Commonwealth Consolidated Acts Commonwealth Consolidated ActsAct No. 21 of 1990 as amended
This compilation was prepared on 8 October 2009
taking into account amendments up to Act No. 96 of 2009
The text of any of those amendments not in force
on that date is appended in the Notes section
The operation of amendments that have been incorporated may be affected by application provisions that are set out in the Notes section
Prepared by the Office of Legislative Drafting and
Publishing,
Attorney‑General's Department, Canberra
Contents
Chapter 1--Preliminary 1
1............ Short title [see Note 1] ....................................................................... 1
2............ Commencement [see Note 1] .............................................................. 1
3............ Interpretation ...................................................................................... 1
3A......... Declaration--member of European Community .............................. 15
3B......... Declaration--country covered by non‑EC/EFTA MRA ................. 16
3C......... Exempting monographs in pharmacopoeias ..................................... 16
4............ Objects of Act .................................................................................. 16
5............ Act to bind Crown ............................................................................ 17
5A......... Application of the Criminal Code--extended geographical jurisdiction 17
6............ Operation of Act .............................................................................. 17
6AAA... Commonwealth consent to conferral of functions etc. on its officers and authorities by corresponding State laws .......................................................................................................... 18
6AAB... When duty imposed ......................................................................... 18
6AAC... Imposing duty under State law ......................................................... 20
6AAD... Conferral of jurisdiction on federal courts ........................................ 21
6AAE.... Consequences of State law conferring duty, function or power on Commonwealth officer or Commonwealth authority .......................................................................................................... 21
6B......... Review of certain decisions under State laws ................................... 22
6C......... Fees payable to Commonwealth under State laws ........................... 22
7............ Declaration that goods are/are not therapeutic goods ....................... 22
7A......... Authorised persons .......................................................................... 23
7B......... Kits ................................................................................................... 24
7C......... Secretary may arrange for use of computer programs to make decisions 24
8............ Power to obtain information with respect to therapeutic goods ...... 25
9............ Arrangements with States etc. .......................................................... 25
Chapter 2--Australian Register of Therapeutic Goods 27
9A......... Australian Register of Therapeutic Goods ....................................... 27
9B......... When registrations or listings of medical devices are taken to be cancelled 28
9C......... Inspection of entries in Register ....................................................... 30
9D......... Variation of entries in Register ......................................................... 30
9E.......... Publication of list of goods on Register ............................................ 31
Chapter 3--Medicines and other therapeutic goods that are not medical devices 32
Part 3‑1--Standards 32
10.......... Determination of standards .............................................................. 32
10A....... Application of standards to medical devices .................................... 33
13.......... Special provisions relating to standards ........................................... 33
14.......... Criminal offences for importing, supplying or exporting goods that do not comply with standards 35
14A....... Civil penalties for importing, supplying or exporting goods that do not comply with standards 39
14B....... Application of Customs Act 1901 .................................................... 40
15.......... Criminal offences relating to breaching a condition of a consent ...... 41
15AA.... Civil penalty relating to breaching a condition of a consent ............. 41
Part 3‑2--Registration and listing of therapeutic goods 43
Division 1--Preliminary 43
15A....... Application of this Part to medical devices ...................................... 43
16.......... Therapeutic goods and gazetted groups ........................................... 45
18.......... Exempt goods ................................................................................... 46
18A....... Exemption because of emergency ..................................................... 46
19.......... Exemptions for special and experimental uses ................................. 50
19A....... Exemptions where unavailability etc. of therapeutic goods ............. 53
19B....... Criminal offences relating to registration or listing etc. of imported, exported, manufactured and supplied therapeutic goods ................................................................................................. 54
19C....... Notice required to adduce evidence in support of exception under subsection 19B(6) 58
19D....... Civil penalties relating to registration or listing etc. of imported, exported, manufactured and supplied therapeutic goods ................................................................................................. 60
20.......... Criminal offences relating to notifying the Secretary and to importing goods exempt under section 18A 62
5>20A....... Civil penalty relating to the importation, exportation, manufacture or supply of sponsored goods without proper notification ........................................................................................ 63
21.......... Offence relating to wholesale supply ............................................... 64
21A....... General criminal offences relating to this Part .................................. 64
21B....... General civil penalties relating to this Part ....................................... 69
22.......... General offences relating to this Part ................................................ 70
22AA.... Civil penalty for breaching a condition of an exemption .................. 73
22A....... Criminal offences for false statements in applications for registration 73
22B....... Civil penalty for false statements in applications for registration ... 74
Division 2--Registration and listing 75
23.......... Applications generally ...................................................................... 75
24.......... Applications for registration ............................................................ 75
24A....... When evaluation fee due for payment .............................................. 76
24B....... Payment of evaluation fee by instalments ........................................ 76
24C....... Recovery of evaluation fee ............................................................... 77
24D....... Reduction of evaluation fee where evaluation not completed within prescribed period 77
24E........ Deemed refusal of application .......................................................... 78
25.......... Evaluation and registration of therapeutic goods .............................. 78
25A....... When the Secretary must not use protected information ................. 82
25B....... Registration of therapeutic device to which EC/EFTA attestation of conformity applies 83
26.......... Listing of therapeutic goods ............................................................. 84
26AA.... Listing of therapeutic device to which EC/EFTA attestation of conformity applies 87
26A....... Listing of certain medicines .............................................................. 88
26B....... Certificates required in relation to patents ....................................... 91
26BA.... Approved form for notices ............................................................... 93
26C....... Certificates required in relation to patent infringement proceedings 93
26D....... Requirements for interlocutory injunction ....................................... 95
27.......... Registration or listing number ........................................................... 97
28.......... Conditions of registration or listing .................................................. 97
29.......... Duration of registration or listing ................................................... 100
29A....... Criminal offence for failing to notify adverse effects etc. of goods 100
29AA.... Civil penalty for failing to notify adverse effects etc. of goods ..... 100
29B....... Notification of adverse effects etc. where application withdrawn or lapses 101
29C....... Civil penalties for failing to notify adverse effects etc. where application withdrawn or lapses 102
29D....... Suspension of registration or listing ............................................... 102
29E........ When suspension takes effect etc. .................................................. 104
29F........ Revocation of suspension ............................................................... 104
29G....... Effect of suspension ....................................................................... 105
30.......... Cancellation of registration or listing .............................................. 105
30A....... Revocation of cancellation of registration or listing upon request .. 108
30C....... Consultation with Gene Technology Regulator ............................. 109
30D....... Secretary may seek advice about classes of GM products or genetically modified organisms 109
30E........ Secretary to take advice into account ............................................. 110
Division 2A--Public notification and recovery of therapeutic goods 111
30EA..... Public notification and recovery of therapeutic goods ................... 111
30EB..... Publication of requirements ............................................................ 113
30EC..... Criminal offences for non‑compliance with requirements .............. 113
30ECA.. Civil penalty for non‑compliance with requirements ..................... 114
30ED..... Powers of suspension and cancellation unaffected ......................... 114
Division 3--General 115
30F........ Criminal offences for goods exempt under section 18A not conforming to standards etc. 115
30FA..... Civil penalty for goods exempt under section 18A not conforming to standards etc. 117
30G....... Disposal of unused goods exempt under section 18A .................... 117
30H....... Record for goods exempt under section 18A .................................. 118
31.......... Secretary may require information ................................................. 119
31AAA. Civil penalty for providing false or misleading information in relation to medicines listed under section 26A 121
5>31A....... Secretary may require information etc. about goods exempt under section 18 122
5>31AA.... Secretary may require information etc. about goods exempt under section 18A 123
5>31B....... Secretary may require information relating to approvals and authorities under section 19 124
5>31C....... Criminal offence for failing to give information or documents sought under section 31A, 31AA or 31B 125
5>31D....... False or misleading information ...................................................... 125
31E........ False or misleading documents ....................................................... 126
31F........ Self‑incrimination ............................................................................ 127
Part 3‑3--Manufacturing of therapeutic goods 128
33A....... Application of this Part to medical devices .................................... 128
34.......... Exempt goods and exempt persons ................................................ 128
35.......... Criminal offences relating to manufacturing therapeutic goods ...... 128
35A....... Civil penalties relating to manufacturing therapeutic goods ........... 131
35B....... Criminal offences relating to breaching a condition of a licence ...... 132
35C....... Civil penalty relating to breaching a condition of a licence ............. 133
36.......... Manufacturing principles ............................................................... 133
37.......... Application for licence ................................................................... 134
38.......... Grant of licence ............................................................................... 135
39.......... Term of licence ............................................................................... 137
40.......... Conditions of licences ..................................................................... 138
41.......... Revocation and suspension of licences ........................................... 140
41A....... Publication of list of manufacturers etc. ......................................... 142
Chapter 4--Medical devices 143
Part 4‑1--Introduction 143
Division 1--Overview of this Chapter 143
41B....... General ............................................................................................ 143
41BA.... Requirements for medical devices (Parts 4‑2 and 4‑3) ................... 143
41BB..... Administrative processes (Parts 4‑4 to 4‑10) ................................ 143
41BC..... Enforcement (Part 4‑11) ................................................................. 144
Division 2--Interpretation 145
41BD.... What is a medical device ................................................................. 145
41BE..... Kinds of medical devices ................................................................ 146
41BEA.. Excluded purposes .......................................................................... 147
41BF..... System or procedure packs ............................................................ 147
41BG.... Manufacturers of medical devices .................................................. 147
41BH.... Meaning of compliance with essential principles ........................... 148
41BI...... Meaning of non‑application of conformity assessment procedures 149
Division 3--Application provisions 150
41BJ...... Application of this Chapter to medical devices covered by Part 3‑2 150
41BK.... Application of the Criminal Code .................................................. 150
Part 4‑2--Essential principles and medical device standards 151
41C....... What this Part is about ................................................................... 151
Division 1--Essential principles 152
41CA.... Essential principles ......................................................................... 152
Division 2--Medical device standards 153
41CB..... Medical device standards ................................................................ 153
41CC..... Content of medical device standards .............................................. 153
41CD.... Inconsistencies between medical device standards ......................... 154
Part 4‑3--Conformity assessment procedures 155
41D....... What this Part is about ................................................................... 155
Division 1--Conformity assessment procedures 156
41DA.... Conformity assessment procedures ............................................... 156
41DB.... Medical device classifications ......................................................... 157
Division 2--Conformity assessment standards 158
