Commonwealth Consolidated Regulations Commonwealth Consolidated RegulationsStatutory Rules 1990 No. 394 as amended
This compilation was prepared on 11
September 2009
taking into account amendments up to SLI 2009 No. 228
Prepared by the Office of Legislative Drafting and
Publishing,
Attorney‑General's Department, Canberra
Contents
Part 1 Preliminary
1 Name of Regulations [see Note 1] 13
2 Interpretation 13
2A Authorised officers 20
3 Corresponding State law 20
3A Unacceptable presentations 21
Part 2 Advertisements
Division 1 Application of Part
4 Application of Part 2 22
4A Interpretation 22
Division 2 Advertisements for which approval is needed
5B Interpretation 22
5BA Means that are not broadcast media 23
5C Application of Division 23
5F Applications for approval of advertisements 24
5G Approval of advertisements 24
5H Notice of approval or refusal to approve an advertisement 25
5J Distinguishing numbers for approved advertisements 25
5K Variation of conditions of approval 25
5L Withdrawal of approval 26
5M Review by Minister of decisions of the Secretary 26
5N Notice of Minister's decisions 27
5P Review by Tribunal of decisions of the Minister 28
5Q Delegations 28
Division 3 General provisions about advertising therapeutic goods
6 Restricted representations 29
6A Approval of use of restricted representation -- public interest criteria 29
6B Prohibited and required representations 29
7 Exempt goods and exempt devices 30
Division 4 Generic information about ingredients or components of therapeutic goods
8 Compliance with the Code 30
8A Publication of generic information 31
Division 5 General
9 Orders about advertisements or generic information 31
Part 2A Patient information
9A Information about certain therapeutic goods to be supplied 32
9B Information about therapeutic goods manufactured using human embryos 33
Part 2C Australian Register of Therapeutic Goods
Division 2C.1 Registered and listed therapeutic goods
10 Goods to be included in parts of the Register (Act s 9A) 35
5> 10A Change of person in whose name goods are listed or registered 35
10B Transfers within the Register 38
10C Re‑assignment of registration or listing numbers 39
10D Notice of reassignment of registration or listing numbers 41
Division 2C.2 Medical devices included in the Register under Chapter 4
10E Goods to be included in part of the Register for medical devices (Act s 9A) 41
5> 10F Change of person in relation to whom a medical device is included in the Register under Chapter 4 of the Act 41
Part 3 Registration, listing and exemption of therapeutic goods
11 Characteristics that separate and distinguish certain medicines from other therapeutic goods 45
12 Exempt goods 46
12A Unapproved medicines -- exemption in life‑threatening cases 47
12AAA Emergency goods -- early cessation of exemption 48
12AAB Disposal of unused emergency goods 49
12AA Applications for special and experimental uses 49
12AB Goods imported etc for experimental uses 50
12AC Powers of authorised officers in relation to goods imported etc for experimental uses 50
12AD Use of goods for experimental purposes -- specified conditions 51
12B Exemptions for special and experimental uses 52
12C Application of Part 3‑2 to medical devices (Act s 15A) 53
15 Application of registration or listing number to goods 53
15A Conditions of registration of therapeutic goods 54
16 Listing of Therapeutic Goods 55
16AA Documents and other information that may be required (Act subs 31 (2)) 55
Part 3A Applications for evaluation
Division 1 Goods mentioned in Part 1 of Schedule 10
16A Interpretation -- working day 56
16B Notification of acceptance or rejection of application 56
16C Periods within which certain evaluations must be made 57
16D Periods within which certain applications must be decided 59
16E Failure to decide an application within specified time 60
16F Applications under subsection 9D (3) of the Act -- periods within which certain decisions must be made 60
16G Shorter evaluation period in certain cases 62
Division 2 Applications for evaluation of substances
16GA Evaluation other than evaluation under subsection 9D (1), (2) or (3) or 24 (1) of the Act 62
Part 3B Orphan drugs
16H Orphan drug 64
16I Application for orphan drug designation 64
16J Orphan drug designation 65
Part 4 Licensing of manufacturers
17 Exempt goods for the purposes of subsection 34 (1) of the Act 66
18 Exempt Persons 66
19 Requirements for licence holders 66
20 Conditions of licences 67
21 Persons having control of production etc to be named 68
22 Transfer of licences 68
Part 5 Examination, testing and analysis of goods
23 Interpretation 71
24 Authorised officer -- powers and duties 72
25 Official analysts 72
26 Taking of samples for testing 73
26A Receiving samples for testing 73
27 Examination and testing of sample 74
28 Relevant tests 75
29 Certificate of official analyst 76
30 Review of findings of official analyst 77
31 Payment for samples 80
32 Offences relating to analysis etc 80
33 Identity cards 81
Part 6 Committees
Division 1 Therapeutic Goods Committee, Medical Devices Evaluation Committee and Australian Drug Evaluation Committee
34 Therapeutic Goods Committee 83
35 Medical Devices Evaluation Committee 85
36 Australian Drug Evaluation Committee 87
37 Minister or Secretary may seek further advice 88
38 Tenure of office of members 89
39 Disclosure of interest 89
40 Acting members 90
41 Meetings of Committees 90
42 Effect of vacancy on Committees 91
Division 2 Therapeutic Goods Advertising Code Council
42A Therapeutic Goods Advertising Code Council 92
42B Functions of the Council 92
42C Membership of the Council 92
42D Term of office of Council members 93
42E Chairperson of the Council 94
42F Resignation 94
42G Cessation of membership 94
42H Alternate members 94
42J Observers to Council 95
42K Quorum 96
42L Meetings 96
42M Effect of vacancy 97
42N Disclosure of interest 97
42P Procedure generally 98
42Q Annual report 98
Division 3 Complaints Resolution Panel
Subdivision 1 General
42R Complaints Resolution Panel 98
42S Function of the Panel 98
42T Membership of the Panel 98
42U Term of office of Panel members 100
42V Cessation of office 100
42W Alternate members 100
42X Observers to Panel 101
42Y Quorum 102
42Z Meetings 102
42ZA Effect of vacancy 103
42ZB Disclosure of interest 103
42ZC Reports to Council 104
Subdivision 2 Procedure -- Complaints about advertisements and generic information
42ZCAA Definitions for Subdivision 2 104
42ZCAB Complaints about advertisements or generic information 104
42ZCAC Procedure on receipt of a complaint 105
42ZCAD Dealing with complaint 105
42ZCAE Powers of Panel 106
42ZCAF Withdrawal of complaint 106
42ZCAG Dealing with subject matter despite withdrawal of complaint 107
42ZCAGA Panel may refer complaint to another authority 107
42ZCAH Dealing with matters not specified in complaint 108
42ZCAI Action that Panel may take 108
42ZCAJ Panel not to deal with complaint if court proceedings begun 110
42ZCAK Procedure generally 110
42ZCAL Register of complaints 111
Division 3A National Drugs and Poisons Schedule Committee
Subdivision 1 Preliminary
42ZCA Definitions for Division 3A 111
Subdivision 2 Functions of Committee
42ZCB Committee may establish subcommittees 111
Subdivision 3 Constitution of Committee
42ZCC Membership of Committee 112
42ZCD Committee members 112
42ZCE Jurisdictional members 113
42ZCF Appointment to be in writing 113
42ZCG Appointment of Chair 113
42ZCH Term of appointment 113
42ZCI Resignation 114
42ZCJ Disclosure of interests 114
