Commonwealth Consolidated Acts Commonwealth Consolidated ActsAct No. 21 of 1990 as amended
This compilation was
prepared on 28 March 2012
taking into account amendments up to Act No. 77 of 2011
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
3AA...... Homoeopathic preparations and homoeopathic standards ................. 18
3AB...... Anthroposophic preparations and anthroposophic standards ............ 19
3A......... Declaration--member of European Community ............................... 20
3B......... Declaration--country covered by non-EC/EFTA MRA ................... 20
3C......... Exempting monographs in pharmacopoeias ...................................... 21
4............ Objects of Act ................................................................................... 21
5............ Act to bind Crown ............................................................................ 22
5A......... Application of the Criminal Code--extended geographical jurisdiction 22
6............ Operation of Act ............................................................................... 22
6AAA... Commonwealth consent to conferral of functions etc. on its officers and authorities by corresponding State laws 23
6AAB... When duty imposed .......................................................................... 23
6AAC... Imposing duty under State law .......................................................... 25
6AAD... Conferral of jurisdiction on federal courts ......................................... 25
6AAE.... Consequences of State law conferring duty, function or power on Commonwealth officer or Commonwealth authority .......................................................................................................... 26
6B......... Review of certain decisions under State laws .................................... 27
6C......... Fees payable to Commonwealth under State laws ............................. 27
7............ Declaration that goods are/are not therapeutic goods ......................... 27
7A......... Authorised persons ........................................................................... 28
7B......... Kits .................................................................................................... 29
7C......... Secretary may arrange for use of computer programs to make decisions 29
7D......... Form for product information for medicine ....................................... 30
8............ Power to obtain information with respect to therapeutic goods ......... 30
9............ Arrangements with States etc. ........................................................... 31
Chapter 2--Australian Register of Therapeutic Goods 32
9A......... Australian Register of Therapeutic Goods ........................................ 32
9B......... When registrations or listings of medical devices are taken to be cancelled 33
9C......... Inspection of entries in Register ........................................................ 35
9D......... Variation of entries in Register .......................................................... 35
9E.......... Publication of list of goods on Register ............................................ 38
Chapter 3--Medicines and other therapeutic goods that are not medical devices 39
Part 3-1--Standards 39
10.......... Determination of standards ............................................................... 39
10A....... Application of standards to medical devices ...................................... 40
13.......... Special provisions relating to Ministerial standards and default standards 40
13A....... Special provisions relating to homoeopathic standards and anthroposophic standards 42
14.......... Criminal offences for importing, supplying or exporting goods that do not comply with standards 42
14A....... Civil penalties for importing, supplying or exporting goods that do not comply with standards 47
14B....... Application of Customs Act 1901 ..................................................... 49
15.......... Criminal offences relating to breaching a condition of a consent ....... 49
15AA.... Civil penalty relating to breaching a condition of a consent ............... 50
15AB.... Conditions relating to exceptional release of biologicals ................... 51
Part 3-2--Registration and listing of therapeutic goods 52
Division 1--Preliminary 52
15A....... Application of this Part to medical devices ........................................ 52
15B....... Application of this Part to a biological .............................................. 54
16.......... Therapeutic goods and gazetted groups ............................................. 55
18.......... Exempt goods ................................................................................... 56
18A....... Exemption because of emergency ..................................................... 57
19.......... Exemptions for special and experimental uses .................................. 60
19A....... Exemptions where unavailability etc. of therapeutic goods ............... 62
19B....... Criminal offences relating to registration or listing etc. of imported, exported, manufactured and supplied therapeutic goods ................................................................................................ 64
19C....... Notice required to adduce evidence in support of exception under subsection 19B(6) 68
19D....... Civil penalties relating to registration or listing etc. of imported, exported, manufactured and supplied therapeutic goods .......................................................................................................... 69
20.......... Criminal offences relating to notifying the Secretary and to importing goods exempt under section 18A 71
20A....... Civil penalty relating to the importation, exportation, manufacture or supply of sponsored goods without proper notification ........................................................................................ 73
21.......... Offence relating to wholesale supply ................................................ 74
21A....... General criminal offences relating to this Part ................................... 74
21B....... General civil penalties relating to this Part ......................................... 79
22.......... General offences relating to this Part ................................................. 80
22AA.... Civil penalty for breaching a condition of an exemption ................... 82
22A....... Criminal offences for false statements in applications for registration 83
22B....... Civil penalty for false statements in applications for registration ....... 84
Division 2--Registration and listing 85
23.......... Applications generally ....................................................................... 85
24.......... Applications for registration .............................................................. 85
24A....... When evaluation fee due for payment ............................................... 86
24B....... Payment of evaluation fee by instalments .......................................... 86
24C....... Recovery of evaluation fee ................................................................ 87
24D....... Refund of evaluation fee where evaluation not completed within prescribed period 87
24E........ Deemed refusal of application ........................................................... 87
25.......... Evaluation and registration of therapeutic goods ............................... 88
25AA.... Approved product information for medicine ..................................... 92
25A....... When the Secretary must not use protected information .................... 93
25B....... Registration of therapeutic device to which EC/EFTA attestation of conformity applies 94
26.......... Listing of therapeutic goods .............................................................. 95
26AA.... Listing of therapeutic device to which EC/EFTA attestation of conformity applies 98
26A....... Listing of certain medicines ............................................................... 99
26B....... Certificates required in relation to patents ........................................ 102
26BA.... Approved form for notices .............................................................. 104
26BB..... Permissible ingredients ................................................................... 104
26BC..... Variation of determination under section 26BB --Minister's initiative 105
26BD.... Variation of determination under section 26BB --application by person 105
26C....... Certificates required in relation to patent infringement proceedings 106
26D....... Requirements for interlocutory injunction ....................................... 108
27.......... Registration or listing number ......................................................... 110
28.......... Conditions of registration or listing ................................................. 110
28A....... Certification of manufacturing steps outside Australia following application for listing 114
29.......... Duration of registration or listing .................................................... 114
29A....... Criminal offence for failing to notify adverse effects etc. of goods . 114
29AA.... Civil penalty for failing to notify adverse effects etc. of goods ....... 115
29B....... Notification of adverse effects etc. where application withdrawn or lapses 116
29C....... Civil penalties for failing to notify adverse effects etc. where application withdrawn or lapses 116
29D....... Suspension of registration or listing ................................................ 117
29E........ When suspension takes effect etc. ................................................... 118
29F........ Revocation of suspension ............................................................... 119
29G....... Effect of suspension ........................................................................ 119
30.......... Cancellation of registration or listing ............................................... 120
30A....... Revocation of cancellation of registration or listing upon request ... 123
30C....... Consultation with Gene Technology Regulator ............................... 123
30D....... Secretary may seek advice about classes of GM products or genetically modified organisms 124
30E........ Secretary to take advice into account ............................................... 124
Division 2A--Public notification and recovery of therapeutic goods 126
