Commonwealth Numbered Regulations Commonwealth Numbered RegulationsGreg Hunt
Minister for Health
Contents
Division 1--General 1
1............ Name............................................................................................................................. 1
2............ Commencement............................................................................................................. 1
3............ Authority....................................................................................................................... 1
4............ Schedules...................................................................................................................... 1
5............ Interpretation................................................................................................................. 1
6............ Meaning of maximum value for safety net purposes..................................................... 6
Division 2--Application of this instrument to electronic prescriptions and electronic orders 8
7............ Preparing electronic prescriptions.................................................................................. 8
8............ Date when a prescription is written or a pharmaceutical benefit is prescribed............... 8
9............ Requirement to give information in writing................................................................... 8
10.......... Requirement to give a prescription................................................................................ 8
11.......... Approval of kinds of electronic communications.......................................................... 9
12.......... Approval of information technology requirements........................................................ 9
Part 2--Approvals under Part VII of the Act 10
13.......... Purpose of this Part..................................................................................................... 10
14.......... Application for certain approvals to be in approved form............................................ 10
15.......... Application for approval as authorised optometrist, authorised midwife or authorised nurse practitioner 10
16.......... Numbering of approvals.............................................................................................. 10
17.......... Certain requirements to be met after cancellation etc. of approval--approved pharmacists 11
Part 3--Safety net concession cards and pharmaceutical benefits entitlement cards 12
Division 1--Pharmaceutical benefits prescription record forms etc. 12
18.......... Pharmaceutical benefits prescription record forms etc................................................. 12
Division 2--Issue of safety net concession cards 13
19.......... Application for safety net concession card.................................................................. 13
20.......... Prescribed offices........................................................................................................ 13
Division 3--Issue of pharmaceutical benefits entitlement card 14
21.......... Application for pharmaceutical benefits entitlement card............................................. 14
22.......... Prescribed offices........................................................................................................ 14
Division 4--Additional and replacement concession cards and entitlement cards 15
23.......... Purpose of this Division.............................................................................................. 15
24.......... Application for, and issue of, additional concession cards and entitlement cards........ 15
25.......... Application for, and issue of, replacement concession cards and entitlement cards..... 16
26.......... Refusal to issue additional or replacement cards by person other than the Secretary... 16
27.......... Refusal to issue additional or replacement cards by the Secretary............................... 17
28.......... Review of decisions.................................................................................................... 17
Part 4--Supply of pharmaceutical benefits 18
Division 1--General matters relating to supply 18
29.......... Meaning of practitioner.............................................................................................. 18
30.......... Variation of application of determination of maximum number of repeats or maximum number or quantity of units.................................................................................................................................... 18
Division 2--Supply by particular PBS prescribers 21
31.......... Meaning of practitioner.............................................................................................. 21
32.......... Prescriber bag supplies--practitioners on ships.......................................................... 21
33.......... Prescriber bag supplies--obtaining benefits by practitioners...................................... 21
34.......... Prescriber bag supplies--supply of pharmaceutical benefits by approved pharmacists 22
35.......... Prescriber bag supplies--payment for pharmaceutical benefits................................... 22
36.......... Pharmaceutical benefits obtained by approved medical practitioners for the purposes of section 93 of the Act 23
37.......... Payment for pharmaceutical benefits obtained by approved medical practitioners for the purposes of section 93 of the Act.................................................................................................................................... 24
Part 5--Prescriptions and supply 26
38.......... Purpose of this Part..................................................................................................... 26
39.......... Writing prescriptions--general.................................................................................... 26
40.......... Writing prescriptions--prescriptions other than medication chart prescriptions.......... 26
41.......... Writing prescriptions--medication chart prescriptions................................................ 28
42.......... Information about status of person.............................................................................. 30
43.......... Restriction on using PBS forms.................................................................................. 31
44.......... Supply of pharmaceutical benefit on first presentation of prescription........................ 31
45.......... Supply of pharmaceutical benefit on basis of medication chart prescription................ 32
46.......... Continued dispensing supply of pharmaceutical benefit.............................................. 34
47.......... Information about status of person--continued dispensing supplies and medication chart prescriptions 34
48.......... Supply of pharmaceutical benefits before surrender of written prescription................ 35
49.......... Circumstances in which quantity of repeated supply can be directed to be supplied on one occasion 36
50.......... Continued dispensing supplies--repeated supply not to be supplied on one occasion 37