42ZCK Termination of Committee membership 115
42ZCL Leave of absence 115
Subdivision 4 Committee procedures
42ZCM Committee procedures 115
42ZCN Committee procedures generally 116
42ZCO Meetings 116
42ZCP Presiding member 116
42ZCQ Quorum 117
42ZCR Voting 117
42ZCS Records and reports 117
Subdivision 5 Scheduling procedures
42ZCT Definitions for Subdivision 5 118
42ZCU Public notice of scheduling meetings 118
42ZCV Consideration of public submissions 118
42ZCW Other matters to be considered by Committee 119
42ZCX Record of reasons for scheduling decisions 119
42ZCY Public notice of amendment 119
42ZCZ Further public submissions 120
42ZCZA Public consultation by subcommittee 120
42ZCZB Urgent scheduling 120
Division 4 Complementary Medicines Evaluation Committee
Subdivision 1 Interpretation
42ZD Definition 121
Subdivision 2 Functions of Committee
42ZE Committee's evaluating function 121
42ZF Committee may give advice to Minister or Secretary 122
42ZG Committee may establish sub‑committees 123
42ZH Minister or Secretary may seek further advice 123
42ZI Committee may seek advice and assistance 123
Subdivision 3 Constitution of Committee
42ZJ Establishment and membership of Committee 123
42ZK Appointment of Committee members 123
42ZL Expertise and experience of members 124
42ZM Appointment of Chair 124
42ZN Minister may nominate expert advisers 124
42ZO Term of appointment 125
42ZP Resignation 125
42ZQ Disclosure of interests 125
42ZR Termination of appointment 126
42ZS Leave of absence 127
Subdivision 4 Committee procedures
42ZT Committee procedures 127
42ZU Committee procedures generally 127
42ZV Meetings 127
42ZW Presiding member 128
42ZX Quorum 128
42ZY Voting 128
42ZZ Records and reports 128
Division 5 Medicines Evaluation Committee
Subdivision 1 Interpretation
42ZZA Definitions 129
Subdivision 2 Establishment of Committee
42ZZB Establishment and constitution of Committee 129
Subdivision 3 Functions of Committee
42ZZC Committee's evaluating function 129
42ZZD Committee may give advice to Minister or Secretary 130
42ZZE Committee may establish sub‑committees 131
42ZZF Minister or Secretary may seek further advice 131
42ZZG Committee may seek advice and assistance 131
Subdivision 4 Constitution of Committee
42ZZH Establishment and membership of Committee 132
42ZZI Appointment of Committee members 132
42ZZJ Expertise and experience of members 132
42ZZK Appointment of Chair 133
42ZZL Minister may nominate expert advisers 133
42ZZM Term of appointment 133
42ZZN Resignation 133
42ZZO Disclosure of interests 134
42ZZP Termination of appointment 134
42ZZQ Leave of absence 135
Subdivision 5 Committee procedures
42ZZR Committee procedures 135
42ZZS Committee procedures generally 135
42ZZT Meetings 136
42ZZU Presiding member 136
42ZZV Quorum 136
42ZZW Voting 136
42ZZX Records and reports 136
Part 7 Charges for registration, listing and inclusion, licences, exemptions, costs and fees
Division 1 Charges for registration, listing and inclusion of therapeutic goods, exemptions and licences
Subdivision 1 Charges for registration, listing and inclusion of medical devices
43AAA Time for payment of charge 137
Subdivision 2 Low value turnover
43AAB Definitions 137
43AAC Application requirements 138
43AAD Decision by the Secretary -- exemption application 139
43AAE Actual turnover -- new entries in the Register 139
43AAF Decision based on actual turnover 140
43AAG Requests by Secretary for additional information 140
43AAH Decision by the Secretary -- new information 141
43AAI Appeal to AAT 142
Subdivision 3 Charges for licensing
43AAJ Charges reduced if annual turnover not more than $76 800 142
Division 2 Fees and costs
43 Fees 142
43A When is no application fee payable? 143
43AA Fee for evaluation -- reduction in certain circumstances 143
43AB Circumstances in which inspection fee covered by annual charge 144
44 Testing of samples -- recovery of costs 144
45 Waiver or reduction of fees 144
45AA Payment of fees in instalments 149
45A Charges reduced if annual turnover is not more than $76 800 151
Part 7A Infringement notices
45B Purpose and effect of Part 152
Part 8 Miscellaneous
46A Delegation under the Act 153
46 Release of information 153
47 Delegation -- powers and functions under these Regulations 155
47A Delegation -- powers under paragraph 19 (1) (a) of the Act 155
47B Provision of information concerning medicines and medical devices 156
48 Review of decisions 157
Schedule 1 Part 2 does not apply to members of an Australian branch of one of these bodies 160
Schedule 2 Prohibited and required representations 162
Part 1 Prohibited representations 162
Part 2 Required representations 164
Part 3 Vitamins referred to in Item 3 of Part 1 of this Schedule 165
Schedule 3 Therapeutic goods required to be included in the part of the Register for registered goods 166
Part 1 Therapeutic devices attracting a higher fee, and medicines 166
Part 2 Therapeutic devices attracting a lower fee 168
Part 3 Therapeutic goods attracting no fee under Division 1 or 2 of Part 3‑2 of the Act 169
Schedule 4 Therapeutic goods required to be included in the part of the Register for listed goods 170
Part 1 Listable goods 170
Part 2 Vitamins and their salts to which paragraph (b) of item 3 of Part 1 of this Schedule applies 175
Part 3 Minerals and their salts to which paragraph (c) of Item 3 of Part 1 of this Schedule applies 176
Part 4 Herbal substances to which paragraph (d) of item 3 of Part 1 of this Schedule applies 179
Division 1 Plant material from which herbal substances in listable goods must not be derived 179
Division 2 Plant material from which herbal substances may be derived for listable goods that are consistent with certain qualifications 181
Part 5 Substances specified for item 3 of Part 1 192
Division 1 Substances, not mentioned in Division 2 or 3, that may be ingredients of preparations 192
Division 2 Substances subject to dosage limit 194
Division 3 Substances requiring a label with an advisory statement 195
Schedule 5 Therapeutic goods exempt from the operation of Part 3‑2 of the Act 197
Schedule 5A Therapeutic goods exempt from the operation of Part 3‑2 of the Act subject to conditions 205
Schedule 5B Disposal of unused emergency goods 220
Schedule 6 Therapeutic devices prescribed for the purposes of paragraph 26 (1) (g) of the Act 225
Schedule 7 Therapeutic goods exempt from the operation of Part 3‑3 of the Act unless supplied as pharmaceutical benefits 226
Schedule 8 Persons exempt from the operation of Part 3‑3 of the Act 230
Schedule 9 Fees 233
Part 1 Interpretation of table 233
Part 2 Table of fees 235
Schedule 10 Therapeutic goods for evaluation 257
Part 1 Evaluation by the Drug Safety and Evaluation Branch of the Department 257
Part 2 Evaluation by the Office of Complementary Medicines 258
Part 3 Evaluation by OTC Medicine Evaluation Section of the Department 258
Schedule 11 Criteria prescribed under paragraph 26 (1) (k) of the Act 260
Part 1 Therapeutic goods for which quality or safety criteria are prescribed 260
Part 2 Quality and safety criteria 261
Schedule 12 Patient information documents 263
Schedule 13 Patient information documents 266
Schedule 14 Designated active ingredients 269
Schedule 15 Infringement notices 270
Notes 278
Notes to the Therapeutic Goods Regulations 1990
Note 1
The Therapeutic Goods Regulations 1990 (in force under the Therapeutic Goods Act 1989) as shown in this compilation comprise Statutory Rules 1990 No. 394 amended as indicated in the Tables below.
For application, saving or transitional provisions see Table A.
