Commonwealth Consolidated Regulations

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NATIONAL HEALTH (PHARMACEUTICAL BENEFITS) REGULATIONS 1960 - NOTES

- made under the National Health Act 1953

Statutory Rules 1960 No. 17 as amended

This compilation was prepared on 21 April 2012
taking into account amendments up to SLI 2012 No. 55

Prepared by the Office of Legislative Drafting and Publishing,
Attorney-General's Department, Canberra


Contents

Part 1                           Preliminary                                                                 

Division 1.1                  Interpretation                                                                  

                        1       Name of Regulations [see Note 1]                                    7

                        2       Commencement                                                              7

                        3       Repeal and saving                                                          7

                        4       Transitional                                                                     8

                        5       Interpretation                                                                   8

Division 1.2                  Application of Regulations to electronic prescriptions and electronic orders       

                      5A       Preparing electronic prescriptions                                  12

                      5B       Date when a prescription is written or a pharmaceutical benefit is prescribed 13

                      5C       Requirement to give information in writing                       13

                      5D       Requirement to give a prescription                                 13

                      5E       Approval of kinds of electronic communications             14

                      5F       Approval of information technology requirements           15

Part II                            Approvals under Part VII of the Act                     

                        8       Application for approval to be in approved form             16

                    8AA       Application for approval as authorised optometrist, authorised midwife or authorised nurse practitioner                                                                    16

                      8A       Numbering of approvals                                                16

                        9       Certain requirements to be met after cancellation etc of approval      17

Part IIAAA                 Formularies, co-marketed brands and therapeutic groups    

                  9AAC       Co-marketed brands                                                      18

Part IIAA                    Safety net concession cards                                 

                    9AA       Safety net concession card                                           19

                    9AB       Additional concession cards                                          20

                    9AC       Replacement concession cards                                      21

                    9AD       Refusal to issue additional or replacement concession cards            22

                    9AE       Review of decisions                                                      23

                    9AF       Prescribed offices (Act s 84DA (5))                                23

Part IIA                        Pharmaceutical benefits entitlement cards       

                      9A       Pharmaceutical benefits prescription record forms          24

                      9B       Pharmaceutical benefits entitlement card                        26

                    9BA       Prescribed offices for the purposes of subsection 84E (5) of the Act           26

                      9C       Additional entitlement cards                                           27

                      9D       Replacement entitlement cards                                       28

                      9E       Refusal to issue additional or replacement entitlement cards 29

                      9F       Review of decisions                                                      30

Part III                          Pharmaceutical benefits                                         

                       13       Variation of application of determination of maximum number of repeats or maximum number or quantity of units                                                            31

Part IV                         Supply of pharmaceutical benefits by medical practitioners, authorised midwives and authorised nurse practitioners  

                       14       Meaning of practitioner                                                  35

                       15       Practitioners not authorised under sections 93 and 93AA of the Act  35

                       16       Obtaining benefits by practitioners under sections 93 and 93AA of the Act    35

                       17       Supply of pharmaceutical benefits by approved pharmacists under sections 93 and 93AA of the Act                                                                               37

                       18       Payment for pharmaceutical benefits supplied under sections 93 and 93AA of the Act           37

                    18A       Benefits obtained by approved medical practitioners for the purposes of section 93 38

Part V                           Prescriptions and supply                                       

                       19       Writing of prescriptions                                                 40

                    19A       Prescribed matters (Act s 84AA (1), (1A), (2) and (3))       42

                    19B       Restriction on using PBS and NHS forms                       44

                       20       Recovery of cost of pharmaceutical benefits prescribed for persons not entitled or in excessive quantities                                                                      45

                       21       Supply of pharmaceutical benefit on first presentation of prescription           46

                       22       Supply of pharmaceutical benefits before surrender of written prescription    47

                       24       Circumstances in which quantity of repeated supply can be directed to be supplied on one occasion                                                                       49