30EA..... Public notification and recovery of therapeutic goods ..................... 126
30EB..... Publication of requirements ............................................................. 128
30EC..... Criminal offences for non-compliance with requirements ............... 128
30ECA.. Civil penalty for non-compliance with requirements ....................... 129
30ED..... Powers of suspension and cancellation unaffected .......................... 129
Division 3--General 130
30F........ Criminal offences for goods exempt under section 18A not conforming to standards etc. 130
30FA..... Civil penalty for goods exempt under section 18A not conforming to standards etc. 132
30G....... Disposal of unused goods exempt under section 18A .................... 132
30H....... Record for goods exempt under section 18A .................................. 133
31.......... Secretary may require information .................................................. 133
31AAA. Civil penalty for providing false or misleading information in relation to medicines listed under section 26A 138
31A....... Secretary may require information etc. about goods exempt under section 18 138
31AA.... Secretary may require information etc. about goods exempt under section 18A 140
31B....... Secretary may require information relating to approvals and authorities under section 19 140
31C....... Criminal offence for failing to give information or documents sought under section 31A, 31AA or 31B 142
31D....... False or misleading information ...................................................... 142
31E........ False or misleading documents ....................................................... 143
31F........ Self-incrimination ............................................................................ 143
Part 3-2A--Biologicals 145
Division 1--Preliminary 145
32.......... What this Part is about .................................................................... 145
32A....... Meaning of biological ..................................................................... 145
32AA.... Biological classes ............................................................................ 146
32AB.... When biologicals are separate and distinct from other biologicals ... 146
Division 2--Main criminal offences and civil penalties 148
32B....... What this Division is about ............................................................. 148
32BA.... Criminal offences for importing a biological ................................... 148
32BB..... Criminal offences for exporting a biological ................................... 150
32BC..... Criminal offences for manufacturing a biological ............................ 152
32BD.... Criminal offences for supplying a biological ................................... 154
32BE..... Notice required to adduce evidence in support of exception to offences .. 157
32BF..... Civil penalties for importing, exporting, manufacturing or supplying a biological 159
32BG.... Criminal offence and civil penalty relating to a failure to notify the Secretary about manufacturing 162
32BH.... Criminal offence relating to wholesale supply ................................. 163
32BI...... Criminal offence for using a biological not included in the Register 164
32BJ...... General criminal offences relating to this Part ................................. 166
32BK..... Civil penalty for making misrepresentations about biologicals ........ 168
Division 3--Exemptions 169
Subdivision A--Preliminary 169
32C....... What this Division is about ............................................................. 169
Subdivision B--Exempting biologicals under the regulations 169
32CA.... Exempt biologicals .......................................................................... 169
Subdivision C--Exempting biologicals to deal with emergencies 170
32CB..... Minister may make exemptions ....................................................... 170
32CC..... Conditions of exemptions ............................................................... 171
32CD.... Variation or revocation of exemption .............................................. 172
32CE..... Informing persons of exemption etc. ............................................... 172
32CF..... Notification and tabling ................................................................... 173
32CG.... Disposal of unused biologicals ....................................................... 173
32CH.... Criminal offences for breaching a condition of an exemption ......... 174
32CI...... Civil penalty for breaching a condition of an exemption ................. 175
32CJ...... Criminal offences and civil penalty for biologicals not conforming to standards etc. 175
Subdivision D--Exempting biologicals for special and experimental uses 178
32CK..... Approvals for importing, exporting or supplying a biological for special and experimental uses 178
32CL..... Conditions of use of biological for experimental purposes in humans 179
32CM.... Exemptions for medical practitioners .............................................. 180
32CN.... Criminal offences relating to the giving of an authority to a medical practitioner 181
Subdivision E--Exempting biologicals where substitutes are unavailable etc. 183
32CO.... Approvals where substitutes for biologicals are unavailable etc. ..... 183
Division 4--Including biologicals in the Register 186
Subdivision A--Preliminary 186
32D....... What this Division is about ............................................................. 186
Subdivision B--Class 1 biologicals 186
32DA.... Application for inclusion in the Register ......................................... 186
32DB.... Inclusion of Class 1 biological in the Register ................................ 187
32DC.... Refusal to include Class 1 biological in the Register ....................... 188
Subdivision C--Biologicals other than Class 1 biologicals 188
32DD.... Application for inclusion in the Register ......................................... 188
32DE..... Evaluation of biologicals ................................................................. 189
32DF..... Inclusion of biological in the Register ............................................. 189
32DG.... Refusal to include biological in the Register .................................... 190
32DH.... Lapsing of application ..................................................................... 191
32DI...... Evaluation fee .................................................................................. 191
32DJ..... When evaluation fee due for payment ............................................. 192
32DK.... Payment of evaluation fee by instalments ........................................ 192
32DL..... Recovery of evaluation fee .............................................................. 192
32DM... Reduction of evaluation fee where evaluation not completed within prescribed period 192
Subdivision D--Transitional provisions for existing biologicals 193
32DN.... Transitional provisions for existing biologicals ............................... 193
Subdivision E--Criminal offences and civil penalties 196
32DO.... Criminal offences for false statements in applications for including biologicals in the Register 196
32DP..... Civil penalty for false statements in applications for including biologicals in the Register 197
32DQ.... Criminal offence and civil penalty for failing to notify adverse effects etc. of biological while it is included in the Register ........................................................................................................ 197
32DR.... Criminal offences and civil penalties for failing to notify adverse effects etc. of biological where application withdrawn or lapses .......................................................................................... 198
Subdivision F--Advice from Gene Technology Regulator 200
32DS..... Consultation with Gene Technology Regulator ............................... 200
32DT..... Secretary may seek advice about classes of GM products or genetically modified organisms 201
32DU.... Secretary to take advice into account ............................................... 201
Division 5--Conditions 202
32E........ What this Division is about ............................................................. 202
32EA..... Conditions applying automatically .................................................. 202
32EB..... Certification of manufacturing steps outside Australia .................... 204
32EC..... Imposition of conditions by legislative instrument .......................... 205
32ED..... Imposition of conditions at time biological included in the Register 205
32EE..... Imposition or variation or removal of conditions after biological included in the Register 205
32EF..... Criminal offences for breach of condition ....................................... 206
32EG..... Civil penalty for breach of condition ............................................... 207
Division 6--Suspension from the Register 208
32F........ What this Division is about ............................................................. 208
32FA..... Suspension of biological from the Register ..................................... 208
32FB..... When suspension takes effect etc. ................................................... 209
32FC..... Revocation of suspension ............................................................... 210
32FD..... Effect of suspension ........................................................................ 211
Division 7--Cancellation from the Register 212
32G....... What this Division is about ............................................................. 212
32GA.... Immediate cancellation of biological from the Register in various circumstances 212
32GB.... Immediate cancellation of biological from the Register after failure to comply with information gathering notice 213
32GC.... Cancellation of biological from the Register after notice of proposed cancellation 214
32GD.... Revocation of cancellation of biological upon request ..................... 215
32GE..... Publication of cancellation of entry from Register ........................... 215
32GF..... Date of effect of cancellation of entries from Register ..................... 216
Division 8--Public notification and recovery of biologicals 217
32H....... What this Division is about ............................................................. 217
32HA.... Public notification and recovery of biologicals ................................ 217