Table of Instruments
|
Year and |
Date of notification |
Date of |
Application, saving or |
|
1990 No. 394 |
6 Dec 1991 |
15 Feb 1991 |
|
|
1991 No. 84 |
30 Apr 1991 |
Rr. 3.1, 5.2, 7.1, 10.2, 11.1, 12.2, 12.4, 13.1 and
14.1: 15 Feb 1991 |
-- |
|
1991 No. 485 |
24 Dec 1991 |
24 Dec 1991 |
-- |
|
1992 No. 19 |
31 Jan 1992 |
R. 10: 1 July 1992 |
-- |
|
1992 No. 89 |
14 Apr 1992 |
14 Apr 1992 |
-- |
|
1992 No. 109 |
28 Apr 1992 |
28 Apr 1992 |
-- |
|
1992 No. 332 |
27 Oct 1992 |
27 Oct 1992 |
-- |
|
1992 No. 370 |
30 Nov 1992 |
30 Nov 1992 |
-- |
|
1992 No. 430 |
24 Dec 1992 |
Rr. 4 and 7: 1 Jan 1993 |
-- |
|
1993 No. 141 |
25 June 1993 |
1 July 1993 |
-- |
|
1994 No. 150 |
2 June 1994 |
2 June 1994 |
R. 22 |
|
1994 No. 222 |
30 June 1994 |
1 July 1994 |
-- |
|
1994 No. 364 |
1 Nov 1994 |
1 Nov 1994 |
-- |
|
1995 No. 33 |
8 Mar 1995 |
8 Mar 1995 |
-- |
|
1995 No. 111 |
31 May 1995 |
1 June 1995 |
-- |
|
1995 No. 192 |
30 June 1995 |
1 July 1995 |
-- |
|
1995 No. 208 |
4 July 1995 |
Rr. 6 and 9.3: |
R. 19 |
|
1995 No. 253 |
29 Aug 1995 |
29 Aug 1995 |
-- |
|
1995 No. 320 |
3 Nov 1995 |
3 Nov 1995 |
-- |
|
1995 No. 328 |
3 Nov 1995 |
6 Nov 1995 (see r. 1 and Gazette 1995, No. S423) |
-- |
|
1996 No. 9 |
31 Jan 1996 |
31 Jan 1996 |
-- |
|
1996 No. 25 (a) |
5 Feb 1996 |
5 Feb 1996 |
-- |
|
1996 No. 131 |
28 June 1996 |
1 July 1996 |
-- |
|
1996 No. 200 |
11 Sept 1996 |
11 Sept 1996 |
-- |
|
1996 No. 208 |
26 Sept 1996 |
26 Sept 1996 |
-- |
|
1997 No. 162 |
30 June 1997 |
1 July 1997 |
-- |
|
1997 No. 398 |
24 Dec 1997 |
24 Dec 1997 |
-- |
|
1997 No. 399 |
24 Dec 1997 |
Rr. 1.1, 3.1, 9 and 10: 24 Dec 1997 |
-- |
|
1997 No. 400 |
24 Dec 1997 |
24 Dec 1997 |
-- |
|
1997 No. 401 (b) |
24 Dec 1997 |
24 Dec 1997 |
-- |
|
1998 No. 227 |
16 July 1998 |
16 July 1998 |
-- |
|
1998 No. 247 |
31 July 1998 |
1 Aug 1998 |
-- |
|
1998 No. 369 |
22 Dec 1998 |
1 Jan 1999 |
-- |
|
1999 No. 62 |
16 Apr 1999 |
16 Apr 1999 |
-- |
|
1999 No. 209 |
16 Sept 1999 |
16 Sept 1999 |
R. 4 |
|
1999 No. 324 |
16 Dec 1999 |
16 Dec 1999 |
-- |
|
2000 No. 29 |
23 Mar 2000 |
Rr. 1, 2 and 3 (1) and Schedule 1: 23 Mar 2000 |
-- |
|
2000 No. 48 |
19 Apr 2000 |
19 Apr 2000 |
-- |
|
2000 No. 70 |
12 May 2000 |
1 July 2000 |
-- |
|
2000 No. 123 |
22 June 2000 |
22 June 2000 |
-- |
|
2000 No. 124 |
22 June 2000 |
1 July 2000 |
-- |
|
2000 No. 267 |
28 Sept 2000 |
28 Sept 2000 |
-- |
|
2000 No. 358 |
20 Dec 2000 |
20 Dec 2000 |
-- |
|
2001 No. 159 |
29 June 2001 |
29 June 2001 |
-- |
|
2001 No. 160 |
29 June 2001 |
1 July 2001 |
-- |
|
2001 No. 252 |
20 Sept 2001 |
22 Sept 2001 (see r. 2) |
-- |
|
2001 No. 343 |
21 Dec 2001 |
Rr. 1-3 and Schedule 1:
30 Sept 2001 |
-- |
|
2002 No. 9 |
21 Feb 2002 |
21 Feb 2002 |
-- |
|
2002 No. 84 |
9 May 2002 |
9 May 2002 |
-- |
|
2002 No. 114 |
7 June 2002 |
7 June 2002 |
-- |
|
2002 No. 143 |
27 June 2002 |
1 July 2002 |
-- |
|
2002 No. 234 |
4 Oct 2002 |
4 Oct 2002 (see r. 2) |
-- |
|
2002 No. 315 |
19 Dec 2002 |
Rr. 1-3 and Schedule 1:
19 Dec 2002 |
-- |
|
2002 No. 345 |
20 Dec 2002 |
Rr. 1-3 and Schedule 1: 20 Dec 2002 |
-- |
|
2003 No. 111 |
13 June 2003 |
13 June 2003 |
-- |
|
2003 No. 151 |
26 June 2003 |
1 July 2003 |
-- |
|
2003 No. 257 |
16 Oct 2003 |
16 Oct 2003 |
-- |
|
2003 No. 258 |
16 Oct 2003 |
Rr. 1-3 and Schedule 1: 16 Oct 2003 |
-- |
|
2003 No. 301 |
5 Dec 2003 |
5 Dec 2003 |
-- |
|
2003 No. 361 |
23 Dec 2003 |
23 Dec 2003 |
-- |
|
2004 No. 78 |
30 Apr 2004 |
30 Apr 2004 |
-- |
|
2004 No. 127 |
18 June 2004 |
1 July 2004 |
R. 4 |
|
2004 No. 159 |
25 June 2004 |
1 July 2004 |
-- |
|
2005 No. 192 |
19 Aug 2005 (see F2005L02312) |
20 Aug 2005 |
-- |
|
2006 No. 122 |
2 June 2006 (see F2006L01615) |
3 June 2006 |
-- |
|
2006 No. 212 |
10 Aug 2006 (see F2006L02573) |
11 Aug 2006 |
-- |
|
2007 No. 161 |
25 June 2007 (see F2007L01521) |
1 July 2007 |
-- |
|
2008 No. 117 |
20 June 2008 (see F2008L01367) |
1 July 2008 |
-- |
|
2009 No. 63 |
15 Apr 2009 (see F200900839) |
16 Apr 2009 |
-- |
|
2009 No. 140 |
25 June 2009 (see F2009L01826) |
26 June 2009 |
-- |
|
2009 No. 141 |
25 June 2009 (see F2009L02019) |
1 July 2009 |
-- |
|
2009 No. 179 |
9 July 2009 (see F2009L02089) |
10 July 2009 |
-- |
|
2009 No. 228 |
10 Sept 2009 (see F2009L02935) |
11 Sept 2009 |
-- |
(a) Statutory Rules 1996 No. 25 was disallowed by the House of Representatives on 10 September 1996.
(b) Statutory Rules 1997 No. 401 was disallowed by the Senate on 31 March 1998.
