... Prescriber bag supplies—supply of pharmaceutical benefits by approved pharmacists           34

18.......................... Prescriber bag supplies—payment for pharmaceutical benefits                35

18A....................... Benefits obtained by approved medical practitioners for the purposes of section 93                35

Part 5—Prescriptions and supply                                                                              38

18B........................ Purpose of Part................................................................. 38

19.......................... Writing of prescriptions.................................................... 38

19AA.................... Item in residential medication chart is prescription............ 41

19A....................... Information about status of person................................... 43

19B........................ Restriction on using PBS and NHS forms....................... 45

21.......................... Supply of pharmaceutical benefit on first presentation of prescription     45

21A....................... Supply of pharmaceutical benefit on basis of medication chart prescription             46

21B........................ Continued dispensing supply of pharmaceutical benefit... 49

21C........................ Information about status of person—continued dispensing and medication chart prescriptions               49

22.......................... Supply of pharmaceutical benefits before surrender of written prescription             50

24.......................... Circumstances in which quantity of repeated supply can be directed to be supplied on one occasion      52

24A....................... Continued dispensing—repeated supply not to be supplied on one occasion           53

25.......................... Repeated supplies of pharmaceutical benefits................... 53

26.......................... Repeat authorisations........................................................ 56

26AA.................... Repeat authorisation form—continued dispensing............ 59

26A....................... Deferred supply authorisations......................................... 59

27.......................... Presentation of prescriptions in trading hours................... 61

28.......................... Presentation of urgent prescriptions.................................. 61

30.......................... Special charge for delivery................................................ 62

31.......................... Receipt of pharmaceutical benefit...................................... 62

Part 6—Miscellaneous                                                                                                       66

31B........................ Purpose of Part................................................................. 66

32.......................... Retention of prescriptions etc............................................ 66

32A....................... Keeping documents—continued dispensing..................... 67

32B........................ Keeping documents—medication chart prescriptions........ 68

33.......................... Proper stocks to be kept.................................................... 69

35.......................... Standards of composition and purity of pharmaceutical benefits and additives        69

36.......................... Labelling of pharmaceutical benefits—full cost................ 70

37.......................... Surrender of forms........................................................... 70

37AA.................... Payment for pharmaceutical benefit supplied on basis of medication chart prescription           71

Part 6A—Price reduction and price disclosure                                                 72

Division 1—Price reduction                                                                                    72

37A....................... Reduction day................................................................... 72

37B........................ Listed brands of pharmaceutical items, reduction days and percentages   72

Division 2—Price disclosure                                                                                   73

Subdivision 1—Interpretation                                                                              73

37C........................ Meaning of data collection period.................................... 73

37D....................... Meaning of price sampling day........................................ 74

37E........................ Special rules for certain listed brands................................ 74

Subdivision 2—Weighted average disclosed price                                          76

37F........................ Method for determining weighted average disclosed price of listed brand of pharmaceutical item           76

37G....................... Step 1—Net revenue for brand......................................... 76

37H....................... Step 2—Adjusted volume for brand................................. 76

37J......................... Step 3—Average approved ex‑manufacturer price for brand 77

37K........................ Step 4—Disclosed price for brand.................................... 78

37L........................ Step 5—Price percentage difference of brand................... 78

37M....................... Step 6—Repeat steps for each brand of pharmaceutical item 79

37N....................... Step 7—Total adjusted volume of brands of pharmaceutical item            79

37P........................ Step 8—Weighted average percentage difference of brands of pharmaceutical item                79

37Q....................... Step 9—Repeat steps for each pharmaceutical item with related brands   80

37R........................ Step 10—Weighted average percentage difference for listed brand and all related brands       81

37S........................ Step 11—Weighted average disclosed price for listed brand of pharmaceutical item               82

Subdivision 3—Price disclosure requirements                                                 82

37T........................ Price disclosure requirements........................................... 82

Part 7—Arrangements of the Pharmaceutical Benefits Advisory Committee     85

38.......................... Definitions for Part........................................................... 85

38A....................... Appointments to Committee—nominating bodies............ 85

38B........................ Number of nominations for appointment.......................... 86

39.......................... Chairperson...................................................................... 86

40.......................... Resignation....................................................................... 86

41.......................... Presiding member............................................................. 87

42.......................... Meetings of the Committee............................................... 87

43.......................... Quorum............................................................................ 87

44.......................... Voting............................................................................... 87

45.......................... Disclosure of pecuniary interests by Chairperson and members              88

46.......................... Resolutions without a formal meeting............................... 89

47.......................... Reports and recommendations.......................................... 90

48.......................... Remuneration for chair and members of sub‑committees. 90

Part 8—Transitional provisions                                                                                  91

Division 2—Amendments made by National Health (Pharmaceutical Benefits) Amendment Regulation 2013 (No. 1)                                                                  91

53.......................... Pharmaceutical item price and pricing quantity for delisted brands in main disclosure cycle with relevant day of 30 September 2013........................................................... 91

Division 3—Provisions for National Health (Pharmaceutical Benefits) Amendment (Price Disclosure) Regulation 2014                                                                                  93

54.......................... Application of Regulations............................................... 93

55.......................... Data collection periods...................................................... 93

56.......................... Expiry of this Division..................................................... 94

Schedule 3—Co‑marketed brands                                                             95

Schedule 5—Listed brands of pharmaceutical items, reduction days and percentages                                                                                                                         96

Schedule 6—Prescribed offices for subsections 84DA(5) and 84E(5) of the Act              98

Schedule 9—Pharmaceutical item price and pricing quantity for certain delisted brands with main disclosure cycle relevant day of 30 September 2013   100

Endnotes                                                                                                                                  101

Endnote 1—About the endnotes                                                                          101

Endnote 2—Abbreviation key                                                                              103

Endnote 3—Legislation history                                                                           104

Endnote 4—Amendment history                                                                         111

Endnote 5—Uncommenced amendments [none]                                        132

Endnote 6—Modifications [none]                                                                       132

Endnote 7—Misdescribed amendments [none]                                           132

Endnote 8—Miscellaneous [none]                                                                      132

 


Part 1Preliminary

Division 1.1Interpretation

1  Name of Regulations

                   These Regulations are the National Health (Pharmaceutical Benefits) Regulations 1960.

2  Commencement

                   These Regulations shall come into operation on 1 March 1960.

3  Repeal and saving

             (1)  The National Health (Pharmaceutical Benefits) Regulations (comprising Statutory Rules 1956, Nos. 54 and 75; 1957, Nos. 25 and 52; 1958, Nos. 23 and 42; and 1959, Nos. 4, 28 and 64) are repealed.

             (2)  A prescription or repeat authorization duly written before the commencement of these Regulations in accordance with the regulations repealed by this regulation shall be deemed, for the purposes of these Regulations, to be duly written in accordance with these Regulations.

             (3)  The repeal of the regulations made by subregulation (1) does not affect the power of a Committee of Inquiry established under Division 2 of Part VIII of the Act to inquire into and report, as provided in regulation 19 of the regulations so repealed, on the prescribing before the commencement of these Regulations by a medical practitioner in the circumstances specified in that regulation and, where a Committee of Inquiry has so reported before the commencement of these Regulations or so reports after the commencement of these Regulations, the medical practitioner is liable to repay to the Commonwealth the amount payable under that regulation as if the repealed regulations were still in force.

4  Transitional

                   The National Health (Pharmaceutical Benefits) Regulations as in force immediately before 1 January 1999 continue to apply to a prescription made out in duplicate, the duplicate being marked with the word ‘Duplicate’.

5  Interpretation

             (1)  In these Regulations, unless the contrary intention appears:

applicable amount has the same meaning as in Part VII of the Act.

approved electronic communication means an electronic communication of a kind approved in writing by the Secretary under regulation 5E for the purposes of the provision in which the expression is used.

approved hospital means a hospital the governing body of which is an approved hospital authority.

approved hospital authority means a hospital authority approved under section 94 of the Act.

approved information technology requirements means information technology requirements of a kind approved in writing by the Secretary under regulation 5F for the purposes of the provision in which the expression is used.

approved medical practitioner means a medical practitioner approved under section 92 of the Act.

approved pharmacist has the meaning given by subsection 84(1) of the Act.

Note:          The definition in subsection 84(1) of the Act provides that approved pharmacist means a person for the time being approved under section 90 of the Act and includes certain other persons described in that definition. Under paragraph 91(7)(a) of the Act, a person granted permission to supply pharmaceutical benefits under subsection 91(1) of the Act is to be treated as if the person is approved under section 90 of the Act as an approved pharmacist. Under paragraph 91(7)(c) of the Act, references in the Act to an approval granted under section 90 of the Act include references to an approval treated as having been granted under section 90 by paragraph 91(7)(a) of the Act.

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

authorised midwife has the meaning given by subsection 84(1) of the Act.

authorised nurse practitioner has the meaning given by subsection 84(1) of the Act.

authorised optometrist has the meaning given by subsection 84(1) of the Act.

authority prescription means a prescription that prescribes a pharmaceutical benefit and that has been authorised:

                     (a)  in accordance with subregulation 13(5); or

                     (b)  in accordance with authority required procedures that:

                              (i)  are part of the circumstances determined by the Minister under paragraph 85(7)(b) of the Act for the pharmaceutical benefit; or

                             (ii)  are part of the conditions determined by the Minister under subsection 85A(2A) of the Act for the pharmaceutical benefit; or

                            (iii)  are incorporated by reference into the circumstances determined for the pharmaceutical benefit under subsection 85B(4) of the Act.

brand, for a pharmaceutical item, means a brand of the pharmaceutical item within the meaning of subsection 84(1) of the Act.

Commonwealth price has the same meaning as in Part VII of the Act.

concessional beneficiary has the same meaning as in Part VII of the Act.

concession card has the same meaning as in Part VII of the Act.

data collection period, for a brand of a pharmaceutical item: see regulation 37C.

delisted brand, of a pharmaceutical item: a listed brand of a pharmaceutical item becomes a delisted brand when a determination made under subsection 85(6) of the Act is no longer in force for that brand.

dependant, in relation to a concessional beneficiary, has the same meaning as in Part VII of the Act.

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

electronic communication has the meaning given by subsection 5(1) of the Electronic Transactions Act 1999.

electronic order form means a form that is approved in writing by the Secretary under subparagraph 16(1)(b)(ii) for the purposes of lodging an order under paragraph 16(1)(b).

electronic prescription means a prescription that is prepared and submitted:

                     (a)  in accordance with approved information technology requirements (if any), by means of an approved electronic communication; and

                     (b)  in accordance with a form approved by the Secretary under sub‑subparagraph 19(1)(a)(iia)(B).

entitlement card has the same meaning as in Part VII of the Act.

final day, in relation to a data collection period, means the last day of the data collection period.

incentive, for a brand of a pharmaceutical item, includes anything given as an incentive to take supply of the brand (including a delisted brand before it was delisted) whether the incentive is given:

                     (a)  before the supply of the brand, but on condition of taking supply; or

                     (b)  at, or after, the time of the supply of the brand; or

                     (c)  over a period of time; or

                     (d)  directly for the brand; or

                     (e)  indirectly for the brand (for a group of brands of pharmaceutical items or other products, for example).

information technology requirements has the meaning given by subsection 5(1) of the Electronic Transactions Act 1999.

initial month, for a brand of a pharmaceutical item that was not a listed brand immediately before the brand’s start day, means the first month of the brand’s first data collection period.

last listed brand, of a pharmaceutical item, means the brand of the pharmaceutical item that was the last to become a delisted brand before the final day.

Medicare Australia/DVA copy, for a paper‑based prescription, means the duplicate of the prescription on which appear the words ‘Medicare Australia/DVA copy’.

medicare number has the same meaning as in Part VII of the Act.

medication chart prescription means a prescription mentioned in subregulation 19AA(1).

optometrist has the meaning given by subsection 84(1) of the Act.

out‑patient medication has the same meaning as in Part VII of the Act.

paper‑based prescription means a prescription that is prepared in duplicate in accordance with subparagraph 19(1)(a)(i), (ii) or (iii).

paperless claim for payment means a claim for a payment from the Commonwealth, in relation to the supply of a pharmaceutical benefit:

                     (a)  using the Claims Transmission System, within the meaning given by subsection 99AAA(1) of the Act; and

                     (b)  to which, or in which, prescriptions, repeat authorisations or deferred supply authorisations are not required to be attached or included.

participating dental practitioner has the same meaning as in Part VII of the Act.

PBS prescriber has the meaning given by subsection 84(1) of the Act.

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

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

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

pharmacist/patient copy, for a paper‑based prescription, means the original of the prescription on which appear the words ‘pharmacist/patient copy’.

prescription means a paper‑based prescription or an electronic prescription, and includes an authority prescription and a medication chart prescription.

price adjustment means an adjustment under:

                     (a)  a price agreement; or

                     (b)  a price determination; or

                     (c)  Division 3A of Part VII of the Act.

price sampling day: see regulation 37D.

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

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

ready‑prepared pharmaceutical benefit means a pharmaceutical benefit in respect of which a determination made under subsection 85(6) of the Act is in force.

record form has the same meaning as in Part VII of the Act.

related brand, of a brand of a pharmaceutical item, means a brand of a pharmaceutical item that has the same drug and manner of administration as the first pharmaceutical item (including another brand of the same pharmaceutical item), but does not include a brand of an exempt item.

Note:          For the definition of exempt item, see subsection 84(1) of the Act.

relevant entitlement period has the same meaning as in Part VII of the Act.

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

repeat authorisation form means the form mentioned in subparagraph 26 (1A)(a)(i), which is used, among other purposes, to support a claim for a payment from the Commonwealth under section 99AAA of the Act in relation to a supply of a pharmaceutical benefit.

residential care has the meaning given by section 41–3 of the Aged Care Act 1997.

residential medication chart has the meaning given by subregulation 19AA(6).

responsible person has the same meaning as in Part VII of the Act.

start day, for a brand of a pharmaceutical item, means the day on which the brand was first required to comply with the price disclosure requirements under section 99ADD of the Act.

supply certification form: see subregulation (4).

the Act means the National Health Act 1953.

             (2)  In these Regulations, unless the contrary intention appears, a reference to prescribing or to the writing of a prescription shall be read as a reference to the writing of a prescription for the supply of a pharmaceutical benefit under Part VII of the Act.

             (3)  In these Regulations, unless the contrary intention appears:

                     (a)  a reference to the holder of a concession card or an entitlement card shall be read as a reference to a person who is, by virtue of section 84G of the Act, to be taken to be a holder of the card;

                    (aa)  a reference to the original holder of a concession card is a reference to the person to whom a concession card has been issued under section 84DA of the Act;

                     (b)  a reference to the original holder of an entitlement card shall be read as a reference to the person to whom an entitlement card has been issued under section 84E of the Act; and

                     (c)  a reference to a member of the family of a person shall be read as a reference to a person who is a member of that family within the meaning of section 84B of the Act.

             (4)  In these Regulations, a supply certification form means a form that:

                     (a)  is included by an approved supplier in a paperless claim for payment as certification that the supply of a pharmaceutical benefit is made in accordance with the Act; and

                     (b)  includes the following details:

                              (i)  the name and approval number of the supplier;

                             (ii)  the address of the premises at or from which the pharmaceutical benefits mentioned in subparagraph (iv) are supplied, being premises at or from which the supplier is approved to supply pharmaceutical benefits;

                            (iii)  the number used by the supplier to identify the claim period;

                            (iv)  for each type of prescription that is covered by the claim—the serial numbers of the pharmaceutical benefits that have been supplied and that are the subject of the claim, identified using a range of serial numbers for each of the following categories:

                                        (A)  general patients;

                                        (B)  concessional beneficiaries, dependants of concessional beneficiaries and holders of concession cards;

                                        (C)  holders of entitlement cards;

                             (v)  the total number of claims for each category mentioned in sub‑subparagraphs (iv)(A) to (C);

                            (vi)  a certification that the pharmaceutical benefits mentioned in subparagraph (iv) have been supplied in accordance with the Act and instruments made under that Act;

                           (vii)  a declaration that the information in the form is correct, and signed by the supplier or an authorised representative of the supplier;

                          (viii)  particulars that identify the person signing the form under subparagraph (vii).

Example for subparagraph (b)(iv):   A medication chart prescription is a type of prescription.

Division 1.2Application of Regulations to electronic prescriptions and electronic orders

5A  Preparing electronic prescriptions

                   A reference in these Regulations to writing or preparing a prescription, a repeat authorisation or a deferred supply authorisation, whether the expression writing, preparing or any other expression is used, is taken to include:

                     (a)  for an electronic prescription—writing or preparing the prescription by means of an electronic form approved by the Secretary under sub‑subparagraph 19(1)(a)(iia)(B) for the purposes of writing an electronic prescription; and

                     (b)  for a repeat authorisation that relates to an electronic prescription—writing or preparing the authorisation by means of an electronic form authorised by the Secretary under subparagraph 26(1A)(a)(i) for the supply of a pharmaceutical benefit under an electronic prescription; and

                     (c)  for a deferred supply authorisation that relates to an electronic prescription—writing or preparing the authorisation by means of an electronic form authorised by the Secretary under paragraph 26A(2)(a) for deferring the supply of a pharmaceutical benefit under an electronic prescription.

5B  Date when a prescription is written or a pharmaceutical benefit is prescribed

                   A reference in these Regulations to the day or date on which a prescription is written by a PBS prescriber or the day or date on which a pharmaceutical benefit is prescribed is, in relation to an electronic prescription, the day or date on which the prescription is signed by the PBS prescriber.

5C  Requirement to give information in writing

             (1)  If, under these Regulations, a person is required to write information on a prescription, a repeat authorisation, a deferred supply authorisation or an order form, that requirement is taken to have been met in relation to an electronic prescription, an authorisation that relates to an electronic prescription or an electronic order form, if the person gives the information:

                     (a)  in accordance with approved information technology requirements (if any); and

                     (b)  by means of an approved electronic communication.

             (2)  This regulation applies to a requirement to write information on a prescription, a repeat authorisation, a deferred supply authorisation or an order form, whether the expression write, certify, endorse, identify, indicate, mark, specify, state, or any other expression is used.

5D  Requirement to give a prescription

                   If, under these Regulations, a prescription is required to be given or presented to an approved pharmacist or an approved medical practitioner for the purpose of supplying a pharmaceutical benefit to the person for whom the prescription was written, that requirement is taken to have been met in relation to an electronic prescription if:

                     (a)  the person who will receive the pharmaceutical benefit (whether or not for the person’s own use) requests the pharmacist or practitioner to supply the pharmaceutical benefit; and

                     (b)  the pharmacist or practitioner consents, within the meaning of subsection 5(1) of the Electronic Transactions Act 1999, to the prescription being given or presented, in accordance with approved information technology requirements (if any), by means of an approved electronic communication; and

                     (c)  the prescription is accessible by the pharmacist or practitioner.

5E  Approval of kinds of electronic communications

                   The Secretary may, in writing, approve a kind of electronic communication for 1 or more of the following purposes:

                     (a)  preparing or submitting an electronic prescription;

                     (b)  giving information, for the purposes of these Regulations, in relation to an electronic prescription, an authorisation that relates to an electronic prescription or an electronic order form;

                     (c)  giving or presenting an electronic prescription to an approved pharmacist or an approved medical practitioner under these Regulations;

                     (d)  submitting an electronic prescription to the Minister in accordance with paragraph 13(2)(b);

                     (e)  lodging an order with an approved pharmacist to obtain a pharmaceutical benefit for the purpose of section 93 of the Act;

                      (f)  submitting a receipt for a pharmaceutical benefit received under paragraph 16(1)(b);

                     (g)  giving an acknowledgment under these Regulations for the supply of a pharmaceutical benefit under an electronic prescription or an authorisation that relates to an electronic prescription;

                     (h)  doing any other thing that is required or permitted to be done for the purposes of these Regulations.

5F  Approval of information technology requirements

                   The Secretary may, in writing, approve information technology requirements for 1 or more of the following purposes:

                     (a)  preparing and submitting an electronic prescription;

                     (b)  giving information, for the purposes of these Regulations, in relation to an electronic prescription, an authorisation that relates to an electronic prescription or an electronic order form;

                     (c)  giving or presenting an electronic prescription to an approved pharmacist or an approved medical practitioner under these Regulations;

                     (d)  lodging an order with an approved pharmacist to obtain a pharmaceutical benefit for the purpose of section 93 of the Act;

                     (e)  submitting a receipt for a pharmaceutical benefit received under paragraph 16(1)(b);

                      (f)  giving an acknowledgment under these Regulations for the supply of a pharmaceutical benefit under an electronic prescription or an authorisation that relates to an electronic prescription;

                     (g)  doing any other thing that is required or permitted to be done for the purposes of these Regulations.

Part 2Approvals under Part VII of the Act

  

8  Application for approval to be in approved form

                   The Minister, in the case of a hospital authority, and the Secretary, in the case of a pharmacist or medical practitioner, may refuse to entertain an application for approval under Part VII of the Act unless the application:

                     (a)  in the case of an application for approval of a pharmacist—is in accordance with a form approved in writing by the Secretary;

                     (b)  in the case of an application for approval of a hospital authority—is in accordance with a form approved in writing by the Secretary; and

                     (c)  in the case of an application for approval of a medical practitioner—is in accordance with a form approved in writing by the Secretary.

8AA  Application for approval as authorised optometrist, authorised midwife or authorised nurse practitioner

                   The following applications must be made in a form acceptable to the Secretary:

                     (a)  an application for approval as an authorised optometrist under subsection 84AAB(1) of the Act;

                     (b)  an application for approval as an authorised midwife under subsection 84AAF(1) of the Act;

                     (c)  an application for approval as an authorised nurse practitioner under subsection 84AAJ(1) of the Act.

8A  Numbering of approvals

             (1)  If the Secretary approves:

                     (a)  a dental practitioner under section 84A of the Act; or

                    (aa)  an optometrist under section 84AAB of the Act; or

                   (ab)  an eligible midwife under section 84AAF of the Act; or

                    (ac)  an eligible nurse practitioner under section 84AAJ of the Act; or

                     (b)  a pharmacist under section 90 of the Act; or

                     (c)  a medical practitioner under section 92 of the Act;

he or she may allot a number to that approval.

          (1A)  If the Secretary grants permission to a person to supply pharmaceutical benefits under subsection 91(1) of the Act, he or she may allot a number to the approval that, under paragraph 91(7)(a) of the Act, is treated as having been granted to the person under section 90 of the Act.