32HB.... Publication of requirements ............................................................. 220
32HC.... Criminal offences for non-compliance with requirements ............... 220
32HD.... Civil penalty for non-compliance with requirements ....................... 221
32HE..... Powers of suspension and cancellation unaffected .......................... 221
Division 9--Obtaining information or documents 222
Subdivision A--Preliminary 222
32J........ What this Division is about ............................................................. 222
Subdivision B--Obtaining information or documents for biologicals included or proposed to be included in the Register 222
32JA..... Secretary may require information or documents ............................ 222
32JB...... Criminal offences for failing to comply with a notice etc. ............... 224
32JC...... Civil penalty for giving false or misleading information or document in compliance with a notice 225
32JD..... Self-incrimination ............................................................................ 225
Subdivision C--Obtaining information or documents for biologicals covered by exemptions 226
32JE...... Secretary may require information etc. about biologicals exempt under the regulations 226
32JF...... Secretary may require information etc. about biologicals exempt to deal with emergencies 227
32JG..... Secretary may require information etc. about biologicals exempt for special and experimental uses 228
32JH..... Secretary may require information etc. about biologicals exempt where substitutes are unavailable etc. 230
32JI....... Criminal offences for failing to comply with a notice etc. ............... 230
32JJ....... Civil penalty for giving false or misleading information or document in compliance with a notice 231
32JK...... Self-incrimination ............................................................................ 231
Subdivision D--Inspecting, copying and retaining documents 232
32JL...... Secretary may inspect and copy documents .................................... 232
32JM..... Secretary may retain documents ...................................................... 232
Part 3-3--Manufacturing of therapeutic goods 233
33A....... Application of this Part to medical devices ...................................... 233
33B....... Application of this Part to biologicals ............................................. 233
34.......... Exempt goods and exempt persons ................................................. 233
35.......... Criminal offences relating to manufacturing therapeutic goods ....... 233
35A....... Civil penalties relating to manufacturing therapeutic goods ............. 236
35B....... Criminal offences relating to breaching a condition
of a
licence
............................................................................................. 237
35C....... Civil penalty relating to breaching a condition of a licence .............. 238
36.......... Manufacturing principles ................................................................ 238
37.......... Application for licence .................................................................... 239
38.......... Grant of licence ............................................................................... 241
38A....... Guidelines for multi-site licences .................................................... 243
38B....... Splitting multi-site licences .............................................................. 243
39.......... Term of licence ................................................................................ 245
40.......... Conditions of licences ..................................................................... 246
40A....... Variation of manufacturing site authorisations--Secretary's own initiative 249
40B....... Variation of licences--application by licence holder ....................... 249
41.......... Revocation and suspension of licences ........................................... 251
41AA.... Spent convictions scheme ............................................................... 254
41AAA. Transfer of licences ......................................................................... 254
41A....... Publication of list of manufacturers etc. .......................................... 254
Chapter 4--Medical devices 255
Part 4-1--Introduction 255
Division 1--Overview of this Chapter 255
41B....... General ............................................................................................ 255
41BA.... Requirements for medical devices (Parts 4-2 and 4-3) .................... 255
41BB..... Administrative processes (Parts 4-4 to 4-10) .................................. 255
41BC..... Enforcement (Part 4-11) .................................................................. 256
Division 2--Interpretation 257
41BD.... What is a medical device ................................................................. 257
41BE..... Kinds of medical devices ................................................................. 258
41BEA.. Excluded purposes .......................................................................... 259
41BF..... System or procedure packs ............................................................. 259
41BG.... Manufacturers of medical devices ................................................... 259
41BH.... Meaning of compliance with essential principles ............................ 260
41BI...... Meaning of non-application of conformity assessment procedures . 261
Division 3--Application provisions 262
41BJ...... Application of this Chapter to medical devices covered by Part 3-2 262
41BJA... Application of this Chapter to a biological ...................................... 262
41BK..... Application of the Criminal Code ................................................... 264
Part 4-2--Essential principles and medical device standards 265
41C....... What this Part is about .................................................................... 265
Division 1--Essential principles 266
41CA.... Essential principles .......................................................................... 266
Division 2--Medical device standards 267
41CB..... Medical device standards ................................................................ 267
41CC..... Content of medical device standards ............................................... 267
41CD.... Inconsistencies between medical device standards .......................... 268
Part 4-3--Conformity assessment procedures 269
41D....... What this Part is about .................................................................... 269
Division 1--Conformity assessment procedures 270
41DA.... Conformity assessment procedures ................................................. 270
41DB.... Medical device classifications ......................................................... 271
Division 2--Conformity assessment standards 272
41DC.... Conformity assessment standards ................................................... 272
41DD.... Content of conformity assessment standards .................................. 272
41DE..... Inconsistencies between conformity assessment standards ............. 273
Part 4-4--Conformity assessment certificates 274
41E........ What this Part is about .................................................................... 274
Division 1--Issuing conformity assessment certificates 275
41EA..... When conformity assessment certificates are required .................... 275
41EB..... Applications .................................................................................... 275
41EC..... Considering applications ................................................................. 276
41ED..... Time for making decisions on applications ..................................... 277
41EE..... Procedure following making a decision whether to issue certificate 278
41EF..... Duration of certificate ...................................................................... 278
41EG..... Lapsing of applications ................................................................... 278
41EH..... Treating applications as having been refused .................................. 279
41EI...... Criminal offences for making a false statement ............................... 280
41EIA... Civil penalty for making a false statement ....................................... 281
Division 2--Conditions 282
41EJ...... Automatic conditions on conformity assessment certificates ........... 282
41EK..... Conditions imposed when conformity assessment certificates are issued 284
41EL..... Conditions imposed after issuing a conformity assessment certificate 284
Division 3--Suspension of conformity assessment certificates 285
41EM.... Suspension of conformity assessment certificates ........................... 285
41EN..... Notice of proposed suspension ....................................................... 285
41EO..... Duration of suspension ................................................................... 286
41EP..... Revocation of suspension ............................................................... 286
41EQ..... Powers of revocation of conformity assessment certificates unaffected 287
Division 4--Revocation of conformity assessment certificates 288
41ER..... Automatic revocation of conformity assessment certificates ........... 288
41ES..... Immediate revocation of conformity assessment certificates ........... 288
41ET..... Revocation of conformity assessment certificates after notice of proposed revocation 288
41EU..... Limiting revocation of conformity assessment certificates to some medical devices of a particular kind 290
41EV..... Publication of revocation etc. of conformity assessment certificates 291
41EW.... Date of effect of revocation etc. of conformity assessment certificates 291
Part 4-5--Including medical devices in the Register 292
41F........ What this Part is about .................................................................... 292
Division 1--Including medical devices in the Register 293
41FA..... What this Division is about ............................................................. 293
41FB..... How this Division works ................................................................ 294
Subdivision A--Applications 294
41FC..... Applications .................................................................................... 294
41FD..... Matters to be certified ...................................................................... 295
41FE..... Criminal offences for making a false statement ............................... 296