41DC.... Conformity assessment standards .................................................. 158
41DD.... Content of conformity assessment standards ................................ 158
41DE..... Inconsistencies between conformity assessment standards ........... 159
Part 4‑4--Conformity assessment certificates 160
41E........ What this Part is about ................................................................... 160
Division 1--Issuing conformity assessment certificates 161
41EA..... When conformity assessment certificates are required ................... 161
41EB..... Applications ................................................................................... 161
41EC..... Considering applications ................................................................ 162
41ED..... Time for making decisions on applications .................................... 164
41EE..... Procedure following making a decision whether to issue certificate 164
41EF..... Duration of certificate ..................................................................... 165
41EG..... Lapsing of applications .................................................................. 165
41EH..... Treating applications as having been refused ................................. 166
41EI...... Criminal offences for making a false statement .............................. 166
41EIA... Civil penalty for making a false statement ..................................... 167
Division 2--Conditions 168
41EJ...... Automatic conditions on conformity assessment certificates ........ 168
41EK..... Conditions imposed when conformity assessment certificates are issued 169
41EL..... Conditions imposed after issuing a conformity assessment certificate 170
Division 3--Suspension of conformity assessment certificates 171
41EM.... Suspension of conformity assessment certificates ......................... 171
41EN..... Notice of proposed suspension ...................................................... 171
41EO..... Duration of suspension .................................................................. 172
41EP..... Revocation of suspension ............................................................... 172
41EQ..... Powers of revocation of conformity assessment certificates unaffected 173
Division 4--Revocation of conformity assessment certificates 174
41ER..... Automatic revocation of conformity assessment certificates ......... 174
41ES...... Immediate revocation of conformity assessment certificates ......... 174
41ET..... Revocation of conformity assessment certificates after notice of proposed revocation 174
41EU..... Limiting revocation of conformity assessment certificates to some medical devices of a particular kind 175
41EV..... Publication of revocation etc. of conformity assessment certificates 176
41EW.... Date of effect of revocation etc. of conformity assessment certificates 176
Part 4‑5--Including medical devices in the Register 177
41F........ What this Part is about ................................................................... 177
Division 1--Including medical devices in the Register 178
41FA..... What this Division is about ............................................................ 178
41FB..... How this Division works ............................................................... 179
Subdivision A--Applications 179
41FC..... Applications ................................................................................... 179
41FD..... Matters to be certified .................................................................... 180
41FE..... Criminal offences for making a false statement .............................. 181
41FEA.. Civil penalty for making a false statement ..................................... 182
Subdivision B--Including kinds of medical devices in the Register 183
41FF..... Obligation to include kinds of medical devices in the Register ....... 183
41FG..... Notification of unsuccessful applications ...................................... 184
Subdivision C--Auditing of applications 184
41FH..... Selecting applications for auditing .................................................. 184
41FI...... Auditing of applications ................................................................. 184
41FJ...... Procedure following audits ............................................................. 185
41FK..... Lapsing of applications .................................................................. 185
Subdivision D--Miscellaneous 186
41FL..... Device number ................................................................................ 186
41FM.... Duration of inclusion in the Register .............................................. 186
Division 2--Conditions 187
41FN..... Conditions applying automatically ................................................ 187
41FO..... Conditions imposed when kinds of medical devices are included in the Register 189
41FP..... Conditions imposed after kinds of medical devices are included in the Register 190
Part 4‑6--Suspension and cancellation from the Register 191
Division 1--Suspension from the Register 191
Subdivision A--General power of suspension 191
41G....... What this Part is about ................................................................... 191
41GA.... Suspension of kinds of medical devices from the Register ............. 191
41GB.... Notice of proposed suspension must be given in certain cases ...... 192
41GC.... Duration of suspension .................................................................. 192
41GD.... Revocation of suspension ............................................................... 193
41GE..... Treating applications for revocation as having been refused .......... 194
Subdivision B--Suspension as a result of suspension under Part 4‑4 194
41GF..... Suspension of kinds of medical devices from the Register ............. 194
41GG.... Duration of suspension .................................................................. 195
41GH.... Revocation of suspension ............................................................... 195
Subdivision C--Effect of suspension 195
41GI...... Effect of suspension ....................................................................... 195
41GJ..... Powers of cancellation from Register unaffected ............................ 196
Division 2--Cancellation of entries from the Register 197
41GK.... Automatic cancellation of entries of kinds of medical devices from the Register 197
41GL..... Immediate cancellation of entries of kinds of medical devices from the Register 197
41GM... Cancellation of entries of kinds of medical devices from the Register after section 41JA notice 198
41GN.... Cancellation of entries of kinds of medical devices from the Register after notice of proposed cancellation 199
41GO.... Limiting cancellation of entries from Register to some medical devices of a particular kind 200
41GP..... Publication of cancellation of entry from Register ......................... 200
41GQ.... Date of effect of cancellation of entries from Register ................... 201
Part 4‑6A--Exempting medical devices to deal with emergencies 202
41GR.... What this Part is about ................................................................... 202
41GS..... Minister may make exemptions ..................................................... 202
41GT.... Conditions of exemptions ............................................................... 203
41GU.... Variation or revocation of exemption ............................................. 204
41GV.... Informing persons of exemption etc. .............................................. 205
41GW... Notification and tabling .................................................................. 205
41GX.... Exclusion of liability of the Commonwealth etc. ............................ 206
41GY.... Disposal of unused medical devices ............................................... 206
Part 4‑7--Other exemptions from including medical devices in the Register 207
41H....... What this Part is about ................................................................... 207
41HA.... Devices exempted from inclusion in the Register ........................... 207
41HB.... Exemptions for special and experimental uses ............................... 208
41HC.... Exemptions for medical practitioners ............................................. 209
Part 4‑8--Obtaining information 211
41J........ What this Part is about ................................................................... 211
Division 1--Information relating to compliance with requirements and other matters 212
41JA..... Secretary may require information ................................................. 212
41JB...... Complying with the Secretary's requirements ............................... 213
41JBA... Civil penalty for giving false or misleading information in purported compliance with a notice 214
41JC...... Self‑incrimination ............................................................................ 215
Division 2--Information relating to medical devices covered by exemptions 216
41JCA... Secretary may require information etc. about medical devices exempt under Part 4‑6A 216
41JD..... Secretary may require information etc. about devices exempted under section 41HA from inclusion in the Register ........................................................................................................ 216
41JE...... Secretary may require information relating to approvals under section 41HB 217
5>41JF...... Secretary may require information relating to authorities under section 41HC 219
5>41JG..... Criminal offences for failing to give information or documents sought under this Division 219
41JH..... False or misleading information ...................................................... 220
41JI....... False or misleading documents ....................................................... 220
41JJ....... Self‑incrimination ............................................................................ 221
Part 4‑9--Public notification and recovery of medical devices 222
41K....... What this Part is about ................................................................... 222
41KA.... Public notification and recovery of medical devices ....................... 222
41KB.... Publication of requirements ............................................................ 224
41KC.... Criminal offences for failing to comply with requirements relating to a kind of medical device 224
41KCA. Civil penalty for failing to comply with requirements relating to a kind of medical device 225
41KD.... Powers of suspension and cancellation unaffected ......................... 225
Part 4‑10--Assessment fees 227
41L........ What this Part is about ................................................................... 227
41LA..... Assessment fees ............................................................................. 227
41LB..... When assessment fee due for payment .......................................... 228
41LC..... Payment of assessment fee by instalments .................................... 228
41LD..... Recovery of assessment fee ............................................................ 228
41LE..... Reduction of conformity assessment fee where decision not made within prescribed period 228
Part 4‑11--Offences and civil penalty provisions relating to medical devices 230
41M...... What this Part is about ................................................................... 230
Division 1--Non‑compliance with essential principles 231
41MA... Criminal offences for importing, supplying or exporting a medical device that does not comply with essential principles ........................................................................................ 231
41MAA Civil penalties for importing, supplying or exporting a medical device that does not comply with essential principles ........................................................................................................ 235
41MB... Exceptions ...................................................................................... 236
41MC... Criminal offences relating to breaching a condition of a consent .... 236
41MCA Civil penalty relating to breaching a condition of a consent ........... 237
41MD... Treating medical devices as prohibited imports or exports ............ 238
Division 2--Failure to apply conformity assessment procedures 239
41ME.... Criminal offences for failing to apply conformity assessment procedures--manufacturers 239
41MEA. Civil penalties for failing to apply conformity assessment procedures--manufacturers 241
41MF.... Criminal offences for failing to apply conformity assessment procedures--sponsors 242
41MG... Exceptions ...................................................................................... 244
41MH... Criminal offence for making false statements in declarations ......... 244
41MHA Civil penalty for making false statements in declarations .............. 245
Division 3--Medical devices not included in the Register and related matters 246
41MI..... Criminal offences for importing, exporting, supplying or manufacturing a medical device not included in the Register ........................................................................................................ 246
41MIA.. Notice required to adduce evidence in support of exception under subsection 41MI(7) 248
41MIB.. Civil penalty for importing, exporting, supplying or manufacturing a medical device not included in the Register ........................................................................................................ 250
41MJ.... Treating medical devices as prohibited imports or exports ............ 251
41MK... Wholesale supply of medical devices not included in the Register 251
41ML.... False advertising about medical devices .......................................... 252
41MLA. Civil penalty for making misrepresentations about medical devices 252
41MM.. Claims about arranging supplies of medical devices not included in the Register 252
41MN... Criminal offences relating to breaches of conditions ...................... 253
41MNA Civil penalties for breaching conditions .......................................... 255
Division 3A--Offences and civil penalties related to exemptions under Part 4‑6A 256
41MNB Criminal offences for breaching a condition of an exemption ......... 256
41MNC Civil penalty for breaching a condition of an exemption ................ 257
41MND Civil penalty for making misrepresentations about medical devices 257
Division 4--Other offences and civil penalty provisions 258
41MO... Criminal offences for misusing medical devices exempted for special or experimental uses 258
41MP.... Criminal offence for failing to notify adverse events etc. ............... 260
41MPA. Civil penalty for failing to notify adverse events etc. .................... 261
41MPB. Relief from liability for contraventions for failing to notify adverse events etc. 263
41MQ... Notification of adverse events etc. where application withdrawn or lapses 263
41MR... Civil penalties for failing to notify adverse effects etc. where application withdrawn or lapses 264
Chapter 5--Advertising, counterfeit therapeutic goods and product tampering 266
Part 5‑1--Advertising and generic information 266
Division 1--Preliminary 266
42AA.... This Part not to apply to advertisements directed at health professionals etc. 266
42AB.... This Part not to apply to advertisements for goods not for human use 267
42AC.... This Part not to apply to advertisements for exported goods ....... 267
42B....... Definitions ...................................................................................... 267
Division 2--Therapeutic goods advertisements for which an approval is required 270