Table of Amendments
|
ad. = added or inserted am. = amended rep. = repealed rs. = repealed and substituted |
|
|
|
Provision affected |
How affected |
|
|
Part 1 |
|
|
|
R. 1......................................... |
rs. 1998 No. 369 |
|
|
R. 2......................................... |
am. 1991 No. 485; 1992 No. 332; 1994 No. 364; 1995 Nos. 111, 208 and 328; 1997 Nos. 398, 399 and 400; 1998 No. 369; 1999 Nos. 62 and 324; 2000 Nos. 29, 48 and 358; 2001 No. 159; 2002 No. 234; 2003 Nos. 111, 151, 301 and 361; 2004 No. 127 |
|
|
Note to r. 2............................. |
ad. 1999 No. 62 |
|
|
R. 2A....................................... |
ad. 2003 No. 361 |
|
|
R. 3......................................... |
am. 1992 Nos. 89 and 430 |
|
|
|
rs. 1995 No. 111 |
|
|
|
am. 1996 No. 200 |
|
|
|
rs. 2003 No. 361 |
|
|
R. 3A....................................... |
ad. 2003 No. 301 |
|
|
|
am. 2005 No. 192 |
|
|
Part 2 |
|
|
|
Division 1 |
|
|
|
Heading to Div. 1 of Part 2. |
ad. 1997 No. 400 |
|
|
Div. 1 of Part 2...................... |
rs. 2003 No. 301 |
|
|
R. 4......................................... |
am. 1992 No. 19; 2001 No. 159 |
|
|
|
rs. 2003 No. 301 |
|
|
R. 4A....................................... |
ad. 2003 No. 301 |
|
|
R. 5......................................... |
rep. 2003 No. 301 |
|
|
R. 5A....................................... |
ad. 1992 No. 19 |
|
|
|
rep. 2003 No. 301 |
|
|
Division 2 |
|
|
|
Div. 2 of Part 2...................... |
ad. 1997 No. 400 |
|
|
R. 5B...................................... |
ad. 1997 No. 400 |
|
|
|
am. 1998 Nos. 227 and 369; 1999 No. 62; 2000 No. 48; 2001 No. 159; 2002 No. 234; 2003 No. 301 |
|
|
R. 5BA.................................... |
ad. 2003 No. 301 |
|
|
R. 5C...................................... |
ad. 1997 No. 400 |
|
|
|
am. 2001 No. 159 |
|
|
Rr. 5D, 5E.............................. |
ad. 1997 No. 400 |
|
|
|
rep. 1999 No. 62 |
|
|
R. 5F....................................... |
ad. 1997 No. 400 |
|
|
|
am. 1999 No. 324 |
|
|
R. 5G...................................... |
ad. 1997 No. 400 |
|
|
|
am. 1999 No. 324; 2000 No. 48; 2003 No. 301 |
|
|
R. 5H...................................... |
ad. 1997 No. 400 |
|
|
R. 5J....................................... |
ad. 1997 No. 400 |
|
|
|
am. 2000 No. 48 |
|
|
R. 5K...................................... |
ad. 1997 No. 400 |
|
|
R. 5L....................................... |
ad. 1997 No. 400 |
|
|
|
am. 1999 No. 62; 2000 No. 48 |
|
|
R. 5M...................................... |
ad. 1997 No. 400 |
|
|
R. 5N...................................... |
ad. 1997 No. 400 |
|
|
R. 5P...................................... |
ad. 1997 No. 400 |
|
|
R. 5Q...................................... |
ad. 1997 No. 400 |
|
|
|
am. 1998 No. 369; 2000 No. 48; 2001 No. 159; 2003 No. 301 |
|
|
Division 3 |
|
|
|
Heading to Div. 3 of Part 2. |
ad. 1997 No. 400 |
|
|
|
rs. 2003 No. 301 |
|
|
Div. 3 of Part 2...................... |
rs. 2003 No. 301 |
|
|
R. 5R...................................... |
ad. 1997 No. 400 |
|
|
|
rep. 2003 No. 301 |
|
|
R. 6......................................... |
am. 1992 No. 19; 1995 No. 253; 1996 No. 9; 1998 No. 227; 2000 No. 48; 2001 No. 159; 2002 Nos. 9 and 234 |
|
|
|
rs. 2003 No. 301 |
|
|
Note to r. 6 (2)....................... |
ad. 2002 No. 9 |
|
|
|
rep. 2003 No. 301 |
|
|
Note to r. 6 (5)....................... |
ad. 2002 No. 9 |
|
|
|
rep. 2003 No. 301 |
|
|
Rr. 6AA, 6AB.......................... |
ad. 2000 No. 48 |
|
|
|
rep. 2003 No. 301 |
|
|
R. 6A....................................... |
ad. 1995 No. 208 |
|
|
|
rs. 2003 No. 301; 2005 No. 192 |
|
|
R. 6B...................................... |
ad. 2003 No. 301 |
|
|
R. 7......................................... |
rs. 2003 No. 301 |
|
|
Rr. 7A-7H.............................. |
ad. 2000 No. 48 |
|
|
|
rep. 2003 No. 301 |
|
|
R. 7J....................................... |
ad. 2000 No. 48 |
|
|
|
rep. 2003 No. 301 |
|
|
Division 4 |
|
|
|
Heading to Div. 4 of Part 2. |
ad. 1997 No. 400 |
|
|
|
rs. 2003 No. 301 |
|
|
Div. 4 of Part 2...................... |
rs. 2003 No. 301 |
|
|
R. 8......................................... |
am. 1997 No. 400 |
|
|
|
rs. 2003 No. 301 |
|
|
|
am. 2006 No. 122 |
|
|
R. 8A....................................... |
ad. 2003 No. 301 |
|
|
|
am. 2006 No. 122 |
|
|
Division 5 |
|
|
|
Div. 5 of Part 2...................... |
ad. 1997 No. 400 |
|
|
|
rep. 2000 No. 48 |
|
|
|
ad. 2003 No. 301 |
|
|
R. 9......................................... |
rs. 2000 No. 48; 2003 No. 301 |
|
|
R. 9AA.................................... |
ad. 1997 No. 400 |
|
|
|
rs. 2000 No. 48 |
|
|
|
am. 2002 No. 315 |
|
|
|
rep. 2003 No. 301 |
|
|
Rr. 9AB-9AE......................... |
ad. 1997 No. 400 |
|
|
|
rep. 2000 No. 48 |
|
|
Part 2A |
|
|
|
Part 2A................................... |
ad. 1992 No. 430 |
|
|
R. 9A....................................... |
ad. 1992 No. 430 |
|
|
|
am. 1994 No. 364; 1995 No. 208; 1998 No. 369; 1999 No. 62; 2002 Nos. 9 and 315 |
|
|
Note to r. 9A (1).................... |
ad. 2003 No. 257 |
|
|
R. 9B...................................... |
ad. 2003 No. 257 |
|
|
Part 2B................................... |
ad. 2000 No. 48 |
|
|
|
rep. 2003 No. 301 |
|
|
R. 9P...................................... |
ad. 2000 No. 48 |
|
|
|
rep. 2003 No. 301 |
|
|
R. 9Q...................................... |
ad. 2000 No. 48 |
|
|
|
rep. 2003 No. 301 |
|
|
R. 9R...................................... |
ad. 2000 No. 48 |
|
|
|
am. 2002 No. 9 |
|
|
|
rep. 2003 No. 301 |
|
|
R. 9S...................................... |
ad. 2000 No. 48 |
|
|
|
am. 2002 No. 315 |
|
|
|
rep. 2003 No. 301 |
|
|
Part 2C |
|
|
|
Part 2C................................... |
ad. 2002 No. 234 |
|
|
Division 2C.1 |
|
|
|
R. 10....................................... |
rs. 2002 No. 234 |
|
|
R. 10A |
|
|
|
R. 10B |
|
|
|
R. 10C |
|
|
|
R. 10D.................................... |
ad. 2002 No. 234 |
|
|
Division 2C.2 |
|
|
|
R. 10E.................................... |
ad. 2002 No. 234 |
|
|
R. 10F.................................... |
ad. 2002 No. 234 |
|
|
|
am. 2009 No. 140 |
|
|
Part 3 |
|
|
|
R. 10A.................................... |
ad. 2001 No. 252 |
|
|
Renumbered r. 11............ |
2002 No. 234 |
|
|
|
am. 2004 No. 127 |
|
|
R. 11....................................... |
am. 1992 No. 89; 1994 No. 150 |
|
|
|
rep. 2002 No. 234 |
|
|
R. 11A.................................... |
ad. 1994 No. 150 |
|
|
|
rep. 2002 No. 234 |
|
|
R. 12....................................... |
am. 1991 No. 84; 1992 No. 89; 1995 No. 33; 1996 No. 9; 2000 No. 358; 2001 No. 343; 2002 Nos. 84, 234 and 345; 2003 No. 258 |
|
|
Heading to r. 12A................. |
am. 1999 No. 62 |
|
|
R. 12A.................................... |
ad. 1991 No. 485 |
|
|
|
am. 1999 No. 62; 2000 No. 358; 2002 Nos. 9 and 234 |
|
|
R. 12AAA................................ |
ad. 2003 No. 111 |
|
|
R. 12AAB............................... |
ad. 2003 No. 111 |
|
|
R. 12AA.................................. |
ad. 2000 No. 358 |
|
|
R. 12AB.................................. |
ad. 2000 No. 358 |
|
|
|
am. 2003 Nos. 258 and 361 |
|
|
Heading to r. 12AC.............. |
rs. 2003 No. 361 |
|
|
R. 12AC................................. |
ad. 2000 No. 358 |
|
|
|
am. 2003 No. 361 |