41FEA.. Civil penalty for making a false statement ....................................... 298
Subdivision B--Including kinds of medical devices in the Register 298
41FF..... Obligation to include kinds of medical devices in the Register ........ 298
41FG..... Notification of unsuccessful applications ........................................ 299
Subdivision C--Auditing of applications 299
41FH..... Selecting applications for auditing ................................................... 299
41FI...... Auditing of applications .................................................................. 299
41FJ...... Procedure following audits ............................................................. 300
41FK..... Lapsing of applications ................................................................... 300
Subdivision D--Miscellaneous 301
41FL..... Device number ................................................................................ 301
41FM.... Duration of inclusion in the Register ............................................... 301
Division 2--Conditions 302
41FN..... Conditions applying automatically .................................................. 302
41FO..... Conditions imposed when kinds of medical devices are included in the Register 304
41FP..... Conditions imposed after kinds of medical devices are included in the Register 305
Part 4-6--Suspension and cancellation from the Register 306
Division 1--Suspension from the Register 306
Subdivision A--General power of suspension 306
41G....... What this Part is about .................................................................... 306
41GA.... Suspension of kinds of medical devices from the Register ............. 306
41GB.... Notice of proposed suspension must be given in certain cases ....... 307
41GC.... Duration of suspension ................................................................... 307
41GD.... Revocation of suspension ............................................................... 308
41GE..... Treating applications for revocation as having been refused ........... 309
Subdivision B--Suspension as a result of suspension under Part 4-4 309
41GF..... Suspension of kinds of medical devices from the Register ............. 309
41GG.... Duration of suspension ................................................................... 310
41GH.... Revocation of suspension ............................................................... 310
Subdivision C--Effect of suspension 310
41GI...... Effect of suspension ........................................................................ 310
41GJ..... Powers of cancellation from Register unaffected ............................ 311
Division 2--Cancellation of entries from the Register 312
41GK.... Automatic cancellation of entries of kinds of medical devices from the Register 312
41GL..... Immediate cancellation of entries of kinds of medical devices from the Register 312
41GM... Cancellation of entries of kinds of medical devices from the Register after section 41JA notice 313
41GN.... Cancellation of entries of kinds of medical devices from the Register after notice of proposed cancellation 314
41GO.... Limiting cancellation of entries from Register to some medical devices of a particular kind 315
41GP..... Publication of cancellation of entry from Register ........................... 315
41GQ.... Date of effect of cancellation of entries from Register ..................... 316
Part 4-6A--Exempting medical devices to deal with emergencies 317
41GR.... What this Part is about .................................................................... 317
41GS..... Minister may make exemptions ....................................................... 317
41GT..... Conditions of exemptions ............................................................... 318
41GU.... Variation or revocation of exemption .............................................. 319
41GV.... Informing persons of exemption etc. ............................................... 320
41GW... Notification and tabling ................................................................... 320
41GY.... Disposal of unused medical devices ................................................ 321
Part 4-7--Other exemptions from including medical devices in the Register 322
41H....... What this Part is about .................................................................... 322
41HA.... Devices exempted from inclusion in the Register ............................ 322
41HB.... Exemptions for special and experimental uses ................................ 323
41HC.... Exemptions for medical practitioners .............................................. 324
41HD.... Approvals if substitutes for medical devices are unavailable or in short supply 325
Part 4-8--Obtaining information 329
41J........ What this Part is about .................................................................... 329
Division 1--Information relating to compliance with requirements and other matters 330
41JA..... Secretary may require information .................................................. 330
41JB...... Complying with the Secretary's requirements ................................. 332
41JBA... Civil penalty for giving false or misleading information in purported compliance with a notice 333
41JC...... Self-incrimination ............................................................................ 334
Division 2--Information relating to medical devices covered by exemptions 335
41JCA... Secretary may require information etc. about medical devices exempt under Part 4-6A 335
41JD..... Secretary may require information etc. about devices exempted under section 41HA from inclusion in the Register ........................................................................................................ 335
41JE...... Secretary may require information relating to approvals under section 41HB 336
41JF...... Secretary may require information relating to authorities under section 41HC 338
41JFA... Secretary may require information relating to approvals under section 41HD 338
41JG..... Criminal offences for failing to give information or documents sought under this Division 339
41JH..... False or misleading information ...................................................... 339
41JI....... False or misleading documents ....................................................... 339
41JJ....... Self-incrimination ............................................................................ 340
Part 4-9--Public notification and recovery of medical devices 341
41K....... What this Part is about .................................................................... 341
41KA.... Public notification and recovery of medical devices ........................ 341
41KB..... Publication of requirements ............................................................. 344
41KC..... Criminal offences for failing to comply with requirements relating to a kind of medical device 344
41KCA.. Civil penalty for failing to comply with requirements relating to a kind of medical device 345
41KD.... Powers of suspension and cancellation unaffected .......................... 345
Part 4-10--Assessment fees 346
41L........ What this Part is about .................................................................... 346
41LA..... Assessment fees .............................................................................. 346
41LB..... When assessment fee due for payment ............................................ 347
41LC..... Payment of assessment fee by instalments ...................................... 347
41LD..... Recovery of assessment fee ............................................................ 347
41LE..... Reduction of conformity assessment fee where decision not made within prescribed period 347
Part 4-11--Offences and civil penalty provisions relating to medical devices 349
41M...... What this Part is about .................................................................... 349
Division 1--Non-compliance with essential principles 350
41MA... Criminal offences for importing, supplying or exporting a medical device that does not comply with essential principles ........................................................................................................ 350
41MAA Civil penalties for importing, supplying or exporting a medical device that does not comply with essential principles ........................................................................................................ 354
41MB.... Exceptions ....................................................................................... 355
41MC.... Criminal offences relating to breaching a condition of a consent ..... 355
41MCA. Civil penalty relating to breaching a condition of a consent ............. 356
41MD... Treating medical devices as prohibited imports or exports .............. 357
Division 2--Failure to apply conformity assessment procedures 358
41ME.... Criminal offences for failing to apply conformity assessment procedures--manufacturers 358
41MEA. Civil penalties for failing to apply conformity assessment procedures--manufacturers 360
41MF.... Criminal offences for failing to apply conformity assessment procedures--sponsors 361
41MG... Exceptions ....................................................................................... 363
41MH... Criminal offence for making false statements in declarations .......... 363
41MHA Civil penalty for making false statements in declarations ................ 364
Division 3--Medical devices not included in the Register and related matters 365
41MI..... Criminal offences for importing, exporting, supplying or manufacturing a medical device not included in the Register ........................................................................................................ 365
41MIA.. Notice required to adduce evidence in support of exception under subsection 41MI(7) 367
41MIB.. Civil penalty for importing, exporting, supplying or manufacturing a medical device not included in the Register 369
41MJ..... Treating medical devices as prohibited imports or exports .............. 370
41MK.... Wholesale supply of medical devices not included in the Register .. 370
41ML.... False advertising about medical devices .......................................... 371
41MLA. Civil penalty for making misrepresentations about medical devices 371
41MM... Claims about arranging supplies of medical devices not included in the Register 372
41MN... Criminal offences relating to breaches of conditions ....................... 372