          (1B)  If the Minister substitutes for a decision of the Secretary to which section 90A of the Act applies a decision approving a pharmacist for the purpose of supplying pharmaceutical benefits at or from particular premises, the Minister may allot a number to that approval.

             (2)  If the Minister approves a hospital authority under section 94 of the Act he or she may allot a number to that approval.

9  Certain requirements to be met after cancellation etc of approval

             (1)  If the approval of an approved pharmacist is suspended, revoked or cancelled, the pharmacist must not, in any way, indicate that he or she has been, or is, approved to supply pharmaceutical benefits.

Penalty:  1 penalty unit.

             (2)  An offence against subregulation (1) is an offence of strict liability.

Note:          For strict liability, see section 6.1 of the Criminal Code.

Part 2ACo‑marketed brands

  

9AAC  Co‑marketed brands

                   For subsection 84AE(4) of the Act, the listed brands of a pharmaceutical item specified in columns 2 and 3 of an item in Schedule 3 are co‑marketed brands.

Part 2BSafety net concession cards

  

9AA  Safety net concession card

             (1)  For the purposes of paragraph 84DA(3)(b) of the Act, the following particulars are prescribed in relation to an application under subsection 84DA(1) or (2) of the Act:

                     (a)  the full name of the applicant;

                     (b)  the residential address of the applicant;

                     (c)  the full name of each person who is a member of the applicant’s family;

                     (d)  the relationship of each person referred to in paragraph (c) to the applicant;

                     (e)  the date on which the application is made;

                      (f)  the medicare number of the applicant.

             (2)  For the purposes of paragraph 84DA(3)(b) of the Act, the following documents are prescribed in relation to an application under subsection 84DA(1) or (2) of the Act:

                     (a)  record forms issued to the applicant or to a member of the applicant’s family that:

                              (i)  record the value of pharmaceutical benefits, repatriation pharmaceutical benefits and out‑patient medication supplied to the applicant, or to a member of the applicant’s family, during the relevant entitlement period to which the application relates; and

                             (ii)  bear a statement signed by the applicant declaring that the pharmaceutical benefits, repatriation pharmaceutical benefits and out‑patient medication recorded in the form were so supplied;

                     (b)  in respect of any other pharmaceutical benefit, repatriation pharmaceutical benefit or out‑patient medication so supplied, any document that establishes the value of that pharmaceutical benefit, repatriation pharmaceutical benefit or out‑patient medication.

9AB  Additional concession cards

             (1)  A person whose concession card has been lost, stolen, damaged or destroyed may apply for an additional concession card to the Secretary.

             (2)  A person who is a holder of a concession card, other than a person referred to in subregulation (1), may apply for an additional concession card to:

                     (a)  the Secretary; or

                     (b)  where the original concession card was issued by an approved pharmacist, approved medical practitioner, public hospital authority or approved hospital authority—that approved pharmacist, approved medical practitioner, public hospital authority or approved hospital authority.

             (3)  An application under subregulation (1) or (2) for an additional concession card must:

                     (a)  be in accordance with the form approved by the Secretary; and

                     (b)  set out:

                              (i)  the full name of the applicant; and

                             (ii)  the residential address of the applicant; and

                            (iii)  the full name of each person (other than the applicant) who is a member of the family of the original holder of the concession card and the relationship of that person to the original holder; and

                            (iv)  the number (if known to the applicant) of any other concession card held by a member of the family of the original holder of the concession card; and

                             (v)  if the application is made under subregulation (1)—the number (if known to the applicant) of the concession card that the applicant holds; and

                            (vi)  the medicare number of the applicant; and

                     (c)  be signed and dated by the applicant; and

                     (d)  be accompanied by the original concession card unless the application is made under subregulation (1).

             (4)  Where, on an application to a person for the issue of an additional concession card, the person is satisfied, having regard to:

                     (a)  the matters contained in the application; and

                     (b)  any other relevant matters;

that an additional concession card should be issued to the applicant, the person must issue an additional concession card to the applicant.

9AC  Replacement concession cards

             (1)  An original holder of a concession card may apply for the issue of a replacement card.

             (2)  An application under subregulation (1) must:

                     (a)  be made, in accordance with the form approved by the Secretary, to:

                              (i)  the Secretary; or

                             (ii)  where the original concession card was issued by an approved pharmacist, approved medical practitioner, public hospital authority or approved hospital authority—that approved pharmacist, approved medical practitioner, public hospital authority or approved hospital authority; and

                     (b)  set out:

                              (i)  the full name of the applicant; and

                             (ii)  the residential address of the applicant; and

                            (iii)  the full name of any new family member and his or her relationship to the applicant; and

                            (iv)  the medicare number of the applicant; and

                     (c)  be signed and dated by the applicant; and

                     (d)  be accompanied by the original concession card unless the application is made to the Secretary.

             (3)  Where, on an application to a person for the issue of a replacement card, the person is satisfied, having regard to:

                     (a)  the matters contained in the application; and

                     (b)  any other relevant matters;

that:

                     (c)  the applicant is the original holder of the concession card to which the application relates; and

                     (d)  each person identified in the application in accordance with subparagraph (2)(b)(iii) became, after the issue of that concession card and during the relevant entitlement period in respect of which that card was issued, a member of the original card holder’s family;

the person must issue a replacement concession card to the applicant.

9AD  Refusal to issue additional or replacement concession cards

             (1)  Where an approved pharmacist, approved medical practitioner, public hospital authority or approved hospital authority makes:

                     (a)  a decision under regulation 9AB refusing to issue an additional concession card; or

                     (b)  a decision under regulation 9AC refusing to issue a replacement concession card;

the applicant may apply to the Secretary under subregulation 9AB(2) or regulation 9AC for the issue of the additional concession card or replacement concession card, as the case requires.

             (2)  Where the Secretary makes:

                     (a)  a decision under regulation 9AB refusing to issue an additional concession card; or

                     (b)  a decision under regulation 9AC refusing to issue a replacement concession card;

the Secretary must, by notice in writing, inform the applicant of the making of, and reasons for, the decision.

             (3)  A notice under subregulation (2) must include a statement to the effect:

                     (a)  that an application may be made, subject to the Administrative Appeals Tribunal Act 1975, by or on behalf of a person whose interests are affected by the decision, to the Administrative Appeals Tribunal for review of the decision; and

                     (b)  that a person whose interests are affected by the decision may, except where subsection 28(4) of that Act applies, request a statement under section 28 of that Act.

             (4)  A failure to comply with subregulation (3) in relation to a decision does not affect the validity of the decision.

9AE  Review of decisions

                   An application may be made to the Administrative Appeals Tribunal for review of a decision of the Secretary:

                     (a)  refusing to issue an additional concession card under regulation 9AB; or

                     (b)  refusing to issue a replacement concession card under regulation 9AC.

9AF  Prescribed offices

                   For subsection 84DA(5) of the Act, each office mentioned in Schedule 6 is a prescribed office.

Part 2CPharmaceutical benefits entitlement cards

  

9A  Pharmaceutical benefits prescription record forms

             (1)  For the purposes of paragraph 84D(3)(b) of the Act, the following particulars of the person to whom a record form is issued are prescribed particulars:

                     (a)  the Christian or given names and the surname of the person;

                     (b)  the address of the person.

             (2)  For the purposes of subsection 84D(4) of the Act, the following particulars of a person who is a member of the family of a person to whom a record form is issued are prescribed particulars:

                     (a)  the Christian or given names and the surname of the person;

                     (b)  the relationship of the person to the person to whom the record form is issued.

             (4)  For the purposes of paragraph 84D(7)(c) of the Act, the following particulars in relation to the supply of a pharmaceutical benefit or repatriation pharmaceutical benefit are prescribed:

                     (a)  the code number set out in relation to that pharmaceutical benefit or repatriation pharmaceutical benefit in the Schedule of Pharmaceutical Benefits published by the Department;

                     (b)  the number allotted under regulation 8A to the approval of the approved pharmacist, approved medical practitioner or approved hospital authority supplying the pharmaceutical benefit or repatriation pharmaceutical benefit;

                     (c)  the maximum value of the pharmaceutical benefit or repatriation pharmaceutical benefit for safety net purposes.

          (4A)  For the purposes of paragraph 84D(11)(c) of the Act, the following particulars in relation to the supply of out‑patient medication are prescribed:

                     (a)  particulars that identify the medication;

                     (b)  particulars that identify the public hospital at which the medication was supplied;

                     (c)  the applicable amount.

             (5)  The maximum value of a pharmaceutical benefit for safety net purposes is:

                     (a)  if the price of the pharmaceutical benefit is charged under paragraph 87(2)(a), (b) or (c) of the Act:

                              (i)  the price mentioned for the prescription in the relevant paragraph of subsection 87(2) of the Act as in force when the price is charged; or

                             (ii)  if the price charged is less than the amount mentioned in subparagraph (i)—the amount of the price charged; or

                     (b)  if the price of the pharmaceutical benefit is charged under paragraph 87(2)(e) of the Act:

                              (i)  the price mentioned for the prescription in paragraph 87(2)(e) of the Act as in force when the price is charged; or

                             (ii)  if the agreed price, within the meaning of subsection 84C(6) of the Act as in force when the price is charged, of the pharmaceutical benefit is less than the amount mentioned in subparagraph (i)—the amount of the agreed price; or

                            (iii)  if the price charged is less than the amount mentioned in subparagraph (i) and less than the agreed price mentioned in subparagraph (ii)—the amount of the price charged.

             (6)  The maximum value of a repatriation pharmaceutical benefit for safety net purposes is the amount charged for the benefit in accordance with a scheme referred to in subsection 91(1) of the Veterans’ Entitlements Act 1986.

9B  Pharmaceutical benefits entitlement card

             (1)  For the purposes of paragraph 84E(3)(b) of the Act, the following particulars are prescribed in relation to an application under subsection 84E(1) or (2) of the Act:

                     (a)  the full name of the applicant;

                     (b)  the residential address of the applicant;

                     (c)  the full name of each person who is a member of the applicant’s family;

                     (d)  the relationship of each person referred to in paragraph (c) to the applicant;

                     (e)  the date on which the application is made;

                      (f)  the medicare number of the applicant.

             (2)  For the purposes of paragraph 84E(3)(b) of the Act, the following documents are prescribed in relation to an application under subsection 84E(1) or (2) of the Act:

                     (a)  record forms issued to the applicant or to a member of the applicant’s family that:

                              (i)  record the value of pharmaceutical benefits, repatriation pharmaceutical benefits and out‑patient medication supplied to the applicant, or to a member of the applicant’s family, during the relevant entitlement period to which the application relates; and

                             (ii)  bear a statement signed by the applicant declaring that the pharmaceutical benefits, repatriation pharmaceutical benefits and out‑patient medication recorded in the forms were so supplied;

                     (b)  in respect of any other pharmaceutical benefit, repatriation pharmaceutical benefit or out‑patient medication so supplied, any document that establishes the value of that pharmaceutical benefit, repatriation pharmaceutical benefit or out‑patient medication.

9BA  Prescribed offices

                   For subsection 84E(5) of the Act, each office mentioned in Schedule 6 is a prescribed office.

9C  Additional entitlement cards

             (1)  A person whose entitlement card has been lost, stolen, damaged or destroyed may apply for an additional entitlement card to the Secretary.

             (2)  A person who is a holder of a entitlement card, other than a person referred to in subregulation (1), may apply for an additional entitlement card to:

                     (a)  the Secretary; or

                     (b)  where the original entitlement card was issued by an approved pharmacist, approved medical practitioner, public hospital authority or approved hospital authority—that approved pharmacist, approved medical practitioner, public hospital authority or approved hospital authority.

             (3)  An application under subregulation (1) or (2) for an additional entitlement card must:

                     (a)  be in accordance with the form approved by the Secretary; and

                     (b)  set out:

                              (i)  the full name of the applicant; and

                             (ii)  the residential address of the applicant; and

                            (iii)  the full name of each person (other than the applicant) who is a member of the family of the original holder of the entitlement card and the relationship of that person to the original holder; and

                            (iv)  the number (if known to the applicant) of any other entitlement card held by a member of the family of the original holder of the entitlement card; and

                             (v)  if the application is made under subregulation (1)—the number (if known to the applicant) of the entitlement card that the applicant holds; and

                            (vi)  the medicare number of the applicant; and

                     (c)  be signed and dated by the applicant; and

                     (d)  be accompanied by the original entitlement card unless the application is made under subregulation (1).

             (4)  Where, on an application to a person for the issue of an additional entitlement card, the person is satisfied, having regard to:

                     (a)  the matters contained in the application; and

                     (b)  any other relevant matters;

that an additional entitlement card should be issued to the applicant, the person must issue an additional entitlement card to the applicant.

9D  Replacement entitlement cards

             (1)  An original holder of a entitlement card may apply for the issue of a replacement card.

             (2)  An application under subregulation (1) must:

                     (a)  be made, in accordance with the form approved by the Secretary, to:

                              (i)  the Secretary; or

                             (ii)  where the original entitlement card was issued by an approved pharmacist, approved medical practitioner, public hospital authority or approved hospital authority—that approved pharmacist, approved medical practitioner, public hospital authority or approved hospital authority; and

                     (b)  set out:

                              (i)  the full name of the applicant; and

                             (ii)  the residential address of the applicant; and

                            (iii)  the full name of any new family member and his or her relationship to the applicant; and

                            (iv)  the medicare number of the applicant; and

                     (c)  be signed and dated by the applicant; and

                     (d)  be accompanied by the original entitlement card unless the application is made to the Secretary.

             (3)  Where, on an application to a person for the issue of a replacement card, the person is satisfied, having regard to:

                     (a)  the matters contained in the application; and

                     (b)  any other relevant matters;

that:

                     (c)  the applicant is the original holder of the entitlement card to which the application relates; and

                     (d)  each person identified in the application in accordance with subparagraph (2)(b)(iii) became, after the issue of that entitlement card and during the relevant entitlement period in respect of which that card was issued, a member of the original card holder’s family;

the person must issue a replacement entitlement card to the applicant.

9E  Refusal to issue additional or replacement entitlement cards

             (1)  Where an approved pharmacist, approved medical practitioner, public hospital authority or approved hospital authority makes:

                     (a)  a decision under regulation 9C refusing to issue an additional entitlement card; or

                     (b)  a decision under regulation 9D refusing to issue a replacement entitlement card;

the applicant may apply to the Secretary under subregulation 9C(2) or regulation 9D for the issue of the additional entitlement card or replacement entitlement card, as the case requires.

             (2)  Where the Secretary makes:

                     (a)  a decision under regulation 9C refusing to issue an additional entitlement card; or

                     (b)  a decision under regulation 9D refusing to issue a replacement entitlement card;

the Secretary must, by notice in writing, inform the applicant of the making of, and reasons for, the decision.

             (3)  A notice under subregulation (2) must include a statement to the effect:

                     (a)  that an application may be made, subject to the Administrative Appeals Tribunal Act 1975, by or on behalf of a person whose interests are affected by the decision, to the Administrative Appeals Tribunal for review of the decision; and

                     (b)  that a person whose interests are affected by the decision may, except where subsection 28(4) of that Act applies, request a statement under section 28 of that Act.

             (4)  A failure to comply with subregulation (3) in relation to a decision does not affect the validity of the decision.

9F  Review of decisions

                   An application may be made to the Administrative Appeals Tribunal for review of a decision of the Secretary:

                     (a)  refusing to issue an additional entitlement card to a person under regulation 9C; or

                     (b)  refusing to issue a replacement entitlement card to a person under regulation 9D.

Part 3Pharmaceutical benefits

  

13  Variation of application of determination of maximum number of repeats or maximum number or quantity of units

             (1)  For the purposes of subsection 85A(3) of the Act, the Minister is authorised to vary, in accordance with subregulation (5), in relation to a person included in the class of persons to whom this regulation applies, the application of the determinations in force under paragraph 85A(2)(a) or (b) of the Act.

Note:          See subsection 85A(3A) of the Act for the Minister’s power to determine rules relating to an authorisation of a variation.

             (2)  This regulation applies to a person in respect of whom a practitioner submits a prescription that is not in accordance with a determination in force under paragraph 85A(2)(a) or (b) of the Act:

                     (a)  to the Secretary, in one of the forms specified in paragraph (3)(a); or

                     (b)  to the Minister, using a method specified in paragraph (3)(b).

             (3)  A prescription submitted under subregulation (2) must:

                     (a)  in the case of a prescription submitted to the Secretary—be prepared and signed by the practitioner:

                              (i)  in a form approved in writing by the Secretary and completed by the practitioner in ink in his or her own handwriting; or

                             (ii)  in a form, prepared by means of a computer, that is in accordance with the form approved by the Secretary under subparagraph (i); or

                            (iii)  in a form, prepared by means of a computer, approved in writing for the purpose by the Secretary and in the format approved in writing by the Secretary; or

                          (iiia)  in a form approved in writing by the Secretary under sub‑subparagraph 19(1)(a)(iia)(B) for the purposes of writing an electronic prescription; or

                            (iv)  by a method approved in writing by the Secretary; or

                     (b)  in the case of a prescription submitted to the Minister—be submitted by the practitioner giving the Minister details of the prescription that has been prepared and signed by the practitioner in accordance with paragraph (a):

                              (i)  by telephone; or

                             (ii)  by means of an approved electronic communication.

             (4)  For the purposes of paragraph (2)(a), a prescription that has been prepared and signed by the practitioner in accordance with paragraph (3)(a) is taken to have been submitted by him or her if it is submitted by one of his or her employees.

             (5)  A variation under subregulation (1) in relation to a person may be made:

                     (a)  if a paper‑based prescription is submitted in accordance with a form specified in subparagraph (3)(a)(i), (ii) or (iii) or by a method approved under subparagraph (3)(a)(iv)—by the Minister signing his or her authorisation of the prescription on it and:

                              (i)  if the Minister requires the practitioner to alter the prescription—by returning it to the practitioner for alteration before the practitioner gives it to the person in respect of whom it was prepared; or

                             (ii)  in any other case:

                                        (A)  by returning it to the practitioner; or

                                        (B)  if requested by the practitioner—by sending it to the person in respect of whom it was prepared; or

                    (aa)  if an electronic prescription is submitted in accordance with a form approved under subparagraph (3)(a) (iiia)—by the Minister signing his or her authorisation of the prescription on the electronic prescription and:

                              (i)  if the Minister requires the practitioner to alter the prescription—by returning it, including by means of an electronic communication, to the practitioner for alteration before the practitioner gives it to the person in respect of whom it was prepared; or

                             (ii)  in any other case:

                                        (A)  by returning it, including by means of an electronic communication, to the practitioner; or

                                        (B)  if requested by the practitioner—by making the prescription accessible by the person in respect of whom it was prepared or by an approved pharmacist for the purpose of supplying a pharmaceutical benefit to the person in respect of whom the prescription was prepared; or

                     (b)  if a prescription is submitted in accordance with paragraph (2)(b) by telephone—orally, at the time the Minister is given details of the prescription; or

                     (c)  if a prescription is submitted in accordance with paragraph (2)(b) by means of an electronic communication—by the Minister sending his or her authorisation, by electronic communication, to the practitioner.

             (6)  If the Minister makes a variation in accordance with paragraph (5)(b) or (c):

                     (a)  the Minister must tell the practitioner, orally or by electronic communication, the number that has been allotted to the authorised prescription; and

                     (b)  the practitioner must:

                              (i)  mark that number on the prescription; and

                             (ii)  retain, for 1 year from the date on which the variation was made:

                                        (A)  if the prescription is a paper‑based prescription—a copy of the prescription; or

                                        (B)  if the prescription is an electronic prescription—the electronic prescription.

             (7)  For subparagraph (6)(b)(ii), the date on which the Minister makes a variation in relation to a person in respect of whom a practitioner submits an electronic prescription is:

                     (a)  if the electronic prescription was submitted in accordance with paragraph (5)(b)—the date on which the Minister tells the practitioner the number that has been allotted to the authorised prescription; and

                     (b)  if the electronic prescription was submitted in accordance with paragraph (5)(c)—the date on which the Minister sends, by means of an electronic communication, his or her authorisation of the prescription to the practitioner.

             (8)  In this regulation:

practitioner means any of the following:

                     (a)  an authorised optometrist;

                     (b)  a medical practitioner;

                     (c)  an authorised midwife;

                     (d)  an authorised nurse practitioner.

Part 4Supply of pharmaceutical benefits by particular PBS prescribers

  

14  Meaning of practitioner

                   In this Part:

practitioner means any of the following:

                     (a)  a medical practitioner;

                     (b)  an authorised midwife;

                     (c)  an authorised nurse practitioner.

15  Prescriber bag supplies—practitioners on ships

                   A practitioner who is practising his or her profession on a ship is not authorised to supply pharmaceutical benefits under section 93, 93AA or 93AB of the Act.

16  Prescriber bag supplies—obtaining benefits by practitioners

             (1)  For sections 93, 93AA and 93AB of the Act, a practitioner who is not an approved medical practitioner may obtain a pharmaceutical benefit only if he or she lodges with an approved pharmacist:

                     (a)  an order, in duplicate, signed by the practitioner, in accordance with a form approved in writing by the Secretary; or

                     (b)  an order, in accordance with subregulation (1A), that is:

                              (i)  signed by the practitioner; and

                             (ii)  in accordance with an electronic form approved in writing by the Secretary.

          (1A)  For paragraph (1)(b), an order is lodged with an approved pharmacist if:

                     (a)  it is lodged in accordance with any approved information technology requirements and by an approved electronic communication; and

                     (b)  the practitioner, or an agent of the practitioner, who will receive the pharmaceutical benefit asks the approved pharmacist to supply the pharmaceutical benefit under the order; and

                     (c)  the approved pharmacist consents, within the meaning of subsection 5(1) of the Electronic Transactions Act 1999, to the order being lodged, in accordance with any approved information technology requirements and by an approved electronic communication; and

                     (d)  the order is accessible by the approved pharmacist.

             (2)  A practitioner who is not an approved medical practitioner may obtain a pharmaceutical benefit under subregulation (1) only once in a calendar month.