|
|
R. 12AD................................. |
ad. 2000 No. 358 |
|
|
|
am. 2002 No. 234 |
|
|
R. 12B.................................... |
ad. 1991 No. 485 |
|
|
|
am. 1992 No. 19; 1999 No. 62; 2000 No. 358; 2003 Nos. 258 and 361 |
|
|
R. 12C.................................... |
ad. 2002 No. 234 |
|
|
R. 13....................................... |
am. 1992 No. 19; 2002 No. 9 |
|
|
Renumbered r. 10A.......... |
2002 No. 234 |
|
|
R. 14....................................... |
am. 2002 No. 9; 2002 No. 234 |
|
|
Renumbered r. 10B......... |
2002 No. 234 |
|
|
R. 14A.................................... |
ad. 1992 No. 430 |
|
|
Renumbered r. 10C......... |
2002 No. 234 |
|
|
Rr. 14B, 14C......................... |
ad. 1992 No. 430 |
|
|
|
rep. 2002 No. 234 |
|
|
R. 15....................................... |
am. 1992 No. 19; 1997 No. 398; 1999 No. 62 |
|
|
R. 15A.................................... |
ad. 2003 No. 258 |
|
|
R. 16....................................... |
am. 1992 No. 89 |
|
|
R. 16AA.................................. |
ad. 2003 No. 151 |
|
|
Part 3A |
|
|
|
Heading to Part 3A.............. |
am. 1999 No. 62 |
|
|
|
rs. 2000 No. 29 |
|
|
Part 3A................................... |
ad. 1992 No. 19 |
|
|
Division 1 |
|
|
|
Heading to Div. 1 of............. |
ad. 2000 No. 29 |
|
|
R. 16A.................................... |
ad. 1992 No. 19 |
|
|
R. 16B.................................... |
ad. 1992 No. 19 |
|
|
R. 16C.................................... |
ad. 1992 No. 19 |
|
|
|
am. 1992 No. 109; 1998 No. 227; 1999 No. 62 |
|
|
R. 16D.................................... |
ad. 1992 No. 19 |
|
|
|
am. 1992 No. 109; 1998 No. 227; 1999 No. 62; 2003 No. 151 |
|
|
R. 16E.................................... |
ad. 1992 No. 19 |
|
|
Heading to r. 16F................. |
rs. 2003 No. 151 |
|
|
R. 16F.................................... |
ad. 1992 No. 19 |
|
|
|
am. 1998 No. 227; 1999 No. 62 |
|
|
R. 16G.................................... |
ad. 1992 No. 109 |
|
|
|
am. 1998 No. 227; 1999 No. 62 |
|
|
Division 2 |
|
|
|
Div. 2 of Part 3A.................... |
ad. 2000 No. 29 |
|
|
Heading to r. 16GA.............. |
rs. 2003 No. 151 |
|
|
R. 16GA................................. |
ad. 2000 No. 29 |
|
|
|
am. 2003 No. 151 |
|
|
Part 3B |
|
|
|
Part 3B................................... |
ad. 1997 No. 399 |
|
|
R. 16H.................................... |
ad. 1997 No. 399 |
|
|
|
am. 1999 No. 62 |
|
|
R. 16I...................................... |
ad. 1997 No. 399 |
|
|
|
am. 1999 No. 62 |
|
|
R. 16J..................................... |
ad. 1997 No. 399 |
|
|
|
am. 1999 No. 62 |
|
|
Part 4 |
|
|
|
R. 17....................................... |
am. 1994 No. 150; 2002 No. 234 |
|
|
R. 18....................................... |
am. 2002 No. 234 |
|
|
R. 22....................................... |
am. 1992 Nos. 19 and 89 |
|
|
Part 5 |
|
|
|
R. 23....................................... |
am. 1994 No. 150; 2001 No. 252; 2002 No. 234; 2003 |
|
|
R. 24....................................... |
am. 1991 No. 84; 2002 No. 234; 2004 No. 78 |
|
|
R. 25....................................... |
am. 1994 No. 150; 2001 No. 252; 2002 No. 234 |
|
|
R. 26....................................... |
am. 1994 No. 150; 2001 No. 252 |
|
|
R. 26A.................................... |
ad. 2001 No. 252 |
|
|
|
am. 2002 No. 234 |
|
|
R. 27....................................... |
rs. 1994 No. 150 |
|
|
|
am. 2002 No. 234 |
|
|
R. 28....................................... |
am. 2002 No. 234 |
|
|
R. 29....................................... |
am. 1994 Nos. 150 and 364; 2001 No. 252; 2002 No. 234 |
|
|
R. 30....................................... |
am. 2002 No. 234; 2003 No. 361 |
|
|
R. 31....................................... |
am. 2001 No. 252; 2002 No. 234 |
|
|
R. 32....................................... |
am. 1994 No. 150; 2002 No. 9 |
|
|
R. 33....................................... |
am. 2002 No. 9 |
|
|
Part 6 |
|
|
|
Division 1 |
|
|
|
Heading to Div. 1 of Part 6. |
ad. 1997 No. 400 |
|
|
|
rs. 2002 No. 234 |
|
|
R. 34....................................... |
am. 1995 No. 208; 1999 No. 62; 2002 No. 234 |
|
|
R. 35....................................... |
am. 1991 No. 485; 1999 No. 62 |
|
|
|
rs. 2002 No. 234 |
|
|
R. 36....................................... |
am. 1991 No. 485; 1999 No. 62; 2002 No. 234 |
|
|
R. 37....................................... |
am. 1997 No. 400 |
|
|
R. 38....................................... |
am. 1991 No. 485; 1997 No. 400; 2002 No. 234; 2009 No. 63 |
|
|
R. 39....................................... |
am. 1997 No. 400 |
|
|
R. 40....................................... |
am. 1997 No. 400 |
|
|
R. 41....................................... |
am. 1991 No. 485; 1997 No. 400; 2002 No. 234 |
|
|
R. 42....................................... |
am. 1997 No. 400 |
|
|
Division 2 |
|
|
|
Div. 2 of Part 6...................... |
ad. 1997 No. 400 |
|
|
R. 42A.................................... |
ad. 1997 No. 400 |
|
|
R. 42B.................................... |
ad. 1997 No. 400 |
|
|
|
am. 2001 No. 159; 2003 No. 301 |
|
|
R. 42C.................................... |
ad. 1997 No. 400 |
|
|
|
am. 1998 No. 369; 2002 No. 234; 2003 Nos. 111 and 258; 2006 No. 122 |
|
|
R. 42D.................................... |
ad. 1997 No. 400 |
|
|
|
am. 2003 No. 361 |
|
|
R. 42E.................................... |
ad. 1997 No. 400 |
|
|
|
am. 1998 No. 369; 2002 No. 234; 2003 No. 111 |
|
|
R. 42F.................................... |
ad. 1997 No. 400 |
|
|
R. 42G.................................... |
ad. 1997 No. 400 |
|
|
R. 42H.................................... |
ad. 1997 No. 400 |
|
|
|
am. 2000 No. 48 |
|
|
R. 42J..................................... |
ad. 1997 No. 400 |
|
|
|
am. 2000 No. 48; 2001 No. 159; 2002 No. 315; 2003 Nos. 258 and 361; 2006 No. 122; 2009 No. 63 |
|
|
R. 42K.................................... |
ad. 1997 No. 400 |
|
|
|
am. 1998 No. 369; 2002 No. 234; 2003 No. 111 |
|
|
R. 42L.................................... |
ad. 1997 No. 400 |
|
|
R. 42M.................................... |
ad. 1997 No. 400 |
|
|
R. 42N.................................... |
ad. 1997 No. 400 |
|
|
R. 42P.................................... |
ad. 1997 No. 400 |
|
|
R. 42Q.................................... |
ad. 1997 No. 400 |
|
|
Division 3 |
|
|
|
Heading to Div. 3 of Part 6. |
rs. 2000 No. 48 |
|
|
Div. 3 of Part 6...................... |
ad. 1997 No. 400 |
|
|
Subdivision 1 |
|
|
|
Heading to Subdiv. 1 of...... |
ad. 2000 No. 48 |
|
|
R. 42R.................................... |
ad. 1997 No. 400 |
|
|
R. 42S.................................... |
ad. 1997 No. 400 |
|
|
|
am. 2000 No. 48 |
|
|
R. 42T.................................... |
ad. 1997 No. 400 |
|
|
|
am. 1998 No. 369; 2000 No. 48; 2002 No. 234 |
|
|
R. 42U.................................... |
ad. 1997 No. 400 |
|
|
|
am. 2003 No. 361 |
|
|
R. 42V.................................... |
ad. 1997 No. 400 |
|
|
R. 42W................................... |
ad. 1997 No. 400 |
|
|
|
am. 2000 No. 48 |
|
|
R. 42X.................................... |
ad. 1997 No. 400 |
|
|
|
am. 2003 No. 258 |
|
|
R. 42Y.................................... |
ad. 1997 No. 400 |
|
|
|
am. 1998 No. 369; 2000 No. 48; 2002 Nos. 234 and 315; 2003 No. 111 |