41MNA Civil penalties for breaching conditions .......................................... 374
Division 3A--Offences and civil penalties related to exemptions under Part 4-6A 376
41MNB. Criminal offences for breaching a condition of an exemption ......... 376
41MNC. Civil penalty for breaching a condition of an exemption ................. 377
41MND Civil penalty for making misrepresentations about medical devices 377
Division 4--Other offences and civil penalty provisions 378
41MO... Criminal offences for misusing medical devices exempted for special or experimental uses 378
41MP.... Criminal offence for failing to notify adverse events etc. ................ 380
41MPA. Civil penalty for failing to notify adverse events etc. ....................... 382
41MPB. Relief from liability for contraventions for failing to notify adverse events etc. 383
41MQ... Notification of adverse events etc. where application withdrawn or lapses 384
41MR.... Civil penalties for failing to notify adverse effects etc. where application withdrawn or lapses 384
Chapter 5--Advertising, counterfeit therapeutic goods and product tampering 386
Part 5-1--Advertising and generic information 386
Division 1--Preliminary 386
42AA.... This Part not to apply to advertisements directed at health professionals etc. 386
42AB.... This Part not to apply to advertisements for goods not for human use 387
42AC.... This Part not to apply to advertisements for exported goods ........... 387
42B....... Definitions ...................................................................................... 387
42BAA. Therapeutic Goods Advertising Code ............................................. 389
Division 2--Therapeutic goods advertisements for which an approval is required 390
42BA.... Application of Division ................................................................... 390
42C....... Offences relating to publication of advertisements .......................... 390
Division 3--General provisions about advertising therapeutic goods 393
42DA.... Simplified outline ............................................................................ 393
42DB.... Definitions ...................................................................................... 393
42DD.... Restricted representations ................................................................ 393
42DE..... Applications for approval of use of restricted representation .......... 394
42DF..... Approval of use of restricted representation .................................... 394
42DG.... Notice of approval or refusal ........................................................... 394
42DH.... Variation of conditions of approval ................................................. 395
42DI...... Withdrawal of approval ................................................................... 395
42DJ..... Prohibited and required representations .......................................... 396
42DK.... Use of restricted or prohibited representations ................................ 396
Division 3A--Therapeutic goods advertisements for which an approval is not required 397
42DKA. Application of Division ................................................................... 397
42DKB.. Certain representations not to be published or broadcast ................. 397
42DL..... Advertising offences ....................................................................... 397
42DM... Compliance with Code .................................................................... 399
Division 4--Generic information about ingredients or components of therapeutic goods 400
42DN.... Application of Division ................................................................... 400
42DO.... Compliance with the Code .............................................................. 400
42DP..... Offences--publication of generic information ................................ 400
Part 5-2--Counterfeit therapeutic goods 401
42E........ Offence of dealing with counterfeit therapeutic goods .................... 401
42EA..... Civil penalty relating to dealing with counterfeit therapeutic goods . 402
42EB..... Relief from liability for certain contraventions relating to dealing with counterfeit therapeutic goods 402
42F........ Customs treatment of counterfeit therapeutic goods ........................ 403
Part 5-3--Product tampering 404
42T........ Notifying of actual or potential tampering ....................................... 404
42U....... Meaning of actual or potential tampering etc. ................................ 405
42V....... Recovery of therapeutic goods because of actual or potential tampering 405
42VA.... Civil penalty relating to the recovery of therapeutic goods because of actual or potential tampering 407
42VB.... Relief from liability for contraventions relating to the recovery of therapeutic goods because of actual or potential tampering ........................................................................................ 408
42W...... Supply etc. of therapeutic goods that are subject to recovery requirements 409
42X....... Saving of other laws ....................................................................... 410
Chapter 5A--Enforcement 411
Part 5A-1--Civil penalties 411
Division 1--Obtaining an order for a civil penalty 411
42Y....... Federal Court may order person to pay pecuniary penalty for contravening civil penalty provision 411
42YA.... What is a civil penalty provision? .................................................... 412
42YB.... Meaning of penalty unit .................................................................. 412
42YC.... Persons involved in contravening civil penalty provision ............... 412
42YD.... Recovery of a pecuniary penalty ..................................................... 412
42YE..... Gathering information for application for pecuniary penalty ........... 413
Division 2--Civil penalty proceedings and criminal proceedings 414
42YF..... Civil proceedings after criminal proceedings ................................... 414
42YG.... Criminal proceedings during civil proceedings ............................... 414
42YH.... Criminal proceedings after civil proceedings ................................... 414
42YI...... Evidence given in proceedings for civil penalty not admissible in criminal proceedings 414
Part 5A-2--Infringement notices 416
42YJ..... Infringement notices in respect of offences ..................................... 416
42YK.... Infringement notices in respect of civil penalty provisions .............. 416
Part 5A-3--Enforceable undertakings 417
42YL..... Enforcement of undertakings .......................................................... 417
Chapter 6--Administration 418
Part 6-1--Payment of charges 418
43.......... By whom charges payable .............................................................. 418
44.......... Time for payment of charges ........................................................... 418
44A....... Exemptions from liability to pay charges ........................................ 419
44B....... Recovery of unpaid charges ............................................................ 420
45.......... Therapeutic Goods Administration Account ................................... 421
Part 6-2--Entry, searches and warrants 423
45A....... Definitions ...................................................................................... 423
46.......... Searches to monitor compliance with Act ....................................... 424
46A....... Searches of certain premises to monitor compliance with Act ......... 424
46B....... Searches and seizures on public health grounds .............................. 426
47.......... Searches and seizures related to offences and civil penalty provisions 426
48.......... General powers of authorised persons in relation to premises ........ 427
48A....... Details of warrant to be given to occupier etc. ................................. 428
48B....... Announcement before entry ............................................................ 429
48C....... Use of electronic equipment at premises ......................................... 429
48D....... Compensation for damage to electronic equipment ......................... 431
48E........ Copies of seized things to be provided ............................................ 431
48F........ Occupier entitled to be present during search .................................. 432
48G....... Receipts for things seized under warrant ......................................... 432
48H....... Retention of seized things ............................................................... 432
48J........ Magistrate may permit a thing to be retained ................................... 433
49.......... Monitoring warrants ....................................................................... 433
50.......... Offence and civil penalty provision related warrants ....................... 434
51.......... Offence and civil penalty provision related warrants by telephone .. 435
51A....... Searches at request of manufacturer ................................................ 437
51B....... Offences relating to warrants .......................................................... 437
52.......... Identity cards ................................................................................... 438
Part 6-3--Scheduling of substances 439
52AA.... Overview ........................................................................................ 439
52A....... Definitions ...................................................................................... 439
52B....... Advisory Committee on Medicines Scheduling .............................. 440
52C....... Advisory Committee on Chemicals Scheduling .............................. 441
52CA.... Joint meetings ................................................................................. 441
52D....... Poisons Standard ............................................................................ 442
52E........ Secretary to take certain matters into account in exercising powers . 442
52EAA.. Application for amendment of the Poisons Standard ...................... 443
52EA..... Poisons Standard--validation etc. ................................................... 444
52EB..... Compensation for acquisition of property ....................................... 445
52EC..... Review of scheduling regime .......................................................... 446
Chapter 7--Miscellaneous 448