51.......... Repeated supplies of pharmaceutical benefits.............................................................. 37
52.......... Repeat authorisations................................................................................................... 40
53.......... Deferred supply authorisations.................................................................................... 42
54.......... Presentation of prescriptions in trading hours............................................................. 43
55.......... Presentation of urgent prescriptions............................................................................ 43
56.......... Special charge for delivery.......................................................................................... 43
57.......... Receipt of pharmaceutical benefit................................................................................ 43
Part 6--Other matters relating to prescriptions and supply etc. 47
58.......... Purpose of this Part..................................................................................................... 47
59.......... Keeping documents--other than for continued dispensing supplies or medication chart prescriptions 47
60.......... Keeping documents--continued dispensing supplies.................................................. 48
61.......... Keeping documents--medication chart prescriptions.................................................. 49
62.......... Proper stocks to be kept.............................................................................................. 49
63.......... Standards of composition and purity of pharmaceutical benefits and ingredients........ 49
64.......... Labelling of pharmaceutical benefits--full cost........................................................... 50
65.......... Surrender of forms...................................................................................................... 50
Part 7--Price reduction and price disclosure 51
Division 1--Price reduction 51
66.......... Reduction day.............................................................................................................. 51
Division 2--Price disclosure 52
Subdivision A--Interpretation 52
67.......... Meaning of data collection period............................................................................... 52
68.......... Meaning of price sampling day................................................................................... 53
69.......... Special rules for certain listed brands.......................................................................... 53
Subdivision B--Weighted average disclosed price 54
70.......... Method for determining weighted average disclosed price of listed brand of pharmaceutical item 54
71.......... Step 1--net revenue for brand..................................................................................... 54
72.......... Step 2--adjusted volume for brand............................................................................. 54
73.......... Step 3--average approved ex-manufacturer price for brand........................................ 54
74.......... Step 4--disclosed price for brand............................................................................... 55
75.......... Step 5--price percentage difference of brand.............................................................. 55
76.......... Step 6--repeat steps for each brand of pharmaceutical item........................................ 56
77.......... Step 7--total adjusted volume of brands of pharmaceutical item................................. 56
78.......... Step 8--weighted average percentage difference of brands of pharmaceutical item.... 56
79.......... Step 9--repeat steps for each pharmaceutical item with related brands....................... 57
80.......... Step 10--weighted average percentage difference for listed brand and all related brands....... 57
81.......... Step 11--weighted average disclosed price for listed brand of pharmaceutical item... 58
82.......... When weighted average disclosed price is the same as the applicable approved ex-manufacturer price 58
Subdivision C--Information that must not be taken into account 59
83.......... Information that must not be taken into account.......................................................... 59
84.......... Originator brands........................................................................................................ 59
Subdivision D--Price disclosure requirements 60
85.......... Price disclosure requirements...................................................................................... 60
Part 8--Arrangements for the Pharmaceutical Benefits Advisory Committee 62
Division 1--Matters relating to the appointment of members of the Committee 62
86.......... Nominating bodies...................................................................................................... 62
87.......... Number of nominations for appointment..................................................................... 63
88.......... Resignation.................................................................................................................. 63
Division 2--Matters relating to the procedure of the Committee 64
89.......... Purpose of this Division.............................................................................................. 64
90.......... Presiding member........................................................................................................ 64
91.......... Meetings of the Committee.......................................................................................... 64
92.......... Quorum....................................................................................................................... 64
93.......... Voting......................................................................................................................... 64
94.......... Disclosure of pecuniary interests by members............................................................ 65
95.......... Resolutions without a formal meeting......................................................................... 66
96.......... Reports and recommendations..................................................................................... 66
Division 3--Matters relating to sub-committees 67
97.......... Remuneration for chair and members of sub-committees............................................ 67
Part 9--Application, savings and transitional provisions 68
98.......... Definitions................................................................................................................... 68
99.......... Things done under old regulations.............................................................................. 68
100........ Savings--document retention provisions relating to obtaining pharmaceutical benefits 68
101........ Savings--document retention provisions relating to the supply of pharmaceutical benefits 68
Schedule 1--Prescribed offices 70
1............ Table of prescribed offices.......................................................................................... 70
Schedule 2--Repeals 72
National Health (Pharmaceutical Benefits) Regulations 1960 72