                       25       Repeated supplies of pharmaceutical benefits                50

                       26       Repeat authorisations                                                    52

                    26A       Deferred supply authorisations                                      55

                       27       Presentation of prescriptions in trading hours                 57

                       28       Presentation of urgent prescriptions                               57

                       30       Special charge for delivery                                            58

                       31       Receipt of pharmaceutical benefit                                  58

Part VI                         Miscellaneous                                                           

                       32       Retention of prescriptions etc                                        60

                       33       Proper stocks to be kept                                               61

                       35       Standards of composition and purity of pharmaceutical benefits and additives         62

                       36       Labelling of pharmaceutical benefits -- full cost             62

                       37       Surrender of forms                                                        63

Part VIA                      Price reductions                                                       

Division 1                       General                                                                                                     

                    37A       Definitions for Part VIA                                                  64

                    37B       Listed brands of pharmaceutical items, reduction days and percentages       64

                    37C       Adjusted approved price to pharmacists                        65

                    37D       Approved ex-manufacturer price -- general                    65

                  37DA       Approved ex-manufacturer price -- listed brand having same drug and manner of administration as listed brand already subject to price disclosure requirements and prior disclosure cycle    65

Division 2                     Weighted average disclosed price                                  

                  37DB       Application                                                                   66

                    37E       Weighted average disclosed price -- information            67

                  37EA       Disclosure cycles and data collection periods for listed brands of pharmaceutical items -- general                                                                         67

                  37EB       Disclosure cycles                                                          68

                  37EC       Data collection periods                                                  68

                  37ED       Listed brand having a drug and manner of administration not subject to price disclosure requirements before relevant day  -- first disclosure cycle and beginning of data collection period for brand                                                                      69

                  37EE       End dates for data collection periods for relevant brands covered by regulation 37ED          70

                  37EF       Subsequent main disclosure cycle --subsequent data collection periods      71

                  37EG       Listed brand moving from supplementary disclosure cycle A to main disclosure cycle           71

                  37EH       Listed brand moving from interim supplementary disclosure cycle and supplementary disclosure cycle B to main disclosure cycle                                    71

                     37F       Listed brand having same drug and manner of administration as listed brand already subject to price disclosure requirements -- disclosure cycle and beginning of data collection period for brand                                                                            72

                    37G       Weighted average disclosed price                                  73

Division 3                     Price disclosure requirements                                        

                    37H       Price disclosure requirements -- content of information for reporting periods            77

                  37HA       Price disclosure requirements -- prescribed person        78

                      37I       Price disclosure requirements -- manner and form          79

                     37J       Price disclosure requirements -- information and reporting periods   79

                   37JA       Price disclosure requirements -- additional reporting periods           80

Division 4                     Price reduction day                                                        

                    37K       Price reduction -- prescribed reduction day                    81

Part 7                           Arrangements of the Pharmaceutical Benefits Advisory Committee           

                       38       Interpretation                                                                 82

                    38A       Appointments to Committee -- nominating bodies (Act s 100B (1A)) 82

                    38B       Number of nominations for appointment (Act s 100B (1B)) 83

                       39       Chairperson                                                                  83

                       40       Resignation                                                                   84

                       41       Presiding member                                                         84

                       42       Meetings of the Committee                                            84

                       43       Quorum                                                                        84

                       44       Voting                                                                          85

                       45       Disclosure of pecuniary interests by Chairperson and members        85

                       46       Resolutions without a formal meeting                             87

                       47       Reports and recommendations                                      87

                       48       Remuneration for chair and members of sub-committees 87

Schedule 3                   Co-marketed brands                                                     88

Schedule 5                   Listed brands of pharmaceutical items, reduction days and percentages  89

Schedule 6                   Prescribed offices for subsections 84DA (5) and 84E (5) of the Act 91

Notes                                                                                                          93

 


Notes to the National Health (Pharmaceutical Benefits) Regulations 1960

Note 1

The National Health (Pharmaceutical Benefits) Regulations 1960 (in force under the National Health Act 1953) as shown in this compilation comprise Statutory Rules 1960 No. 17 amended as indicated in the Tables below.

For all relevant information pertaining to application, saving or transitional provisions see Table A.

Table of Instruments

Year and
number

Date of notification
in Gazette or FRLI registration

Date of
commencement

Application, saving or
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

--

(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.