53.......... Retention of material on withdrawal of application ......................... 448
53A....... Alternative verdicts for various offences ......................................... 448
54.......... Offences and forfeiture ................................................................... 450
54AA.... Offences for contravening conditions or requirements imposed under the regulations 450
54AB.... Criminal offence for damaging etc. documents ............................... 451
54AC.... Civil penalty for damaging etc. documents ...................................... 451
54A....... Time for bringing prosecutions ....................................................... 452
54B....... Application of this Act to an executive officer of a body corporate . 452
54C....... Establishing whether an executive officer took reasonable steps to prevent the commission of an offence or the contravention of a civil penalty provision ........................................ 453
55.......... Conduct by directors, servants and agents ...................................... 453
56.......... Judicial notice .................................................................................. 455
56A....... Certificates to provide evidence of certain matters ........................... 455
57.......... Delegation ....................................................................................... 457
58.......... Export certifications ........................................................................ 460
59.......... Fees ................................................................................................. 460
60.......... Review of decisions ........................................................................ 460
60A....... New information on review--discretion to remit ............................ 463
61.......... Release of information .................................................................... 466
61A....... Immunity from civil actions ............................................................ 471
62.......... Consequential amendments ............................................................. 472
63.......... Regulations ..................................................................................... 472
Chapter 8--Repeal and transitional provisions 476
64.......... Interpretation ................................................................................... 476
65.......... Repeal ............................................................................................. 476
66.......... Transitional arrangements for goods required to be registered or listed 476
67.......... Transitional provision for therapeutic goods for export only .......... 478
68.......... Transitional arrangements for Part 3-3 ............................................ 478
69.......... Continuation of standards and requirements ................................... 479
Schedule--Consequential Amendments 480
Notes 481
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. |
-- |
|
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 |
-- |
|
|
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, 119-157): 31 May
2006 |
||
|
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 and 5-7:
18 June 2009 |
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: 1 July
2010 |
Sch. 1 (item 13), Sch. 2 (item 4) and Sch. 3 (items 7, 10) [see Table A] |
|
8, 2010 |
1 Mar 2010 |
Schedule 5 (item 124):
Royal Assent |
-- |
|
|
Therapeutic Goods Amendment (2009 Measures No. 3) Act 2010 |
54, 2010 |
31 May 2010 |
Schedule 1: 31 May
2011 |
Sch. 1 (items |
|
Therapeutic Goods Amendment (2010 Measures No. 1) Act 2010 |
141, 2010 |
15 Dec 2010 |
Schedule 1 and Schedule
2 (items 7A-21): 16 Dec 2010 |
Sch. 1A (item 10) and Sch. 2 (items 7, 21) [see Table A] |
|
Statute Law Revision Act 2011 |
5, 2011 |
22 Mar 2011 |
Schedule 7 (item 140): 19 Apr 2011 |
-- |
|
Acts Interpretation Amendment Act 2011 |
46, 2011 |
27 June 2011 |
Schedule 2 (items 1150-1156) and Schedule 3 (items 10, 11): 27 Dec 2011 |
Sch. 3 (items 10, 11) [see Table A] |
|
Therapeutic Goods Amendment (2011 Measures No. 1) Act 2011 |
77, 2011 |
25 July 2011 |
26 July 2011 |
Sch. 1 (items 6-8) [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 and 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 |
(l) Subsection 2(1) (items 31 and 38) of the Statute Law Revision Act 2010 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 5, items 1 to 51 |
The day this Act receives the Royal Assent. |
1 March 2010 |
|
38. Schedule 5, Parts 2 and 3 |
Immediately after the provision(s) covered by table item 31. |
1 March 2010 |
(m) Subsection 2(1) (item 5) of the Therapeutic Goods Amendment (2010 Measures No. 1) Act 2010 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 |
|
5. Schedule 2, Part 3 |
The later of: (a) immediately after the commencement of the provision(s) covered by table item 2; and (b) immediately after the commencement of Schedule 1 to the Therapeutic Goods Amendment (2009 Measures No. 3) Act 2010. |
31 May 2011 (paragraph (b) applies) |
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; Nos. 54 and 141, 2010; No. 5, 2011 |
|
|
Ss. 3AA, 3AB..................... |
ad. No. 76, 2009 |
|
ad. No. 116, 1997 |
|
|
|
am. No. 12, 2000 |
|
ad. No. 56, 2002 |
|
|
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; No. 54, 2010 |
|
ad. No. 76, 1993 |
|
|
am. No. 76, 1993; No. 24, 2002; No. 141, 2010 |
|
|
ad. No. 76, 1993 |
|
|
ad. No. 76, 1993 |
|
|
|
am. No. 24, 2002; No. 54, 2010 |
|
ad. No. 76, 2009 |
|
|
S. 7D.................................. |
ad. No. 141, 2010 |
|
am. No. 84, 1991; No. 6, 1996; No. 111, 2001; No. 38, 2009 |
|
|
am. No. 54, 2010 |
|
|
Chapter 2 |
|
|
Chapt. 2............................ |
ad. No. 24, 2002 |
|
ad. No. 24, 2002 |
|
|
|
am. No. 56, 2002; No. 54, 2010 |
|
ad. No. 24, 2002 |
|
|
|
am. No. 140, 2007 |
|
ad. No. 24, 2002 |
|
|
|
am. No. 38, 2009 |
|
ad. No. 24, 2002 |
|
|
|
am. Nos. 54 and 141, 2010; No. 77, 2011 |
|
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; No. 46, 2011 |
|
|
Note to s. 10(1)................. |
ad. No. 76, 2009 |
|
ad. No. 24, 2002 |
|
|
Ss. 11, 12.......................... |
rep. No. 76, 2009 |
|
Heading to s. 13............... |
am. No. 76, 2009 |
|
rs. No. 38, 2009 |
|
|
S. 13A................................ |
ad. No. 76, 2009 |
|
Subhead. to s. 14(5)......... |
rs. No. 54, 2010 |
|
am. No. 85, 1995; No. 6, 1996; No. 39, 2003 |
|
|
|
rs. No. 39, 2006 |
|
|
am. No. 38, 2009; No. 54, 2010 |
|
ad. No. 39, 2006 |
|
|
|
am. No. 54, 2010 |
|
ad. No. 39, 2006 |
|
|
am. No. 6, 1996; No. 111, 2001 |
|
|
|
rs. No. 39, 2006 |
|
|
am. No. 38, 2009 |
|
ad. No. 39, 2006 |
|
|
S. 15AB.............................. |
ad. No. 54, 2010 |
|
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 |
|
|
S. 15B................................ |
ad. No. 54, 2010 |
|
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; No. 54, 2010 |
|
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; No. 54, 2010 |
|
|
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; No. 141, 2010 |
|
|
am. Nos. 84 and 204, 1991; No. 77, 2011 |
|
|
ad. No. 84, 1991 |
|
|
|
am. No. 204, 1991; No. 77, 2011 |
|
ad. No. 84, 1991 |
|
|
|
am. No. 24, 2002 |
|
ad. No. 84, 1991 |
|
|
Heading to s. 24D............ |
am. No. 77, 2011 |
|
ad. No. 204, 1991 |
|
|
|
am. No. 56, 2002; No. 76, 2009; No. 77, 2011 |
|
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; Nos. 54 and 141, 2010 |
|
|
Note to s. 25(1)................. |
ad. No. 34, 1998 |
|
S. 25AA.............................. |
ad. No. 141, 2010 |
|
ad. No. 34, 1998 |
|
|
|
am. No. 54, 2010 |
|
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; No. 76, 2009; Nos. 54 and 141, 2010 |
|
|
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; Nos. 54 and 141, 2010 |
|
ad. No. 120, 2004 |
|
|
|
am. No. 2, 2006; No. 38, 2009 |
|
ad. No. 2, 2006 |
|
|
ad. No. 76, 2009 |
|
|
|
rs. No. 141, 2010 |
|
Heading to s. 26BC.......... |
am. No. 141, 2010 |
|
ad. No. 76, 2009 |
|
|
Heading to s. 26BD.......... |
am. No. 141, 2010 |
|
ad. No. 76, 2009 |
|
|
|
am. No. 141, 2010 |
|
ad. No. 76, 2009 |
|
|
|
rep. No. 141, 2010 |
|
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; No. 54, 2010 |
|
|
ad. 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 |
|
|
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; No. 141, 2010 |
|
|
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; No. 54, 2010 |
|
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; Nos. 54 and 141, 2010; No. 77, 2011 |
|
|
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 |
|
Part 3-2A |
|
|
Part 3-2A........................... |
ad. No. 54, 2010 |
|
Division 1 |
|
|
S. 32.................................. |
am. Nos. 84 and 204, 1991; No. 76, 1993; No. 6, 1996 |
|
|
rep. No. 24, 2002 |
|
|
ad. No. 54, 2010 |
|
S. 32A................................ |
ad. No. 54, 2010 |
|
Ss. 32AA, 32AB................. |
ad. No. 54, 2010 |
|
Division 2 |
|
|
S. 32B................................ |
ad. No. 54, 2010 |
|
Ss. 32BA-32BK................. |
ad. No. 54, 2010 |
|
Division 3 |
|
|
Subdivision A |
|
|
S. 32C................................ |
ad. No. 54, 2010 |
|
Subdivision B |
|
|
S. 32CA............................. |
ad. No. 54, 2010 |
|
Subdivision C |
|
|
S. 32CB............................. |
ad. No. 54, 2010 |
|
Note 1 to s. 32CB(1)......... |
am. No. 46, 2011 |
|
Ss. 32CC, 32CD................ |
ad. No. 54, 2010 |
|
Note to s. 32CD(1)........... |
am. No. 46, 2011 |
|
Ss. 32CE-32CJ................. |
ad. No. 54, 2010 |
|
Subdivision D |
|
|
Ss. 32CK-32CN................ |
ad. No. 54, 2010 |
|
Subdivision E |
|
|
S. 32CO............................. |
ad. No. 54, 2010 |
|
Division 4 |
|
|
Subdivision A |
|
|
S. 32D................................ |
ad. No. 54, 2010 |
|
Subdivision B |
|
|
Ss. 32DA-32DC................ |
ad. No. 54, 2010 |
|
Subdivision C |
|
|
Ss. 32DD-32DM............... |
ad. No. 54, 2010 |
|
Subdivision D |
|
|
S. 32DN............................. |
ad. No. 54, 2010 |
|
Subdivision E |
|
|
Ss. 32DO-32DR............... |
ad. No. 54, 2010 |
|
Subdivision F |
|
|
Ss. 32DS-32DU................ |
ad. No. 54, 2010 |
|
Division 5 |
|
|
S. 32E................................ |
ad. No. 54, 2010 |
|
Ss. 32EA-32EG................ |
ad. No. 54, 2010 |
|
Division 6 |
|
|
S. 32F................................ |
ad. No. 54, 2010 |
|
Ss. 32FA-32FD................. |
ad. No. 54, 2010 |
|
Division 7 |
|
|
S. 32G............................... |
ad. No. 54, 2010 |
|
Ss. 32GA-32GF................ |