             (3)  A practitioner, or an agent of a practitioner, who receives a pharmaceutical benefit under subregulation (1), must:

                     (a)  prepare a receipt for the benefit supplied, using the part of the order form identified for that purpose, that includes the following information:

                              (i)  the date of supply of the benefit;

                             (ii)  if the benefit is received by an agent of the practitioner—the agent’s address; and

                     (b)  if the order is lodged in accordance with paragraph (1)(a)—give the receipt to the approved pharmacist supplying the benefit; and

                     (c)  if the order is lodged in accordance with paragraph (1)(b):

                              (i)  submit the receipt, in accordance with any approved information technology requirements and by an approved electronic communication; and

                             (ii)  ensure the receipt is accessible by the approved pharmacist supplying the benefit.

17  Prescriber bag supplies—supply of pharmaceutical benefits by approved pharmacists

             (1)  An approved pharmacist commits an offence if:

                     (a)  he or she supplies a pharmaceutical benefit on an order lodged under regulation 16; and

                     (b)  neither of the following circumstances applies:

                              (i)  the pharmacist knows the practitioner whose signature appears on the order;

                             (ii)  if he or she does not know the practitioner, the pharmacist:

                                        (A)  is given the full name and address of the practitioner by the person who lodged the order; and

                                        (B)  if the practitioner is a medical practitioner—is given the medical registration number of the practitioner by the person who lodged the order; and

                                        (C)  for any other practitioner—is given the number allotted to the approval for the practitioner by the Secretary under subregulation 8A(1) by the person who lodged the order; and

                                        (D)  writes on the order form the details mentioned in sub‑subparagraphs (A), (B) and (C).

Penalty:  0.4 penalty units.

             (2)  An offence against subregulation (1) is an offence of strict liability.

18  Prescriber bag supplies—payment for pharmaceutical benefits

                   An approved pharmacist who has supplied a pharmaceutical benefit to a practitioner under section 93, 93AA or 93AB of the Act on an order lodged under regulation 16 and in accordance with these Regulations is entitled to payment from the Commonwealth for the supply of the pharmaceutical benefit at the rate and subject to the conditions determined by the Minister and applicable at the time of the supply.

18A  Benefits obtained by approved medical practitioners for the purposes of section 93

             (1)  An approved medical practitioner commits an offence if he or she obtains a pharmaceutical benefit for the purpose of section 93 of the Act by lodging with an approved pharmacist an order under regulation 16.

Penalty:  0.2 penalty units.

             (2)  An approved medical practitioner commits an offence if he or she obtains a pharmaceutical benefit for the purpose of section 93 of the Act more than once in each month.

Penalty:  0.2 penalty units.

             (3)  An approved medical practitioner who obtains a pharmaceutical benefit for the purpose of section 93 of the Act must give a notice to the Secretary that he or she has obtained the benefit.

Penalty:  0.2 penalty units.

             (4)  For subregulation (3), the notice must be:

                     (a)  in a form authorised by the Secretary; and

                     (b)  signed and dated by the practitioner.

             (5)  An approved medical practitioner who gives a notice to the Secretary under subregulation (3) must retain a copy of the notice for at least 1 year from the date on which he or she gives the notice to the Secretary.

Penalty:  0.2 penalty units.

             (6)  An offence against subregulation (1), (2), (3) or (5) is an offence of strict liability.

Note:          For strict liability, see section 6.1 of the Criminal Code.

             (7)  An approved medical practitioner who:

                     (a)  obtains a pharmaceutical benefit for the purpose of section 93 of the Act in accordance with these Regulations; and

                     (b)  gives a notice to the Secretary under subregulation (3) about the benefit; and

                     (c)  gives the Secretary a claim in accordance with a form made available by the Secretary to approved medical practitioners for that purpose; and

                     (d)  completes the claim form in accordance with directions on that form;

is entitled to payment from the Commonwealth in respect of the pharmaceutical benefit at the rate applicable for the supply of the same benefit on an order under regulation 16.

Part 5Prescriptions and supply

  

18B  Purpose of Part

             (1)  Unless otherwise specified, this Part is made for section 105 of the Act.

             (2)  This Part:

                     (a)  prescribes terms and conditions relating to the supply of pharmaceutical benefits; and

                     (b)  provides rules about writing prescriptions.

19  Writing of prescriptions

             (1)  A prescription, other than a medication chart prescription, is duly written only if a PBS prescriber:

                     (a)  prepares the prescription:

                              (i)  in duplicate, by handwriting the prescription in ink on a prescription form:

                                        (A)  that is as nearly as practicable 18 centimetres long by 12 centimetres wide; and

                                        (B)  on which appears the name and address of the PBS prescriber and, subject to subregulation (4), the letters ‘PBS’; and

                                        (C)  on the original of which appear the words ‘pharmacist/patient copy’; and

                                        (D)  on the duplicate of which appear the words ‘Medicare Australia/DVA copy’; or

                             (ii)  in duplicate, by means of a computer on a prescription form:

                                        (A)  that is as nearly as practicable 18 centimetres long by 12 centimetres wide; and

                                        (B)  on which appears the name and address of the PBS prescriber and, subject to subregulation (4), the letters ‘PBS’; and

                                        (C)  on the original of which appear the words ‘pharmacist/patient copy’; and

                                        (D)  on the duplicate of which appear the words ‘Medicare Australia/DVA copy’; and

                                         (E)  that is approved in writing for the purpose by the Secretary; or

                           (iia)  by means of a form:

                                        (A)  on which appear the name and address of the PBS prescriber and the letters ‘PBS’; and

                                        (B)  that is approved in writing by the Secretary for the purpose of writing an electronic prescription; or

                            (iii)  by another method approved in writing by the Secretary; and

                    (aa)  signs the prescription after it is prepared; and

                     (b)  for an authority prescription other than an authority prescription mentioned in subregulation (6)—writes on it:

                              (i)  the authority approval number allotted by the Chief Executive Medicare, unless the prescription is to be posted or delivered to the Chief Executive Medicare for authorisation; or

                             (ii)  the streamlined authority code that is part of:

                                        (A)  the circumstances determined by the Minister under paragraph 85(7)(b) of the Act for the pharmaceutical benefit that is prescribed; or

                                        (B)  the conditions determined by the Minister under subsection 85A(2A) of the Act for the pharmaceutical benefit that is prescribed; and

                     (c)  specifies on the prescription the date on which the prescription is written; and

                    (ca)  for a participating dental practitioner, authorised optometrist, authorised midwife or authorised nurse practitioner—states in the prescription the number allotted to his or her approval under regulation 8A; and

                     (d)  states in the prescription the name of the person for whom the pharmaceutical benefit is to be supplied and the address of that person; and

                     (e)  identifies in the prescription the pharmaceutical benefit by such particulars as are necessary to identify the pharmaceutical benefit; and

                      (f)  states in the prescription:

                              (i)  the quantity or number of units of the pharmaceutical benefit to be supplied; and

                             (ii)  if the supply of the benefit is to be repeated—the number of times it is to be repeated; and

                     (g)  if the pharmaceutical benefit to be supplied is not a ready‑prepared pharmaceutical benefit—indicates in the prescription the manner in which the pharmaceutical benefit is to be administered; and

                     (h)  if, under regulation 24, the medical practitioner, authorised midwife or authorised nurse practitioner directs in the prescription the supply on the one occasion of a quantity or number of units of a pharmaceutical benefit exceeding the quantity or number of units that could otherwise be prescribed—writes on the prescription ‘Reg 24’ or ‘Regulation 24’.

             (2)  However, a prescription, other than a medication chart prescription, will not be taken to be duly written by the PBS prescriber if it provides for the supply of a pharmaceutical benefit to:

                     (a)  a person if the PBS prescriber has written, on the same day, another prescription for the supply of the same or an equivalent pharmaceutical benefit to the person; or

                     (b)  more than 1 person.

             (4)  For the purposes of sub‑subparagraphs (1)(a)(i)(B) and (1)(a)(ii)(B), a prescription form that was printed before 1 June 1996 may contain the letters ‘NHS’ instead of the letters ‘PBS’.

             (5)  For subparagraphs (1)(a)(ii), (iia) and (iii), a prescription must not be prepared using a computer program that operates, or may operate, to indicate on a prescription by default, for the purpose of subsection 103(2A) of the Act, that only the brand of pharmaceutical benefit specified in the prescription is to be supplied.

             (6)  Paragraph (1)(b) does not apply to authority prescriptions that have been authorised in accordance with authority required procedures that are incorporated by reference into the circumstances determined for a pharmaceutical benefit under subsection 85B(4) of the Act.

Note:          If a streamlined authority code or an authority approval number must be written on an authority prescription, and the code or number is not written on the authority prescription, the special patient contribution mentioned in subsection 85B(4) of the Act is not payable by the Commonwealth: see subsection 85B(5) of the Act.

19AA  Item in residential medication chart is prescription

             (1)  A completed item in a residential medication chart is a prescription (a medication chart prescription) if the chart contains the information set out for the chart in a condition determined under paragraph 93A(2)(b) of the Act.

             (2)  However, a completed item in a residential medication chart is not a medication chart prescription if it provides for the supply of a pharmaceutical benefit to more than one person.

             (3)  A medication chart prescription must not be prepared using a computer program that operates, or may operate, to indicate on a prescription by default, for subsection 103(2A) of the Act, that only the brand of pharmaceutical benefit specified in the prescription is to be supplied.

             (4)  If a section in a residential medication chart requires a streamlined authority code (if any) to be entered, the code is the streamlined authority code that is part of:

                     (a)  the circumstances determined by the Minister under paragraph 85(7)(b) of the Act for the pharmaceutical benefit that is prescribed; or

                     (b)  the conditions determined by the Minister under subsection 85A(2A) of the Act for the pharmaceutical benefit that is prescribed; or

                     (c)  the circumstances determined for the pharmaceutical benefit under subsection 85B(5) of the Act.

             (5)  However, a streamlined authority code mentioned in paragraph (4)(c) does not need to be entered in a section of a chart for the section to be a completed item.

Note:          If the streamlined authority code is not written in the section of the chart, the special patient contribution mentioned in subsection 85B(4) of the Act is not payable by the Commonwealth: see subsection 85B(5) of the Act.

             (6)  In this regulation:

completed item in a residential medication chart means a section of the chart:

                     (a)  in which the medical practitioner prescribing the pharmaceutical benefit has:

                              (i)  entered the information about the pharmaceutical benefit that the section requires the medical practitioner to enter; and

                             (ii)  written the date of prescribing; and

                            (iii)  written his or her signature; and

                     (b)  in which appears the letters ‘PBS’.

Examples for subparagraph (a)(i):   Particulars sufficient to identify the pharmaceutical benefit being prescribed, and the dose, route and frequency of administration of the pharmaceutical benefit.

Note:          An item in a residential medication chart may set out fields that only need to have information filled in if the information is relevant to that prescription.

residential medication chart means a chart:

                     (a)  for prescribing, and recording the administration of, pharmaceutical benefits to persons receiving residential care; and

                     (b)  that contains the standard fields and characteristics for the chart, as set out in a condition determined under paragraph 93A(2)(b) of the Act.

Note:          A residential medication chart may also be used for prescribing, and recording the administration of, drugs, medicines and other substances that are not pharmaceutical benefits.

19A  Information about status of person

          (1A)  This regulation does not apply in relation to a medication chart prescription.

Note:          See regulation 21C for information about the status of a person for a medication chart prescription, and for a continued dispensing supply under section 89A of the Act.

             (1)  For the purposes of subsections 84AA(1), (1A), (2) and (3) of the Act, the following information is prescribed:

                     (a)  in relation to a person who is a concessional beneficiary:

                              (i)  information that the person is a concessional beneficiary; and

                             (ii)  the number specified on a card held by the person (being a card issued by the Commonwealth) as being an entitlement number (however described) in relation to the person;

                     (b)  in relation to a person who is a holder of a concession card:

                              (i)  information that the person is the holder of a concession card; and

                             (ii)  the number of the card;

                   (ba)  in relation to a person who is a holder of an entitlement card:

                              (i)  information that the person is the holder of an entitlement card; and

                             (ii)  the number of the card;

                     (c)  in relation to a person who is a dependant of a concessional beneficiary:

                              (i)  information that the person is a dependant of a concessional beneficiary; and

                             (ii)  the number specified on a card held by that concessional beneficiary (being a card issued by the Commonwealth) as being an entitlement number (however described) in relation to the person.

             (2)  For the purposes of subsections 84AA(1) and (1A) of the Act, prescribed information shall be written or marked on a prescription by making:

                     (a)  in accordance with a form approved by the Secretary for the purposes of this subregulation, provision on the prescription for the supply of that information; or

                     (b)  where the Minister has, by notice in writing published in the Gazette, given his or her consent to that effect—an endorsement on the prescription in a form that, immediately before the commencement of this regulation, was a prescribed form for the purposes of section 84AA of the Act as then in force;

and inserting:

                     (c)  in the case of information that the person to whom the prescription relates is a concessional beneficiary or a dependant of a concessional beneficiary—a tick or a cross in the square provided on the prescription for the supply of such information in relation to the person;

                   (da)  in the case of information that the person to whom the prescription relates is a holder of a concession card or an entitlement card—a tick or a cross in the square provided on the prescription for the supply of such information in relation to the person; and

                     (e)  in a case where the information is the entitlement number referred to in subparagraph (1)(a)(ii), (1)(b)(ii), (1)(ba)(ii) or (1)(c)(ii) (as the case may be) in relation to the person to whom the prescription relates—the letters and digits forming that number, in the appropriate sequence, in the squares provided on the prescription for the supply of such information.

          (2A)  For a prescription to which subsection 84AA(1) or (1A) of the Act applies, subregulations (1) and (2) do not apply if:

                     (a)  the claim for a payment from the Commonwealth in relation to the supply of the pharmaceutical benefit to which the prescription relates is made under the Claims Transmission System, within the meaning of section 99AAA of the Act; and

                     (b)  the claim includes the card number that, under subregulation (1) would, except for this subregulation, be required.

             (3)  For the purposes of subsections 84AA(2) and (3) of the Act, prescribed information shall be communicated to a pharmacist orally or in writing.

19B  Restriction on using PBS and NHS forms

             (1)  A person commits an offence if:

                     (a)  he or she writes a prescription on a form bearing the letters ‘PBS’, ‘NHS’ or ‘N. H. S’; and

                     (b)  the prescription is not written in accordance with, or for a purpose authorised by, these Regulations; and

                     (c)  the letters ‘PBS’, ‘NHS’ or ‘N. H. S’ (as the case may be) are not clearly struck out, or obliterated.

Penalty:  0.4 penalty units.

             (2)  An offence against subregulation (1) is an offence of strict liability.

Note:          For strict liability, see section 6.1 of the Criminal Code.

21  Supply of pharmaceutical benefit on first presentation of prescription

          (1A)  This regulation does not apply in relation to the supply of a pharmaceutical benefit, under subsection 93A(4) of the Act, on the basis of a medication chart prescription.

Note:          See regulation 21A.

             (1)  An approved pharmacist or an approved medical practitioner must not supply a pharmaceutical benefit to a person on the first presentation of a prescription for the supply of that benefit to the person, unless:

                     (a)  subject to regulations 22, 26 and 26A, the prescription is:

                              (i)  written in accordance with these Regulations; and

                             (ii)  given to the pharmacist or practitioner; and

                    (aa)  the date of supply of the benefit is on or before the first anniversary of the date on which the prescription was written; and 

                     (b)  the pharmacist or practitioner writes on the prescription (including, for a paper‑based prescription, both the original and the duplicate):

                              (i)  the pharmacist’s or practitioner’s name and approval number under regulation 8A; and

                             (ii)  a number that identifies the prescription.

             (2)  An approved hospital authority must not supply a pharmaceutical benefit to a person on the first presentation of a prescription for the supply of that benefit to that person, unless:

                     (a)  subject to regulations 22, 26 and 26A, the prescription is:

                              (i)  written in accordance with these Regulations; and

                             (ii)  given to the pharmacist or practitioner; and

                    (aa)  the date of supply of the benefit is on or before the first anniversary of the date on which the prescription was written; and 

                     (b)  the prescription (including, for a paper‑based prescription, both the original and the duplicate) is marked, for the hospital authority, with:

                              (i)  the hospital authority’s name and approval number under regulation 8A; and

                             (ii)  a number that identifies the prescription.

             (3)  In this regulation, a reference to the first presentation of a prescription is taken to mean, in relation to an electronic prescription, the first occasion when the prescription is accessed by an approved pharmacist or an approved medical practitioner for the purpose of supplying a pharmaceutical benefit to the person for whom the prescription was written.

21A  Supply of pharmaceutical benefit on basis of medication chart prescription

             (1)  This regulation applies in relation to the supply of a pharmaceutical benefit, under subsection 93A(4) of the Act, on the basis of a medication chart prescription.

             (2)  An approved pharmacist or an approved medical practitioner may supply a pharmaceutical benefit on the basis of a medication chart prescription only if:

                     (a)  a copy of the residential medication chart is given to the approved pharmacist or approved medical practitioner; and

                     (b)  the residential medication chart is written in accordance with any requirements for the chart in these Regulations and any conditions determined under paragraph 93A(2)(b) of the Act; and

                     (c)  the date on which the pharmaceutical benefit is supplied by the approved pharmacist or approved medical practitioner is:

                              (i)  during the period of validity of the residential medication chart; and

                             (ii)  is no later than the stop date (if any) indicated in the prescription; and

                     (d)  the approved pharmacist or approved medical practitioner writes on the copy of the residential medication chart the following for the supply:

                              (i)  the approved pharmacist’s or approved medical practitioner’s name and approval number under regulation 8A;

                             (ii)  an identification number for the supply;

                            (iii)  the date on which the pharmaceutical benefit is supplied.

             (3)  For paragraph (2)(c), the period of validity of a residential medication chart:

                     (a)  starts on the day in a calendar month (the first calendar month) when the first prescription for a pharmaceutical benefit is written in the residential medication chart; and

                     (b)  ends on the last day of the third calendar month that starts after the first calendar month.

Example:    The first prescription is written in a residential medication chart on 11 June. The period of validity of the residential medication chart starts on 11 June and ends on 30 September.

Note:          calendar month is defined in section 2B of the Acts Interpretation Act 1901.

             (4)  An approved pharmacist or an approved medical practitioner may supply up to a maximum quantity of a pharmaceutical item or pharmaceutical benefit more than once on the basis of a particular medication chart prescription for the pharmaceutical benefit only if:

                     (a)  the prescription indicates that an ongoing supply of the pharmaceutical benefit is authorised for the period of validity of the chart; or

                     (b)  the prescription indicates a stop date for the supply of the pharmaceutical benefit and, based on the dose and frequency of administration of the pharmaceutical benefit indicated in the prescription, more than one supply of a maximum quantity of the pharmaceutical item or pharmaceutical benefit is needed before the stop date is reached.

Note:          See paragraph 85A(2)(a) of the Act in relation to maximum quantities of pharmaceutical items or pharmaceutical benefits.

             (5)  If paragraphs (4)(a) and (b) do not apply, an approved pharmacist or an approved medical practitioner may only supply the quantity of the pharmaceutical benefit needed to give effect to the prescription, up to a maximum quantity of the pharmaceutical item or pharmaceutical benefit.

Note:          The following information entered in the prescription may also indicate the quantity of the pharmaceutical benefit that is needed:

(a)    the dose and frequency of administration of the pharmaceutical benefit;

(b)    the date of prescribing, or the start date (if any) for administration of the pharmaceutical benefit;

(c)    the stop date (if any) for administration of the pharmaceutical benefit.

             (6)  However, for a supply:

                     (a)  on the basis of a prescription mentioned in paragraph (4)(a); or

                     (b)  mentioned in subregulation (5);

an approved pharmacist or an approved medical practitioner may supply up to a maximum quantity of the pharmaceutical item or pharmaceutical benefit even if the period of validity of the residential medication chart will end before administration of that quantity in accordance with the prescription would finish.

             (7)  An approved hospital authority must not supply a pharmaceutical benefit on the basis of a medication chart prescription.

21B  Continued dispensing supply of pharmaceutical benefit

             (1)  This regulation applies in relation to the supply of a pharmaceutical benefit to a person by an approved pharmacist under subsection 89A(1) of the Act.

             (2)  The approved pharmacist must not supply the pharmaceutical benefit unless the approved pharmacist writes on the repeat authorisation form for the supply:

                     (a)  the approved pharmacist’s name and approval number under regulation 8A; and

                     (b)  an identification number for the supply; and

                     (c)  the date on which the pharmaceutical benefit is supplied by the approved pharmacist.

21C  Information about status of person—continued dispensing and medication chart prescriptions

             (1)  This regulation applies in relation to:

                     (a)  the supply of a pharmaceutical benefit to a person (the patient) by an approved pharmacist under subsection 89A(1) of the Act; and

                     (b)  the supply of a pharmaceutical benefit by an approved medical practitioner or approved pharmacist, under subsection 93A(4) of the Act, on the basis of a medication chart prescription written for a person (the patient).

             (2)  The approved pharmacist or approved medical practitioner must collect the following information at the time of supply:

                     (a)  information about whether the patient is, at the time of the supply:

                              (i)  a concessional beneficiary or a dependant of a concessional beneficiary; or

                             (ii)  the holder of a concession card or entitlement card;

                     (b)  for a person mentioned in subparagraph (a)(i)—the number specified on a card, issued by the Commonwealth, as an entitlement number (however described) in relation to the person;

                     (c)  for a person mentioned in subparagraph (a)(ii)—the number of the concession card or entitlement card.

             (3)  The approved pharmacist or approved medical practitioner must include the information collected under subregulation (2) in the claim for a payment from the Commonwealth in relation to the supply using the Claims Transmission System, within the meaning given by subsection 99AAA(1) of the Act.

22  Supply of pharmaceutical benefits before surrender of written prescription

             (1)  Subject to this regulation, a pharmaceutical benefit may be supplied to a person, in a case of urgency, by an approved pharmacist before the prescription for that pharmaceutical benefit is given to the pharmacist if:

                     (a)  a PBS prescriber advises the pharmacist of the details of the prescription; or

                     (b)  the PBS prescriber has written and signed a prescription that is sent by facsimile transmission service to the pharmacist by:

                              (i)  the PBS prescriber; or

                             (ii)  a person under the control of the PBS prescriber.

             (2)  If:

                     (a)  the prescribing of a pharmaceutical benefit under subregulation (1) is subject to a condition that an authority for the prescription is to be obtained from:

                              (i)  the Minister and the Chief Executive Medicare; or

                             (ii)  either of those persons; and

                     (b)  the PBS prescriber informs an approved pharmacist or approved medical practitioner that the PBS prescriber has been notified by the Minister or the Chief Executive Medicare (by oral or other means) that an authority will be given; and

                     (c)  the PBS prescriber complies with subregulation (1);

the approved pharmacist or approved medical practitioner may supply the pharmaceutical benefit.