42BA.... Application of Division .................................................................. 270
42C....... Offences relating to publication of advertisements ........................ 270
Division 3--General provisions about advertising therapeutic goods 273
42DA.... Simplified outline ............................................................................ 273
42DB.... Definitions ...................................................................................... 273
42DD.... Restricted representations .............................................................. 273
42DE..... Applications for approval of use of restricted representation ....... 274
42DF..... Approval of use of restricted representation ................................. 274
42DG.... Notice of approval or refusal .......................................................... 274
42DH.... Variation of conditions of approval ................................................ 275
42DI...... Withdrawal of approval .................................................................. 275
42DJ..... Prohibited and required representations ......................................... 276
42DK.... Use of restricted or prohibited representations .............................. 276
Division 3A--Therapeutic goods advertisements for which an approval is not required 277
42DKA. Application of Division .................................................................. 277
42DKB. Certain representations not to be published or broadcast .............. 277
42DL..... Advertising offences ....................................................................... 277
42DM... Compliance with Code ................................................................... 279
Division 4--Generic information about ingredients or components of therapeutic goods 280
42DN.... Application of Division .................................................................. 280
42DO.... Compliance with the Code ............................................................. 280
42DP..... Offences--publication of generic information ................................ 280
Part 5‑2--Counterfeit therapeutic goods 281
42E........ Offence of dealing with counterfeit therapeutic goods ................... 281
42EA..... Civil penalty relating to dealing with counterfeit therapeutic goods 282
42EB..... Relief from liability for certain contraventions relating to dealing with counterfeit therapeutic goods 282
42F........ Customs treatment of counterfeit therapeutic goods ..................... 283
Part 5‑3--Product tampering 284
42T....... Notifying of actual or potential tampering ..................................... 284
42U....... Meaning of actual or potential tampering etc. ................................ 285
42V....... Recovery of therapeutic goods because of actual or potential tampering 285
42VA.... Civil penalty relating to the recovery of therapeutic goods because of actual or potential tampering 287
42VB..... Relief from liability for contraventions relating to the recovery of therapeutic goods because of actual or potential tampering ........................................................................................ 288
42W...... Supply etc. of therapeutic goods that are subject to recovery requirements 288
42X....... Saving of other laws ........................................................................ 289
Chapter 5A--Enforcement 290
Part 5A‑1--Civil penalties 290
Division 1--Obtaining an order for a civil penalty 290
42Y....... Federal Court may order person to pay pecuniary penalty for contravening civil penalty provision 290
42YA.... What is a civil penalty provision? ................................................... 291
42YB..... Meaning of penalty unit ................................................................. 291
42YC..... Persons involved in contravening civil penalty provision .............. 291
42YD.... Recovery of a pecuniary penalty ................................................... 291
42YE..... Gathering information for application for pecuniary penalty ........ 292
Division 2--Civil penalty proceedings and criminal proceedings 293
42YF..... Civil proceedings after criminal proceedings .................................. 293
42YG.... Criminal proceedings during civil proceedings ................................ 293
42YH.... Criminal proceedings after civil proceedings .................................. 293
42YI...... Evidence given in proceedings for civil penalty not admissible in criminal proceedings 293
Part 5A‑2--Infringement notices 295
42YJ...... Infringement notices in respect of offences .................................... 295
42YK.... Infringement notices in respect of civil penalty provisions ........... 295
Part 5A‑3--Enforceable undertakings 296
42YL..... Enforcement of undertakings .......................................................... 296
Chapter 6--Administration 297
Part 6‑1--Payment of charges 297
43.......... By whom charges payable .............................................................. 297
44.......... Time for payment of charges .......................................................... 297
44A....... Exemptions from liability to pay charges ....................................... 298
45.......... Therapeutic Goods Administration Account ................................. 300
Part 6‑2--Entry, searches and warrants 301
45A....... Definitions ...................................................................................... 301
46.......... Searches to monitor compliance with Act ...................................... 302
46A....... Searches of certain premises to monitor compliance with Act ....... 302
46B....... Searches and seizures on public health grounds ............................. 303
47.......... Searches and seizures related to offences and civil penalty provisions 304
48.......... General powers of authorised persons in relation to premises ...... 305
48A....... Details of warrant to be given to occupier etc. ............................... 306
48B....... Announcement before entry ........................................................... 307
48C....... Use of electronic equipment at premises ........................................ 307
48D....... Compensation for damage to electronic equipment ........................ 308
48E........ Copies of seized things to be provided .......................................... 309
48F........ Occupier entitled to be present during search ................................ 309
48G....... Receipts for things seized under warrant ....................................... 310
48H....... Retention of seized things .............................................................. 310
48J........ Magistrate may permit a thing to be retained ................................. 311
49.......... Monitoring warrants ....................................................................... 311
50.......... Offence and civil penalty provision related warrants ..................... 312
51.......... Offence and civil penalty provision related warrants by telephone 313
51A....... Searches at request of manufacturer ............................................... 315
51B....... Offences relating to warrants .......................................................... 315
52.......... Identity cards .................................................................................. 315
Part 6‑3--National Drugs and Poisons Schedule Committee 317
52A....... Definitions ...................................................................................... 317
52B....... Establishment and constitution of Committee ............................... 317
52C....... Functions of Committee ................................................................. 318
52D....... Poisons Standard ............................................................................ 318
52E........ Matters to be taken into account in exercising powers .................. 319
52EA..... Poisons Standard--validation etc. .................................................. 320
52EB..... Compensation for acquisition of property ..................................... 321
Part 6‑4--Complementary medicines 323
52F........ Definitions ...................................................................................... 323
52G....... Establishment and constitution of Committee ............................... 323
Chapter 7--Miscellaneous 324
53.......... Retention of material on withdrawal of application ....................... 324
53A....... Alternative verdicts for various offences ........................................ 324
54.......... Offences and forfeiture ................................................................... 325
54AA.... Offences for contravening conditions or requirements imposed under the regulations 326
54AB.... Criminal offence for damaging etc. documents ............................... 327
54AC.... Civil penalty for damaging etc. documents ..................................... 327
54A....... Time for bringing prosecutions ....................................................... 327
54B....... Application of this Act to an executive officer of a body corporate 327
54C....... Establishing whether an executive officer took reasonable steps to prevent the commission of an offence or the contravention of a civil penalty provision ...................................... 328
55.......... Conduct by directors, servants and agents ..................................... 329
56.......... Judicial notice ................................................................................. 330
56A....... Certificates to provide evidence of certain matters ........................ 331
57.......... Delegation ....................................................................................... 333
58.......... Export certifications ....................................................................... 334
59.......... Fees ................................................................................................. 335
60.......... Review of decisions ........................................................................ 335
60A....... New information on review--discretion to remit ........................... 337
61.......... Release of information .................................................................... 339
62.......... Consequential amendments ............................................................ 345
63.......... Regulations ..................................................................................... 345
Chapter 8--Repeal and transitional provisions 348
64.......... Interpretation .................................................................................. 348
65.......... Repeal ............................................................................................. 348
66.......... Transitional arrangements for goods required to be registered or listed .. 348
67.......... Transitional provision for therapeutic goods for export only ........ 350
68.......... Transitional arrangements for Part 3‑3 ........................................... 350
69.......... Continuation of standards and requirements .................................. 351
Schedule--Consequential Amendments 352
Notes 353
An Act relating to therapeutic goods
Notes to
the
Therapeutic Goods Act 1989 Note 1 The Therapeutic Goods Act 1989 as shown in this
compilation comprises Act
No. 21, 1990 amended as indicated in the Tables below. All relevant information pertaining to application, saving or
transitional provisions prior to 30 May 2000 is not included in this
compilation. For subsequent information see Table A. Table of Acts
|
Act |
Number |
Date |
Date of commencement |
Application, saving or transitional provisions |
|
21, 1990 |
17 Jan 1990 |
15 Feb 1991 |
|
|
|
Community Services and Health Legislation Amendment Act (No. 2) 1990 |
141, 1990 |
28 Dec 1990 |
Part 8 (ss. 78-81): (a) |
-- |
|
Community Services and Health Legislation Amendment Act 1991 |
84, 1991 |
26 June 1991 |
S. 14: 1 Aug 1991 (see s. 2(2) and Gazette 1991,
No. S207) |
Ss. 33-36 |
|
204, 1991 |
24 Dec 1991 |
24 Dec 1991 |
||
|
Health, Housing and Community Services Legislation Amendment Act 1992 |
88, 1992 |
30 June 1992 |
Ss. 82-88: Royal Assent (b) |
S. 83(2) |
|
Health and Community Services Legislation Amendment Act (No. 2) 1993 |
76, 1993 |
25 Nov 1993 |
Ss. 29(h) and |
|
|
85, 1995 |
1 July 1995 |
|||
|
6, 1996 |
11 June 1996 |
11 June 1996 |
S. 84 |
|
|
116, 1997 |
7 July 1997 |
Schedule 1 (Part 2 [items 2-14]): 1 Jan 1999 (see Gazette 1998, No. S609) |
-- |
|
|
as amended by |
|
|
|
|
|
3, 1999 |
29 Mar 1999 |
(see 3, 1999 below) |
-- |
|
|
152, 1997 |
24 Oct 1997 |
Schedule 2 (item 1249): 1 Jan 1998 (see Gazette 1997, No. GN49) (d) |
-- |
|
|
34, 1998 |
17 Apr 1998 |
17 Apr 1998 |
-- |
|
|
3, 1999 |
29 Mar 1999 |
Schedule 2: (e) |
-- |
|
|
Public Employment (Consequential and Transitional) Amendment Act 1999 |
146, 1999 |
11 Nov 1999 |
Schedule 1 (items 936-938): 5 Dec 1999 (see Gazette 1999, No. S584) (f) |
-- |
|
12, 2000 |
31 Mar 2000 |
31 Mar 2000 |
-- |
|
|
56, 2000 |
30 May 2000 |
30 May 2000 |
Sch. 1 (item 5) [see Table A] |
|
|
120, 2000 |
12 Sept 2000 |
Schedule 1: 10 Oct 2000 |
Sch. 1 (items 4, 6, 8, 10, 17) [see Table A] |
|
|
170, 2000 |
21 Dec 2000 |
22 June 2001 |
-- |
|
|
14, 2001 |
22 Mar 2001 |
22 Sept 2001 |
Sch. 1 (item 36) [see Table A] |
|
|
81, 2001 |
10 July 2001 |
S. 2(6): Royal Assent (g) |
S. 2(6) [see Table A] |
|
|
Health and Aged Care Legislation Amendment (Application of Criminal Code) Act 2001 |
111, 2001 |
17 Sept 2001 |
17 Sept 2001 |
S. 4 [see Table A] |
|
23, 2002 |
4 Apr 2002 |
4 Apr 2002 |
-- |
|
|
24, 2002 |
4 Apr 2002 |
Schedule 1: 4 Oct 2002 |
Sch. 1 (items 38, 46, 55) [see Table A] |
|
|
as amended by |
|
|
|
|
|
56, 2002 |
3 July 2002 |
Schedule 3 (item 22): (see 56, 2002 below) |
-- |
|
|
39, 2006 |
3 May 2006 |
Schedule 1 (item 158): (h) |
-- |
|
|
140, 2007 |
14 Sept 2007 |
Schedule 1 (items 7, 8): 3 Oct 2007 |
-- |
|
|
56, 2002 |
3 July 2002 |
Schedule 1 (items 6, 7), Schedule 3
(items 4, 22) and Schedule 4 (item 1): (i) |
Sch. 3 (items 20, 21) [see Table A] |
|
|
39, 2003 |
27 May 2003 |
Schedule 1 (items 1-19) and Schedule 2: 27 Nov 2003 |
Sch. 1 (items 41, 55, 60) [see Table A] |
|
|
120, 2004 |
16 Aug 2004 |
Schedule 7: 1 Jan 2005 |
Sch. 7 (item 7) [see Table A] |
|
|
8, 2005 |
22 Feb 2005 |
S. 4 and Schedule 1 (items 493, 496): Royal Assent |
S. 4 and Sch. 1 (item 496) [see Table A] |
|
|
2, 2006 |
1 Mar 2006 |
Schedule 1: 3 Apr 2006 (see F2006L00889) |
Sch. 1 (item 15) [see Table A] |
|
|
Therapeutic Goods Amendment (Repeal of Ministerial responsibility for approval of RU486) Act 2006 |
5, 2006 |
3 Mar 2006 |
3 Mar 2006 |
S. 3 [see Table A] |
|
39, 2006 |
3 May 2006 |
Schedule 1 (items 1-117, |
||
|
as amended by |
|
|
|
|
|
140, 2007 |
14 Sept 2007 |
Schedule 1 (items 4-6): 3 Oct 2007 |
-- |
|
|
National Health and Medical Research Council Amendment Act 2006 |
50, 2006 |
9 June 2006 |
Schedule 1: 1 July 2006 |
-- |
|
96, 2006 |
5 Sept 2006 |
5 Sept 2006 |
-- |
|
|
140, 2007 |
14 Sept 2007 |
3 Oct 2007 |
-- |
|
|
9, 2008 |
20 Mar 2008 |
20 Mar 2008 |
-- |
|
|
73, 2008 |
3 July 2008 |
Schedule 1 (item 47): (k) |
-- |
|
|
Therapeutic Goods Legislation Amendment (Annual Charges) Act 2008 |
96, 2008 |
3 Oct 2008 |
Schedule 1 (items 1-3): 1 Jan 2009 (see F2008L04263) |
Sch. 1 (item 3) [see Table A] |
|
Therapeutic Goods Amendment (Medical Devices and Other Measures) Act 2009 |
38, 2009 |
17 June 2009 |
Schedules 1, 2, |
Sch. 2 (item 4), Sch. 3 (item 23), Sch. 4 (item 20), Sch. 5 (item 3) and Sch. 6 (item 12) [see Table A] |
|
Therapeutic Goods Amendment (2009 Measures No. 1) Act 2009 |
76, 2009 |
27 Aug 2009 |
Schedules 1, 3, 6
and Schedule 7 (items 1-28): 28 Aug 2009 |
Sch. 1 (item 7), Sch. 2 (items 25, 26), Sch.