|
|
|
rs. 2003 No. 301 |
|
|
R. 42Z.................................... |
ad. 1997 No. 400 |
|
|
R. 42ZA.................................. |
ad. 1997 No. 400 |
|
|
R. 42ZB.................................. |
ad. 1997 No. 400 |
|
|
R. 42ZC................................. |
ad. 1997 No. 400 |
|
|
|
rs. 2000 No. 48 |
|
|
Subdivision 2 |
|
|
|
Subdiv. 2 of Div. 3 of Part 6 |
ad. 2000 No. 48 |
|
|
R. 42ZCAA............................. |
ad. 2000 No. 48 |
|
|
|
am. 2001 No. 159 |
|
|
Note to r. 42ZCAA................ |
rep. 2001 No. 159 |
|
|
R. 42ZCAB............................ |
ad. 2000 No. 48 |
|
|
|
am. 2001 No. 159; 2002 No. 234; 2003 No. 301; 2004 No. 159 |
|
|
R. 42ZCAC............................ |
ad. 2000 No. 48 |
|
|
R. 42ZCAD............................ |
ad. 2000 No. 48 |
|
|
|
am. 2002 No. 315; 2003 No. 111 |
|
|
R. 42ZCAE............................ |
ad. 2000 No. 48 |
|
|
R. 42ZCAF............................. |
ad. 2000 No. 48 |
|
|
R. 42ZCAG............................ |
ad. 2000 No. 48 |
|
|
R. 42ZCAGA.......................... |
ad. 2006 No. 122 |
|
|
R. 42ZCAH............................ |
ad. 2000 No. 48 |
|
|
R. 42ZCAI.............................. |
ad. 2000 No. 48 |
|
|
|
am. 2002 Nos. 234 and 315; 2003 No. 301; 2006 No. 122 |
|
|
R. 42ZCAJ............................. |
ad. 2000 No. 48 |
|
|
R. 42ZCAK............................ |
ad. 2000 No. 48 |
|
|
R. 42ZCAL............................. |
ad. 2002 No. 315 |
|
|
Division 3A |
|
|
|
Div. 3A of Part 6.................... |
ad. 1999 No. 209 |
|
|
Subdivision 1 |
|
|
|
R. 42ZCA............................... |
ad. 1999 No. 209 |
|
|
Subdivision 2 |
|
|
|
R. 42ZCB............................... |
ad. 1999 No. 209 |
|
|
Subdivision 3 |
|
|
|
R. 42ZCC.............................. |
ad. 1999 No. 209 |
|
|
R. 42ZCD.............................. |
ad. 1999 No. 209 |
|
|
R. 42ZCE............................... |
ad. 1999 No. 209 |
|
|
R. 42ZCF............................... |
ad. 1999 No. 209 |
|
|
R. 42ZCG.............................. |
ad. 1999 No. 209 |
|
|
R. 42ZCH.............................. |
ad. 1999 No. 209 |
|
|
R. 42ZCI................................ |
ad. 1999 No. 209 |
|
|
R. 42ZCJ............................... |
ad. 1999 No. 209 |
|
|
R. 42ZCK............................... |
ad. 1999 No. 209 |
|
|
R. 42ZCL............................... |
ad. 1999 No. 209 |
|
|
Subdivision 4 |
|
|
|
R. 42ZCM.............................. |
ad. 1999 No. 209 |
|
|
R. 42ZCN.............................. |
ad. 1999 No. 209 |
|
|
R. 42ZCO.............................. |
ad. 1999 No. 209 |
|
|
R. 42ZCP............................... |
ad. 1999 No. 209 |
|
|
R. 42ZCQ.............................. |
ad. 1999 No. 209 |
|
|
R. 42ZCR.............................. |
ad. 1999 No. 209 |
|
|
R. 42ZCS............................... |
ad. 1999 No. 209 |
|
|
Subdivision 5 |
|
|
|
R. 42ZCT............................... |
ad. 1999 No. 209 |
|
|
R. 42ZCU.............................. |
ad. 1999 No. 209 |
|
|
R. 42ZCV............................... |
ad. 1999 No. 209 |
|
|
R. 42ZCW.............................. |
ad. 1999 No. 209 |
|
|
R. 42ZCX............................... |
ad. 1999 No. 209 |
|
|
R. 42ZCY............................... |
ad. 1999 No. 209 |
|
|
R. 42ZCZ............................... |
ad. 1999 No. 209 |
|
|
R. 42ZCZA............................. |
ad. 1999 No. 209 |
|
|
R. 42ZCZB............................ |
ad. 1999 No. 209 |
|
|
Division 4 |
|
|
|
Div. 4 of Part 6...................... |
ad. 1999 No. 62 |
|
|
Subdivision 1 |
|
|
|
Subdiv. 1 of Div. 4 of............ |
ad. 1999 No. 62 |
|
|
R. 42ZD................................. |
ad. 1999 No. 62 |
|
|
Subdivision 2 |
|
|
|
Subdiv. 2 of Div. 4 of............ |
ad. 1999 No. 62 |
|
|
R. 42ZE.................................. |
ad. 1999 No. 62 |
|
|
|
am. 2000 No. 29 |
|
|
R. 42ZF.................................. |
ad. 1999 No. 62 |
|
|
|
am. 2000 No. 29 |
|
|
R. 42ZG................................. |
ad. 1999 No. 62 |
|
|
R. 42ZH................................. |
ad. 1999 No. 62 |
|
|
R. 42ZI................................... |
ad. 1999 No. 62 |
|
|
Subdivision 3 |
|
|
|
Subdiv. 3 of Div. 4 of............ |
ad. 1999 No. 62 |
|
|
R. 42ZJ.................................. |
ad. 1999 No. 62 |
|
|
R. 42ZK.................................. |
ad. 1999 No. 62 |
|
|
R. 42ZL.................................. |
ad. 1999 No. 62 |
|
|
R. 42ZM................................. |
ad. 1999 No. 62 |
|
|
R. 42ZN................................. |
ad. 1999 No. 62 |
|
|
|
am. 2000 No. 29 |
|
|
R. 42ZO................................. |
ad. 1999 No. 62 |
|
|
R. 42ZP.................................. |
ad. 1999 No. 62 |
|
|
R. 42ZQ................................. |
ad. 1999 No. 62 |
|
|
|
am. 2000 No. 29 |
|
|
R. 42ZR................................. |
ad. 1999 No. 62 |
|
|
R. 42ZS.................................. |
ad. 1999 No. 62 |
|
|
Subdivision 4 |
|
|
|
Subdiv. 4 of Div. 4 of............ |
ad. 1999 No. 62 |
|
|
R. 42ZT.................................. |
ad. 1999 No. 62 |
|
|
R. 42ZU................................. |
ad. 1999 No. 62 |
|
|
R. 42ZV.................................. |
ad. 1999 No. 62 |
|
|
R. 42ZW................................. |
ad. 1999 No. 62 |
|
|
R. 42ZX.................................. |
ad. 1999 No. 62 |
|
|
|
am. 2000 No. 29 |
|
|
R. 42ZY.................................. |
ad. 1999 No. 62 |
|
|
R. 42ZZ.................................. |
ad. 1999 No. 62 |
|
|
Division 5 |
|
|
|
Div. 5 of Part 6...................... |
ad. 2000 No. 29 |
|
|
Subdivision 1 |
|
|
|
Subdiv. 1 of Div. 5 of............ |
ad. 2000 No. 29 |
|
|
R. 42ZZA................................ |
ad. 2000 No. 29 |
|
|
Subdivision 2 |
|
|
|
Subdiv. 2 of Div. 5 of............ |
ad. 2000 No. 29 |
|
|
R. 42ZZB............................... |
ad. 2000 No. 29 |
|
|
Subdivision 3 |
|
|
|
Subdiv. 3 of Div. 5 of............ |
ad. 2000 No. 29 |
|
|
R. 42ZZC............................... |
ad. 2000 No. 29 |
|
|
R. 42ZZD............................... |
ad. 2000 No. 29 |
|
|
R. 42ZZE............................... |
ad. 2000 No. 29 |
|
|
R. 42ZZF................................ |
ad. 2000 No. 29 |
|
|
R. 42ZZG............................... |
ad. 2000 No. 29 |
|
|
Subdivision 4 |
|
|
|
Subdiv. 4 of Div. 5 of............ |
ad. 2000 No. 29 |
|
|
R. 42ZZH............................... |
ad. 2000 No. 29 |
|
|
R. 42ZZI................................. |
ad. 2000 No. 29 |
|
|
R. 42ZZJ................................ |
ad. 2000 No. 29 |
|
|
|
am. 2003 No. 258 |
|
|
R. 42ZZK............................... |
ad. 2000 No. 29 |
|
|
R. 42ZZL................................ |
ad. 2000 No. 29 |
|
|
R. 42ZZM............................... |
ad. 2000 No. 29 |
|
|
R. 42ZZN............................... |
ad. 2000 No. 29 |
|
|
R. 42ZZO............................... |
ad. 2000 No. 29 |
|
|
R. 42ZZP............................... |
ad. 2000 No. 29 |
|
|
R. 42ZZQ............................... |
ad. 2000 No. 29 |
|
|
Subdivision 5 |
|
|
|
Subdiv. 5 of Div. 5 of............ |
ad. 2000 No. 29 |
|
|
R. 42ZZR............................... |
ad. 2000 No. 29 |
|
|
R. 42ZZS............................... |
ad. 2000 No. 29 |
|
|
R. 42ZZT................................ |
ad. 2000 No. 29 |
|