             (3)  A PBS prescriber referred to in subregulation (1) must ensure that, for a paper‑based prescription, the original and a duplicate of the prescription are received by the relevant pharmacist or medical practitioner no later than 7 days after the day on which the benefit was supplied.

Penalty:  0.2 penalty units.

       (3AA)  A PBS prescriber referred to in subregulation (1) must ensure that, for an electronic prescription, the prescription is accessible by the relevant pharmacist or medical practitioner no later than 7 days after the day on which the benefit was supplied.

Penalty:  0.2 penalty units.

          (3A)  An offence against subregulation (3) or (3AA) is an offence of strict liability.

Note:          For strict liability, see section 6.1 of the Criminal Code.

             (4)  A PBS prescriber who has communicated with an approved pharmacist or approved medical practitioner under subregulation (2) must ensure that, for a paper‑based prescription, the original and a duplicate of the prescription are received by the relevant pharmacist or medical practitioner no later than 7 days after the day on which the benefit was supplied.

Penalty:  0.2 penalty units.

       (4AA)  A PBS prescriber who has communicated with an approved pharmacist or approved medical practitioner under subregulation (2) must ensure that, for an electronic prescription, the prescription is accessible by the relevant pharmacist or medical practitioner no later than 7 days after the day on which the benefit was supplied.

Penalty:  0.2 penalty units.

          (4A)  An offence against subregulation (4) or (4AA) is an offence of strict liability.

Note:          For strict liability, see section 6.1 of the Criminal Code.

             (5)  This regulation does not apply to:

                     (a)  a pharmaceutical benefit for which the prescription must be in writing, under a law of the State or Territory where the premises of the approved pharmacist are located; and

                     (b)  a pharmaceutical benefit to be supplied, under subsection 93A (4) of the Act, on the basis of a medication chart prescription.

24  Circumstances in which quantity of repeated supply can be directed to be supplied on one occasion

             (1)  A medical practitioner may, in pursuance of subsection 88 (6) of the Act, instead of directing a repeated supply of a pharmaceutical benefit in accordance with Part VII of the Act, direct in a prescription the supply on one occasion of a quantity or number of units of the pharmaceutical benefit allowable under that subsection if he or she is satisfied that:

                     (a)  the maximum quantity or number of units applicable in relation to the pharmaceutical benefit under a determination of the Minister under section 85A of the Act is insufficient for the medical treatment of the person for whom the prescription is written; and

                     (b)  that person requires the pharmaceutical benefit for the treatment of a chronic illness or is residing in a place remote from the approved pharmacist nearest to that person’s place of residence; and

                     (c)  that person could not, without great hardship, obtain the required quantity or number of units of the pharmaceutical benefit by means of repeated supplies on separate occasions.

             (2)  For subsection 88(6B) of the Act, an authorised midwife or authorised nurse practitioner may, instead of directing a repeated supply, direct in a prescription the supply on one occasion of a quantity or number of units of the pharmaceutical benefit allowable under subsection 88(6A) of the Act if he or she is satisfied that:

                     (a)  the maximum quantity or number of units applicable for the pharmaceutical benefit under a determination under section 85A and subsection 88(1D) or (1E) of the Act is insufficient for the treatment of the person for whom the prescription is written; and

                     (b)  the person requires the pharmaceutical benefit for the treatment of a chronic illness or is residing in a place remote from the approved pharmacist nearest to the person’s place of residence; and

                     (c)  the person could not, without great hardship, obtain the required quantity or number of units of the pharmaceutical benefit by means of repeated supplies on separate occasions.

             (3)  However, this regulation does not apply in relation to the writing of a medication chart prescription.

24A  Continued dispensing—repeated supply not to be supplied on one occasion

             (1)  This regulation applies in relation to the supply (the continued dispensing supply) of a pharmaceutical benefit by an approved pharmacist under subsection 89A(1) of the Act on the basis of a previous prescription from a PBS prescriber.

             (2)  If the PBS prescriber directed in the prescription the supply on one occasion of a quantity or number of units of the pharmaceutical benefit allowable under subsection 88(6) of the Act, instead of directing a repeated supply, the direction does not apply for the purposes of the continued dispensing supply.

25  Repeated supplies of pharmaceutical benefits

             (1)  A pharmaceutical benefit shall not be supplied a number of times greater than the number specified in the prescription.

             (2)  Subregulation (3) applies to a pharmaceutical benefit in relation to which:

                     (a)  the Minister determines, under paragraph 85A(2)(b) of the Act, that the maximum number of occasions on which the supply of the benefit may, in one prescription, be directed to be repeated is more than 4; and

                     (b)  the Minister determines, under paragraph 85A(2)(c) of the Act, that the manner of administration that may, in a prescription, be directed to be used in relation to the benefit is administration otherwise than by application to the eye.

             (3)  A pharmaceutical benefit to which this subregulation applies may be supplied to the person in respect of whom the prescription for the supply of the benefit was written if:

                     (a)  the supplier of the benefit reasonably believes that the person has not received a supply of the pharmaceutical benefit, or of another brand of that benefit, in the period of 20 days immediately preceding the day on which it is to be supplied to the person; or

                     (b)  the supplier of the benefit:

                              (i)  reasonably believes that a supply of the pharmaceutical benefit that was previously supplied to the person has been destroyed, lost or stolen; and

                             (ii)  writes the words ‘immediate supply necessary’:

                                        (A)  for a paper‑based prescription—on the Medicare Australia/DVA copy; or

                                        (B)  for an electronic prescription—on the prescription; and

                            (iii)  signs the Medicare Australia/DVA copy or the electronic prescription, as the case requires; or

                     (c)  the supplier of the benefit:

                              (i)  reasonably believes that, having regard to the person’s circumstances, the supply of the benefit is necessary, without delay, for the treatment of the person; and

                             (ii)  writes the words ‘immediate supply necessary’:

                                        (A)  for a paper‑based prescription—on the Medicare Australia/DVA copy; or

                                        (B)  for an electronic prescription—on the prescription; and

                            (iii)  signs the Medicare Australia/DVA copy or the electronic prescription, as the case requires.

             (4)  A pharmaceutical benefit other than a benefit to which subregulation (3) applies may be supplied to the person in respect of whom the prescription for the supply of the benefit was written if:

                     (a)  the supplier of the benefit reasonably believes that the person has not received a supply of the pharmaceutical benefit, or of another brand of that benefit, in the period of 4 days immediately preceding the day on which it is supplied to the person; or

                     (b)  the supplier of the benefit:

                              (i)  reasonably believes that a supply of the pharmaceutical benefit that was previously supplied to the person has been destroyed, lost or stolen; and

                             (ii)  writes the words ‘immediate supply necessary’:

                                        (A)  for a paper‑based prescription—on the Medicare Australia/DVA copy; or

                                        (B)  for an electronic prescription—on the prescription; and

                            (iii)  signs the Medicare Australia/DVA copy or the electronic prescription, as the case requires; or

                     (c)  the supplier of the benefit:

                              (i)  reasonably believes that, having regard to the person’s circumstances, the supply of the benefit is necessary, without delay, for the treatment of the person; and

                             (ii)  writes the words ‘immediate supply necessary’:

                                        (A)  for a paper‑based prescription—on the Medicare Australia/DVA copy; or

                                        (B)  for an electronic prescription—on the prescription; and

                            (iii)  signs the Medicare Australia/DVA copy or the electronic prescription, as the case requires.

Continued Dispensing

             (5)  Subject to subregulation (2), if the pharmaceutical benefit is supplied to a person by an approved pharmacist (the supplier) under subsection 89A(1) of the Act, subregulation (3) or (4) applies as if:

                     (a)  the person had presented the supplier with a prescription that:

                              (i)  had been written by a PBS prescriber in accordance with the Act and these Regulations; and

                             (ii)  did not include a medicare number; and

                            (iii)  did not direct a repeated supply of the pharmaceutical benefit; and

                     (b)  subparagraphs (3)(b)(ii) and (c)(ii) or (4)(b)(ii) and (c)(ii) were omitted, and the words ‘immediate supply necessary’ were required to be written on the repeat authorisation form for the supply; and

                     (c)  subparagraphs (3)(b)(iii) and (c)(iii) or (4)(b)(iii) and (c)(iii) were omitted, and the supplier were required to sign the repeat authorisation form mentioned in paragraph (b).

Medication chart prescriptions

             (6)  Subject to subregulation (2), if the pharmaceutical benefit is supplied by an approved pharmacist or an approved medical practitioner (the supplier), under subsection 93A(4) of the Act, on the basis of a medication chart prescription:

                     (a)  subregulation (1) does not apply; and

                     (b)  subregulation (3) or (4) applies as if:

                              (i)  the supply is made to the facility providing the residential care to the person for whom the prescription was written; and

                             (ii)  the words ‘immediate supply necessary’ and the supplier’s signature were required to be written on the copy of the residential medication chart given to the supplier.

26  Repeat authorisations

       (1AA)  This regulation does not apply in relation to the supply of a pharmaceutical benefit, under subsection 93A(4) of the Act, on the basis of a medication chart prescription.

             (1)  Subregulation (1A) applies if:

                     (a)  an approved pharmacist, or an approved medical practitioner, or an approved hospital authority supplies a pharmaceutical benefit under:

                              (i)  a Medicare Australia/DVA copy of a paper‑based prescription that contains a direction to supply the benefit more than once; or

                             (ii)  a pharmacist/patient copy of a paper‑based prescription to which is attached a deferred supply authorisation that contains a direction to supply the benefit more than once; or

                            (iii)  a pharmacist/patient copy of a paper‑based prescription to which is attached a repeat authorisation that contains a direction to supply the benefit more than once; or

                            (iv)  an electronic prescription:

                                        (A)  that contains a direction to supply the benefit more than once; or

                                        (B)  to which is attached or linked, by electronic means, a deferred supply authorisation that contains a direction to supply the benefit more than once; or

                                        (C)  to which is attached or linked, by electronic means, a repeat authorisation that contains a direction to supply the benefit more than once; and

                     (b)  subsequent supplies of the pharmaceutical benefit can be made under the prescription at the time of supply under paragraph (a).

          (1A)  The approved pharmacist, approved medical practitioner or approved hospital authority must:

                     (a)  on or before supplying the pharmaceutical benefit:

                              (i)  prepare a repeat authorisation in accordance with a form (including a paper‑based or an electronic form) authorised by the Secretary for the supply of the pharmaceutical benefit; and

                             (ii)  if the prescription for the benefit is written on an authority prescription—mark the number of the authority prescription on the repeat authorisation; and

                            (iii)  if the prescription for the benefit is a paper‑based prescription—attach the repeat authorisation to the pharmacist/patient copy and give the repeat authorisation and pharmacist/patient copy to the person to whom the pharmaceutical benefit is supplied; and

                            (iv)  if the prescription for the benefit is an electronic prescription—attach or link, by electronic means, the repeat authorisation to the electronic prescription and ensure that the person to whom the pharmaceutical benefit is supplied:

                                        (A)  is given a print‑out of the repeat authorisation and prescription; or

                                        (B)  is able to access the repeat authorisation and prescription; and

                     (b)  for the supply of the pharmaceutical benefit on the first occasion—mark on the repeat authorisation:

                              (i)  the name and address of the approved supplier; and

                             (ii)  the approval number given to the approved supplier under regulation 8A; and

                            (iii)  the identifying number given to the prescription by the approved supplier; and

                            (iv)  if the pharmaceutical benefit is a substitute benefit for the purposes of subsection 103(2A) of the Act—the brand name of the substitute benefit; and

                     (c)  for the supply of the pharmaceutical benefit on a subsequent occasion—mark on the repeat authorisation:

                              (i)  the date on which the most recent supply was made; and

                             (ii)  the identifying number given to the prescription under subparagraph (b)(iii).

Penalty:  0.2 penalty units.

          (1B)  An offence against subregulation (1A) is an offence of strict liability.

Note:          For strict liability, see section 6.1 of the Criminal Code.

             (2)  An approved pharmacist, approved medical practitioner or approved hospital authority is not authorised to supply a pharmaceutical benefit upon presentation of only the pharmacist/patient copy of a paper‑based prescription unless:

                     (a)  the approved pharmacist, approved medical practitioner or approved hospital authority is given a repeat authorisation or a deferred supply authorisation that:

                              (i)  is related to that pharmacist/patient copy by a number or numbers; and

                             (ii)  indicates that the pharmaceutical benefit to be supplied has not been supplied for the number of times directed in the prescription; and

                     (b)  there is written on the repeat authorisation or deferred supply authorisation the approval number given to the supplier under regulation 8A; and

                     (c)  the date of supply of the benefit is on or before the first anniversary of the date on which the prescription was written.

             (3)  Where a pharmaceutical benefit is supplied by an approved hospital authority in the circumstances set out in subregulation (1), the approved hospital authority shall cause the requirements of subregulations (1), (1A) and (2) to be complied with by the medical practitioner or pharmacist by whom, or under whose direct supervision, the pharmaceutical benefit is supplied.

26AA  Repeat authorisation form—continued dispensing

             (1)  An approved pharmacist must use a repeat authorisation form for the purposes of making a claim for a payment from the Commonwealth under section 99AAA of the Act in relation to a supply of a pharmaceutical benefit under subsection 89A(1) of the Act.

             (2)  However, the approved pharmacist must not use the form for authorising a repeated supply of the pharmaceutical benefit under that subsection.

26A  Deferred supply authorisations

          (1A)  This regulation does not apply in relation to the supply of a pharmaceutical benefit, under subsection 93A(4) of the Act, on the basis of a medication chart prescription.

             (1)  Where a prescription contains a direction to supply more than 1 pharmaceutical benefit, the approved pharmacist, approved medical practitioner or approved hospital authority to whom the prescription is presented may, at the request of the person for whom the prescription is written, defer the supply of one or more of the pharmaceutical benefits.

             (2)  An approved pharmacist, approved medical practitioner or approved hospital authority that defers the supply of a pharmaceutical benefit must:

                     (a)  prepare a deferred supply authorisation, on and in accordance with a form (including a paper‑based or an electronic form) authorised by the Secretary, in respect of each pharmaceutical benefit the deferral of the supply of which is requested; and

                     (b)  mark on the deferred supply authorisation prepared by him the number allotted to his or her approval under regulation 8A; and

                     (c)  if the prescription is a paper‑based prescription:

                              (i)  mark on the original and duplicate of the prescription, across the wording relating to the pharmaceutical benefit the supply of which is being deferred, the words ‘original supply deferred’; and

                             (ii)  attach the deferred supply authorisation prepared by the pharmacist, medical practitioner or hospital authority to the pharmacist/patient copy; and

                            (iii)  give the authorisation and pharmacist/patient copy to the person for whom the prescription is written at the same time as the benefit on the original prescription is supplied; and

                     (d)  if the prescription is an electronic prescription:

                              (i)  mark on the prescription, in relation to the pharmaceutical benefit the supply of which is being deferred, the words ‘original supply deferred’; and

                             (ii)  attach or link, by electronic means, the deferred supply authorisation prepared by the pharmacist, medical practitioner or hospital authority to the prescription; and

                            (iii)  give a print‑out of the deferred supply authorisation and prescription to the person to whom the pharmaceutical benefit is supplied or ensure that the deferred supply authorisation and prescription are accessible by that person.

             (3)  Where an approved hospital authority defers the supply of a pharmaceutical benefit in the circumstance set out in subregulation (1), the authority shall cause the requirements of subregulation (2) to be complied with by the medical practitioner or pharmacist by whom, or under whose direct supervision, the other pharmaceutical benefit to which the prescription refers is supplied.

27  Presentation of prescriptions in trading hours

             (1)  An approved pharmacist shall, at all times, keep prominently displayed at each of the premises in respect of which he or she is approved, so as to be readily visible to persons who enter the premises, a notice setting out the normal trading hours during which services for the supply of pharmaceutical benefits are available.

             (2)  Subject to regulation 28, a person is entitled to be supplied with a pharmaceutical benefit from an approved pharmacist during normal trading hours only.

28  Presentation of urgent prescriptions

             (1)  A prescription for the supply of a pharmaceutical benefit marked ‘Urgent’, that marking being initialled, in the case of a paper‑based prescription, by the medical practitioner, participating dental practitioner, authorised midwife or authorised nurse practitioner writing the prescription, may be presented at any time to an approved pharmacist at the premises in respect of which he or she is approved.

             (2)  An approved pharmacist must supply a pharmaceutical benefit as soon as practicable if:

                     (a)  a prescription is presented to the pharmacist under subregulation (1); and

                     (b)  any charge lawfully demanded for the prescription is paid.

Penalty:  0.2 penalty units.

             (3)  An offence against subregulation (2) is an offence of strict liability.

Note:          For strict liability, see section 6.1 of the Criminal Code.

             (4)  It is a defence to a prosecution for an offence against subregulation (2) if the pharmacist had a reasonable excuse.

Note:          A defendant bears an evidential burden in relation to the matter mentioned in subregulation (4) (see section 13.3 of the Criminal Code).

30  Special charge for delivery

                   For subsection 87(4) of the Act, when a pharmaceutical benefit is supplied by delivery at or to a place other than premises in respect of which the approved pharmacist is approved or the premises at which an approved medical practitioner carries on his or her practice, as the case may be, the pharmacist or medical practitioner may make a special charge equal to the cost of delivery.

31  Receipt of pharmaceutical benefit

             (1)  A person commits an offence if:

                     (a)  the person receives a pharmaceutical benefit under Part VII of the Act (whether or not for the person’s own use) from an approved supplier; and

                     (b)  the supply of the pharmaceutical benefit by the approved supplier is not a supply under subsection 89A(1) of the Act; and

                     (c)  at the time of supply, the approved supplier is not permitted to make a paperless claim for payment in relation to the supply of the pharmaceutical benefit; and

                     (d)  at the time of supply, the approved supplier asks the person to write on the prescription, repeat authorisation or deferred supply authorisation for the pharmaceutical benefit:

                              (i)  an acknowledgment that the person has received the benefit; and

                             (ii)  the date on which the person received the benefit; and

                            (iii)  if the benefit is not for the person’s own use—the person’s address; and

                     (e)  it is practicable for the person to comply with the request mentioned in paragraph (d); and

                      (f)  the person does not comply with the request mentioned in paragraph (d).

Penalty:  0.2 penalty units.

          (1A)  If a person is required to write an acknowledgment in accordance with subregulation (1) for the supply of a pharmaceutical benefit under an electronic prescription, or an authorisation that relates to an electronic prescription, that requirement is taken to have been met if:

                     (a)  the acknowledgment is given, in accordance with approved information technology requirements (if any), by means of an approved electronic communication; or

                     (b)  the person writes the acknowledgment on a print‑out of the electronic prescription or the authorisation that relates to an electronic authorisation.

          (1B)  If a person writes an acknowledgment in accordance with paragraph (1A)(b), the approved pharmacist, approved medical practitioner or approved hospital authority must write on the electronic prescription, or the authorisation that relates to an electronic prescription, that the person has written the acknowledgment on a print‑out of the prescription or authorisation.

Penalty:  0.2 penalty units.

             (2)  An approved pharmacist, approved medical practitioner or approved hospital authority must not demand an acknowledgment of the supply of a pharmaceutical benefit to a person if the pharmacist, medical practitioner or hospital authority has not supplied the benefit to that person.

Penalty:  0.2 penalty units.

             (3)  An approved supplier commits an offence if:

                     (a)  the approved supplier supplies a pharmaceutical benefit under Part VII of the Act, other than under subsection 89A(1) of the Act; and

                     (b)  it is not practicable for the approved supplier to obtain, from the person receiving the pharmaceutical benefit (whether or not for the person’s own use), a written acknowledgement that the person has received the benefit; and

                     (c)  the approved supplier does not make a paperless claim for payment in relation to the supply of the pharmaceutical benefit; and

                     (d)  the approved supplier does not certify on the prescription, repeat authorisation or deferred supply authorisation for the pharmaceutical benefit:

                              (i)  the date on which the pharmaceutical benefit was supplied by the approved supplier; and

                             (ii)  the reason why it was not practicable for the approved supplier to obtain the written acknowledgement mentioned in paragraph (b).

Penalty:  0.2 penalty units.

Paperless claim for payment from Commonwealth

             (4)  An approved supplier commits an offence if:

                     (a)  the approved supplier supplies a pharmaceutical benefit under Part VII of the Act, other than under subsection 89A(1) of the Act; and

                     (b)  the approved supplier makes a paperless claim for payment in relation to the supply of the pharmaceutical benefit; and

                     (c)  the approved supplier does not include a completed supply certification form in the paperless claim for payment.

Penalty:  0.2 penalty units.

Continued dispensing supply of pharmaceutical benefit

             (5)  A person commits an offence if:

                     (a)  the person receives a pharmaceutical benefit (whether or not for the person’s own use) from an approved pharmacist under subsection 89A(1) of the Act; and

                     (b)  at the time of the supply, the approved pharmacist asks the person to write on the repeat authorisation form for the supply:

                              (i)  an acknowledgement that the person has received the pharmaceutical benefit; and

                             (ii)  the date on which the person received the benefit; and

                            (iii)  if the benefit is not for the person’s own use—the person’s address; and

                     (c)  it is practicable for the person to comply with the request mentioned in paragraph (b); and

                     (d)  the person does not comply with the request mentioned in paragraph (b).

Penalty:  0.2 penalty units.

             (6)  An approved pharmacist commits an offence if:

                     (a)  the approved pharmacist supplies a pharmaceutical benefit to a person under subsection 89A(1) of the Act; and

                     (b)  it is not practicable for the approved pharmacist to obtain, from the person receiving the pharmaceutical benefit (whether or not for the person’s own use), a written acknowledgement that the person has received the benefit; and

                     (c)  the approved pharmacist does not write on the repeat authorisation form for the supply:

                              (i)  the date on which the pharmaceutical benefit was supplied by the approved pharmacist; and

                             (ii)  the reason why it was not practicable for the approved pharmacist to obtain the written acknowledgement mentioned in paragraph (b).

Penalty:  0.2 penalty units.

             (7)  An offence against this regulation is an offence of strict liability.

Part 6Miscellaneous

  

31B  Purpose of Part

                   Unless otherwise specified, this Part is made for section 105 or 140 of the Act.