3 (item 16), Sch. 5 (item 5), Sch. 6 (item 14) and Sch. 7
(items |
|
Therapeutic Goods Amendment (2009 Measures No. 2) Act 2009 |
96, 2009 |
29 Sept 2009 |
Schedule 1: [see
Note 4 and Table A] |
Sch. 1 (item 13), Sch. 2 (item 4) and Sch. 3 (items 7, 10) [see Table A] |
(a) The Therapeutic Goods Act 1989 was amended by Part 8 (sections 78-81) only of the Community Services and Health Legislation Amendment Act (No. 2) 1990, subsection 2(6) of which provides as follows:
(6) Part 8 commences immediately after the commencement of the Therapeutic Goods Act 1989.
The Therapeutic Goods Act 1989 came into operation on 15 February 1991.
(b) The Therapeutic Goods Act 1989 was amended by sections 82-88 only of the Health, Housing and Community Services Legislation Amendment Act 1992, subsection 2(1) of which provides as follows:
(1) Subject to this section, this Act commences on the day on which it receives the Royal Assent.
(c) The Therapeutic Goods Act 1989 was amended by the Customs, Excise and Bounty Legislation Amendment Act 1995, subsections 2(1) and (5) of which provide as follows:
(1) Subject to subsections (2), (3), (4), (5) and (6), this Act commences on the day on which it receives the Royal Assent.
(5) Schedules 2 and 3, items 1, 26 to 45, 49 to 53 and 56 and 67 of Schedule 4, Schedule 6, items 6 to 11 of Schedule 7 and Schedules 8 and 10 commence on 1 July 1995.
(d) The Therapeutic Goods Act 1989 was amended by Schedule 2 (item 1249) only of the Audit (Transitional and Miscellaneous) Amendment Act 1997, subsection 2(2) of which provides as follows:
(2) Schedules 1, 2 and 4 commence on the same day as the Financial Management and Accountability Act 1997.
(e) Subsection 2(3) of the Therapeutic Goods Legislation Amendment Act 1999 provides as follows:
(3) Schedule 2 is taken to have commenced immediately after the commencement of Part 2 of Schedule 1 to the Therapeutic Goods Amendment Act 1997.
Part 2 of Schedule 1 commenced on 1 January 1999 (see Gazette 1998, No. S609) .
(f) The Therapeutic Goods Act 1989 was amended by Schedule 1 (items 936-938) only of the Public Employment (Consequential and Transitional) Amendment Act 1999, subsections 2(1) and (2) of which provide as follows:
(1) In this Act, commencing time means the time when the Public Service Act 1999 commences.
(2) Subject to this section, this Act commences at the commencing time.
(g) The Therapeutic Goods Act 1989 was amended by Schedule 3 (item 8) only of the Australia New Zealand Food Authority Amendment Act 2001, subsections 2(1)(a), (2) and (5) of which provide as follows:
(1) The following provisions commence on the day on which this Act receives the Royal Assent:
(a) sections 1, 2 and 3;
(2) Part 1 of Schedule 1 (other than item 120A), and Schedule 3, commence on the first day after the commencement of this section on which an amendment of the Australia New Zealand Joint Food Standards Agreement comes into force in accordance with Article 10 of that Agreement.
(5) As soon as practicable after the commencement of the following provisions:
(a) Part 1 of Schedule 1 (other than item 120A);
(b) Schedule 3;
the Minister must cause to be published in the Gazette a notice specifying the day on which those provisions commenced.
(h) The proposed amendments made by Schedule 2 (items 1-11, 13-23) of the Therapeutic Goods Amendment (Medical Devices) Act 2002 and Schedule 2 (item 12) of the Therapeutic Goods Amendment (Medical Devices) Act 2002 as amended by Schedule 1 (item 158) of the Therapeutic Goods Amendment Act (No. 1) 2006 were repealed by Schedule 1 (item 8) of the Therapeutic Goods Amendment Act 2007 before they commenced.
(i) Subsection 2(1) (items 2(b), 4, 6 and 7) of the Therapeutic Goods and Other Legislation Amendment Act 2002 provides as follows:
(1) Each provision of this Act specified in column 1 of the table commences, or is taken to have commenced, on the day or at the time specified in column 2 of the table.
|
Commencement information |
||
|
Column 1 |
Column 2 |
Column 3 |
|
Provision(s) |
Commencement |
Date/Details |
|
2. Schedule 1, items 6 and 7 |
The later of: (b) immediately after Schedule 1 to the Therapeutic Goods Amendment (Medical Devices) Act 2002 commences |
4 October 2002 |
|
4. Schedule 3, item 4 |
Immediately after item 22 of Schedule 3 commences, subject to subsection (3) |
4 October 2002 |
|
6. Schedule 3, item 22 |
Immediately after Schedule 1 to the Therapeutic Goods Amendment (Medical Devices) Act 2002 commences, subject to subsection (3) |
4 October 2002 |
|
7. Schedule 4, item 1 |
Immediately after Schedule 1 to the Therapeutic Goods Amendment (Medical Devices) Act 2002 commences |
4 October 2002 |
(j) Subsection 2(1) (item 4) of the Therapeutic Goods Amendment Act (No. 1) 2003 provides as follows:
(1) Each provision of this Act specified in column 1 of the table commences, or is taken to have commenced, on the day or at the time specified in column 2 of the table.
|
Provision(s) |
Commencement |
Date/Details |
|
4. Schedule 1, item 79 |
Immediately after the commencement of the Health and Aged Care Legislation Amendment (Application of Criminal Code) Act 2001 |
17 September 2001 |
(k) Subsection 2(1) (item 31) of the Statute Law Revision Act 2008 provides as follows:
(1) Each provision of this Act specified in column 1 of the table commences, or is taken to have commenced, in accordance with column 2 of the table. Any other statement in column 2 has effect according to its terms.
|
Provision(s) |
Commencement |
Date/Details |
|
31. Schedule 1, item 47 |
Immediately after the commencement of item 79 of Schedule 1 to the Therapeutic Goods Amendment Act (No. 1) 2003. |
17 September 2001 |
Table of Amendments
|
ad. = added or inserted am. = amended rep. = repealed rs. = repealed and substituted |
|
|
Provision affected |
How affected |
|
Chapter 1 |
|
|
Heading to Part 1............... |
rep. No. 24, 2002 |
|
Heading to Chapt. 1........... |
ad. No. 24, 2002 |
|
am. No. 141, 1990; No. 84, 1991; No. 88, 1992; No. 76, 1993; No. 6, 1996; No. 116, 1997; No. 34, 1998; No. 3, 1999; Nos. 12, 56, 120 and 170, 2000; Nos. 14, 81 and 111, 2001; No. 24, 2002 (as am. by No. 56, 2002); No. 56, 2002; No. 39, 2003; Nos. 5, 39 and 50, 2006; No. 9, 2008; Nos. 38, 76 and 96, 2009 |
|
|
ad. No. 116, 1997 |
|
|
|
am. No. 12, 2000 |
|
ad. No. 56, 2002 |
|
|
S. 3C.................................. |
ad. No. 38, 2009 |
|
rs. No. 204, 1991; No. 76, 1993; No. 3, 1999 |
|
|
|
am. No. 24, 2002 |
|
am. No. 39, 2006 |
|
|
ad. No. 111, 2001 |
|
|
|
rs. No. 39, 2006 |
|
am. No. 76, 1993 |
|
|
S. 6AA............................... |
ad. No. 6, 1996 |
|
|
am. No. 111, 2001 |
|
|
rep. No. 5, 2006 |
|
S. 6AB............................... |
ad. No. 6, 1996 |
|
|
rep. No. 5, 2006 |
|
S. 6A.................................. |
ad. No. 76, 1993 |
|
|
am. No. 146, 1999 |
|
|
rep. No. 56, 2002 |
|
ad. No. 56, 2002 |
|
|
ad. No. 56, 2002 |
|
|
|
am. No. 56, 2002 |
|
ad. No. 76, 1993 |
|
|
am. No. 76, 1993; No. 24, 2002 |
|
|
ad. No. 76, 1993 |
|
|
ad. No. 76, 1993 |
|
|
|
am. No. 24, 2002 |
|
S. 7C.................................. |
ad. No. 76, 2009 |
|
am. No. 84, 1991; No. 6, 1996; No. 111, 2001; No. 38, 2009 |
|
|
Chapter 2 |
|
|
Chapt. 2............................. |
ad. No. 24, 2002 |
|
ad. No. 24, 2002 |
|
|
|
am. No. 56, 2002 |
|
ad. No. 24, 2002 |
|
|
|
am. No. 140, 2007 |
|
ad. No. 24, 2002 |
|
|
|
am. No. 38, 2009 |
|
ad. No. 24, 2002 |
|
|
Chapter 3 |
|
|
Heading to Part 2............... |
rep. No. 24, 2002 |
|
Heading to Chapt. 3........... |
ad. No. 24, 2002 |
|
Note to Chapt. 3................. |
ad. No. 24, 2002 |
|
|
rs. No. 140, 2007 |
|
Part 3‑1 |
|
|
Heading to Part 3‑1............ |
ad. No. 24, 2002 |
|
am. No. 24, 2002; Nos. 38 and 76, 2009 |
|
|
Note to s. 10(1).................. |
ad. No. 76, 2009 |
|
ad. No. 24, 2002 |
|
|
rep. No. 76, 2009 |
|
|
rs. No. 38, 2009 |
|
|
am. No. 85, 1995; No. 6, 1996; No. 39, 2003 |
|
|
|
rs. No. 39, 2006 |
|
|
am. No. 38, 2009 |
|
ad. No. 39, 2006 |
|
|
am. No. 6, 1996; No. 111, 2001 |
|
|
|
rs. No. 39, 2006 |
|
|
am. No. 38, 2009 |
|
ad. No. 39, 2006 |
|
|
Part 3‑2 |
|
|
Heading to Part 3............... |
rep. No. 24, 2002 |
|
Heading to Part 3‑2............ |
ad. No. 24, 2002 |
|
Division 1 |
|
|
ad. No. 24, 2002 |
|
|
am. No. 141, 1990; No. 84, 1991; No. 76, 1993; No. 14, 2001; No. 24, 2002 |