ad. No. 54, 2010 |
|
Division 8 |
|
|
S. 32H................................ |
ad. No. 54, 2010 |
|
Ss. 32HA-32HE................ |
ad. No. 54, 2010 |
|
Division 9 |
|
|
Subdivision A |
|
|
S. 32J................................ |
ad. No. 54, 2010 |
|
Subdivision B |
|
|
Ss. 32JA-32JD................. |
ad. No. 54, 2010 |
|
Subdivision C |
|
|
Ss. 32JE-32JK.................. |
ad. No. 54, 2010 |
|
Subdivision D |
|
|
Ss. 32JL, 32JM................. |
ad. No. 54, 2010 |
|
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 |
|
|
S. 33B................................ |
ad. No. 54, 2010 |
|
am. No. 6, 1996; No. 111, 2001; No. 23, 2002; No. 39, 2003 |
|
|
|
rs. No. 39, 2006 |
|
|
am. No. 38, 2009; No. 54, 2010 |
|
ad. No. 39, 2006 |
|
|
|
am. No. 54, 2010 |
|
ad. No. 39, 2006 |
|
|
|
am. No. 38, 2009 |
|
ad. No. 39, 2006 |
|
|
am. No. 76, 2009 |
|
|
Subheads. to s. 37(2), (3) |
ad. No. 76, 2009 |
|
am. No. 76, 1993; No. 56, 2002; No. 96, 2006; No. 76, 2009 |
|
|
Subhead. to s. 38(1A)...... |
ad. No. 76, 2009 |
|
Subhead. to s. 38(2)......... |
ad. No. 76, 2009 |
|
Subheads. to s. 38(3), (4) |
ad. No. 76, 2009 |
|
am. No. 76, 1993; No. 34, 1998; No. 39, 2003; No. 39, 2006; Nos. 38 and 76, 2009 |
|
|
Note 1 to s. 38(2B)........... |
am. No. 46, 2011 |
|
ad. No. 76, 2009 |
|
|
am. No. 23, 2002; No. 54, 2010 |
|
|
am. No. 76, 1993; No. 56, 2002; No. 39, 2003; Nos. 38 and 76, 2009; No. 54, 2010 |
|
|
ad. No. 76, 2009 |
|
|
Note 1 to s. 40B(4)........... |
am. No. 46, 2011 |
|
am. No. 34, 1998; No. 23, 2002; No. 39, 2003; No. 39, 2006; Nos. 38 and 76, 2009; No. 54, 2010 |
|
|
ad. No. 38, 2009 |
|
|
ad. No. 76, 2009 |
|
|
S. 42.................................. ....................................... |
am. No. 76,
1993 |
|
am. No. 76, 2009 |
|
|
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 |
|
ad. No. 96, 2009 |
|
|
ad. No. 24, 2002 |
|
|
ad. No. 24, 2002 |
|
|
|
am. No. 76, 2009 |
|
ad. No. 24, 2002 |
|
|
Division 3 |
|
|
ad. No. 24, 2002 |
|
|
S. 41BJA............................ |
ad. No. 54, 2010 |
|
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; No. 46, 2011 |
|
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 |
|
|
|
am. No. 46, 2011 |
|
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 |
|
|
|
am. No. 39, 2003; No. 39, 2006; No. 38, 2009 |
|
ad. No. 24, 2002 |
|
|
|
am. No. 54, 2010 |
|
ad. No. 24, 2002 |
|
|
ad. No. 24, 2002 |
|
|
|
am. No. 38, 2009; No. 141, 2010 |
|
ad. No. 24, 2002 |
|
|
ad. No. 24, 2002 |
|
|
|
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. Nos. 38 and 76, 2009 |
|
ad. No. 24, 2002 |
|
|
Division 3 |
|
|
ad. No. 24, 2002 |
|
|
Division 4 |
|
|
ad. No. 24, 2002 |
|
|
ad. No. 24, 2002 |
|
|
|
am. No. 39, 2003; No. 39, 2006; No. 38, 2009 |
|
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 |
|
|
|
am. No. 39, 2003; No. 96, 2009 |
|
ad. No. 24, 2002 |
|
|
|
am. No. 39, 2003 |
|
|
rs. No. 39, 2006 |
|
|
am. No. 38, 2009 |
|
ad. No. 39, 2006 |
|
|
Subdivision B |
|
|
ad. No. 24, 2002 |
|
|
|
am. No. 96, 2009 |
|
ad. No. 24, 2002 |
|
|
Subdivision C |
|
|
ad. No. 24, 2002 |
|
|
ad. No. 24, 2002 |
|
|
|
am. No. 141, 2010 |
|
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 |
|
|
|
am. No. 39, 2003 |
|
ad. No. 24, 2002 |
|
|
ad. No. 24, 2002 |
|
|
|
am. No. 39, 2006 |
|
ad. No. 24, 2002 |
|
|
Part 4-6A |
|
|
Part 4-6A........................... |
ad. No. 38, 2009 |
|
ad. No. 38, 2009 |
|
|
S. 41GX............................. |
ad. No. 38, 2009 |
|
|
rep. No. 54, 2010 |
|
ad. No. 38, 2009 |
|
|
Part 4-7 |
|
|
Heading to Part 4-7.......... |
rs. No. 38, 2009 |
|
ad. No. 24, 2002 |
|
|
|
am. No. 38, 2009; No. 141, 2010 |
|
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 |
|
|
|
am. No. 54, 2010 |
|
S. 41HD............................. |
ad. No. 141, 2010 |
|
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 |
|
|
|
am. No. 39, 2003; Nos. 38 and 76, 2009 |
|
ad. No. 24, 2002 |
|
|
|
am. No. 39, 2006; No. 38, 2009 |
|
ad. No. 39, 2006 |
|
|
ad. No. 24, 2002 |
|
|
|
am. No. 39, 2006 |
|
Division 2 |
|
|
ad. No. 38, 2009 |
|
|
ad. No. 24, 2002 |
|
|
|
am. No. 39, 2006 |
|
S. 41JFA............................ |
ad. No. 141, 2010 |
|
ad. No. 24, 2002 |
|
|
|
rs. No. 39, 2006 |
|
|
am. No. 38, 2009; No. 141, 2010 |
|
Note to s. 41JG................ |
am. No. 38, 2009; No. 141, 2010 |
|
ad. No. 24, 2002 |
|
|
|
am. No. 39, 2006; No. 38, 2009; No. 141, 2010 |
|
Part 4-9 |
|
|
ad. No. 24, 2002 |
|
|
ad. No. 24, 2002 |
|
|
|
am. No. 38, 2009; Nos. 54, and 141, 2010 |
|
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 |
|
|
|
am. No. 39, 2003 |
|
|
rs. No. 39, 2006 |
|
|
am. No. 38, 2009 |
|
ad. No. 39, 2006 |
|
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am. No. 38, 2009 |
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ad. No. 24, 2002 |
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am. No. 39, 2006 |
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Note to s. 41MB(2)........... |
rep. No. 39, 2006 |
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Notes 1, 2 to s. 41MB(2).. |
ad. No. 39, 2006 |
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ad. No. 24, 2002 |
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rs. No. 39, 2006 |
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am. No. 38, 2009 |
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ad. No. 39, 2006 |
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ad. No. 24, 2002 |
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am. No. 39, 2006 |
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Division 2 |
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ad. No. 24, 2002 |
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am. No. 39, 2003 |
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rs. No. 39, 2006 |
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am. No. 38, 2009 |
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ad. No. 39, 2006 |
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am. No. 38, 2009 |
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ad. No. 24, 2002 |
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am. No. 39, 2003 |
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rs. No. 39, 2006 |
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am. No. 38, 2009 |
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ad. No. 24, 2002 |
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am. No. 39, 2006 |
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Note to s. 41MG(2)........... |
rep. No. 39, 2006 |
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Notes 1, 2 to s. 41MG(2).. |
ad. No. 39, 2006 |
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Heading to s. 41MH......... |
rs. No. 39, 2006 |
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ad. No. 24, 2002 |
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am. No. 39, 2003; No. 38, 2009 |
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ad. No. 39, 2006 |
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Division 3 |
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ad. No. 24, 2002 |
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am. No. 39, 2003 |
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rs. No. 39, 2006 |
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am. No. 38, 2009; No. 141, 2010 |
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ad. No. 39, 2006 |
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ad. No. 39, 2006 |
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am. No. 38, 2009; No. 141, 2010 |
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ad. No. 24, 2002 |
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am. No. 39, 2006 |
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ad. No. 24, 2002 |
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am. No. 38, 2009; No. 141, 2010 |
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Heading to s. 41ML.......... |
rs. No. 39, 2006; No. 96, 2009 |
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ad. No. 24, 2002 |
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am. No. 39, 2006; No. 38, 2009 |
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rs. No. 96, 2009 |
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ad. No. 39, 2006 |
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am. No. 141, 2010 |
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ad. No. 24, 2002 |
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am. No. 38, 2009 |
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ad. No. 24, 2002 |
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rs. No. 39, 2006 |
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am. No. 38, 2009; No. 141, 2010 |
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ad. No. 39, 2006 |
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Division 3A |
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Div. 3A of Part 4-11.......... |
ad. No. 38, 2009 |
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ad. No. 38, 2009 |
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Division 4 |
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Heading to Div. 4 of......... |
rs. No. 39, 2006 |
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ad. No. 24, 2002 |
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rs. No. 39, 2006 |
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am. No. 38, 2009 |
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Heading to s. 41MP......... |
rs. No. 39, 2006 |
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ad. No. 24, 2002 |
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am. No. 39, 2006; No. 38, 2009 |
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ad. No. 39, 2006 |
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ad. No. 24, 2002 |
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am. No. 39, 2006; No. 38, 2009 |
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ad. No. 39, 2006 |
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Chapter 5 |
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Heading to Part 4A........... |
rep. No. 24, 2002 |
|
Heading to Chapt. 5........ |
ad. No. 24, 2002 |
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Part 4A............................... |
ad. No. 3, 1999 |
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Part 5-1 |
|
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Heading to Part 5-1.......... |
ad. No. 24, 2002 |
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rs. No. 39, 2003 |