32  Retention of prescriptions etc

             (1)  If an approved pharmacist, approved medical practitioner, or approved hospital authority supplies a pharmaceutical benefit (other than a supply of a dangerous drug) he or she must:

                     (a)  if the benefit was supplied under a paper‑based prescription or an order lodged under paragraph 16(1)(a)—retain the forms mentioned in subregulation (2) in his or her possession for at least 1 year from the date of supply; or

                     (b)  if the benefit was supplied under an electronic prescription or an order lodged under paragraph 16(1)(b)—retain the forms mentioned in subregulation (2) for at least 1 year from the date of supply.

Penalty:  0.2 penalty units.

          (1A)  However, subregulation (1) does not apply to:

                     (a)  the supply of a pharmaceutical benefit under subsection 89A(1) of the Act; or

                     (b)  the supply of a pharmaceutical benefit, under subsection 93A(4) of the Act, on the basis of a medication chart prescription.

Note:          See regulations 32A and 32B.

             (2)  For subregulation (1), the following forms are specified:

                     (a)  in the case of supply upon a prescription not bearing instructions to supply the pharmaceutical benefit more than once:

                              (i)  for a paper‑based prescription—the pharmacist/patient copy; or

                             (ii)  for an electronic prescription—the electronic prescription;

                     (b)  in the case of supply upon a prescription bearing instructions to supply the pharmaceutical benefit more than once, if it is supplied on the last occasion on which supply is authorised:

                              (i)  for a paper‑based prescription—the pharmacist/patient copy in respect of which repeat authorisations were issued; or

                             (ii)  for an electronic prescription—the electronic prescription and the repeat authorisation;

                     (c)  in the case of supply under section 93 of the Act:

                              (i)  for a paper‑based prescription—the duplicate of the order lodged under regulation 16, or the notification form mentioned in subregulation 18A(3), as the case requires; or

                             (ii)  for an electronic prescription—the electronic order form or the notification form mentioned in subregulation 18A(3), as the case requires.

             (3)  An offence against subregulation (1) is an offence of strict liability.

Note:          For strict liability, see section 6.1 of the Criminal Code.

             (4)  In this regulation:

dangerous drug means a drug or medicinal preparation in respect of which the law of the State or Territory in which the prescription is written provides that a pharmacist who dispenses that drug or medicinal preparation, or who dispenses it on the last of a number of occasions of supply indicated in a prescription for its supply, must take possession of the prescription and cancel it or deliver it to the authority administering that law.

32A  Keeping documents—continued dispensing

             (1)  This regulation applies if an approved pharmacist supplies a pharmaceutical benefit to a person under subsection 89A(1) of the Act.

             (2)  The approved pharmacist commits an offence if:

                     (a)  the approved pharmacist supplies a pharmaceutical benefit to a person under subsection 89A(1) of the Act; and

                     (b)  the approved pharmacist does not keep the following information for at least 2 years from the date on which the pharmaceutical benefit was supplied by the approved pharmacist:

                              (i)  the information that supports the claim for payment made under section 99AAA of the Act in relation to the supply of the pharmaceutical benefit;

                             (ii)  the information, about the supply of the pharmaceutical benefit, that is given to the PBS prescriber who most recently prescribed the pharmaceutical benefit to the person.

Penalty:  0.2 penalty units.

             (3)  An offence against this regulation is an offence of strict liability.

32B  Keeping documents—medication chart prescriptions

             (1)  This regulation applies if an approved pharmacist or an approved medical practitioner supplies a pharmaceutical benefit, under subsection 93A(4) of the Act, on the basis of a medication chart prescription.

             (2)  The approved pharmacist or approved medical practitioner commits an offence if:

                     (a)  the approved pharmacist or approved medical practitioner supplies a pharmaceutical benefit on the basis of a medication chart prescription; and

                     (b)  the approved pharmacist or approved medical practitioner does not keep a copy of the residential medication chart in which the prescription is written for at least 2 years from the date on which the last pharmaceutical benefit was supplied by the approved pharmacist or approved medical practitioner on the basis of a prescription in the residential medication chart.

Penalty:  0.2 penalty units.

             (3)  An offence against this regulation is an offence of strict liability.

33  Proper stocks to be kept

             (1)  An approved pharmacist must, as far as practicable, keep in stock an adequate supply of all drugs and medicinal preparations that he or she may reasonably be expected to be called upon to supply as pharmaceutical benefits, or to use as ingredients of pharmaceutical benefits.

Penalty:  0.2 penalty units.

             (2)  An offence against subregulation (1) is an offence of strict liability.

Note:          For strict liability, see section 6.1 of the Criminal Code.

35  Standards of composition and purity of pharmaceutical benefits and additives

             (1)  If:

                     (a)  under the Therapeutic Goods Act 1989, a drug, medicine or substance must be of a particular standard of composition or purity; and

                     (b)  the drug, medicine or substance is to be supplied as a pharmaceutical benefit;

the standard of composition or purity of the drug, medicine or substance is the standard for the purposes of the Act.

             (2)  If:

                     (a)  under the Therapeutic Goods Act 1989, a drug, medicine or substance must be of a particular standard of composition or purity; and

                     (b)  the drug, medicine or substance is used as an additive in another drug, medicine or substance (in this subregulation called ‘the finished product’); and

                     (c)  the finished product is to be supplied as a pharmaceutical benefit;

the standard of composition or purity of the drug, medicine or substance used as an additive is the standard for the purposes of the Act.

Note:          See also paragraph 103(5)(f) of the Act.

36  Labelling of pharmaceutical benefits—full cost

             (1)  A pharmaceutical benefit supplied by an approved supplier must be labelled with the words ‘full cost’ followed by the full cost of the pharmaceutical benefit.

             (2)  Subregulation (1) does not apply to:

                     (a)  an approved supplier to which section 99AAB of the Act applies; or

                     (b)  an approved hospital authority; or

                     (c)  a pharmaceutical benefit obtained under subsection 93(2), 93AA(2) or 93AB(2) of the Act; or

                     (d)  a pharmaceutical benefit to which subsection 99(2A), (2AB) or (2B) of the Act applies; or

                     (e)  the supply of a pharmaceutical benefit, under subsection 93A(4) of the Act, on the basis of a medication chart prescription.

             (3)  For this regulation, the full cost of a pharmaceutical benefit is the sum of:

                     (a)  the Commonwealth price of the pharmaceutical benefit within the meaning given by Part VII of the Act; and

                     (b)  the special patient contribution charged under subsection 87(2A) of the Act.

Note:          The special patient contribution is an amount calculated under subsection 85B(5) of the Act.

37  Surrender of forms

             (1)  The Secretary may, by notice in writing served on a person, require that person to surrender to the Secretary or to a person specified in the notice, within a time specified in the notice, any forms that have been supplied to that person by or on behalf of the Commonwealth under or for the purpose of Part VII of that Act or these Regulations and that are in the possession of the person.

             (2)  A person upon whom a notice is served in pursuance of subregulation (1) shall comply with that notice.

Penalty:  0.2 penalty units.

             (3)  An offence against subregulation (2) is an offence of strict liability.

Note:          For strict liability, see section 6.1 of the Criminal Code.

37AA  Payment for pharmaceutical benefit supplied on basis of medication chart prescription

                   For subsection 93A(6) of the Act, an approved pharmacist or approved medical practitioner who supplied a pharmaceutical benefit under subsection 93A(4) of the Act, to a prescribed institution mentioned in paragraph 93A(1)(b) of the Act, is entitled to payment from the Commonwealth for the supply of the pharmaceutical benefit at the rate, and subject to the conditions:

                     (a)  determined by the Minister; and

                     (b)  that apply at the time of the supply.

Part 6APrice reduction and price disclosure

Division 1Price reduction

37A  Reduction day

                   For paragraph 99ADH(2)(b) of the Act, 1 August and 1 December in any year are prescribed.

37B  Listed brands of pharmaceutical items, reduction days and percentages

                   For section 99ACK of the Act, the listed brands of pharmaceutical items, the reduction days for those brands and percentages for those brands that are mentioned in Schedule 5 are prescribed.

Division 2Price disclosure

Subdivision 1Interpretation

37C  Meaning of data collection period

Start of first data collection period

             (1)  The first data collection period for a brand of a pharmaceutical item starts on the brand’s start day.

End of first data collection period

             (2)  If, on the day before the start day for the brand (the starting brand) the price disclosure requirements apply to a related brand of the starting brand, the starting brand’s first data collection period ends when the data collection period for any of the related brands ends.

             (3)  Otherwise, the starting brand’s first data collection period ends on:

                     (a)  if the start day occurs between 2 April and 1 October—the next 31 March; or

                     (b)  if the start day occurs between 2 October and 1 April—the next 30 September.

Start and end of subsequent data collection periods

             (4)  After the first data collection period for a listed brand of a pharmaceutical item, each subsequent data collection period for the brand:

                     (a)  starts immediately after the end of the previous data collection period; and

                     (b)  ends on the next 31 March or 30 September, whichever is sooner.

Example 1: If a brand to which subregulation (2) applies has a start day of 1 July 2014, and the data collection period for a related brand ends on 30 September 2014:

(a)    the first data collection period starts on 1 July 2014; and

(b)    the first data collection period ends on 30 September 2014; and

(c)    subsequent data collection periods will be the 6 month periods that start on 1 October 2014, 1 April 2015, 1 October 2015 and so on.

Example 2: If a brand to which subregulation (3) applies has a start day of 1 August 2014:

(a)    the first data collection period starts on 1 August 2014; and

(b)    the first data collection period ends on 31 March 2015; and

(c)    subsequent data collection periods will be the 6 month periods that start on 1 April 2015, 1 October 2015, 1 April 2016 and so on.

Example 3: If a brand to which subregulation (3) applies has a start day of 1 December 2014:

(a)    the first data collection period starts on 1 December 2014; and

(b)    the first data collection period ends on 30 September 2015; and

(c)    subsequent data collection periods will be the 6 month periods that start on 1 October 2015, 1 April 2016, 1 October 2016 and so on.

37D  Meaning of price sampling day

                   A day is a price sampling day for a data collection period for a brand of a pharmaceutical item if the day:

                     (a)  is the first day of a calendar month; and

                     (b)  the day is within whichever of the following periods commenced earlier:

                              (i)  the data collection period;

                             (ii)  the data collection period for another brand of the same pharmaceutical item.

37E  Special rules for certain listed brands

             (1)  Subregulations (3), (4) and (5) apply to a listed brand of a pharmaceutical item if:

                     (a)  paragraphs 99ADB(3B)(a) and (b) of the Act apply to the listed brand; and

                     (b)  a weighted average disclosed price does not exist for another listed brand of the same pharmaceutical item for the data collection period.

             (2)  Subregulations (4) and (5) apply to a listed brand of a pharmaceutical item if:

                     (a)  the start day for the listed brand is the relevant day; and

                     (b)  a weighted average disclosed price does not exist for another listed brand of the same pharmaceutical item for the data collection period.

Approved ex‑manufacturer price on relevant day

             (3)  For paragraph 99ADB(3B)(c) of the Act, the approved ex‑manufacturer price of the listed brand of the pharmaceutical item on the relevant day is the approved ex‑manufacturer price of the brand on the start day minus any amount that would have been added, and plus any amount that would have been deducted, because of a price adjustment, had the brand been a listed brand in the period:

                     (a)  starting on the relevant day; and

                     (b)  ending immediately before the brand’s start day.

Deemed data collection period and approved ex‑manufacturer price for determining weighted average disclosed price

             (4)  For the purpose of determining the weighted average disclosed price of the listed brand under Subdivision 2, the brand is taken to have had a data collection period:

                     (a)  beginning on the earliest day on which the data collection period began for any related brand of the listed brand; and

                     (b)  ending on the day before the relevant day.

             (5)  For the purpose of determining the weighted average disclosed price of the listed brand under Subdivision 2, the approved ex‑manufacturer price of the listed brand on a price sampling day is taken to have been the approved ex‑manufacturer price of the listed brand on the brand’s start day minus any amount that would have been added, and plus any amount that would have been deducted, because of a price adjustment, had the brand been a listed brand in the period:

                     (a)  starting on the price sampling day; and

                     (b)  ending immediately before the brand’s start day.

Note:          This enables an average approved ex‑manufacturer price to be worked out for the purpose of determining the weighted average disclosed price.

Subdivision 2Weighted average disclosed price

37F  Method for determining weighted average disclosed price of listed brand of pharmaceutical item

             (1)  This Subdivision is made for subsection 99ADB(6) of the Act.

             (2)  Regulations 37G to 37S prescribe the method for determining the weighted average disclosed price of a listed brand of a pharmaceutical item in respect of a data collection period for the listed brand.

             (3)  When using the method, the Minister may disregard information provided under regulation 37T for a data collection period if the information is incomplete.

Note:          Section 99ADA of the Act provides that Division 3B (Price disclosure) of Part VII of the Act does not apply to brands of exempt items.

37G  Step 1—Net revenue for brand

             (1)  Work out the net revenue for the listed brand of the pharmaceutical item for the data collection period for the brand.

             (2)  The net revenue is the revenue from sales of the listed brand for the data collection period, other than for the listed brand’s initial month, minus the value of any incentive given in relation to sales of the listed brand for the data collection period, other than for the listed brand’s initial month.

37H  Step 2—Adjusted volume for brand

             (1)  Work out the adjusted volume of the listed brand of the pharmaceutical item sold for the data collection period for the brand.

             (2)  The adjusted volume is the number of packs of the listed brand sold for the data collection period, other than for the listed brand’s initial month, worked out as if the size of the pack equals the pricing quantity of the listed brand on the final day.

Note:          For the definition of pricing quantity, see subsection 84AK(1) of the Act.

37J  Step 3—Average approved ex‑manufacturer price for brand

             (1)  Work out the average approved ex‑manufacturer price of the listed brand of the pharmaceutical item for the data collection period for the brand.

             (2)  The average approved ex‑manufacturer price is the amount worked out by:

                     (a)  adding together, for each price sampling day for the listed brand for the data collection period:

                              (i)  if the listed brand had an approved ex‑manufacturer price on the price sampling day—the approved ex‑manufacturer price; or

                             (ii)  if the listed brand did not have an approved ex‑manufacturer price on the price sampling day—the approved ex‑manufacturer price of a listed brand of the same pharmaceutical item; and

                     (b)  dividing that amount by the number of price sampling days for the listed brand for the data collection period.

Note:          A price sampling day may be within the data collection period for another brand of the same pharmaceutical item (see regulation 37D).

Adjustment for variation in pricing quantity

             (3)  If the pricing quantity of a brand on a price sampling day is different from the pricing quantity of the brand on the final day, for the purposes of subregulation (2) the approved ex‑manufacturer price of the brand on the price sampling day is taken to be:

where:

AEMP means the approved ex‑manufacturer price of the brand on the price sampling day (for the pricing quantity of the brand on the price sampling day).

PQ1 means the pricing quantity of the brand on the price sampling day.

PQ2 means the pricing quantity of the brand on the final day.

37K  Step 4—Disclosed price for brand

             (1)  Work out the disclosed price of the listed brand of the pharmaceutical item for the data collection period for the brand.

             (2)  The disclosed price is:

                     (a)  if the adjusted volume (see step 2) of the listed brand is zero or less—zero; or

                     (b)  if the adjusted volume (see step 2) of the listed brand is more than zero:

                              (i)  the amount worked out by dividing the net revenue for the listed brand (see step 1) by the adjusted volume; or

                             (ii)  if the amount worked out under subparagraph (i) is more than the average approved ex‑manufacturer price for the listed brand for the data collection period—the average approved ex‑manufacturer price of the listed brand.

37L  Step 5—Price percentage difference of brand

             (1)  Work out the price percentage difference of the listed brand of the pharmaceutical item for the data collection period.

             (2)  The price percentage difference of the listed brand is the amount (expressed as a percentage to 2 decimal places) worked out as follows:

                     (a)  subtract the listed brand’s disclosed price for the data collection period (see step 4) from the listed brand’s average approved ex‑manufacturer price for the data collection period (see step 3); and

                     (b)  divide that amount by the listed brand’s average approved ex‑manufacturer price for the data collection period.

37M  Step 6—Repeat steps for each brand of pharmaceutical item

             (1)  For each other brand of the same pharmaceutical item (including delisted brands) work out the price percentage difference of the brand for the data collection period ending on the same day as the data collection period of the listed brand.

             (2)  The price percentage difference of the other brand is worked out using steps 1 to 5, reading references to the listed brand as references to the other brand.

             (3)  If the other brand of the pharmaceutical item is a delisted brand on the final day, then the pricing quantity of the delisted brand on the final day is taken to be:

                     (a)  if there is a listed brand of the same pharmaceutical item on the final day—the pricing quantity of the listed brand; or

                     (b)  if there is no listed brand of the same pharmaceutical item on the final day—the pricing quantity of the last listed brand immediately before it was delisted.

Note:          The pricing quantity of the brand on the final day is needed for working out the adjusted volume (step 2) and the average approved ex‑manufacture price (step 3).

37N  Step 7—Total adjusted volume of brands of pharmaceutical item

             (1)  Work out the total adjusted volume of the brands of the pharmaceutical item.

             (2)  The total adjusted volume is the amount worked out by adding together the adjusted volume for each brand of the pharmaceutical item for the brand’s data collection period.

37P  Step 8—Weighted average percentage difference of brands of pharmaceutical item

             (1)  Work out the weighted average percentage difference of the brands of the pharmaceutical item.

             (2)  The weighted average percentage difference is:

                     (a)  if the total adjusted volume of the brands of the pharmaceutical item (see step 7) is zero or less—zero; or

                     (b)  if the total adjusted volume of the brands of the pharmaceutical item (see step 7) is more than zero—the amount (expressed as a percentage to 2 decimal places) worked out by:

                              (i)  for each brand of the pharmaceutical item, multiplying the adjusted volume of the brand for the brand’s data collection period (see step 2) by the price percentage difference of the brand for the data collection period (see step 5); and

                             (ii)  adding up each of those amounts; and

                            (iii)  dividing that amount by the total adjusted volume of the brands of the pharmaceutical item.

37Q  Step 9—Repeat steps for each pharmaceutical item with related brands

             (1)  For each brand (including delisted brands) of a pharmaceutical item with the same drug and manner of administration as the listed brand but a different form (the other pharmaceutical item), other than an exempt item, work out the price percentage difference of the brand for the data collection period ending on the same day as the data collection period of the listed brand.

             (2)  The price percentage of difference of a brand of the other pharmaceutical item is worked out using steps 1 to 5, reading references to the listed brand as references to the brand of the other pharmaceutical item.

             (3)  If a brand of the other pharmaceutical item is a delisted brand on the final day, then the pricing quantity of the delisted brand on the final day is taken to be:

                     (a)  if there is a listed brand of the other pharmaceutical item on the final day—the pricing quantity of the listed brand of the other pharmaceutical item; or

                     (b)  if there is no listed brand of the other pharmaceutical item on the final day—the pricing quantity of the last listed brand of the other pharmaceutical item immediately before it was delisted.

Note:          The pricing quantity of the brand on the final day is needed for working out the adjusted volume (step 2) and the average approved ex‑manufacture price (step 3).

             (4)  For each pharmaceutical item with the same drug and manner of administration as the listed brand but a different form, other than an exempt item, work out the weighted average percentage difference of the brands of the pharmaceutical item (using steps 7 and 8).

37R  Step 10—Weighted average percentage difference for listed brand and all related brands

             (1)  Work out the weighted average percentage difference for the listed brand and all related brands.

             (2)  The weighted average percentage difference is the amount (expressed as a percentage to 2 decimal places) worked out as follows:

                     (a)  for each pharmaceutical item with the same drug and manner of administration as the listed brand (including the pharmaceutical item of the listed brand):

                              (i)  multiply the total adjusted volume for the brands of the pharmaceutical item (see step 7) by the average approved ex‑manufacturer price for a brand of the pharmaceutical item (see step 3); and

                             (ii)  multiply that amount by the weighted average percentage difference of the brands of the pharmaceutical item (see step 8);

                     (b)  add up the amounts worked out under subparagraph (a)(ii);

                     (c)  add up the amounts worked out under subparagraph (a)(i);

                     (d)  divide the amount worked out under paragraph (b) by the amount worked out under paragraph (c).

             (3)  However:

                     (a)  if the amount worked out under paragraph (2)(c) is zero or less, the weighted average percentage difference is zero; and

                     (b)  if the amount worked out under paragraph (2)(d) is 99% or more, the weighted average percentage difference is 99%.

37S  Step 11—Weighted average disclosed price for listed brand of pharmaceutical item

             (1)  Work out the weighted average disclosed price of the listed brand of the pharmaceutical item for the data collection period.

             (2)  The weighted average disclosed price of the listed brand of the pharmaceutical item is the average approved ex‑manufacturer price for the listed brand reduced by the weighted average percentage difference for all related brands (see step 10).

             (3)  However, if the pricing quantity of the listed brand of the pharmaceutical item on the final day is different from the pricing quantity of the listed brand on the relevant day, the weighted average disclosed price is:

where:

PQ1 means the pricing quantity of the listed brand on the final day.

PQ2 means the pricing quantity of the listed brand on the relevant day.

WR means the average approved ex‑manufacturer price for the listed brand reduced by the weighted average percentage difference for all related brands (see step 10).

Note:          See section 99ADHA of the Act for price reductions for brands listed after the end of the data collection period.

Subdivision 3Price disclosure requirements

37T  Price disclosure requirements

             (1)  This regulation is made for subsection 99ADC(1) of the Act.

Prescribed information

             (2)  The responsible person must provide the following information in relation to the supply of a brand of a pharmaceutical item, other than the supply to a public hospital:

                     (a)  the start and end dates of the period to which the information relates;

                     (b)  the name of the brand;

                     (c)  the name of the responsible person;

                     (d)  the name of the drug in the pharmaceutical item;

                     (e)  the form of the drug, including its strength;

                      (f)  the manner of administration of the form of the drug;

                     (g)  the number or quantity of units in a pack (the number of tablets in a pack, for example);

                     (h)  the number of packs sold;

                      (i)  the revenue from sales of the brand, excluding GST;

                      (j)  if any incentive is given in relation to the brand:

                              (i)  the kind of incentive; and

                             (ii)  the value of the incentive, excluding GST.

             (3)  If information is provided under paragraph (2)(i), the information must not also be provided under paragraph (2)(j).