Table of Amendments

ad. = added or inserted      am. = amended      rep. = repealed      rs. = repealed and substituted

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

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 II

 

Heading to Part II.................

am. 1979 No. 55; 1982 No. 69; 1986 No. 91

 

rs. 2008 No. 54

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 IIAAA

 

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 IIAA

 

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

Part IIA

 

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

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 III

 

Heading to Part III................

am. 1979 No. 250

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

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 IV

 

Heading to Part IV...............

rs. 1979 No. 250; 2010 No. 231

R. 14.......................................

ad. 2010 No. 231

R. 15.......................................

rs. 1963 No. 69

 

am. 1994 No. 348; 2004 No. 389

 

rs. 2010 No. 231

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

R. 17.......................................

am. 1967 No. 158; 1977 No. 39; 1986 No. 391

 

rs. 2002 No. 9

 

am. 2006 No. 200

 

rs. 2010 No. 231

R. 18.......................................

am. 1963 No. 69; 1977 No. 39; 1986 No. 391; 2006 No. 200

 

rs. 2010 No. 231

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 V

 

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

Note to r. 19 (1)....................

ad. 2008 No. 54

Heading to r. 19A.................

rs. 2001 No. 68

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

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

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

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

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

R. 25.......................................

am. 1990 No. 337; 1994 No. 348; 1998 No. 374; 2001 No. 68; 2005 No. 207; 2006 No. 200

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

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

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

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

Part VI

 

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

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. 344

R. 36.......................................

am. 1977 No. 39; 1994 No. 338

 

rep. 1996 No. 70

 

ad. 2002 No. 344

 

am. 2010 No. 231

R. 37.......................................

am. 1967 No. 158; 1977 No. 39; 1988 No. 56; 2002 No. 9

Part VIA

 

Division 1

 

Heading to Div. 1.................
of Part VIA

ad. 2010 No. 296

R. 37A....................................

ad. 2007 No. 225

 

am. 2010 No. 296

R. 37B....................................

ad. 2007 No. 225

R. 37C....................................

ad. 2007 No. 225

Heading to r. 37D................

rs. 2010 No. 296

R. 37D....................................

ad. 2007 No. 225

 

am. 2008 No. 116; 2010 No. 296

R. 37DA.................................

ad. 2010 No. 296

Division 2

 

Heading to Div. 2.................
of Part VIA

ad. 2010  No. 296

R. 37DB.................................

ad. 2010 No. 296

R. 37E....................................

ad. 2007 No. 225

 

am. 2010 No. 296

Note to r. 37E (4)..................

rs. 2010 No. 296

R. 37EA..................................

ad. 2010 No. 296

R. 37EB..................................

ad. 2010 No. 296

R. 37EC.................................

ad. 2010 No. 296

R. 37ED.................................

ad. 2010 No. 296

R. 37EE..................................

ad. 2010 No. 296

R. 37EF..................................

ad. 2010 No. 296

R. 37EG.................................

ad. 2010 No. 296

R. 37EH.................................

ad. 2010 No. 296

R. 37F.....................................

ad. 2007 No. 225

 

am. 2008 No. 116

 

rs. 2010 No. 296

R. 37G....................................

ad. 2007 No. 225

 

rs. 2010 No. 296

Division 3

 

Heading to Div. 3.................
of Part VIA

ad. 2010 No. 296

R. 37H....................................

ad. 2007 No. 225

 

rs. 2010 No. 296

R. 37HA.................................

ad. 2008 No. 116

 

rs. 2011 No. 29

 

am. 2012 No. 55

R. 37I......................................

ad. 2007 No. 225

 

am. 2010 No. 296

R. 37J.....................................

ad. 2007 No. 225

 

rs. 2010 No. 296

R. 37JA..................................

ad. 2010 No. 296

Division 4

 

Heading to Div. 4.................
of Part VIA

ad. 2010 No. 296

R. 37K....................................

ad. 2009 No. 195

 

am. 2010 No. 296

Part 7

 

Part 7......................................