|
|
S. 17.................................. |
am. No. 84, 1991; No. 3, 1999; No. 56, 2002 |
|
|
rep. No. 24, 2002 |
|
rs. No. 204, 1991 |
|
|
|
am. No. 120, 2000 |
|
ad. No. 23, 2002 |
|
|
|
am. No. 38, 2009 |
|
Note to s. 18A(7) |
|
|
Note 2 to s. 18A(7)............ |
ad. No. 39, 2006 |
|
Note to s. 18A(12)............. |
am. No. 39, 2006 |
|
am. No. 204, 1991; No. 6, 1996; No. 120, 2000 |
|
|
ad. No. 6, 1996 |
|
|
|
am. No. 76, 2009 |
|
ad. No. 39, 2006 |
|
|
|
am. No. 38, 2009 |
|
ad. No. 39, 2006 |
|
|
Heading to s. 20................. |
rs. No. 6, 1996; No. 39, 2006 |
|
am. No. 204, 1991; No. 85, 1995; No. 6, 1996; No. 56, 2000; No. 111, 2001; No. 23, 2002; No. 39, 2003; No. 39, 2006; No. 38, 2009 |
|
|
Note to s. 20(1).................. |
ad. No. 23, 2002 |
|
|
rep. No. 39, 2006 |
|
Note to s. 20(1A)............... |
ad. No. 111, 2001 |
|
|
rep. No. 39, 2006 |
|
ad. No. 39, 2006 |
|
|
am. No. 204, 1991; No. 6, 1996; No. 111, 2001; No. 23, 2002; No. 38, 2009 |
|
|
ad. No. 39, 2006 |
|
|
|
am. No. 38, 2009 |
|
ad. No. 39, 2006 |
|
|
am. No. 204, 1991; No. 6, 1996; No. 120, 2000; Nos. 14 and 111, 2001; No. 23, 2002; No. 39, 2003; No. 39, 2006; Nos. 38 and 96, 2009 |
|
|
Note 1 to s. 22(7AB).......... |
rs. No. 39, 2006 |
|
ad. No. 39, 2006 |
|
|
ad. No. 204, 1991 |
|
|
|
am. No. 6, 1996; No. 111, 2001; No. 39, 2003 |
|
|
rs. No. 39, 2006 |
|
|
am. No. 38, 2009 |
|
ad. No. 39, 2006 |
|
|
Division 2 |
|
|
S. 23AA............................. |
ad. No. 6, 1996 |
|
|
rep. No. 5, 2006 |
|
am. No. 84, 1991; No. 76, 1993 |
|
|
am. Nos. 84 and 204, 1991 |
|
|
ad. No. 84, 1991 |
|
|
|
am. No. 204, 1991 |
|
ad. No. 84, 1991 |
|
|
|
am. No. 24, 2002 |
|
ad. No. 84, 1991 |
|
|
ad. No. 204, 1991 |
|
|
|
am. No. 56, 2002; No. 76, 2009 |
|
ad. No. 88, 1992 |
|
|
Heading to s. 25................. |
rs. No. 6, 1996 |
|
am. Nos. 84 and 204, 1991; No. 76, 1993; No. 116, 1997; No. 12, 2000; Nos. 24 and 56, 2002; No. 39, 2003; No. 120, 2004; No. 2, 2006 |
|
|
Note to s. 25(1) ................. |
ad. No. 34, 1998 |
|
ad. No. 34, 1998 |
|
|
Heading to s. 25B.............. |
am. No. 56, 2002 |
|
ad. No. 116, 1997 |
|
|
|
am. No. 56, 2002 |
|
am. No. 76, 1993; No. 6, 1996; No. 116, 1997; No. 12, 2000; No. 14, 2001; Nos. 24 and 56, 2002; No. 39, 2003; No. 120, 2004; No. 2, 2006 |
|
|
Heading to s. 26AA........... |
am. No. 56, 2002 |
|
ad. No. 116, 1997 |
|
|
|
am. No. 56, 2002 |
|
Heading to s. 26A.............. |
rs. No. 14, 2001 |
|
ad. No. 6, 1996 |
|
|
|
am. No. 116, 1997; No. 12, 2000; No. 14, 2001; Nos. 24 and 56, 2002; No. 39, 2003; No. 120, 2004; No. 2, 2006; No. 76, 2009 |
|
ad. No. 120, 2004 |
|
|
|
am. No. 2, 2006; No. 38, 2009 |
|
ad. No. 2, 2006 |
|
|
ad. No. 120, 2004 |
|
|
|
am. No. 38, 2009 |
|
ad. No. 120, 2004 |
|
|
rs. No. 84, 1991 |
|
|
am. No. 84, 1991; No. 76, 1993; No. 3, 1999; No. 14, 2001; No. 39, 2003; No. 76, 2009 |
|
|
Note to s. 29...................... |
ad. No. 76, 2009 |
|
Heading to s. 29A.............. |
rs. No. 39, 2006 |
|
ad. No. 88, 1992 |
|
|
|
am. No. 6, 1996; No. 39, 2003; No. 39, 2006; No. 38, 2009 |
|
ad. No. 39, 2006 |
|
|
ad. No. 88, 1992 |
|
|
|
am. No. 6, 1996; No. 111, 2001; No. 39, 2003; No. 39, 2006; No. 38, 2009 |
|
ad. No. 39, 2006 |
|
|
Ss. 29D-29G..................... |
ad. No. 76, 2009 |
|
am. No. 88, 1992; No. 6, 1996; No. 34, 1998; No. 56, 2000; Nos. 14 and 111, 2001; No. 39, 2003; No. 39, 2006; No. 76, 2009 |
|
|
S. 30A................................ |
ad. No. 6, 1996 |
|
|
am. No. 111, 2001; No. 23, 2002 |
|
|
rep. No. 39, 2003 |
|
|
ad. No. 76, 2009 |
|
S. 30B................................ |
ad. No. 116, 1997 |
|
|
rep. No. 39, 2003 |
|
ad. No. 170, 2000 |
|
|
|
am. No. 96, 2009 |
|
Heading to s. 30D.............. |
am. No. 96, 2009 |
|
ad. No. 170, 2000 |
|
|
|
am. No. 96, 2009 |
|
ad. No. 170, 2000 |
|
|
Division 2A |
|
|
Div. 2A of Part 3‑2............. |
ad. No. 39, 2003 |
|
ad. No. 39, 2003 |
|
|
|
am. No. 39, 2006; No. 76, 2009 |
|
ad. No. 39, 2003 |
|
|
ad. No. 39, 2003 |
|
|
|
rs. No. 39, 2006 |
|
|
am. No. 38, 2009 |
|
ad. No. 39, 2006 |
|
|
Heading to s. 30ED............ |
am. No. 76, 2009 |
|
ad. No. 39, 2003 |
|
|
|
am. No. 76, 2009 |
|
Division 3 |
|
|
Heading to s. 30F............... |
am. No. 39, 2006 |
|
ad. No. 23, 2002 |
|
|
|
am. No. 39, 2006; No. 38, 2009 |
|
ad. No. 39, 2006 |
|
|
ad. No. 23, 2002 |
|
|
ad. No. 23, 2002 |
|
|
|
am. No. 38, 2009 |
|
am. No. 84, 1991; No. 76, 1993; No. 6, 1996; No. 34, 1998; Nos. 14 and 111, 2001; No. 39, 2003; No. 39, 2006; No. 38, 2009 |
|
|
ad. No. 39, 2006 |
|
|
Heading to s. 31A.............. |
rs. No. 23, 2002 |
|
ad. No. 120, 2000 |
|
|
|
am. No. 39, 2006 |
|
ad. No. 23, 2002 |
|
|
|
am. No. 39, 2006 |
|
ad. No. 120, 2000 |
|
|
|
am. No. 39, 2006 |
|
Heading to s. 31C.............. |
am. No. 23, 2002 |
|
|
rs. No. 39, 2006 |
|
ad. No. 120, 2000 |
|
|
|
am. No. 23, 2002 |
|
|
rs. No. 39, 2006 |
|
|
am. No. 38, 2009 |
|
ad. No. 120, 2000 |
|
|
|
am. No. 23, 2002; No. 39, 2006; No. 38, 2009 |
|
ad. No. 120, 2000 |
|
|
|
am. No. 39, 2006; No. 38, 2009 |
|
ad. No. 120, 2000 |
|
|
|
am. No. 39, 2006 |
|
S. 32.................................. |
am. Nos. 84 and 204, 1991; No. 76, 1993; No. 6, 1996 |
|
|
rep. No. 24, 2002 |
|
S. 33.................................. |
rep. No. 24, 2002 |
|
Part 3‑3 |
|
|
Heading to Part 4............... |
rep. No. 24, 2002 |
|
Heading to Part 3‑3............ |
ad. No. 24, 2002 |
|
ad. No. 24, 2002 |
|
|
am. No. 6, 1996; No. 111, 2001; No. 23, 2002; No. 39, 2003 |
|
|
|
rs. No. 39, 2006 |
|
|
am. No. 38, 2009 |
|
ad. No. 39, 2006 |
|
|
ad. No. 39, 2006 |
|
|
|
am. No. 38, 2009 |
|
ad. No. 39, 2006 |
|
|
am. No. 76, 2009 |
|
|
am. No. 76, 1993; No. 56, 2002; No. 96, 2006 |
|
|
am. No. 76, 1993; No. 34, 1998; No. 39, 2003; No. 39, 2006 |
|
|
am. No. 23, 2002 |
|
|
am. No. 76, 1993; No. 56, 2002; No. 39, 2003 |
|
|
am. No. 34, 1998; No. 23, 2002; No. 39, 2003; No. 39, 2006 |
|
|
S. 42.................................. ....................................... |
am. No. 76,
1993 |
|
Chapter 4 |
|
|
Chapt. 4............................. |
ad. No. 24, 2002 |
|
Note to Chapt. 4................. |
rs. No. 140, 2007 |
|
Part 4‑1 |
|
|
Division 1 |
|
|
ad. No. 24, 2002 |
|
|
|
am. No. 39, 2006 |
|
ad. No. 24, 2002 |
|
|
ad. No. 24, 2002 |
|
|
|
am. No. 38, 2009 |
|
ad. No. 24, 2002 |
|
|
|
am. No. 39, 2006 |
|
Note to s. 41BC.................. |
am. No. 39, 2006 |
|
Division 2 |
|
|
ad. No. 24, 2002 |
|
|
|
am. No. 76, 2009 |
|
S. 41BEA......................... a |
ad. No. 96, 2009 |
|
ad. No. 24, 2002 |
|
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ad. No. 24, 2002 |
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am. No. 76, 2009 |
|
ad. No. 24, 2002 |
|
|
Division 3 |
|
|
ad. No. 24, 2002 |
|
|
Part 4‑2 |
|
|
ad. No. 24, 2002 |
|
|
Note to s. 41C.................... |
am. No. 39, 2006 |
|
Division 1 |
|
|
ad. No. 24, 2002 |
|
|
Division 2 |
|
|
ad. No. 24, 2002 |
|
|
|
am. No. 76, 2009 |
|
Note to s. 41CB(1)............. |
ad. No. 76, 2009 |
|
ad. No. 24, 2002 |
|
|
|
am. No. 38, 2009 |
|
ad. No. 24, 2002 |
|
|
Part 4‑3 |
|
|
ad. No. 24, 2002 |
|
|
Note 1 to s. 41D................. |
am. No. 39, 2006 |
|
Division 1 |
|
|
ad. No. 24, 2002 |
|
|
Division 2 |
|
|
ad. No. 24, 2002 |
|
|
|
am. No. 76, 2009 |
|
Note to s. 41DC(1)............. |
ad. No. 76, 2009 |
|
ad. No. 24, 2002 |
|
|
Part 4‑4 |
|
|
ad. No. 24, 2002 |
|
|
Division 1 |
|
|
ad. No. 24, 2002 |
|
|
Note to s. 41EB(2)............. |
rs. No. 39, 2006 |
|
ad. No. 24, 2002 |
|
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|
am. No. 39, 2003; No. 39, 2006 |
|
ad. No. 24, 2002 |
|
|
ad. No. 24, 2002 |
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rs. No. 39, 2006 |
|
|
am. No. 38, 2009 |
|
ad. No. 39, 2006 |
|
|
Division 2 |
|
|
Note to heading of Div. 2... |
rs. No. 39, 2006 |
|
ad. No. 24, 2002 |
|
|
|
am. No. 76, 2009 |
|
ad. No. 24, 2002 |
|
|
Division 3 |
|
|
ad. No. 24, 2002 |
|
|
Division 4 |
|
|
ad. No. 24, 2002 |
|
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ad. No. 24, 2002 |
|
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|
am. No. 39, 2003; No. 39, 2006 |
|
ad. No. 24, 2002 |
|
|
Part 4‑5 |
|
|
ad. No. 24, 2002 |
|
|
Division 1 |
|
|
ad. No. 24, 2002 |
|
|
Note 2 to s. 41FA............... |
am. No. 39, 2006 |
|
ad. No. 24, 2002 |
|
|
Subdivision A |
|
|