             (4)  The information mentioned in each of paragraphs (2)(h), (i) and (j), to the extent that the information relates to the brand’s initial month, must be provided separately.

             (5)  An amount provided under paragraph (2)(i) or (j) must be:

                     (a)  expressed in Australian dollars; and

                     (b)  rounded to the nearest whole dollar, rounding 50 cents upwards.

Prescribed person

             (6)  The responsible person must provide the information to:

                     (a)  Australian Healthcare Associates Pty Ltd (ABN 82 072 790 848); or

                     (b)  if the responsible person receives written notice from the Department to provide the information to the Secretary—the Secretary.

Prescribed manner and form

             (7)  The responsible person must provide the information in a form approved by the Secretary.

             (8)  The completed form must:

                     (a)  include all the statements and information required by the form; and

                     (b)  be signed (or authorised for electronic transmission) by a person who is authorised by the responsible person to provide the information.

Prescribed times

             (9)  Subject to subregulation (10), the responsible person must provide the information:

                     (a)  for each period between 1 April and 30 September in a year—before the end of 11 November in that year; and

                     (b)  for each period between 1 October and the next 31 March—before the end of the next 12 May.

           (10)  However, for the period between a brand’s start day and the next 31 March or 30 September, whichever is the sooner, the responsible person must provide the information:

                     (a)  if the start day happens between 1 April and 30 September in a year—before the end of 11 November in that year; or

                     (b)  if the start day happens between 1 October and the next 31 March—before the end of the next 12 May.

Part 7Arrangements of the Pharmaceutical Benefits Advisory Committee

  

38  Definitions for Part

                   In this Part:

Chairperson means the Chairperson appointed under regulation 39.

Committee means the Pharmaceutical Benefits Advisory Committee established under section 100A of the Act.

Drug Utilisation Sub‑Committee means the sub‑committee of that name established under section 101A of the Act.

Economics Sub‑Committee means the sub‑committee of that name established under section 101A of the Act.

member means a member of the Committee.

38A  Appointments to Committee—nominating bodies

             (1)  For paragraph 100B(1A)(a) of the Act, the following consumer organisations are prescribed:

                     (a)  the Consumers’ Health Forum of Australia;

                     (b)  the Australian Federation of AIDS Organisations;

                     (c)  the Australian Consumers’ Association.

             (2)  For paragraph 100B(1A)(b) of the Act, the following professional associations of health economists are prescribed:

                     (a)  the Australian Health Economics Society Inc;

                     (b)  the Economic Society of Australia Inc.

             (3)  For paragraph 100B(1A)(c) of the Act, the following professional associations of pharmacists are prescribed:

                     (a)  the Pharmacy Guild of Australia;

                     (b)  the Pharmaceutical Society of Australia;

                     (c)  the Society of Hospital Pharmacists of Australia.

             (4)  For paragraph 100B(1A)(d) of the Act, the following professional associations of medical practitioners are prescribed:

                     (a)  the Australian Medical Association Limited;

                     (b)  the Royal Australian College of General Practitioners;

                     (c)  the Australian Divisions of General Practice Limited;

                     (d)  the Doctors Reform Society—Australia Inc;

                     (e)  the Australian Federation of Medical Women Inc.

             (5)  For paragraph 100B(1A)(e) of the Act, the following professional associations of clinical pharmacologists are prescribed:

                     (a)  the Royal Australasian College of Physicians;

                     (b)  the Australasian Society of Clinical and Experimental Pharmacologists and Toxicologists.

             (6)  For paragraph 100B(1A)(f) of the Act, the following professional associations of specialists are prescribed:

                     (a)  the Australian Medical Association Limited;

                     (b)  the Royal Australasian College of Physicians;

                     (c)  the Committee of Presidents of Medical Colleges.

38B  Number of nominations for appointment

                   For subsection 100B(1B) of the Act, each body prescribed for subsection 100B(1A) of the Act must be asked to nominate at least 3 persons for selection for appointment as members of the Committee.

39  Chairperson

                   The Minister must appoint one of the members of the Committee as the Chairperson of the Committee.

40  Resignation

             (1)  The Chairperson of the Committee may resign as Chairperson by notice in writing given to the Minister.

             (2)  A member of the Committee may resign from the Committee by notice in writing given to the Minister.

41  Presiding member

             (1)  The Chairperson must preside at any meeting of the Committee at which he or she is present or, under subregulation 42(3), is taken to be present.

             (2)  If the Chairperson is absent from a meeting, the members attending the meeting must elect a member to preside at that meeting.

42  Meetings of the Committee

             (1)  The Chairperson may, at any time, by notice in writing to all members, convene a meeting of the Committee at the time and place set out in the notice.

             (2)  For the purposes of subregulation (1), the Chairperson and members of the Committee may:

                     (a)  attend a meeting in person; or

                     (b)  participate in a meeting by telephone or closed circuit television.

             (3)  If the Chairperson, or a member, participates in a meeting in accordance with paragraph 2(b), he or she is taken to be present at the meeting.

             (4)  The Committee must keep minutes of its meetings.

43  Quorum

                   At a meeting of the Committee, a quorum is the number of members who constitute a majority of the membership of the Committee.

44  Voting

             (1)  At a meeting of the Committee, the Chairperson and other members present each have a deliberative vote.

             (2)  A matter requiring a decision at a meeting must be determined by a majority of the votes of the Chairperson and other members present and voting.

             (3)  If an equal number of votes is cast for and against a matter at a meeting:

                     (a)  the Chairperson, or the member elected under subregulation 41(2) to preside at the meeting, may exercise a casting vote; and

                     (b)  if the Chairperson or that member declines to exercise a casting vote—the matter is resolved in the negative.

             (4)  Decisions of the Committee must be recorded in the minutes of the meeting.

45  Disclosure of pecuniary interests by Chairperson and members

             (1)  The Chairperson must tell the Minister in writing, as soon as practicable after the beginning of each financial year, of all direct or indirect pecuniary interests that the Chairperson has, or proposes to acquire, in a business or in a body corporate carrying on a business that could conflict with that person’s duties as Chairperson.

             (2)  Each member must tell the Minister in writing, as soon as practicable after the beginning of each financial year, of all direct or indirect pecuniary interests that the member has, or proposes to acquire, in a business or in a body corporate carrying on a business that could conflict with that person’s duties as a member.

             (3)  If the Chairperson or a member does not have an interest of the kind mentioned in subregulation (1) or (2) respectively, he or she must give a statement to that effect to the Minister.

             (4)  If the Chairperson, or the presiding member, has a direct or indirect pecuniary interest in a matter that is to be considered at a meeting, the Chairperson or the presiding member:

                     (a)  must disclose the interest to the members present at the meeting; and

                     (b)  must not take part in the meeting during the consideration of that matter unless the members present at the meeting agree that the Chairperson or the presiding member may take part in the meeting.

             (5)  If the Chairperson, or the presiding member, is precluded from taking part in a meeting or part of a meeting because of the operation of paragraph (4)(b), the members present must elect one of the members present to act in the place of the Chairperson or the presiding member for the duration of the Committee’s consideration of the matter.

             (6)  If a member (other than the Chairperson or the presiding member) has a direct or indirect pecuniary interest in a matter that is to be considered at a meeting, the member:

                     (a)  must disclose the interest to the Chairperson, or the presiding member, at the commencement of the meeting; and

                     (b)  must not take part in the meeting during the consideration of that matter unless the Chairperson, or the presiding member, allows the member to take part in the meeting.

             (7)  The following matters must be recorded in the minutes of a meeting:

                     (a)  a disclosure made under subregulation (4) or (6);

                     (b)  an agreement under paragraph (4)(b);

                     (c)  the consent of the Chairperson, or the presiding member, under paragraph (6)(b).

             (8)  In this regulation, presiding member means, in relation to a meeting of the Committee, a member elected under subregulation 41(2) to preside at the meeting.

46  Resolutions without a formal meeting

                   If a majority of the members of the Committee sign a document that includes a statement that they are in favour of a resolution in the terms set out in the document, the resolution is taken to have been passed at a meeting of the Committee:

                     (a)  on the day on which the document is signed; or

                     (b)  if the members sign the document on different days—on the day on which the document is signed by the member who completes the majority.

47  Reports and recommendations

             (1)  A report or a recommendation made to the Minister by the Committee as part of its consideration of a matter must be in writing.

             (2)  If:

                     (a)  the members are not unanimous in agreeing to a report or a recommendation; and

                     (b)  a member who is not part of the majority asks the Chairperson to include, as part of the report or recommendation:

                              (i)  a statement that the members are not unanimous; or

                             (ii)  an explanation of the opinion of the member; or

                            (iii)  a separate report or recommendation made by the member;

the report or recommendation must include the matter requested by the member.

48  Remuneration for chair and members of sub‑committees

             (1)  This regulation:

                     (a)  is made for paragraph 140(a) of the Act; and

                     (b)  prescribes the fees and allowances payable to the chair and members of the Drug Utilisation Sub‑Committee and the Economics Sub‑Committee.

             (2)  The fees and allowances are the amounts payable to the chair and members of professional committees mentioned in clause B1 of Schedule B to the Remuneration Tribunal Determination 2012/13: Remuneration and Allowances for Holders of Part‑Time Public Office.

Part 8Transitional provisions

Division 2Amendments made by National Health (Pharmaceutical Benefits) Amendment Regulation 2013 (No. 1)

53  Pharmaceutical item price and pricing quantity for delisted brands in main disclosure cycle with relevant day of 30 September 2013

             (1)  The pharmaceutical item price for a delisted brand mentioned in an item of the table in Schedule 9 is to be worked out in the following way:

                     (a)  deduct from the amount specified for the delisted brand in column 5 any amount that would have been deducted as the result of a price adjustment if the delisted brand was a listed brand in the period that:

                              (i)  began on the commencement of the National Health (Pharmaceutical Benefits) Amendment Regulation 2013 (No. 1); and

                             (ii)  ended on the relevant day;

                     (b)  add to the amount worked out in paragraph (a) any amount that would have been added to the amount specified in column 5 under a price agreement or price determination if the delisted brand had been a listed brand in the period that:

                              (i)  began on the commencement of the National Health (Pharmaceutical Benefits) Amendment Regulation 2013 (No. 1); and

                             (ii)  ended on the relevant day.

             (2)  The pricing quantity for a delisted brand mentioned in an item of the table in Schedule 9 is the amount specified for the delisted brand in column 6.

             (3)  In this regulation:

price adjustment means an adjustment under:

                     (a)  a price agreement; or

                     (b)  a price determination; or

                     (c)  Division 3A of Part VII of the Act.

price agreement has the same meaning as in Part VII of the Act.

price determination has the same meaning as in Part VII of the Act.

relevant day has the same meaning as in subsection 99ADB(1) of the Act.

Division 3Provisions for National Health (Pharmaceutical Benefits) Amendment (Price Disclosure) Regulation 2014

54  Application of Regulations

             (1)  These Regulations, as amended by the National Health (Pharmaceutical Benefits) Amendment (Price Disclosure) Regulation 2014, apply in relation to a data collection period that ends after 1 February 2014.

             (2)  This regulation applies subject to regulation 55.

55  Data collection periods

             (1)  The data collection period for a brand that, under the old Regulations:

                     (a)  started on a date, or between the dates, mentioned in column 1 of the following table (the brand’s start date); and

                     (b)  was due to end on the date mentioned in column 2 of the table;

instead ends on the date mentioned in column 3 of the table.

 

New data collection period end dates

Item

Column 1

Column 2

Column 3

Starts on or between

Due to end on

Instead ends on

1

1 February 2013

30 September 2014

31 March 2014

2

2 February 2013 to
1 June 2013

31 May 2014

31 March 2014

3

1 June 2013

30 September 2014

31 March 2014

4

2 June 2013 to
1 October 2013

30 September 2014

31 March 2014

5

1 October 2013

30 September 2014

31 March 2014

6

2 October 2013 to 1 February 2014

31 January 2015

30 September 2014

7

1 February 2014

30 September 2015

30 September 2014

8

2 February 2014 to
1 April 2014

31 May 2015

30 September 2014

9

2 April 2014 to
1 June 2014

31 May 2015

31 March 2015

 

             (2)  If the brand is a listed brand, the next data collection period for the brand starts on the day after the date mentioned in column 3 of the table.

             (3)  The responsible person for a brand to which item 6, 7 or 8 of the table applies must provide the information required under regulation 37H of the old Regulations for the period between the brand’s start date and 31 March 2014, in accordance with regulations 37HA to 37J of the old Regulations, before the end of 12 May 2014.

             (4)  In this regulation:

brand means a listed or delisted brand of a pharmaceutical item, other than an exempt item.

old Regulations means these Regulations as in force immediately before these Regulations were amended by the National Health (Pharmaceutical Benefits) Amendment (Price Disclosure) Regulation 2014.

56  Expiry of this Division

                   This Division expires on 3 April 2016 as if it had been repealed by another regulation.


Schedule 3Co‑marketed brands

(regulation 9AAC)

  

  

Column 1

Column 2

Column 3

Item

Listed brand of pharmaceutical item

Listed brand of pharmaceutical item

 

Brand

Drug

Form

Manner of administration

Brand

Drug

Form

Manner of administration

1

Avapro

Irbesartan

Tablet 75 mg

Oral

Karvea

Irbesartan

Tablet 75 mg

Oral

2

Avapro

Irbesartan

Tablet 150 mg

Oral

Karvea

Irbesartan

Tablet 150 mg

Oral

3

Avapro

Irbesartan

Tablet 300 mg

Oral

Karvea

Irebesartan

Tablet 300 mg

Oral

4

Iscover

Clopidogrel

Tablet 75 mg (as hydrogen sulfate)

Oral

Plavix

Clopidogrel

Tablet 75 mg (as hydrogen sulfate)

Oral

Schedule 5Listed brands of pharmaceutical items, reduction days and percentages

(regulation 37B)

   

 

Item

Listed brand of pharmaceutical item

Reduction days

Percentage

Brand

Drug

Form

Manner of administration

1

Nexium

Esomeprazole

Tablet (enteric coated) 20 mg (as magnesium trihydrate)

Oral

1)  1 August 2008

2)  1 August 2011

3)  1 August 2014

4)  1 August 2018

1)     4%

2)     7%

3)     7%

4)     7%

Nexium

Esomeprazole

Tablet (enteric coated) 40 mg (as magnesium trihydrate)

Oral

2

Zoton

Lansoprazole

Capsule 15 mg

Oral

1)  1 August 2008

2)  1 August 2009

3)  1 April 2010

1)     5%

2)     5%

3)   15%

3

Somac

Pantoprazole

Tablet (enteric coated) 20 mg (as sodium sesquihydrate)

Oral

1)  1 August 2008
2)  1 April 2010

1)     4%
2)   21%

Somac

Pantoprazole

Tablet (enteric coated) 40 mg (as sodium sesquihydrate)

Oral

4

Pariet

Rabeprazole

Tablet (enteric coated) containing 10mg rabeprazole sodium

Oral

1)  1 August 2008

2)  1 August 2011

3)  1 August 2014

4)  1 August 2018

1)     4%

2)     7%

3)     7%

4)     7%

Pariet

Rabeprazole

Tablet (enteric coated) containing 20mg rabeprazole sodium

Oral

5

Zanidip

Lercanidipine

Tablet 10 mg

Oral

1)  1 August 2008

2)  1 December 2010

1)     4%

2)   21%

Zanidip

Lercanidipine

Tablet 20 mg

Oral

 


Schedule 6Prescribed offices for subsections 84DA(5) and 84E(5) of the Act

(regulations 9AF and 9BA)

  

1.         Pharmaceutical Benefits Scheme

            Claims Section

            Department of Human Services

            GPO Box 9826

            SYDNEY NSW 2000

2.         Pharmaceutical Benefits Scheme

            Claims Section

            Department of Human Services

            GPO Box 9826

            MELBOURNE VIC 3000

3.         Pharmaceutical Benefits Scheme

            Claims Section

            Department of Human Services

            GPO Box 9826

            BRISBANE QLD 4000

4.         Pharmaceutical Benefits Scheme

            Claims Section

            Department of Human Services

            GPO Box 9826

            PERTH WA 6000

5.         Pharmaceutical Benefits Scheme

            Claims Section

            Department of Human Services

            GPO Box 9826

            ADELAIDE SA 5000

6.         Pharmaceutical Benefits Scheme

            Claims Section

            Department of Human Services

            GPO Box 9826

            HOBART TAS 7000

7.         Pharmaceutical Benefits Scheme

            Claims Section

            Department of Human Services

            GPO Box 9826

            CANBERRA ACT 2600

8.         Pharmaceutical Benefits Scheme

            Claims Section

            Department of Human Services

            GPO Box 9826

            DARWIN NT 0800


Schedule 9Pharmaceutical item price and pricing quantity for certain delisted brands with main disclosure cycle relevant day of 30 September 2013

Note:       See regulation 53.

  

Pharmaceutical item price and pricing quantity for certain delisted brands

Item

Column 1

Column 2

Column 3

Column 4

Column 5

Column 6

Drug

Form

Manner of administration

Brand

Pharmaceutical item price

Pricing quantity

1

Docetaxel

Injection set containing 1 single use vial concentrate for I.V. infusion 20 mg (anhydrous) in 0.5 mL with solvent

Injection

Taxotere

$68.61

1

2

Doxorubicin

Solution for I.V. injection or intravesical administration containing doxorubicin hydrochloride 20 mg in 10 mL single dose vial

Injection/ intravesical

Adriamycin Solution

$8.24

1

3

Mitozantrone

Injection 10 mg (as hydrochloride) in 5 mL

Injection

Pfizer Australia Pty Ltd

$53.34

1


Endnotes

Endnote 1—About the endnotes

The endnotes provide details of the history of this legislation and its provisions. The following endnotes are included in each compilation:

 

Endnote 1—About the endnotes

Endnote 2—Abbreviation key

Endnote 3—Legislation history

Endnote 4—Amendment history

Endnote 5—Uncommenced amendments

Endnote 6—Modifications

Endnote 7—Misdescribed amendments

Endnote 8—Miscellaneous

 

If there is no information under a particular endnote, the word “none” will appear in square brackets after the endnote heading.

 

Abbreviation key—Endnote 2

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

 

Legislation history and amendment history—Endnotes 3 and 4

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

 

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

 

The amendment history in endnote 4 provides information about amendments at the provision level. It also includes information about any provisions that have expired or otherwise ceased to have effect in accordance with a provision of the compiled law.

 

Uncommenced amendments—Endnote 5

The effect of uncommenced amendments is not reflected in the text of the compiled law but the text of the amendments is included in endnote 5.

Modifications—Endnote 6

If the compiled law is affected by a modification that is in force, details of the modification are included in endnote 6.

 

Misdescribed amendments—Endnote 7

An amendment is a misdescribed amendment if the effect of the amendment cannot be incorporated into the text of the compilation. Any misdescribed amendment is included in endnote 7.

 

Miscellaneous—Endnote 8

Endnote 8 includes any additional information that may be helpful for a reader of the compilation.

 

Endnote 2—Abbreviation key

 

ad = added or inserted

pres = present

am = amended

prev = previous

c = clause(s)

(prev) = previously

Ch = Chapter(s)

Pt = Part(s)

def = definition(s)

r = regulation(s)/rule(s)

Dict = Dictionary

Reg = Regulation/Regulations

disallowed = disallowed by Parliament

reloc = relocated

Div = Division(s)

renum = renumbered

exp = expired or ceased to have effect

rep = repealed

hdg = heading(s)

rs = repealed and substituted

LI = Legislative Instrument

s = section(s)

LIA = Legislative Instruments Act 2003

Sch = Schedule(s)

mod = modified/modification

Sdiv = Subdivision(s)

No = Number(s)

SLI = Select Legislative Instrument

o = order(s)

SR = Statutory Rules

Ord = Ordinance

Sub-Ch = Sub-Chapter(s)

orig = original

SubPt = Subpart(s)

par = paragraph(s)/subparagraph(s)
/sub-subparagraph(s)

 

 

Endnote 3—Legislation history

 

Number and year

FRLI registration or gazettal

Commencement

Application, saving and transitional provisions

1960 No. 17

29 Feb 1960

1 Mar 1960

 