ad. 1994 No. 348

R. 38.......................................

ad. 1994 No. 348

 

am. 2000 No. 369; 2009 No. 195

R. 38A....................................

ad. 2000 No. 369

 

am. 2001 No. 68

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

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

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

Table A                  Application, saving or transitional provisions

Select Legislative Instrument 2010 No. 296

Part 2                 Transitional

4              Definitions for Part 2

                In this Part:

data collection period has the meaning given by subregulation 37EC (1) of the National Health (Pharmaceutical Benefits) Regulations 1960.

disclosure cycle has the meaning given by subregulation 37EB (1) of the National Health (Pharmaceutical Benefits) Regulations 1960.

first transitional disclosure cycle has the meaning given by subregulation 6 (2).

former Regulations means the National Health (Pharmaceutical Benefits) Regulations 1960 as in force immediately before 1 December 2010.

main disclosure cycle means a main disclosure cycle mentioned in paragraph 37EB (2) (a) of the National Health (Pharmaceutical Benefits) Regulations 1960.

pharmaceutical item has the meaning given by subregulation 5 (1) of the National Health (Pharmaceutical Benefits) Regulations 1960.

price disclosure requirements has the meaning given by subsection 99ADC (1) of the National Health Act 1953 as in force immediately before 1 December 2010.

reporting period has the same meaning as in regulation 37A of the National Health (Pharmaceutical Benefits) Regulations 1960.

second transitional disclosure cycle has the meaning given by subregulation 6 (3).

third transitional disclosure cycle has the meaning given by subregulation 6 (5).

5              Transitional -- listed brand subject to price disclosure and annual reporting period ends before 1 December 2010

         (1)   This regulation applies to a listed brand of a pharmaceutical item if:

                 (a)     the price disclosure requirements applied for the listed brand, or any other listed brand of any pharmaceutical item having the same drug and manner of administration as the listed brand, before 1 December 2010; and

                (b)     the annual reporting period under regulation 37J of the former Regulations for at least 1 of the listed brands mentioned in paragraph (a) ended before 1 December 2010.

         (2)   The former Regulations apply to the listed brand until the end of the reduction day for the brand under section 99ADH of the former Act.

         (3)   However, if before the end of the reduction day mentioned in subregulation (2) the listed brand is in any of the following disclosure cycles, regulation 6 applies to the brand for those cycles:

                 (a)     the first transitional disclosure cycle;

                (b)     the second transitional disclosure cycle;

                 (c)     the third transitional disclosure cycle.

         (4)   In this regulation:

former Act means the National Health Act 1953 as in force immediately before 1 December 2010.

6              Transitional -- listed brand subject to price disclosure and annual reporting period does not end before 1 December 2010 -- data collection period

         (1)   This regulation and regulation 7 apply to a listed brand of a pharmaceutical item if:

                 (a)     the price disclosure requirements applied for the listed brand, or any other listed brand of any pharmaceutical item having the same drug and manner of administration as the listed brand, before 1 December 2010; and

                (b)     the annual reporting period under regulation 37J of the former Regulations for at least 1 of the listed brands mentioned in paragraph (a) began on 1 of the following dates (the relevant date) and did not end before 1 December 2010:

                          (i)     1 January 2010;

                         (ii)     1 May 2010;

                        (iii)     1 September 2010.

         (2)   The disclosure cycle (the first transitional disclosure cycle), and the data collection period, for:

                 (a)     a listed brand to which subparagraph (1) (b) (i) applies; and

                (b)     any other listed brand of pharmaceutical item having the same drug and manner of administration as the listed brand mentioned in paragraph (a);

                begins on 1 January 2010.

         (3)   The disclosure cycle (the second transitional disclosure cycle), and the data collection period, for:

                 (a)     a listed brand to which subparagraph (1) (b) (ii) applies; and

                (b)     any other listed brand of pharmaceutical item having the same drug and manner of administration as the listed brand mentioned in paragraph (a);

                begins on 1 May 2010.

         (4)   The data collection periods in the first transitional disclosure cycle and the second transitional disclosure cycle end at the end of 30 September 2011.

         (5)   The disclosure cycle (the third transitional disclosure cycle), and the data collection period, for:

                 (a)     a listed brand to which subparagraph (1) (b) (iii) applies; and

                (b)     any other listed brand of pharmaceutical item having the same drug and manner of administration as the listed brand mentioned in paragraph (a);

                begins on 1 September 2010.