ad. No. 24, 2002 |
|
|
Note to s. 41FC(2)............. |
rs. No. 39, 2006 |
|
ad. No. 24, 2002 |
|
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|
am. No. 39, 2003; No. 96, 2009 |
|
ad. No. 24, 2002 |
|
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am. No. 39, 2003 |
|
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rs. No. 39, 2006 |
|
|
am. No. 38, 2009 |
|
ad. No. 39, 2006 |
|
|
Subdivision B |
|
|
ad. No. 24, 2002 |
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am. No. 96, 2009 |
|
ad. No. 24, 2002 |
|
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Subdivision C |
|
|
ad. No. 24, 2002 |
|
|
Subdivision D |
|
|
ad. No. 24, 2002 |
|
|
Division 2 |
|
|
Note to heading of Div. 2... |
rs. No. 39, 2006 |
|
ad. No. 24, 2002 |
|
|
|
am. No. 39, 2006; No. 76, 2009 |
|
ad. No. 24, 2002 |
|
|
Part 4‑6 |
|
|
Division 1 |
|
|
Subdivision A |
|
|
ad. No. 24, 2002 |
|
|
ad. No. 24, 2002 |
|
|
Subdivision B |
|
|
ad. No. 24, 2002 |
|
|
Subdivision C |
|
|
ad. No. 24, 2002 |
|
|
Note to s. 41GI................... |
am. No. 39, 2006 |
|
ad. No. 24, 2002 |
|
|
Division 2 |
|
|
ad. No. 24, 2002 |
|
|
ad. No. 24, 2002 |
|
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|
am. No. 39, 2003 |
|
ad. No. 24, 2002 |
|
|
ad. No. 24, 2002 |
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|
am. No. 39, 2006 |
|
ad. No. 24, 2002 |
|
|
Part 4‑6A |
|
|
Part 4‑6A........................... |
ad. No. 38, 2009 |
|
Ss. 41GR-41GY................ |
ad. No. 38, 2009 |
|
Part 4‑7 |
|
|
Heading to Part 4‑7............ |
rs. No. 38, 2009 |
|
ad. No. 24, 2002 |
|
|
|
am. No. 38, 2009 |
|
ad. No. 24, 2002 |
|
|
Notes to s. 41HA(1), (2).... |
am. No. 39, 2006 |
|
ad. No. 24, 2002 |
|
|
Note to s. 41HB(2)............. |
am. No. 39, 2006 |
|
Note to s. 41HB(7)............. |
am. No. 39, 2006 |
|
ad. No. 24, 2002 |
|
|
Part 4‑8 |
|
|
ad. No. 24, 2002 |
|
|
|
am. No. 38, 2009 |
|
Note to s. 41J..................... |
am. No. 39, 2006 |
|
Division 1 |
|
|
ad. No. 24, 2002 |
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|
am. No. 39, 2003 |
|
ad. No. 24, 2002 |
|
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|
am. No. 39, 2006; No. 38, 2009 |
|
ad. No. 39, 2006 |
|
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ad. No. 24, 2002 |
|
|
|
am. No. 39, 2006 |
|
Division 2 |
|
|
S. 41JCA............................ |
ad. No. 38, 2009 |
|
ad. No. 24, 2002 |
|
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|
am. No. 39, 2006 |
|
ad. No. 24, 2002 |
|
|
|
rs. No. 39, 2006 |
|
|
am. No. 38, 2009 |
|
Note to s. 41JG.................. |
am. No. 38, 2009 |
|
ad. No. 24, 2002 |
|
|
|
am. No. 39, 2006; No. 38, 2009 |
|
Part 4‑9 |
|
|
ad. No. 24, 2002 |
|
|
ad. No. 24, 2002 |
|
|
|
am. No. 38, 2009 |
|
ad. No. 24, 2002 |
|
|
ad. No. 24, 2002 |
|
|
|
rs. No. 39, 2006 |
|
|
am. No. 38, 2009 |
|
ad. No. 39, 2006 |
|
|
ad. No. 24, 2002 |
|
|
Part 4‑10 |
|
|
ad. No. 24, 2002 |
|
|
ad. No. 24, 2002 |
|
|
Part 4‑11 |
|
|
Heading to Part 4‑11.......... |
rs. No. 39, 2006 |
|
ad. No. 24, 2002 |
|
|
|
am. No. 39, 2006; No. 38, 2009 |
|
Note to s. 41M.................... |
am. No. 39, 2006 |
|
Division 1 |
|
|
ad. No. 24, 2002 |
|
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|
am. No. 39, 2003 |
|
|
rs. No. 39, 2006 |
|
|
am. No. 38, 2009 |
|
ad. No. 39, 2006 |
|
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|
am. No. 38, 2009 |
|
ad. No. 24, 2002 |
|
|
|
am. No. 39, 2006 |
|
Note to s. 41MB(2)............. |
rep. No. 39, 2006 |
|
Notes 1, 2 to s. 41MB(2).... |
ad. No. 39, 2006 |
|
ad. No. 24, 2002 |
|
|
|
rs. No. 39, 2006 |
|
|
am. No. 38, 2009 |
|
ad. No. 39, 2006 |
|
|
ad. No. 24, 2002 |
|
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|
am. No. 39, 2006 |
|
Division 2 |
|
|
ad. No. 24, 2002 |
|
|
|
am. No. 39, 2003 |
|
|
rs. No. 39, 2006 |
|
|
am. No. 38, 2009 |
|
ad. No. 39, 2006 |
|
|
|
am. No. 38, 2009 |
|
ad. No. 24, 2002 |
|
|
|
am. No. 39, 2003 |
|
|
rs. No. 39, 2006 |
|
|
am. No. 38, 2009 |
|
ad. No. 24, 2002 |
|
|
|
am. No. 39, 2006 |
|
Note to s. 41MG(2)............ |
rep. No. 39, 2006 |
|
Notes 1, 2 to s. 41MG(2)... |
ad. No. 39, 2006 |
|
Heading to s. 41MH............ |
rs. No. 39, 2006 |
|
ad. No. 24, 2002 |
|
|
|
am. No. 39, 2003; No. 38, 2009 |
|
ad. No. 39, 2006 |
|
|
Division 3 |
|
|
ad. No. 24, 2002 |
|
|
|
am. No. 39, 2003 |
|
|
rs. No. 39, 2006 |
|
|
am. No. 38, 2009 |
|
ad. No. 39, 2006 |
|
|
ad. No. 39, 2006 |
|
|
|
am. No. 38, 2009 |
|
ad. No. 24, 2002 |
|
|
|
am. No. 39, 2006 |
|
ad. No. 24, 2002 |
|
|
|
am. No. 38, 2009 |
|
Heading to s. 41ML............ |
rs. No. 39, 2006; No. 96, 2009 |
|
ad. No. 24, 2002 |
|
|
|
am. No. 39, 2006; No. 38, 2009 |
|
|
rs. No. 96, 2009 |
|
ad. No. 39, 2006 |
|
|
ad. No. 24, 2002 |
|
|
|
am. No. 38, 2009 |
|
ad. No. 24, 2002 |
|
|
|
rs. No. 39, 2006 |
|
|
am. No. 38, 2009 |
|
ad. No. 39, 2006 |
|
|
Division 3A |
|
|
Div. 3A of Part 4‑11........... |
ad. No. 38, 2009 |
|
Ss. 41MNB-41MND............ |
ad. No. 38, 2009 |
|
Division 4 |
|
|
Heading to Div. 4 of........... |
rs. No. 39, 2006 |
|
ad. No. 24, 2002 |
|
|
|
rs. No. 39, 2006 |
|
|
am. No. 38, 2009 |
|
Heading to s. 41MP............ |
rs. No. 39, 2006 |
|
ad. No. 24, 2002 |
|
|
|
am. No. 39, 2006; No. 38, 2009 |
|
ad. No. 39, 2006 |
|
|
ad. No. 24, 2002 |
|
|
|
am. No. 39, 2006; No. 38, 2009 |
|
ad. No. 39, 2006 |
|
|
Chapter 5 |
|
|
Heading to Part 4A............. |
rep. No. 24, 2002 |
|
Heading to Chapt. 5........... |
ad. No. 24, 2002 |
|
Part 4A............................... |
ad. No. 3, 1999 |
|
Part 5‑1 |
|
|
Heading to Part 5‑1............ |
ad. No. 24, 2002 |
|
|
rs. No. 39, 2003 |
|
Division 1 |
|
|
Heading to Div. 1 of........... |
ad. No. 39, 2003 |
|
ad. No. 39, 2003 |
|
|
ad. No. 39, 2003 |
|
|
|
am. No. 38, 2009 |
|
S. 42A................................ |
ad. No. 3, 1999 |
|
|
rep. No. 39, 2003 |
|
ad. No. 3, 1999 |
|
|
|
am. No. 39, 2003; No. 38, 2009 |
|
Division 2 |
|
|
Heading to Div. 2 of........... |
ad. No. 39, 2003 |
|
ad. No. 39, 2003 |
|
|
ad. No. 3, 1999 |
|
|
|
rs. No. 39, 2003 |
|
|
am. No. 39, 2006 |
|
Notes to s. 42C(1), (2)....... |
ad. No. 39, 2006 |
|
Note to s. 42C(4)............... |
ad. No. 39, 2006 |
|
Note to s. 42C(6)............... |
ad. No. 39, 2006 |
|
S. 42D................................ |
ad. No. 3, 1999 |
|
|
rep. No. 39, 2003 |
|
Division 3 |
|
|
Div. 3 of Part 5‑1................ |
ad. No. 39, 2003 |
|
ad. No. 39, 2003 |
|
|
|
rs. No. 38, 2009 |
|
ad. No. 39, 2003 |
|
|
ad. No. 39, 2003 |
|
|
|
rep. No. 38, 2009 |
|
ad. No. 39, 2003 |
|
|
|
am. No. 38, 2009 |
|
Note to s. 42DD(1)............. |
ad. No. 38, 2009 |
|
ad. No. 39, 2003 |
|
|
Division 3A |
|
|
Heading to Div. 3A of......... |
ad. No. 38, 2009 |
|
Ss. 42DKA, 42DKB............ |
ad. No. 38, 2009 |
|
ad. No. 39, 2003 |
|
|
|
am. No. 38, 2009 |
|
ad. No. 39, 2003 |
|
|
Division 4 |
|
|
Div. 4 of Part 5‑1................ |
ad. No. 39, 2003 |
|
ad. No. 39, 2003 |
|
|
Part 5‑2 |
|
|
Heading to Part 4B............. |
rep. No. 24, 2002 |
|
Heading to Part 5‑2............ |
ad. No. 24, 2002 |
|
Part 4B............................... |
ad. No. 56, 2000 |
|
ad. No. 56, 2000 |
|
|
|
am. No. 39, 2003; No. 39, 2006; No. 38, 2009 |
|
ad. No. 39, 2006 |
|
|
ad. No. 56, 2000 |
|
|
Part 5‑3 |
|
|
Heading to Part 4C............. |
rep. No. 24, 2002 |
|
Heading to Part 5‑3............ |
ad. No. 24, 2002 |
|
Part 4C............................... |
ad. No. 120, 2000 |
|
ad. No. 120, 2000 |
|
|
|
am. No. 39, 2006; No. 38, 2009 |
|
ad. No. 120, 2000 |
|
|
ad. No. 120, 2000 |
|
|
|
am. No. 24, 2002; No. 39, 2006; No. 38, 2009 |
|
ad. No. 39, 2006 |
|
|
ad. No. 120, 2000 |
|
|
|
am. No. 39, 2006; No. 38, 2009 |
|
ad. No. 120, 2000 |
|
|
Chapter 5A |
|
|
Chapt. 5A........................... |
ad. No. 39, 2006 |
|
Part 5A‑1 |
|
|
Division 1 |
|
|
ad. No. 39, 2006 |
|
|
ad. No. 39, 2006 |
|
|
ad. No. 39, 2006 |
|
|
|
am. No. 38, 2009 |
|
Division 2 |
|
|
ad. No. 39, 2006 |
|
|
Part 5A‑2 |
|
|
ad. No. 39, 2006 |
|
|
Part 5A‑3 |
|
|
ad. No. 39, 2006 |
|
|
Chapter 6 |
|
|
Heading to Part 5............... |
rep. No. 24, 2002 |
|
Heading to Chapt. 6........... |
ad. No. 24, 2002 |
|
Part 6‑1 |
|
|
Heading to Part 6‑1............ |
ad. No. 24, 2002 |
|
am. No. 24, 2002 |
|
|
am. No. 84, 1991; No. 24, 2002 |
|
|
|
rs. No. 96, 2008 |
|
ad. No. 96, 2008 |
|
|
rs. No. 152, 1997 |
|
|
|