1960 No. 90

28 Oct 1960

1 Nov 1960

1960 No. 102

19 Dec 1960

r. 1: 1 Feb 1961
r. 2: 1 Jan 1961

1961 No. 59

28 Apr 1961

1 May 1961

1961 No. 137

27 Oct 1961

1 Nov 1961

1962 No. 34

18 Apr 1962

1 May 1962

1962 No. 101

31 Oct 1962

1 Nov 1962

1962 No. 114

24 Dec 1962

1 Jan 1963

1963 No. 34

26 Apr 1963

1 May 1963

1963 No. 69

12 Aug 1963

12 Aug 1963

1963 No. 107

31 Oct 1963

1 Nov 1963

1964 No. 12

30 Jan 1964

1 Feb 1964

1964 No. 57

30 Apr 1964

1 May 1964

1964 No. 135

30 Oct 1964

1 Nov 1964

1965 No. 51

30 Apr 1965

1 May 1965

1965 No. 151

28 Oct 1965

1 Nov 1965

1965 No. 152

28 Oct 1965

1 Nov 1965

1966 No. 80

28 Apr 1966

1 May 1966

1966 No. 144

27 Oct 1966

1 Nov 1966

1967 No. 67

1 June 1967

1 June 1967

1967 No. 116

31 Aug 1967

1 Sept 1967

1967 No. 158

30 Nov 1967

1 Dec 1967

1968 No. 44

28 Mar 1968

1 Apr 1968

1968 No. 76

11 July 1968

11 July 1968

1968 No. 88

1 Aug 1968

1 Aug 1968

1968 No. 146

29 Nov 1968

1 Dec 1968

1969 No. 44

27 Mar 1969

1 Apr 1969

1969 No. 107 (a)

31 July 1969

1 Aug 1969

1969 No. 185 (a)

28 Nov 1969

1 Dec 1969

1970 No. 39 (a)

25 Mar 1970

1 Apr 1970

1970 No. 94 (a)

30 July 1970

1 Aug 1970

1970 No. 119

4 Sept 1970

7 Sept 1970

1970 No. 186 (a)

27 Nov 1970

1 Dec 1970

1971 No. 44 (a)

1 Apr 1971

1 Apr 1971

1971 No. 101 (a)

30 July 1971

1 Aug 1971

1971 No. 136

25 Oct 1971

1 Nov 1971

1971 No. 154 (a)

26 Nov 1971

1 Dec 1971

1972 No. 32 (a)

16 Mar 1972

1 Apr 1972

1972 No. 121 (a)

28 July 1972

1 Aug 1972

1972 No. 205 (a)

30 Nov 1972

1 Dec 1972

1973 No. 15 (a)

1 Feb 1973

1 Feb 1973

1973 No. 57 (a)

22 Mar 1973

1 Apr 1973

1973 No. 139 (a)

26 July 1973

1 Aug 1973

1973 No. 229 (a)

29 Nov 1973

1 Dec 1973

1974 No. 37 (a)

29 Mar 1974

1 Apr 1974

1974 No. 126 (a)

30 July 1974

1 Aug 1974

1974 No. 222 (a)

27 Nov 1974

1 Dec 1974

1975 No. 50 (a)

1 Apr 1975

1 Apr 1975

1975 No. 148 (a)

31 July 1975

1 Aug 1975

1975 No. 209 (a)

21 Nov 1975

1 Dec 1975

1976 No. 84 (a)

24 Mar 1976

r. 3: 1 Apr 1976
Remainder: 24 Mar 1976

1976 No. 150 (a)

26 July 1976

1 Aug 1976

1976 No. 195

14 Sept 1976

14 Sept 1976

1976 No. 255 (a)

1 Dec 1976

1 Dec 1976

1977 No. 39 (a)

28 Mar 1977

1 Apr 1977

1977 No. 125 (a)

29 July 1977

1 Aug 1977

1977 No. 221 (a)

24 Nov 1977

1 Dec 1977

1978 No. 47 (a)

29 Mar 1978

1 Apr 1978

1978 No. 142 (a)

27 July 1978

1 Aug 1978

1978 No. 153

24 Aug 1978

24 Aug 1978

1978 No. 245 (a)

30 Nov 1978

1 Dec 1978

1979 No. 51 (a)

30 Mar 1979

1 Apr 1979

1979 No. 55

2 Apr 1979

2 Apr 1979

1979 No. 144 (a)

31 July 1979

1 Aug 1979

1979 No. 250 (a)

30 Nov 1979

1 Dec 1979

1980 No. 69 (a)

31 Mar 1980

1 Apr 1980

1980 No. 213 (a)

29 July 1980

1 Aug 1980

1980 No. 338 (a)

28 Nov 1980

1 Dec 1980

1981 No. 52 (a)

31 Mar 1981

1 Apr 1981

1981 No. 212 (a)

31 July 1981

1 Aug 1981

1981 No. 218

14 Aug 1981

14 Aug 1981

1981 No. 345 (a)

30 Nov 1981

1 Dec 1981

1982 No. 69

19 Mar 1982

19 Mar 1982

1982 No. 76 (a)

31 Mar 1982

1 Apr 1982

1982 No. 179 (a)

30 July 1982

1 Aug 1982

1982 No. 334 (a)

30 Nov 1982

1 Dec 1982

1982 No. 372

31 Dec 1982

1 Jan 1983

1983 No. 28 (a)

31 Mar 1983

1 Apr 1983

1983 No. 102

15 July 1983

15 July 1983

1983 No. 116 (a)

29 July 1983

1 Aug 1983

1983 No. 292

30 Nov 1983

1 Dec 1983

1984 No. 50 (a)

30 Mar 1984

1 Apr 1984

1984 No. 148

11 July 1984

11 July 1984

1984 No. 169 (a)

31 July 1984

1 Aug 1984

1984 No. 342 (a)

30 Nov 1984

1 Dec 1984

1985 No. 32 (a)

1 Apr 1985

1 Apr 1985

1985 No. 184 (a)

1 Aug 1985

1 Aug 1985

1985 No. 320 (a)

29 Nov 1985

1 Dec 1985

1986 No. 38 (a)

27 Mar 1986

1 Apr 1986

1986 No. 194 (a)

31 July 1986

1 Aug 1986

1986 No. 319

31 Oct 1986

31 Oct 1986

1986 No. 320 (a)

31 Oct 1986

1 Nov 1986

1986 No. 391

22 Dec 1986

22 Dec 1986

1987 No. 47

31 Mar 1987

1 Apr 1987

1987 No. 262

12 Nov 1987

12 Nov 1987

1987 No. 279

30 Nov 1987

1 Dec 1987

1988 No. 56

29 Apr 1988

1 May 1988

1989 No. 330 (b)

30 Nov 1989

rr. 1, 2 and 8: 1 Dec 1989
Remainder: 1 Jan 1990

1990 No. 226

12 July 1990

1 Aug 1990

1990 No. 267

21 Aug 1990

1 Aug 1990

1990 No. 337

31 Oct 1990

1 Nov 1990

1990 No. 338

31 Oct 1990

1 Nov 1990 (see r. 1)

1990 No. 437

21 Dec 1990

21 Dec 1990

1991 No. 1

22 Jan 1991

22 Jan 1991

1991 No. 474

23 Dec 1991

1 Jan 1992

1992 No. 226

10 July 1992

10 July 1992

1994 No. 348

18 Oct 1994

rr. 7–9: 1 Jan 1995
r. 21.2: 1 Dec 1994
Remainder: 1 Nov 1994

1996 No. 70

31 May 1996

1 June 1996

1998 No. 374

22 Dec 1998

1 Jan 1999

2000 No. 369

20 Dec 2000

1 Jan 2001 (see r. 2)

2001 No. 68

12 Apr 2001

12 Apr 2001

2002 No. 9

21 Feb 2002

21 Feb 2002

2002 No. 239

11 Oct 2002

1 Feb 2003

2002 No. 344

20 Dec 2002

rr. 1–3 and Schedule 1:
20 Dec 2002
Remainder: 1 Aug 2003

2003 No. 193

31 July 2003

1 Aug 2003

2004 No. 389

23 Dec 2004

13 Jan 2005 (see r. 2)

2005 No. 207

19 Sept 2005 (see F2005L02673)

1 Oct 2005 (see r. 2)

2006 No. 121

2 June 2006 (see F2006L01614)

1 July 2006

2006 No. 200

28 July 2006 (see F2006L02405)

1 Mar 2007

2007 No. 160

25 June 2007 (see F2007L01518)

1 July 2007

2007 No. 225

24 July 2007 (see F2007L02206)

1 Aug 2007

2008 No. 54

14 Apr 2008 (see F2008L00583)

15 Apr 2008

2008 No. 116

20 June 2008 (see F2008L01021)

21 June 2008

2009 No. 195

30 July 2009 (see F2009L02523)

31 July 2009

2010 No. 49

25 Mar 2010 (see F2010L00568)

26 Mar 2010

2010 No. 115

7 June 2010 (see F2010L01069)

8 June 2010

2010 No. 231

21 July 2010 (see F2010L01979)

rr. 1–3 and Schedule 1: 22 July 2010
Schedule 2: 1 Nov 2010

2010 No. 295

25 Nov 2010 (see F2010L02950)

26 Nov 2010

2010 No. 296

26 Nov 2010 (see F2010L02953)

1 Dec 2010

rr. 4–7, 9 and 10
 r. 8 (am. by 2012 No. 56, Sch. 1 [item 1])

as amended by

 

 

 

2012 No. 56

20 Apr 2012 (see F2012L00902)

21 Apr 2012

2010 No. 327

9 Dec 2010 (see F2010L03077)

10 Dec 2010

2011 No. 29

16 Mar 2011 (see F2011L00427)

17 Mar 2011

2011 No. 120

30 June 2011 (see F2011L01364)

1 July 2011

2012 No. 55

20 Apr 2012 (see  F2012L00901)

21 Apr 2012

2012 No. 141

29 June 2012 (see F2012L01443)

1 July 2012

2012 No. 168

13 July 2012 (see F2012L01552)

1 Oct 2012

2012 No. 299

11 Dec 2012 (see F2012L02388)

12 Dec 2012

53, 2013

12 Apr 2013 (see F2013L00650)

13 Apr 2013

60, 2014

2 June 2014 (see F2014L00636)

3 June 2014

 

(a)             The form of introductory words used to make Statutory Rules 1986 No. 320 was as follows:

                  ‘WHEREAS it is provided by subsection 101(4) of the National Health Act 1953 that a drug or medicinal preparation that was not a pharmaceutical benefit under that Act immediately before the commencement of that subsection shall not be prescribed as a pharmaceutical benefit in accordance with section 85 of that Act unless the Pharmaceutical Benefits Advisory Committee has recommended to the Minister that it be so prescribed:

                  ‘AND WHEREAS the Pharmaceutical Benefits Advisory Committee has recommended to the Minister that each of the following drugs or medicinal preparations be prescribed as a pharmaceutical benefit under section 85 of that Act, namely:

                   (a)  Indapamide;

                   (b)  Insulin Neutral, Human (Synthetic);

                   (c)  Insulin Zinc Suspension, Human (Synthetic);

                   (d)  Insulin Zinc Suspension (Crystalline), Human (Synthetic);

                   (e)  Oestrogens—Conjugated;

                    (f)  Piroxicam;

                   (g)  Polygeline; and

                   (h)  Silver Sulphadiazine:

                  ‘AND WHEREAS it is desirable, amongst other things, to prescribe each of those drugs or medicinal preparations as a pharmaceutical benefit under that section:

                  ‘NOW THEREFORE I, the Governor‑General of the Commonwealth of Australia, acting with the advice of the Federal Executive Council, hereby make the following Regulations under the National Health Act 1953.’

                  The form of introductory words used to make Statutory Rules 1969 Nos. 107 and 185, 1970 Nos. 39, 94 and 186, 1971 Nos. 44, 101 and 154, 1972 Nos. 32, 121 and 205, 1973 Nos. 15, 57, 139 and 229, 1974 Nos. 37, 126 and 222, 1975 Nos. 50, 148 and 209, 1976 Nos. 84, 150 and 255, 1977 Nos. 39, 125 and 221, 1978 Nos. 47, 142 and 245, 1979 Nos. 51, 144 and 250, 1980 Nos. 69, 213 and 338, 1981 Nos. 52, 212 and 345, 1982 Nos. 76, 179 and 334, 1983 Nos. 28 and 116, 1984 Nos. 50, 169 and 342, 1985 Nos. 32, 184 and 320, 1986 Nos. 38, 194 and 320 was similar to the form set out above.

(b)             Disallowed by the Senate on 22 December 1989.

Endnote 4—Amendment history

 

Provision affected

How affected

Part 1

 

Heading to Part I..................

rep. 2006 No. 200

Heading to Part 1.................

ad. 2006 No. 200

Division 1.1

 

Heading to Div. 1.1.............

ad. 2006 No. 200

r. 1......................................

rs. 1998 No. 374

r. 2......................................

am. 1977 No. 39

r. 3......................................

rep. 1976 No. 195

r. 4......................................

am. 1977 No. 39

Renumbered r. 3..............

1998 No. 374

r. 4......................................

ad. 1998 No. 374

r. 5......................................

am. 1960 No. 90; 1976 No. 195; 1977 No. 39; 1979 Nos. 55 and 250; 1981 No. 218; 1982 No. 372; 1983 No. 102; 1986 Nos. 319 and 391; 1988 No. 56; 1990 No. 437; 1991 Nos. 1 and 474; 1992 No. 226; 1994 No. 348; 1996 No. 70; 1998 No. 374; 2002 Nos. 239 and 344; 2004 No. 389; 2005 No. 207; 2006 No. 200; 2007 No. 225; 2008 No. 54; 2010 Nos. 231 and 296; 2012 Nos. 141 and 168; No 60, 2014

Division 1.2

 

Div. 1.2 of Part 1.................

ad. 2006 No. 200

r. 5A....................................

ad. 2006 No. 200

r. 5B....................................

ad. 2006 No. 200

 

am. 2008 No. 54

r. 5C....................................

ad. 2006 No. 200

r. 5D....................................

ad. 2006 No. 200

r. 5E....................................

ad. 2006 No. 200

r. 5F....................................

ad. 2006 No. 200

r. 6......................................

am. 1977 No. 39; 1991 No. 474

 

rep. 1994 No. 348

r. 7......................................

am. 1977 No. 39

 

rep. 1984 No. 148

Part 2

 

Heading to Part II................

am. 1979 No. 55; 1982 No. 69; 1986 No. 91

 

rs. 2008 No. 54;

 

rep. 2012 No. 141

Heading to Part 2.................

ad. 2012 No. 141

Heading to r. 8.....................

rs. 2001 No. 68

r. 8......................................

am. 1977 No. 39

 

rs. 1981 No. 218

 

am. 1982 No. 69; 1986 No. 391; 1988 No. 56; 1994 No. 348; 1996 No. 70; 2001 No. 68

r. 8AA.................................

ad. 2008 No. 54

 

rs. 2010 No. 231

r. 8A....................................

ad. 1979 No. 55

 

rs. 1981 No. 218

 

am. 1982 No. 69; 1986 No. 391; 1988 No. 56; 2004 No. 389; 2006 No. 121; 2008 No. 54; 2010 No. 231

r. 9......................................

am. 1967 No. 158; 1977 No. 39; 1986 No. 391; 1994 No. 348

 

rs. 2002 No. 9

Part 2A

 

Heading to Part IIAAA........

rep. 2012 No. 141

Heading to Part 2A..............

ad. 2012 No. 141

r. 9AAA..............................

ad. 2007 No. 225

 

rep. 2010 No. 296

r. 9AAB...............................

ad. 2007 No. 225

 

rep. 2010 No. 296

r. 9AAC...............................

ad. 2007 No. 225

r. 9AAD..............................

ad. 2007 No. 225

 

rep. 2010 No. 49

Part 2B

 

Heading to Part IIAA...........

rep. 2012 No. 141

Heading to Part 2B...............

ad. 2012 No. 141

Part IIAA.............................

ad. 1991 No. 1

r. 9AA.................................

ad. 1991 No. 1

 

am. 1991 No. 474; 1992 No. 226; 1994 No. 348; 2002 No. 344

r. 9AB.................................

ad. 1991 No. 1

 

am. 1992 No. 226; 1994 No. 348; 2002 No. 344

r. 9AC.................................

ad. 1991 No. 1

 

am. 1992 No. 226; 1994 No. 348; 2002 No. 344

r. 9AD.................................

ad. 1991 No. 1

 

am. 1992 No. 226

r. 9AE.................................

ad. 1991 No. 1

Heading to r. 9AF................

rs. 2002 No. 344

r. 9AF..................................

ad. 1991 No. 1

 

am. 1994 No. 348; 2002 No. 344

 

rs. 2012 No. 141

Part 2C

 

Heading to Part IIA..............

rep. 2012 No. 141

Heading to Part 2C...............

ad. 2012 No. 141

Part IIA...............................

ad. 1986 No. 319

r. 9A....................................

ad. 1986 No. 319

 

am. 1990 Nos. 226, 267 and 338; 1991 No. 474; 1992 No. 226; 2002 No. 344

r. 9B....................................

ad. 1986 No. 319

 

rs. 1990 No. 437

 

am. 1991 No. 474; 1992 No. 226; 2002 No. 344

r. 9BA.................................

ad. 1987 No. 262

 

am. 1994 No. 348; 2002 No. 344

 

rs. 2012 No. 141

r. 9C....................................

ad. 1986 No. 319

 

am. 1990 No. 226

 

rs. 1990 No. 437

 

am. 1992 No. 226; 2002 No. 344

r. 9D....................................

ad. 1986 No. 319

 

am. 1990 No. 226

 

rs. 1990 No. 437

 

am. 1992 No. 226; 2002 No. 344

r. 9E....................................

ad. 1986 No. 319

 

am. 1990 No. 226

 

rs. 1990 No. 437

 

am. 1992 No. 226

r. 9F....................................

ad. 1986 No. 319

Part 3

 

Heading to Part III...............

am. 1979 No. 250

 

rep. 2012 No. 141

Heading to Part 3.................

ad. 2012 No. 141

r. 10....................................

am. 1967 No. 158; 1977 No. 39

 

rep. 1987 No. 47

rr. 11, 12.............................

am. 1977 No. 39

 

rep. 1987 No. 47

r. 13....................................

am. 1965 No. 152; 1977 No. 39; 1979 No. 55

 

rs. 1988 No. 56

 

am. 1996 No. 70; 2003 No. 193; 2006 No. 200; 2008 No. 54; 2010 No. 231

Note to r. 13(1) ..................

ad. 2012 No. 141

r. 14....................................

am. 1965 No. 152; 1968 No. 44; 1977 No. 39; 1979 Nos. 55 and 250; 1980 No. 338; 1981 No. 52

 

rep. 1987 No. 47

Part 4

 

Heading to Part IV...............

rs. 1979 No. 250; 2010 No. 231

 

rep. 2012 No. 141

Heading to  Part 4................

ad. 2012 No. 141

r. 14....................................

ad. 2010 No. 231

r. 15....................................

rs. 1963 No. 69

 

am. 1994 No. 348; 2004 No. 389

 

rs. 2010 No. 231; 2012 No. 168

Heading to r. 16...................

rs. 2012 No. 168

r. 16....................................

am. 1963 No. 69; 1977 No. 39; 1986 No. 391; 1988 No. 56; 1994 No. 348; 2002 No. 344; 2006 No. 200

 

rs. 2010 No. 231

 

am. 2012 No. 168

Heading to r. 17...................

rs. 2012 No. 168

r. 17....................................

am. 1967 No. 158; 1977 No. 39; 1986 No. 391

 

rs. 2002 No. 9

 

am. 2006 No. 200

 

rs. 2010 No. 231

Heading to r. 18...................

rs. 2012 No. 168

r. 18....................................

am. 1963 No. 69; 1977 No. 39; 1986 No. 391; 2006 No. 200

 

rs. 2010 No. 231

 

am. 2012 No. 168

r. 18A..................................

ad. 1963 No. 69

 

am. 1967 No. 158; 1977 No. 39; 1986 No. 391; 1988 No. 56; 1994 No. 348

 

rs. 2002 No. 9

Part 5

 

Heading to Part V................

rep. 2012 No. 141

Heading to Part 5.................

ad. 2012 No. 141

r. 18B..................................

ad. 2012 No. 141

r. 19....................................

rs. 1960 No. 90

 

am. 1965 No. 152; 1971 No. 136; 1974 No. 126; 1977 No. 39; 1978 No. 153; 1979 No. 55; 1982 No. 372; 1986 No. 391; 1987 Nos. 47 and 279; 1988 No. 56; 1991 No. 474; 1994 No. 348; 1996 No. 70; 1998 No. 374; 2002 Nos. 239 and 344; 2004 No. 389; 2005 No. 207; 2006 No. 200; 2007 No. 160; 2008 No. 54; 2010; No. 231; 2011 No. 120; 2012 Nos. 141 and 168

Note to r. 19(1) ..................

ad. 2008 No. 54

 

rep. 2012 No. 141

r. 19AA...............................

ad. 2012 No. 141

Heading to r. 19A................

rs. 2001 No. 68; 2012 No. 141

r. 19A..................................

ad. 1971 No. 136

 

rep. 1976 No. 84

 

ad. 1983 No. 102

 

am. 1986 Nos. 319 and 391; 1990 No. 437; 1991 No. 1; 2001 No. 68; 2002 No. 344; 2004 No. 389; 2006 No. 200; 2012 No. 141

r. 19B..................................

ad. 1988 No. 56

 

am. 1991 No. 474

 

rs. 2002 No. 9

r. 20....................................

am. 1977 No. 39; 1979 No. 55; 1981 No. 218; 1987 No. 47; 1994 No. 348

 

rep. 2012 No. 141

r. 21....................................

am. 1960 No. 90; 1965 No. 152; 1977 No. 39; 1978 No. 153; 1979 No. 55; 1981 No. 52; 1985 No. 320; 1986 Nos. 319 and 391; 1987 No. 47; 1988 No. 56; 1998 No. 374

 

rs. 1994 No. 348

 

am. 2006 No. 200; 2012 No. 141

r. 21A..................................

ad. 2012 No. 141

r. 21B..................................

ad. 2012 No. 141

r. 21C..................................

ad. 2012 No. 141

r. 22....................................

am. 1967 No. 158; 1977 No. 39; 1979 No. 55; 1986 No. 391; 1987 No. 47; 1988 No. 56; 1994 No. 348; 2002 No. 9; 2005 No. 207; 2006 No. 200; 2008 No. 54; 2011 No. 120; 2012 No. 141

r. 23....................................

am. 1960 No. 90

 

rs. 1965 No. 152

 

am. 1977 No. 39; 1986 Nos. 319 and 391; 1987 No. 47; 1988 No. 56

 

rep. 1994 No. 348

r. 24....................................

am. 1977 No. 39; 1979 No. 55; 1986 No. 319; 2004 No. 389; 2010 No. 231; 2012 No. 141

r. 24A..................................

ad. 2012 No. 141

r. 25....................................

am. 1990 No. 337; 1994 No. 348; 1998 No. 374; 2001 No. 68; 2005 No. 207; 2006 No. 200; 2012 No. 141

r. 26....................................

am. 1965 No. 152; 1968 No. 76; 1977 No. 39; 1978 No. 153; 1979 No. 55; 1981 Nos. 52 and 218; 1982 No. 372; 1983 No. 102; 1985 No. 320; 1986 Nos. 319 and 391; 1987 No. 47; 1988 No. 56; 1990 No. 437; 1991 Nos. 1 and 474; 1994 No. 348; 1996 No. 70; 1998 No. 374; 2001 No. 68; 2002 No. 9; 2005 No. 207; 2006 No. 200; 2012 No. 141

r. 26AA...............................

ad. 2012 No. 141

r. 26A..................................

ad. 1978 No. 153

 

am. 1979 No. 55; 1981 No. 218; 1982 No. 372; 1983 No. 102; 1986 Nos. 319 and 391; 1988 No. 56; 1990 No. 437; 1991 Nos. 1 and 474; 1994 No. 348; 1996 No. 70; 1998 No. 374; 2001 No. 68; 2004 No. 389; 2006 No. 200; 2012 No. 141

r. 27....................................

am. 1977 No. 39; 1986 No. 391; 1988 No. 56; 1994 No. 348; 2004 No. 389

r. 28....................................

am. 1967 No. 158; 1977 No. 39; 1979 No. 55; 1986 No. 391; 2002 No. 9; 2004 No. 389; 2006 No. 200; 2010 No. 231

r. 29....................................