         (6)   The data collection periods in the third transitional disclosure cycle end at the end of 31 January 2012.

7              Transitional -- listed brand subject to price disclosure and annual reporting period does not end before 1 December 2010 -- reporting period and information

         (1)   For the first transitional disclosure cycle, the quarterly reporting period under regulation 37J of the former Regulations that began on 1 October 2010 is taken to be a reporting period that ends at the end of 31 March 2011.

         (2)   For the second transitional disclosure cycle, the information that must be pro vided for the quarterly reporting period under regulation 37J of the former Regulations that began on 1 August 2010 must be provided within 2 months after the end of that reporting period.

         (3)   For the second transitional disclosure cycle, the quarterly reporting period under regulation 37J of the former Regulations that began on 1 November 2010 is taken to be a reporting period that ends at the end of 31 March 2011.

         (4)   For the third transitional disclosure cycle:

                 (a)     the quarterly reporting period under regulation 37J of the former Regulations that began on 1 September 2010 is taken to be a reporting period that ends at the end of 31 March 2011; and

                (b)     the last reporting period in the data colle ction periods for that disclosure cycle begins on 1 October 2011 and ends at the end of 31 January 2012.

         (5)   The information about incentives to be provided for the listed brand under paragraphs 37H (1) (i) and (j) of the National Health (Pharmaceutical Benefits) Regulations 1960 for the reporting period ending at the end of 31 March 2011 must include information about incentives mentioned in those paragraphs for the period beginning on the relevant date for the brand and ending at the end of 31 March 2011.

         (6)   In this regulation:

relevant date has the meaning given by paragraph 6 (1) (b).

8              Transitional -- listed brand having same drug and manner of administration as listed brand already subject to price disclosure requirements -- first reporting period for brand in third transitional cycle

         (1)   This regulation applies to a listed brand of a pharmaceutical item (the relevant brand) if:

                 (a)     the price disclosure requirements first apply under section 99ADD of the Act for the relevant brand on a day (the relevant day); and

                (b)     both on and before the relevant day, the price disclosure requirements apply for any other listed brand of any pharmaceutical item having the same drug and manner of administration (the other brand) as the relevant brand; and

                 (c)     the other brand is in the third transitional cycle.

         (2)   The first reporting period for the relevant brand:

                 (a)     begins on the relevant day; and

                (b)     ends at the end the first of the following days to occur after the relevant day:

                          (i)     31 March 2011;

                         (ii)     30 September 2011;

                        (iii)     31 January 2012.

         (3)   If the first reporting period for the relevant brand ends on 31 January 2012, information about sales revenue and adjusted volume for the relevant brand for the first month of the first reporting period is excluded when using the method set out in regulation 37G of the National Health (Pharmaceutical Benefits) Regulations 1960.

9              Transitional -- listed brand moving from first or second transitional disclosure cycle to main disclosure cycle

         (1)   This regulation applies if:

                 (a)     regulation 6 applies to a listed brand of a pharmaceutical item; and

                (b)     the brand is in the first transitional disclosure cycle or the second transitional disclosure cycle.

         (2)   The brand moves to a main disclosure cycle on 1 October 2011.

         (3)   The data collection period for the brand in the main disclosure cycle:

                (a)    begins on 1 October 2011; and

               (b)    ends at the end of 30 September 2012.

10            Transitional -- listed brand moving from third transitional disclosure cycle to main disclosure cycle

         (1)   This regulation applies if:

                 (a)     regulation 6 applies to a listed brand of a pharmaceutical item; and

                (b)     the brand is in the third transitional disclosure cycle.

         (2)   The brand moves to a main disclosure cycle on 1 February 2012.

         (3)   The data collection period for the brand in the main disclosure cycle:

                 (a)     begins on 1 February 2012; and

                (b)     ends at the end of 30 September 2013.

         (4)   The first reporting period in the data collection period for the brand in the main disclosure cycle:

                 (a)     begins on 1 February 2012; and

                (b)     ends at the end of 31 March 2012.

 


 



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