am. No. 24, 2002 |
|
|
rs. No. 8, 2005 |
|
Part 6‑2 |
|
|
Heading to Part 6............... |
rep. No. 6, 1996 |
|
Heading to Part 5A............. |
ad. No. 6, 1996 |
|
|
rep. No. 24, 2002 |
|
Heading to Part 6‑2............ |
ad. No. 24, 2002 |
|
ad. No. 6, 1996 |
|
|
|
am. No. 39, 2006 |
|
rs. No. 6, 1996 |
|
|
ad. No. 6, 1996 |
|
|
|
am. Nos. 23 and 24, 2002; Nos. 38 and 76, 2009 |
|
ad. No. 6, 1996 |
|
|
Heading to s. 47................. |
am. No. 39, 2006 |
|
am. No. 76, 1993 |
|
|
|
rs. No. 6, 1996 |
|
|
am. No. 39, 2006 |
|
am. No. 6, 1996; No. 111, 2001; Nos. 38 and 76, 2009 |
|
|
ad. No. 6, 1996 |
|
|
ad. No. 6, 1996 |
|
|
|
am. No. 39, 2006 |
|
ad. No. 6, 1996 |
|
|
ad. No. 6, 1996 |
|
|
|
am. No. 39, 2006 |
|
ad. No. 6, 1996 |
|
|
ad. No. 6, 1996 |
|
|
|
am. No. 39, 2006 |
|
am. No. 6, 1996 |
|
|
Heading to s. 50................. |
am. No. 39, 2006 |
|
am. No. 6, 1996; No. 39, 2006 |
|
|
Heading to s. 51................. |
am. No. 39, 2006 |
|
am. No. 6, 1996 |
|
|
ad. No. 76, 1993 |
|
|
ad. No. 6, 1996 |
|
|
|
am. No. 38, 2009 |
|
am. No. 6, 1996; No. 111, 2001; No. 38, 2009 |
|
|
Part 6‑3 |
|
|
Heading to Part 5B............. |
rep. No. 24, 2002 |
|
Heading to Part 6‑3............ |
ad. No. 24, 2002 |
|
Part 5B............................... |
ad. No. 3, 1999 |
|
ad. No. 3, 1999 |
|
|
ad. No. 3, 1999 |
|
|
|
am. No. 9, 2008 |
|
ad. No. 3, 1999 |
|
|
ad. No. 9, 2008 |
|
|
Part 6‑4 |
|
|
Heading to Part 5C............. |
rep. No. 24, 2002 |
|
Heading to Part 6‑4............ |
ad. No. 24, 2002 |
|
Part 5C............................... |
ad. No. 3, 1999 |
|
ad. No. 3, 1999 |
|
|
Chapter 7 |
|
|
Heading to Part 6............... |
ad. No. 6, 1996 |
|
|
rep. No. 24, 2002 |
|
Heading to Chapt. 7........... |
ad. No. 24, 2002 |
|
rs. No. 24, 2002 |
|
|
ad. No. 39, 2006 |
|
|
Heading to s. 54................. |
rs. No. 6, 1996; No. 39, 2006 |
|
am. No. 204, 1991; No. 76, 1993; No. 6, 1996; No. 24, 2002; No. 39, 2006 |
|
|
ad. No. 3, 1999 |
|
|
|
am. No. 111, 2001; No. 39, 2003; No. 73, 2008 |
|
Heading to s. 54AB............ |
rs. No. 39, 2006 |
|
ad. No. 39, 2003 |
|
|
|
am. No. 39, 2006; No. 38, 2009 |
|
ad. No. 39, 2006 |
|
|
ad. No. 6, 1996 |
|
|
ad. No. 39, 2006 |
|
|
am. No. 6, 1996; No. 39, 2006 |
|
|
am. No. 24, 2002; No. 38, 2009 |
|
|
ad. No. 6, 1996 |
|
|
|
am. No. 24, 2002; No. 39, 2006; Nos. 38 and 76, 2009 |
|
am. Nos. 84 and 204, 1991; No. 88, 1992; No. 6, 1996; No. 146, 1999; Nos. 23 and 24, 2002; No. 5, 2006; Nos. 38 and 96, 2009 |
|
|
am. No. 76, 1993 |
|
|
am. No. 6, 1996; No. 24, 2002; No. 39, 2003; No. 39, 2006; No. 76, 2009 |
|
|
ad. No. 6, 1996 |
|
|
|
am. No. 24, 2002 |
|
am. No. 84, 1991; No. 88, 1992; No. 76, 1993; No. 116, 1997; No. 34, 1998; Nos. 12 and 120, 2000; No. 24, 2002; No. 39, 2006; Nos. 38 and 76, 2009 |
|
|
am. No. 204, 1991; No. 76, 1993; No. 6, 1996; No. 34, 1998; No. 24, 2002 |
|
|
Chapter 8 |
|
|
Heading to Part 7............... |
rep. No. 24, 2002 |
|
Heading to Chapt. 8........... |
ad. No. 24, 2002 |
|
am. No. 76, 1993 |
|
|
Heading to s. 68................. |
am. No. 24, 2002 |
|
am. No. 24, 2002 |
|
|
Schedule |
|
|
Schedule............................ |
am. No. 141, 1990 |
Note 2
Therapeutic Goods Amendment (Medical Devices and Other Measures) Act 2009 (No. 38, 2009)
The following amendments commence on 17 December 2009 unless proclaimed earlier:
Schedule 3
1 Subsection 3(1)
Insert:
major interest holder of a body corporate means a person who:
(a) is in a position to cast, or control the casting of, more than one‑fifth of the maximum number of votes that might be cast at a general meeting of the body corporate; or
(b) holds more than one‑fifth of the issued share capital of the body corporate (excluding any part of that issued share capital that carries no right to participate beyond a specified amount in a distribution of either profits or capital).
2 Paragraphs 38(1)(g) to (i)
Repeal the paragraphs, substitute:
(g) at least one of the following persons:
(i) the applicant;
(ii) a person (a manager) who makes, or participates in making, decisions that affect the whole, or a substantial part, of the applicant's affairs;
(iii) if the applicant is a body corporate--a major interest holder of the body corporate;
has, within the 10 years immediately before the application:
(iv) been convicted of an offence against this Act or a corresponding State law; or
(v) been convicted of an offence against a law of the Commonwealth or a law of a State or Territory involving fraud or dishonesty; or
(vi) been ordered to pay a pecuniary penalty for the contravention of a civil penalty provision of this Act or a corresponding State law; or
(vii) been ordered to pay a pecuniary penalty for the contravention of a civil penalty provision of a law of the Commonwealth or a law of a State or Territory involving fraud or dishonesty; or
(viii) breached a condition of a manufacturing licence; or
(ix) had a manufacturing licence suspended or revoked; or
(x) been a manager, or a major interest holder, of a body corporate in respect of which subparagraph (iv), (v), (vi), (vii), (viii) or (ix) applies in that 10 year period, if the conduct resulting in that subparagraph applying occurred when the person was a manager or major interest holder of the body corporate; or
(h) any other circumstances prescribed by the regulations for the purposes of this paragraph exist.
3 Subsection 38(1A)
Repeal the subsection, substitute:
(1A) A reference in paragraph (1)(g) to a person convicted of an offence includes a reference to a person in respect of whom an order has been made relating to the offence under:
(a) section 19B of the Crimes Act 1914; or
(b) a corresponding provision of a law of a State or Territory.
Note: Section 19B of the Crimes Act 1914 empowers a court that has found a person to have committed an offence to take action without proceeding to record a conviction.
(1AA) Paragraph (1)(g) does not limit paragraph (1)(h).
4 Subsection 38(1B)
Omit "subsection (1A)", substitute "paragraph (1)(g)".
5 Subsection 38(2)
Omit "paragraphs (1)(g), (h) and (i)", substitute "paragraph (1)(g)".
6 Subsection 38(2)
Omit "one or more of those paragraphs", substitute "that paragraph".
7 After paragraph 40(4)(ab)
Insert:
(ac) give the Secretary the information specified in a notice under subsection (6) within the period, and in the manner, specified in the notice; and
8 At the end of section 40
Add:
(6) The Secretary may, by notice in writing given to the holder of a licence, require the holder to give the Secretary, within the specified period and in the specified manner, specified information to be used by the Secretary in deciding whether to revoke or suspend the licence under section 41 in the circumstances referred to in paragraph 41(1)(a).
(7) The period specified in a notice given under subsection (6) must be at least 14 days after the notice is given.
9 Paragraphs 41(1)(a) to (cd)
Repeal the paragraphs, substitute:
(a) at least one of the following persons:
(i) the holder;
(ii) a person (a manager) who makes, or participates in making, decisions that affect the whole, or a substantial part, of the holder's affairs;
(iii) if the holder is a body corporate--a major interest holder of the body corporate;
has:
(iv) been convicted of an offence against this Act or a corresponding State law; or
(v) been convicted of an offence against a law of the Commonwealth or a law of a State or Territory involving fraud or dishonesty; or
(vi) been ordered to pay a pecuniary penalty for the contravention of a civil penalty provision of this Act or a corresponding State law; or
(vii) been ordered to pay a pecuniary penalty for the contravention of a civil penalty provision of a law of the Commonwealth or a law of a State or Territory involving fraud or dishonesty; or
(viii) breached a condition of a manufacturing licence; or
(ix) had a manufacturing licence suspended or revoked; or
(x) been a manager, or a major interest holder, of a body corporate in respect of which subparagraph (iv), (v), (vi), (vii), (viii) or (ix) applies, if the conduct resulting in that subparagraph applying occurred when the person was a manager or major interest holder of the body corporate; or
10 At the end of subsection 41(1)
Add:
; or (h) any other circumstances prescribed by the regulations for the purposes of this paragraph exist.