am. 1967 No. 158

 

rs. 1976 No. 195

 

rep. 1986 No. 319

r. 30....................................

am. 1986 No. 391; 1994 No. 348; 2004 No. 389; 2012 No. 141

r. 31....................................

am. 1960 No. 90; 1965 No. 152; 1967 No. 158; 1977 No. 39; 1983 No. 102; 1986 Nos. 319 and 391; 1987 No. 47; 1988 No. 56; 1990 No. 437; 1991 No. 1

 

rs. 1994 No. 348

 

am. 2002 No. 9; 2006 No. 200; 2012 No. 141

Part 6

 

Heading to Part VI...............

rep. 2012 No. 141

Heading to Part 6.................

ad. 2012 No 141

r. 31B..................................

ad. 2012 No. 141

r. 32....................................

am. 1965 No. 152; 1967 No. 158; 1977 No. 39; 1978 No. 153; 1986 No. 391; 1994 No. 348; 1996 No. 70; 1998 No. 374

 

rs. 2002 No. 9

 

am. 2002 No. 344; 2006 No. 200; 2012 No. 141

r. 32A..................................

ad. 2012 No. 141

r. 32B..................................

ad. 2012 No. 141

r. 33....................................

am. 1967 No. 158; 1977 No. 39; 1986 No. 391

 

rs. 2002 No. 9

r. 34....................................

am. 1977 No. 39; 1979 No. 55; 1986 No. 391; 1988 No. 56

 

rep. 1994 No. 348

r. 35....................................

am. 1962 No. 34; 1964 Nos. 57 and 135; 1969 No. 107; 1977 No. 39; 1987 No. 47

 

rs. 1994 No. 348

Note to r. 35........................

ad. 2012 No. 141

r. 36....................................

am. 1977 No. 39; 1994 No. 338

 

rep. 1996 No. 70

 

ad. 2002 No. 344

 

am. 2010 No. 231; 2012 Nos. 141 and 168

Note to r. 36(3) ..................

am. 2012 No. 168

r. 37....................................

am. 1967 No. 158; 1977 No. 39; 1988 No. 56; 2002 No. 9

r. 37AA...............................

ad. 2012 No. 141

Pt 6A

 

Heading to Part VIA............

rep. 2012 No. 141

Heading to Pt 6A.................

ad. 2012 No. 141

 

rs. No. 53, 2013; No 60, 2014

Div 1

 

Heading to Div. 1................
of Part VIA

ad. 2010 No. 296
rep. 2012 No. 141

Heading to Div. 1................
of Part 6A

ad. 2012 No. 141
rs No 60, 2014

Heading to r. 37A................

rs. 2012 No. 141; No 60, 2014

r. 37A..................................

ad. 2007 No. 225

 

am. 2010 No. 296; 2012 No. 168; No. 53, 2013

 

rs No 60, 2014

hdg to Div 1A of Pt 6A........

ad. No. 53, 2013
rep No 60, 2014

r. 37B..................................

ad. 2007 No. 225

Div 2

 

Div 2 of Pt 6A.....................

ad No 60, 2014

Sdiv 1

 

hdg to Sdiv 1 of Div 2.........

ad No 60, 2014

r. 37C..................................

ad. 2007 No. 225

 

rep. 2012 No. 168

 

ad No 60, 2014

Heading to r. 37D................

rs. 2010 No. 296

 

rep. 2012 No. 168

 

ad No 60, 2014

r. 37D..................................

ad. 2007 No. 225

 

am. 2008 No. 116; 2010 No. 296

 

rep. 2012 No. 168

 

ad No 60, 2014

r. 37DA...............................

ad. 2010 No. 296

 

rep. 2012 No. 168

Heading to Div. 2................
of Part VIA

ad. 2010 No. 296
rep. 2012 No. 141

Heading to Div. 2................
of Part 6A

ad. 2012 No. 141
rep No 60, 2014

r. 37DB...............................

ad. 2010 No. 296

 

rep No 60, 2014

r. 37E..................................

ad. 2007 No. 225

 

am. 2010 No. 296; No. 53, 2013

 

rs No 60, 2014

Note to r. 37E(4).................

rs. 2010 No. 296

 

rep No 53, 2013

r. 37EA...............................

ad. 2010 No. 296

 

am. 2012 No. 141

 

rep No 60, 2014

r. 37EB................................

ad. 2010 No. 296

 

am. No. 53, 2013

 

rep No 60, 2014

Note 1 to r. 37EB(2)............

rs. No. 53, 2013

 

rep No 60, 2014

Note 2 to r. 37EB(2)............

rs. No. 53, 2013

 

rep No 60, 2014

r. 37EC................................

ad. 2010 No. 296

 

am. No. 53, 2013

 

rep No 60, 2014

Heading to r. 37ED..............

am. 2012 No. 168

 

rep No 60, 2014

r. 37ED...............................

ad. 2010 No. 296

 

am. 2012 No. 168

 

rep No 60, 2014

Note to r. 37ED(6) .............

rep. 2012 No. 168

r. 37EE................................

ad. 2010 No. 296

 

am. 2012 No. 168

 

rep No 60, 2014

r. 37EF................................

ad. 2010 No. 296

 

am. No. 53, 2013

 

rep No 60, 2014

r. 37EG...............................

ad. 2010 No. 296

 

am. No. 53, 2013

 

rep No 60, 2014

r. 37EH...............................

ad. 2010 No. 296

 

am. No. 53, 2013

 

rep No 60, 2014

Sdiv 2

 

hdg to Sdiv 2 of Div 2.........

ad No 60, 2014

hdg to r 37F.........................

rs No. 53, 2013; No 60, 2014

r. 37F..................................

ad. 2007 No. 225

 

am. 2008 No. 116

 

rs. 2010 No. 296; 2012 No. 168

 

am. No. 53, 2013

 

rs No 60, 2014

r. 37FA................................

ad. 2012 No. 168

 

am. No. 53, 2013

 

rep No 60, 2014

Note 1 to r. 37FA(1)............

rep. No. 53, 2013

Note 2 to r. 37FA(1)............

rep. No. 53, 2013

r. 37G..................................

ad. 2007 No. 225

 

rs. 2010 No. 296

 

am. 2012 No. 168; No. 53, 2013

 

rs No 60, 2014

Note to r. 37G(5).................

ad, No. 53, 2013

 

rep No 60, 2014

Heading to Div. 3................
of Part VIA

ad. 2010 No. 296
rep. 2012 No. 141

Heading to Div. 3................
of Part 6A

ad. 2012 No. 141
rep No 60, 2014

r. 37H..................................

ad. 2007 No. 225

 

rs. 2010 No. 296

 

am. 2012 No. 168; No. 53, 2013

 

rs No 60, 2014

Note 1 to r. 37H(1)
Renumbered Note.............


No. 53, 2013

 

rep No 60, 2014

Note 2 to r. 37H(1)..............

rep. No. 53, 2013

r. 37HA...............................

ad. 2008 No. 116

 

rs. 2011 No. 29

 

am. 2012 No. 55

 

rep No 60, 2014

Note to r. 37HA(2)..............

ad. No. 53, 2013

 

rep No 60, 2014

r. 37I...................................

ad. 2007 No. 225

 

am. 2010 No. 296

 

rep No 60, 2014

Note to r. 37I(2)..................

ad. No. 53, 2013

 

rep No 60, 2014

r. 37J...................................

ad. 2007 No. 225

 

rs. 2010 No. 296

 

am. 2012 No. 168; No. 53, 2013

 

rs No 60, 2014

Note to r. 37J(6)..................

rep. No. 53, 2013

r. 37JA................................

ad. 2010 No. 296; No. 53, 2013

 

rep No 60, 2014

Note to r. 37JA(6)...............

rep. No. 53, 2013

Heading to Div. 4................
of Part VIA

ad. 2010 No. 296
rep. 2012 No. 141

Heading to Div. 4................
of Part 6A

ad. 2012 No. 141
rep No 60, 2014

r. 37K..................................

ad. 2009 No. 195

 

am. 2010 No. 296

 

rs No 60, 2014

r 37L...................................

ad No 60, 2014

r 37M..................................

ad No 60, 2014

r 37N...................................

ad No 60, 2014

r 37P...................................

ad No 60, 2014

r 37Q...................................

ad No 60, 2014

r 37R...................................

ad No 60, 2014

r 37S...................................

ad No 60, 2014

Sdiv 3

 

Sdiv 3 of Div 2....................

ad No 60, 2014

r 37T...................................

ad No 60, 2014

Part 7

 

Part 7...................................

ad. 1994 No. 348

Heading to r. 38...................

rs. 2012 No. 141

r. 38....................................

ad. 1994 No. 348

 

am. 2000 No. 369; 2009 No. 195

Heading to r. 38A................

rs. 2012 No. 141

r. 38A..................................

ad. 2000 No. 369

 

am. 2001 No. 68

Heading to r. 38B................

rs. 2012 No. 141

r. 38B..................................

ad. 2000 No. 369

r. 39....................................

ad. 1994 No. 348

r. 40....................................

ad. 1994 No. 348

 

rs. 2000 No. 369

r. 41....................................

ad. 1994 No. 348

r. 42....................................

ad. 1994 No. 348

r. 43....................................

ad. 1994 No. 348

r. 44....................................

ad. 1994 No. 348

 

am. 1996 No. 70

r. 45....................................

ad. 1994 No. 348

 

am. 1996 No. 70

r. 46....................................

ad. 1994 No. 348

r. 47....................................

ad. 1994 No. 348

r. 48....................................

ad. 1994 No. 348

 

rep. 2000 No. 369

 

ad. 2009 No. 195

 

am. 2010 Nos. 115 and 327

 

rs. 2012 No. 299

Pt 8

 

Pt 8......................................

ad. 2012 No. 168

Div 1 of Pt 8........................

rep No 60, 2014

r. 49....................................

ad. 2012 No. 168

 

rep No 60, 2014

r. 50....................................

ad. 2012 No. 168

 

rep No 60, 2014

Div 2

 

Div 2 of Pt 8........................

ad No. 53, 2013

r. 51....................................

ad. No. 53, 2103

 

rep No 60, 2014

r. 52....................................

ad No. 53, 2103

 

rep No 60, 2014

r 53.....................................

ad No. 53, 2103

Div 3

 

Div 3 of Pt 8........................

ad No 60, 2014

r 54.....................................

ad No 60, 2014

r 55.....................................

ad No 60, 2014

r 56.....................................

ad No 60, 2014

Schedule 1...........................

ad. 2007 No. 225

 

rep. 2010 No. 296

Schedule 2...........................

ad. 2007 No. 225

 

rep. 2010 No. 296

Schedule 3

 

Schedule 3...........................

ad. 2007 No. 225

Schedule 4...........................

ad. 2007 No. 225

 

rep. 2010 No. 49

Schedule 5

 

Schedule 5...........................

ad. 2007 No. 225

 

rs. 2008 No. 116

 

am. 2010 Nos. 49 and 295

Schedule 6

 

Schedule 1...........................

ad. 2002 No. 344 

 

am. 2005 No. 207

Renumbered Schedule 6...

2007 No. 225

Schedule 6...........................

rs. 2011 No. 120

Schedule 7...........................

ad. 2012 No. 168

 

rep No 60, 2014

Schedule 8...........................

ad. No. 53, 2013

 

rep No 60, 2014

Schedule 9

 

Schedule 9...........................

ad. No. 53, 2013

Heading to Schedule............

ad. 1994 No. 348

 

rep. 2002 No. 344

Heading to The Schedules...

rep. 1977 No. 39

Heading to First Schedule....

rep. 1977 No. 39

Heading to Schedule 1.........

ad. 1977 No. 39

 

rep. 1987 No. 47

First Schedule......................

rs. 1960 No. 90

 

am. 1961 No. 59

 

rs. 1961 No. 137; 1962 Nos. 34 and 101

 

am. 1963 No. 34

 

rs. 1963 No. 107

 

am. 1964 No. 12

 

rs. 1964 Nos. 57 and 135; 1965 No. 51

 

am. 1965 No. 151

 

rs. 1966 No. 80

 

am. 1966 No. 144

 

rs. 1967 No. 67

 

am. 1967 No. 116

 

rs. 1967 No. 158

 

am. 1968 Nos. 44, 88 and 146; 1969 No. 44

 

rs. 1969 No. 107

 

am. 1969 No. 185; 1970 Nos. 39, 94 and 186

 

rs. 1971 Nos. 44 and 101

 

am. 1971 No. 154

 

rs. 1972 No. 32

 

am. 1972 Nos. 121 and 205; 1973 Nos. 15 and 57

 

rs. 1973 No. 139

 

am. 1973 No. 229; 1974 No. 37

 

rs. 1974 No. 126

 

am. 1974 No. 222; 1975 No. 50

 

rs. 1975 No. 148

 

am. 1975 No. 209

 

rs. 1976 No. 84

 

am. 1976 Nos. 150 and 255; 1977 No. 39

Schedule 1...........................

rs. 1977 No. 125

 

am. 1977 No. 221; 1978 Nos. 47 and 142

 

rs. 1978 No. 245

 

am. 1979 No. 51

 

rs. 1979 No. 144

 

am. 1979 No. 250; 1980 Nos. 69 and 213

 

rs. 1980 No. 338

 

am. 1981 No. 52

 

rs. 1981 No. 212

 

am. 1981 No. 345; 1982 No. 76

 

rs. 1982 No. 179

 

am. 1982 No. 334; 1983 No. 28

 

rs. 1983 No. 116

 

am. 1983 No. 292; 1984 Nos. 50, 169 and 342

 

rs. 1985 Nos. 32 and 184

 

am. 1985 No. 320; 1986 No. 38

 

rs. 1986 No. 194

 

am. 1986 No. 320

 

rep. 1987 No. 47

Heading to Second...............
Schedule

rep. 1977 No. 39

Heading to Schedule 2.........

ad. 1977 No. 39

 

rep. 1987 No. 47

Second Schedule.................

rs. 1960 No. 90; 1961 Nos. 59 and 137; 1962 Nos. 34 and 101

 

am. 1962 No. 114; 1963 No. 34

 

rs. 1963 No. 107; 1964 Nos. 57 and 135; 1965 No. 51

 

am. 1965 No. 151

 

rs. 1966 Nos. 80 and 144; 1967 No. 67

 

am. 1967 No. 116

 

rs. 1967 No. 158

 

am. 1968 Nos. 44, 88 and 146; 1969 No. 44

 

rs. 1969 Nos. 107 and 185

 

am. 1970 Nos. 39, 94 and 186

 

rs. 1971 Nos. 44 and 101

 

am. 1971 No. 154

 

rs. 1972 No. 32

 

am. 1972 Nos. 121 and 205; 1973 Nos. 15 and 57

 

rs. 1973 No. 139

 

am. 1973 No. 229; 1974 No. 37

 

rs. 1974 No. 126

 

am. 1974 No. 222; 1975 No. 50

 

rs. 1975 No. 148

 

am. 1975 No. 209

 

rs. 1976 No. 84

 

am. 1976 Nos. 150 and 255; 1977 No. 39

Schedule 2...........................

am. 1977 No. 39

 

rs. 1977 No. 125

 

am. 1977 No. 221; 1978 Nos. 47 and 142

 

rs. 1978 No. 245

 

am. 1979 No. 51

 

rs. 1979 No. 144

 

am. 1979 No. 250; 1980 Nos. 69 and 213

 

rs. 1980 No. 338

 

am. 1981 No. 52

 

rs. 1981 No. 212

 

am. 1981 No. 345; 1982 No. 76

 

rs. 1982 No. 179

 

am. 1982 No. 334; 1983 No. 28

 

rs. 1983 No. 116

 

am. 1983 No. 292; 1984 Nos. 50, 169 and 342

 

rs. 1985 Nos. 32 and 184

 

am. 1985 No. 320; 1986 No. 38

 

rs. 1986 No. 194

 

am. 1986 No. 320

 

rep. 1987 No. 47

Heading to Third Schedule..

rep. 1977 No. 39

Heading to Schedule 3.........

ad. 1977 No. 39

 

rep. 1987 No. 47

Third Schedule....................

rs. 1960 No. 90

 

am. 1960 No. 102

 

rs. 1961 Nos. 59 and 137; 1962 Nos. 34 and 101

 

am. 1962 No. 114; 1963 No. 34

 

rs. 1963 No. 107

 

am. 1964 No. 12

 

rs. 1964 Nos. 57 and 135; 1965 Nos. 51 and 151; 1966 Nos. 80 and 144; 1967 No. 67

 

am. 1967 No. 116

 

rs. 1967 No. 158

 

am. 1968 Nos. 44, 88 and 146; 1969 No. 44

 

rs. 1969 No. 107

 

am. 1969 No. 185; 1970 Nos. 39, 94 and 186

 

rs. 1971 Nos. 44 and 101

 

am. 1971 No. 154

 

rs. 1972 No. 32

 

am. 1972 Nos. 121 and 205; 1973 Nos. 15 and 57

 

rs. 1973 No. 139

 

am. 1973 No. 229; 1974 No. 37

 

rs. 1974 No. 126

 

am. 1974 No. 222; 1975 No. 50

 

rs. 1975 No. 148

 

am. 1975 No. 209

 

rs. 1976 No. 84

 

am. 1976 Nos. 150 and 255; 1977 No. 39

Schedule 3...........................

rs. 1977 No. 125

 

am. 1977 No. 221; 1978 Nos. 47 and 142

 

rs. 1978 No. 245

 

am. 1979 No. 51

 

rs. 1979 No. 144

 

am. 1979 No. 250; 1980 Nos. 69 and 213

 

rs. 1980 No. 338

 

am. 1981 No. 52

 

rs. 1981 No. 212

 

am. 1981 No. 345; 1982 No. 76

 

rs. 1982 No. 179

 

am. 1982 No. 334; 1983 No. 28

 

rs. 1983 No. 116

 

am. 1983 No. 292; 1984 Nos. 50, 169 and 342

 

rs. 1985 Nos. 32 and 184

 

am. 1985 No. 320; 1986 No. 38

 

rs. 1986 No. 194

 

am. 1986 No. 320

 

rep. 1987 No. 47

Heading to Fourth................
Schedule

rep. 1977 No. 39

Heading to Schedule 4.........

ad. 1977 No. 39

 

rep. 1987 No. 47

Fourth Schedule..................

rs. 1961 No. 137; 1962 Nos. 34 and 101; 1963 No. 107; 1964 Nos. 57 and 135; 1965 No. 51; 1966 No. 80

 

am. 1966 No. 144

 

rs. 1967 Nos. 67, 116 and 158; 1969 No. 107

 

am. 1969 No. 185; 1970 Nos. 39 and 186

 

rs. 1971 Nos. 44 and 101; 1972 No. 32

 

am. 1973 No. 57

 

rs. 1973 No. 139

 

am. 1973 No. 229

 

rs. 1974 No. 126

 

am. 1974 No. 222; 1975 No. 50

 

rs. 1975 No. 148; 1976 No. 84

Schedule 4...........................

rs. 1977 No. 125

 

am. 1978 No. 142

 

rs. 1978 No. 245

 

am. 1979 No. 51

 

rs. 1979 No. 144; 1980 No. 338

 

am. 1981 No. 52

 

rs. 1981 No. 212; 1982 No. 179; 1983 No. 116

 

am. 1983 No. 292

 

rs. 1985 Nos. 32 and 184; 1986 No. 194

 

am. 1986 No. 320

 

rep. 1987 No. 47

Heading to Fifth Schedule....

rep. 1977 No. 39

Heading to Schedule 5.........

ad. 1977 No. 39

 

rep. 1987 No. 47

Fifth Schedule.....................

rs. 1960 No. 90

 

am. 1960 No. 102

 

rs. 1961 Nos. 59 and 137; 1962 Nos. 34 and 101

 

am. 1962 No. 114; 1963 No. 34

 

rs. 1963 No. 107

 

am. 1964 No. 12

 

rs. 1964 Nos. 57 and 135; 1965 Nos. 51 and 151; 1966 Nos. 80 and 144; 1967 Nos. 67, 116 and 158; 1968 No. 44

 

am. 1968 No. 88

 

rs. 1968 No. 146

 

am. 1969 No. 44

 

rs. 1969 No. 107

 

am. 1969 No. 185

 

rs. 1970 Nos. 39 and 94

 

am. 1970 Nos. 119 and 186

 

rs. 1971 Nos. 44, 101 and 154; 1972 No. 32

 

am. 1972 Nos. 121 and 205; 1973 Nos. 15 and 57

 

rs. 1973 No. 139

 

am. 1973 No. 229; 1974 No. 37

 

rs. 1974 No. 126

 

am. 1974 No. 222; 1975 No. 50

 

rs. 1975 No. 148

 

am. 1975 No. 209

 

rs. 1976 No. 84

 

am. 1976 Nos. 150 and 255; 1977 No. 39

Schedule 5...........................

am. 1977 No. 39

 

rs. 1977 No. 125

 

am. 1977 No. 221; 1978 Nos. 47 and 142

 

rs. 1978 No. 245

 

am. 1979 No. 51

 

rs. 1979 No. 144

 

am. 1979 No. 250; 1980 Nos. 69 and 213

 

rs. 1980 No. 338

 

am. 1981 No. 52

 

rs. 1981 No. 212

 

am. 1981 No. 345; 1982 No. 76

 

rs. 1982 No. 179

 

am. 1982 No. 334; 1983 No. 28

 

rs. 1983 No. 116

 

am. 1983 No. 292; 1984 Nos. 50, 169 and 342

 

rs. 1985 Nos. 32 and 184

 

am. 1985 No. 320; 1986 No. 38

 

rs. 1986 No. 194

 

am. 1986 No. 320

 

rep. 1987 No. 47

Heading to Sixth Schedule...

rep. 1977 No. 39

Heading to Schedule 6.........

ad. 1977 No. 39

 

rep. 1994 No. 348

Schedule 6...........................

am. 1977 No. 39

 

rs. 1981 No. 218

 

am. 1984 No. 148

 

rep. 1994 No. 348

Heading to Schedule 7.........

rs. 1991 No. 1

 

rep. 1994 No. 348

Schedule 7...........................

ad. 1983 No. 102

 

rep. 1986 No. 319

 

ad. 1987 No. 262

 

rep. 1994 No. 348

 

Endnote 5—Uncommenced amendments [none]

Endnote 6—Modifications [none]

Endnote 7—Misdescribed amendments [none]

Endnote 8—Miscellaneous [none]