|
R. 42ZZU............................... |
ad. 2000 No. 29 |
|
|
R. 42ZZV................................ |
ad. 2000 No. 29 |
|
|
R. 42ZZW.............................. |
ad. 2000 No. 29 |
|
|
R. 42ZZX................................ |
ad. 2000 No. 29 |
|
|
Part 7 |
|
|
|
Heading to Part 7................. |
rs. 1991 No. 84; 2009 No. 141 |
|
|
Division 1 |
|
|
|
Div. 1 of Part 7...................... |
ad. 2009 No. 141 |
|
|
Subdivision 1 |
|
|
|
Subdiv. 1 of Div. 1 of............ |
ad. 2009 No. 141 |
|
|
R. 43AAA................................ |
ad. 2009 No. 141 |
|
|
Subdivision 2 |
|
|
|
ad. 2009 No. 141 |
||
|
R. 43AAB............................... |
ad. 2009 No. 141 |
|
|
R. 43AAC............................... |
ad. 2009 No. 141 |
|
|
R. 43AAD............................... |
ad. 2009 No. 141 |
|
|
R. 43AAE............................... |
ad. 2009 No. 141 |
|
|
R. 43AAF................................ |
ad. 2009 No. 141 |
|
|
R. 43AAG............................... |
ad. 2009 No. 141 |
|
|
R. 43AAH............................... |
ad. 2009 No. 141 |
|
|
R. 43AAI................................. |
ad. 2009 No. 141 |
|
|
Subdivision 3 |
|
|
|
Subdiv. 3 of Div. 1 of............ |
ad. 2009 No. 141 |
|
|
R. 43AAJ................................ |
ad. 2009 No. 141 |
|
|
Division 2 |
|
|
|
Heading to Div. 2 of Part 7. |
ad. 2009 No. 141 |
|
|
R. 43....................................... |
am. 2003 No. 151 |
|
|
R. 43A.................................... |
ad. 1994 No. 222 |
|
|
|
am. 2002 No. 234 |
|
|
R. 43AA.................................. |
ad. 1992 No. 19 |
|
|
R. 43AB.................................. |
ad. 2000 No. 267 |
|
|
R. 45....................................... |
am. 1991 Nos. 84 and 485; 1994 Nos. 222 and 364; 1995 No. 192; 1996 No. 131; 1997 Nos. 162, 398 and 399; 1998 No. 247; 1999 No. 62; 2000 Nos. 123 and 267; 2002 No. 143; 2003 Nos. 151 and 361; 2004 No. 159; 2005 No. 192; 2006 No. 212; 2007 No. 161; 2008 No. 117; 2009 No. 179 |
|
|
R. 45AA.................................. |
ad. 1995 No. 192 |
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am. 2002 No. 234 |
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Heading to r. 45A................. |
am. 1997 No. 162 |
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rs. 2001 No. 160; 2003 No. 151; 2004 No. 159; 2005
No. 192; 2006 No. 212; 2007 No. 161; 2008 No. 117; |
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R. 45A.................................... |
ad. 1991 No. 84 |
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am. 1997 No. 162; 2000 No. 267; 2001 No. 160; 2002 No. 234; 2003 No. 151; 2004 No. 159; 2005 No. 192; 2006 No. 212; 2007 No. 161; 2008 No. 117 |
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rs. 2009 No. 141 |
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Part 7A |
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Part 7A................................... |
ad. 2009 No. 228 |
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R. 45B.................................... |
ad. 2009 No. 228 |
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Part 8 |
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R. 46A.................................... |
ad. 1992 No. 332 |
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rs. 2009 No. 140 |
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R. 46....................................... |
am. 1991 No. 84; 1992 No. 332; 1997 No. 399; 1999 No. 62; 2002 No. 234 |
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R. 47....................................... |
rs. 1991 No. 485 |
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am. 1992 No. 332; 1997 No. 400; 2000 No. 48; 2001 No. 343; 2002 No. 345; 2004 No. 78; 2009 No. 228 |
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R. 47A.................................... |
ad. 1991 No. 485 |
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R. 47AA.................................. |
ad. 2000 No. 358 |
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rep. 2003 No. 361 |
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Heading to r. 47B................. |
am. 1999 No. 62 |
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rs. 2002 No. 234 |
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R. 47B.................................... |
ad. 1991 No. 485 |
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am. 1999 No. 62 |
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rs. 2000 No. 358 |
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am. 2002 No. 234 |
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R. 48....................................... |
am. 1991 No. 84; 1992 Nos. 332 and 430; 1995 No. 192; 1997 No. 399; 2000 No. 48; 2002 No. 234; 2003 No. 301 |
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Schedule 1 |
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Schedule 1............................ |
am. 1992 Nos. 89 and 332; 1994 Nos. 150 and 364; 1995 No. 208; 1997 No. 398; 1999 No. 324; 2001 No. 159; 2003 No. 258; 2006 No. 122 |
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Schedule 2 |
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Heading to Schedule 2....... |
rs. 2003 No. 301 |
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Schedule 2............................ |
am. 1994 No. 150; 1995 No. 208; 1997 No. 398; 1999 No. 324; 2000 No. 48; 2001 Nos. 159 and 252; 2002 No. 234; 2006 No. 122 |
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Schedule 3 |
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Schedule 3............................ |
am. 1991 Nos. 84 and 485; 1992 Nos. 19, 89 and 370; 1994 Nos. 150 and 364; 1995 No. 208; 1997 Nos. 398 and 399; 1999 No. 62; 2002 Nos. 84, 114, 143, 234 and 315; 2004 No. 78 |
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Schedule 4 |
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Heading to Schedule 4....... |
am. 1998 No. 227 |
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rs. 2002 No. 234 |
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Schedule 4............................ |
am. 1991 No. 84; 1992 Nos. 19 and 89; 1994 No. 150; 1995 Nos. 208 and 320; 1996 Nos. 9 and 208; 1997 No. 398; 1998 Nos. 227 and 369; 1999 Nos. 62 and 324; 2000 No. 48; 2001 Nos. 159 and 252; 2002 Nos. 84, 114, 234 and 315; 2003 Nos. 258 and 361; 2004 Nos. 78 and 127 |
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Schedule 5 |
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Heading to Schedule 5....... |
am. 2002 No. 234 |
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Schedule 5............................ |
am. 1991 Nos. 84 and 485; 1992 Nos. 19, 89, 332 and 370; 1994 No. 150; 1995 No. 208; 1996 No. 9; 1997 Nos. 398 and 399; 1999 No. 62; 2000 Nos. 48 and 124; 2001 No. 159; 2002 No. 84; 2003 No. 258 |
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Schedule 5A |
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Heading to Schedule 5A.... |
am. 2002 No. 234 |
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Schedule 5A......................... |
ad. 1991 No. 84 |
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am. 1992 No. 89; 1994 Nos. 150 and 364; 1995 Nos. 33 and 208; 1996 No. 9; 1997 No. 399; 1999 No. 62; 2000 No. 358; 2001 Nos. 159 and 343; 2002 Nos. 84 and 345; 2003 No. 111; 2004 No. 78 |