11 Subsection 41(1A)
Repeal the subsection, substitute:
(1A) A reference in paragraph (1)(a) to a person convicted of an offence includes a reference to a person in respect of whom an order has been made relating to the offence under:
(a) section 19B of the Crimes Act 1914; or
(b) a corresponding provision of a law of a State or Territory.
Note: Section 19B of the Crimes Act 1914 empowers a court that has found a person to have committed an offence to take action without proceeding to record a conviction.
(1B) Paragraph (1)(a) does not limit paragraph (1)(h).
(1C) In paragraph (1)(a):
manufacturing licence means:
(a) a licence granted under this Part; or
(b) a licence, granted under a law of a State or Territory relating to therapeutic goods, relating to manufacturing therapeutic goods.
12 After section 41
Insert:
Nothing in section 40 or 41 affects the operation of Part VIIC of the Crimes Act 1914 (which includes provisions that, in certain circumstances, relieve persons from the requirement to disclose spent convictions and require persons aware of such convictions to disregard them).
13 Paragraphs 41EC(3)(a) to (c)
Repeal the paragraphs, substitute:
(a) whether at least one of the following persons:
(i) the applicant;
(ii) a person (a manager) who makes, or participates in making, decisions that affect the whole, or a substantial part, of the applicant's affairs;
(iii) if the applicant is a body corporate--a major interest holder of the body corporate;
has, within the 10 years immediately before the application:
(iv) been convicted of an offence against this Act or a corresponding State law; or
(v) been convicted of an offence against a law of the Commonwealth or a law of a State or Territory involving fraud or dishonesty; or
(vi) been ordered to pay a pecuniary penalty for the contravention of a civil penalty provision of this Act or a corresponding State law; or
(vii) been ordered to pay a pecuniary penalty for the contravention of a civil penalty provision of a law of the Commonwealth or a law of a State or Territory involving fraud or dishonesty; or
(viii) breached a condition of a conformity assessment certificate; or
(ix) had a conformity assessment certificate suspended or revoked; or
(x) been a manager, or a major interest holder, of a body corporate in respect of which subparagraph (iv), (v), (vi), (vii), (viii) or (ix) applies in that 10 year period, if the conduct resulting in that subparagraph applying occurred when the person was a manager or major interest holder of the body corporate; or
(b) whether any other circumstances prescribed by the regulations for the purposes of this paragraph exist.
14 Subsection 41EC(4)
Repeal the subsection, substitute:
(4) A reference in paragraph (3)(a) to a person convicted of an offence includes a reference to a person in respect of whom an order has been made relating to the offence under:
(a) section 19B of the Crimes Act 1914; or
(b) a corresponding provision of a law of a State or Territory.
Note: Section 19B of the Crimes Act 1914 empowers a court that has found a person to have committed an offence to take action without proceeding to record a conviction.
(5) Paragraph (3)(a) does not limit paragraph (3)(b).
15 Paragraph 41EG(c)
Omit "relating to a kind of medical device to which the application relates".
16 After subsection 41EJ(5)
Insert:
Conditions in regulations
(5A) A conformity assessment certificate is subject to any conditions prescribed by the regulations for the purposes of this subsection.
17 Paragraph 41ET(1)(c)
Repeal the paragraph, substitute:
(c) the Secretary gives to the person a notice under section 41JA that requires the person to give to the Secretary information or documents and the person fails to comply with that notice within a further 10 working days from the day specified in that notice; or
18 Paragraphs 41ET(1)(e) to (g)
Repeal the paragraphs, substitute:
(e) at least one of the following persons:
(i) the person (the holder) in relation to whom the certificate is issued;
(ii) a person (a manager) who makes, or participates in making, decisions that affect the whole, or a substantial part, of the holder's affairs;
(iii) if the holder is a body corporate--a major interest holder of the body corporate;
has:
(iv) been convicted of an offence against this Act or a corresponding State law; or
(v) been convicted of an offence against a law of the Commonwealth or a law of a State or Territory involving fraud or dishonesty; or
(vi) been ordered to pay a pecuniary penalty for the contravention of a civil penalty provision of this Act or a corresponding State law; or
(vii) been ordered to pay a pecuniary penalty for the contravention of a civil penalty provision of a law of the Commonwealth or a law of a State or Territory involving fraud or dishonesty; or
(viii) breached a condition of a conformity assessment certificate; or
(ix) had a conformity assessment certificate suspended or revoked; or
(x) been a manager, or a major interest holder, of a body corporate in respect of which subparagraph (iv), (v), (vi), (vii), (viii) or (ix) applies, if the conduct resulting in that subparagraph applying occurred when the person was a manager or major interest holder of the body corporate; or
(f) any other circumstances prescribed by the regulations for the purposes of this paragraph exist.
19 Subsection 41ET(1A)
Repeal the subsection, substitute:
(1A) A reference in paragraph (1)(e) to a person convicted of an offence includes a reference to a person in respect of whom an order has been made relating to the offence under:
(a) section 19B of the Crimes Act 1914; or
(b) a corresponding provision of a law of a State or Territory.
Note: Section 19B of the Crimes Act 1914 empowers a court that has found a person to have committed an offence to take action without proceeding to record a conviction.
(1B) Paragraph (1)(e) does not limit paragraph (1)(f).
20 At the end of section 41ET
Add:
(4) Nothing in this section affects the operation of Part VIIC of the Crimes Act 1914 (which includes provisions that, in certain circumstances, relieve persons from the requirement to disclose spent convictions and require persons aware of such convictions to disregard them).
21 After subsection 41JA(1)
Insert:
(1A) The Secretary may, by written notice given to a person who is an applicant for a conformity assessment certificate, require the person to give to the Secretary such further information concerning the application as is specified in the notice.
(1B) Requirements under subsections (1) and (1A) may be included in the same notice.
(1C) The Secretary may, by written notice given to a person who holds a conformity assessment certificate, require the person to give to the Secretary specified information to be used by the Secretary in deciding whether to suspend the certificate under section 41EM, or to revoke the certificate under section 41ET, in relation to the circumstances referred to in paragraph 41ET(1)(e).
(1D) Requirements under subsections (1) and (1C) may be included in the same notice.
22 At the end of section 41JA
Add:
(3) Nothing in this section affects the operation of Part VIIC of the Crimes Act 1914 (which includes provisions that, in certain circumstances, relieve persons from the requirement to disclose spent convictions and require persons aware of such convictions to disregard them).
As at 8 October 2009 the amendments are not incorporated in this compilation.
Note 3
Therapeutic Goods Amendment (2009 Measures No. 1)
Act 2009
(No. 76, 2009)
The following amendments commence on 27 February 2010 unless proclaimed earlier:
Schedule 2
1 Subsection 3(1) (definition of manufacturing premises)
Repeal the definition.
2 Subsection 3(1)
Insert:
manufacturing site means premises:
(a) that are for use in the manufacture of a particular kind of therapeutic goods; and
(b) at which the same persons have control of the management of the production of the goods and the procedures for quality control.
3 Subsection 3(1)
Insert:
manufacturing site authorisation means an authorisation referred to in subsection 38(2B) or 40B(4).
4 Paragraph 37(1)(c)
Omit "identify the manufacturing premises", substitute "in accordance with subsections (1A) and (1B), identify one or more manufacturing sites".
5 After subsection 37(1)
Insert:
Manufacturing sites
(1A) Subject to subsection (1B), an application under subsection (1) must relate to one manufacturing site only. This does not prevent other applications from relating to other manufacturing sites.
(1B) If an applicant is of the view that, having regard to the guidelines under section 38A, a licence could be granted covering 2 or more manufacturing sites, the applicant may:
(a) identify those sites in the application; and
(b) state the applicant's reasons for the applicant's view.
6 Paragraph 37(2)(b)
Omit "the premises,", substitute "each manufacturing site identified in the application and the".
Note: The following heading to subsection 37(2) is inserted "Further information".
7 Paragraph 37(2)(b)
Omit "on those premises", substitute "at that site".
Note: The following heading to subsection 37(3) is inserted "Applications or information may be given electronically".
8 Paragraph 38(1)(a)
Omit "particular manufacturing premises", substitute "one or more manufacturing sites".
9 Subsection 38(1)
Omit "to carry out those steps at those premises", substitute "covering one or more manufacturing sites specified in the licence".
10 Paragraph 38(1)(f)
Omit "the premises", substitute "one or more of the manufacturing sites identified in the application".
Note 1: The following heading to subsection 38(1A) is inserted "Interpretation".
Note 2: The following heading to subsection 38(2) is inserted "Special circumstances justifying grant of licence".
11 After subsection 38(2)
Insert:
Guidelines
(2A) The Secretary must have regard to the guidelines under section 38A in granting licences under this section.
What the licence authorises
(2B) For each manufacturing site covered by a licence, the Secretary must authorise, in the licence, the holder of the licence to carry out specified steps in the manufacture of specified therapeutic goods at that manufacturing site.
Note 1: For specification by class, see subsection 46(3) of the Acts Interpretation Act 1901.
Note 2: Sections 40A and 40B deal with variation of authorisations.
Note 1: The following heading to subsection 38(3) is inserted "Notice of decision".
Note 2: The following heading to subsection 38(4) is inserted "Publication in Gazette".
12 After section 38
Insert:
38A Guidelines for multi‑site licences
The Secretary must, by legislative instrument, make guidelines setting out the circumstances in which a licence may cover 2 or more manufacturing sites.
38B Splitting multi‑site licences
(1) This section applies if a licence (the old licence):
(a) either:
(i) was in force under this Part immediately before the commencement of this section; or
(ii) was suspended under this Part immediately before that commencement; and
(b) related to premises that comprise 2 or more sites (the old sites).
(2) As soon as practicable after the commencement of this section, the Secretary must:
(a) by writing, revoke the old licence; and
(b) on the day that the Secretary revokes the old licence, grant new licences (each of which is a new licence) to the holder of the old licence which, when considered together, cover the old sites.
The Secretary must give the holder written notice of the revocation and grant.
Note: Subsections (5) and (6) deal with when each new licence commences and when the old licence ends.
Guidelines
(3) The Secretary must have regard to the guidelines under section 38A in granting licences under this section.
Application of this Part
(4) Subject to this section, subsections 38(2B) and (4) and sections 39 to 41A apply to a new licence in the same way as they apply to a licence granted under section 38.
Note: This means, for example, that:
(a) the Secretary must give a manufacturing site authorisation under subsection 38(2B) in relation to each manufacturing site covered by a new licence; and
(b) the Secretary may impose conditions on a new licence under subsection 40(1) and the statutory conditions under subsection 40(4) will apply to a new licence; and
(c) the Secretary may revoke or suspend a new licence under section 41.
Commencement of new licence
(5) The day specified under subsection 39(1) for the commencement of each new licence granted to the holder of the old licence must be the day (the transition day) after the day each new licence is granted.
Note: Subsection (7) deals with suspending a new licence from the transition day.
When revocation of old licence takes effect
(6) The revocation of the holder's old licence takes effect immediately before the start of the transition day.
Suspension of new licence
(7) If:
(a) subparagraph (1)(a)(ii) applies in relation to an old licence;