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Schedule 5B |
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Schedule 5B......................... |
ad. 2003 No. 111 |
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Schedule 6 |
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Schedule 6............................ |
am. 1992 Nos. 19, 89 and 370; 1994 No. 150; 1995 No. 208; 1997 No. 398; 1999 No. 324 |
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Schedule 7 |
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Heading to Schedule 7....... |
am. 2002 No. 234 |
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Schedule 7............................ |
am. 1991 No. 84; 1992 Nos. 19, 89 and 370; 1994 No. 150; 1995 No. 208; 1997 No. 398; 1998 No. 227; 1999 No. 324; 2000 No. 124; 2001 No. 159 |
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Schedule 8 |
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Heading to Schedule 8....... |
am. 2002 No. 234 |
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Schedule 8............................ |
am. 1992 No. 89; 1994 No. 150; 1997 No. 398; 1999 No. 62 |
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Schedule 9 |
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Schedule 9............................ |
am. 1991 Nos. 84 and 485; 1992 Nos. 19 and 89; 1993 No. 141; 1994 Nos. 150, 222 and 364; 1995 Nos. 192 and 208; 1996 No. 131; 1997 Nos. 162, 398 and 400; 1998 No. 247; 1999 Nos. 62 and 324; 2000 Nos. 29, 70, 123 and 267; 2001 No. 160; 2002 Nos. 143 and 234; 2003 No. 151; 2004 No. 159; 2005 No. 192; 2006 No. 212; 2007 No. 161; 2008 No. 117; 2009 Nos. 141 and 179 |
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Schedule 10 |
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Heading to Schedule 10.... |
rs. 1992 Nos. 332 and 370 |
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am. 1995 No. 208 |
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Schedule 10......................... |
ad. 1992 No. 19 |
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am. 1992 No. 89; 1994 No. 150; 1995 No. 208 |
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rs. 1998 No. 227 |
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am. 1999 No. 62; 2000 No. 29; 2004 No. 78 |
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Schedule 11 |
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Schedule 11......................... |
ad. 1992 No. 89 |
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am. 1999 No. 324; 2002 No. 84 |
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Schedule 12 |
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Schedule 12......................... |
ad. 1992 No. 430 |
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am. 1995 No. 208; 2001 No. 159; 2003 No. 151 |
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Schedule 13 |
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Schedule 13......................... |
ad. 1995 No. 208 |
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am. 2001 No. 159; 2003 No. 151 |
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Schedule 14 |
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Heading to Schedule 14.... |
am. 1999 No. 62 |
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Schedule 14......................... |
ad. 1997 No. 400 |
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rs. 1998 No. 227 |
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Schedule 15 |
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Schedule 15......................... |
ad. 2009 No. 228 |
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Table A Application, saving or transitional provisions
Statutory Rules 1994 No. 150
22. Date of effect of revocation of exemptions
2.1 For the purposes of subsections 18 (3) and 34 (3) of the Therapeutic Goods Act 1989, the revocations of exemptions made by subregulations 15.6, 17.2, 18.2 and 18.3 of these Regulations take effect on 1 July 1994.
Statutory Rules 1995 No. 208
19. Transitional provisions
19.1 If:
(a) an application is made under section 23 of the Act in relation to therapeutic goods to which paragraph (d) or subparagraph (l) (ii) of item 7 in Schedule 5 to the Therapeutic Goods Regulations, as in force immediately before 4 July 1995; and
(b) the application is made in the period from the beginning of 4 July 1995 to the end of 31 December 1995;
Part 3 of the Act applies to those goods as if subregulations 10.5, 11.2 and 11.4 of these Regulations had not commenced until the application is decided.
19.2 If:
(a) an application is made under section 23 of the Act in relation to therapeutic goods to which paragraphs (a) and (g) of item 8 in Schedule 5 to the Therapeutic Goods Regulations, as in force immediately before 4 July 1995; and
(b) the application is made in the period from the beginning of 4 July 1995 to the end of 30 September 1995;
Part 3 of the Act applies to those goods as if subregulations 10.3, 11.5 and 11.8 of these Regulations had not commenced until the application is decided.
Statutory Rules 1999 No. 209
4 Transitional
(1) For the first meeting of the National Drugs and Poisons Schedule Committee:
(a) a quorum is 5 jurisdictional members; and
(b) the public consultation procedures set out in subdivision 5 of Division 3A of Part 6 of the principal Regulations do not apply.
(2) At that meeting, the Committee must make decisions in relation to the classification and scheduling of all substances in relation to which a decision of that kind has been made by AHMAC that does not form part of the first Poisons Standard because the AHMAC decision:
(a) was made on or after 1 April 1999; or
(b) was made before 1 April 1999 but had not been published as part of the first Poisons Standard.
(3) In making a decision about a substance mentioned in subregulation (2) , the Committee:
(a) may, for subsection 52E (1) of the Act, accept the findings of AHMAC about a matter mentioned in that subsection in connection with that substance; and
(b) must take account of the scheduling decision of AHMAC for that substance and the consequences a Committee decision at variance with the AHMAC decision would have for industry and the community.
(4) A word or expression used in subregulation (2) and in section 52A of the Act has the same meaning in that subregulation as it has in that section.
(5) In this Regulation:
Act means the Therapeutic Goods Act 1989.
AHMAC means the Australian Health Ministers' Advisory Council and includes a subcommittee of the Council acting on the Council's behalf.
jurisdictional member has the meaning given by regulation 42ZCE of the principal Regulations.
principal Regulations means the Therapeutic Goods Regulations 1990.
Statutory Rules 2004 No. 127
4 Transitional
Despite the amendments made by these Regulations, the Therapeutic Goods Regulations 1990, as in force immediately before the commencement of these Regulations (the commencement time), continue to apply for a period of 12 months after the commencement time in relation to therapeutic goods that, immediately before the commencement time, were registered goods or listed goods.