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Division 1 |
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Heading to Div. 1 of......... |
ad. No. 39, 2003 |
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ad. No. 39, 2003 |
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am. No. 76, 2009 |
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ad. No. 39, 2003 |
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ad. No. 39, 2003 |
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am. No. 38, 2009 |
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S. 42A................................ |
ad. No. 3, 1999 |
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rep. No. 39, 2003 |
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ad. No. 3, 1999 |
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am. No. 39, 2003; No. 38, 2009 |
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ad. No. 76, 2009 |
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Division 2 |
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Heading to Div. 2 of......... |
ad. No. 39, 2003 |
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ad. No. 39, 2003 |
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ad. No. 3, 1999 |
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rs. No. 39, 2003 |
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am. No. 39, 2006 |
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Notes to s. 42C(1), (2)..... |
ad. No. 39, 2006 |
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Note to s. 42C(4).............. |
ad. No. 39, 2006 |
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Note to s. 42C(6).............. |
ad. No. 39, 2006 |
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S. 42D................................ |
ad. No. 3, 1999 |
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rep. No. 39, 2003 |
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Division 3 |
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Div. 3 of Part 5-1............... |
ad. No. 39, 2003 |
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ad. No. 39, 2003 |
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rs. No. 38, 2009 |
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ad. No. 39, 2003 |
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S. 42DC............................. |
ad. No. 39, 2003 |
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rep. No. 38, 2009 |
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ad. No. 39, 2003 |
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am. Nos. 38 and 76, 2009 |
|
Note to s. 42DD(1)........... |
ad. No. 38, 2009 |
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ad. No. 39, 2003 |
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ad. No. 39, 2003 |
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am. No. 76, 2009 |
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ad. No. 39, 2003 |
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ad. No. 39, 2003 |
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am. No. 8, 2010 |
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Division 3A |
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Heading to Div. 3A of...... |
ad. No. 38, 2009 |
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ad. No. 38, 2009 |
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ad. No. 39, 2003 |
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am. No. 38, 2009; No. 54, 2010 |
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ad. No. 39, 2003 |
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Division 4 |
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Div. 4 of Part 5-1............... |
ad. No. 39, 2003 |
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ad. No. 39, 2003 |
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Part 5-2 |
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Heading to Part 4B........... |
rep. No. 24, 2002 |
|
Heading to Part 5-2.......... |
ad. No. 24, 2002 |
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Part 4B............................... |
ad. No. 56, 2000 |
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ad. No. 56, 2000 |
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am. No. 39, 2003; No. 39, 2006; No. 38, 2009 |
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ad. No. 39, 2006 |
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ad. No. 56, 2000 |
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Part 5-3 |
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Heading to Part 4C.......... |
rep. No. 24, 2002 |
|
Heading to Part 5-3.......... |
ad. No. 24, 2002 |
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Part 4C.............................. |
ad. No. 120, 2000 |
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ad. No. 120, 2000 |
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am. No. 39, 2006; No. 38, 2009 |
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ad. No. 120, 2000 |
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ad. No. 120, 2000 |
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am. No. 24, 2002; No. 39, 2006; No. 38, 2009; No. 54, 2010 |
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ad. No. 39, 2006 |
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ad. No. 120, 2000 |
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am. No. 39, 2006; No. 38, 2009 |
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ad. No. 120, 2000 |
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Chapter 5A |
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Chapt. 5A.......................... |
ad. No. 39, 2006 |
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Part 5A-1 |
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Division 1 |
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ad. No. 39, 2006 |
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ad. No. 39, 2006 |
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ad. No. 39, 2006 |
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am. No. 38, 2009 |
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Division 2 |
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ad. No. 39, 2006 |
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Part 5A-2 |
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ad. No. 39, 2006 |
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Part 5A-3 |
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ad. No. 39, 2006 |
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am. No. 8, 2010 |
|
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 |
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am. No. 24, 2002 |
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am. No. 84, 1991; No. 24, 2002 |
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rs. No. 96, 2008 |
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ad. No. 96, 2008 |
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ad. No. 54, 2010 |
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rs. No. 152, 1997 |
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am. No. 24, 2002 |
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rs. No. 8, 2005 |
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Part 6-2 |
|
|
Heading to Part 6............. |
rep. No. 6, 1996 |
|
Heading to Part 5A........... |
ad. No. 6, 1996 |
|
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rep. No. 24, 2002 |
|
Heading to Part 6-2.......... |
ad. No. 24, 2002 |
|
ad. No. 6, 1996 |
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am. No. 39, 2006 |
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rs. No. 6, 1996 |
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ad. No. 6, 1996 |
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am. Nos. 23 and 24, 2002; Nos. 38 and 76, 2009; Nos. 54 and 141, 2010 |
|
ad. No. 6, 1996 |
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Heading to s. 47............... |
am. No. 39, 2006 |
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am. No. 76, 1993 |
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rs. No. 6, 1996 |
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am. No. 39, 2006 |
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am. No. 6, 1996; No. 111, 2001; Nos. 38 and 76, 2009 |
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ad. No. 6, 1996 |
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ad. No. 6, 1996 |
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am. No. 39, 2006 |
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ad. No. 6, 1996 |
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ad. No. 6, 1996 |
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am. No. 39, 2006 |
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ad. No. 6, 1996 |
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ad. No. 6, 1996 |
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am. No. 39, 2006 |
|
am. No. 6, 1996 |
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|
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 |
|
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ad. No. 76, 1993 |
|
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ad. No. 6, 1996 |
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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 |
|
|
rs. No. 96, 2009 |
|
Part 5B............................... |
ad. No. 3, 1999 |
|
ad. No. 96, 2009 |
|
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ad. No. 3, 1999 |
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am. No. 96, 2009 |
|
ad. No. 3, 1999 |
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rs. No. 96, 2009 |
|
ad. No. 96, 2009 |
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ad. No. 3, 1999 |
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am. No. 9, 2008; No. 96, 2009 |
|
ad. No. 3, 1999 |
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rs. No. 96, 2009 |
|
ad. No. 96, 2009 |
|
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ad. No. 9, 2008 |
|
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ad. No. 96, 2009 |
|
|
Heading to Part 5C.......... |
rep. No. 24, 2002 |
|
Heading to Part 6-4.......... |
ad. No. 24, 2002 |
|
|
rep. No. 76, 2009 |
|
Part 5C.............................. |
ad. No. 3, 1999 |
|
Part 6-4.............................. |
rep. No. 76, 2009 |
|
Ss. 52F, 52G..................... |
ad. No. 3, 1999 |
|
|
rep. No. 76, 2009 |
|
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 |
|
|
|
am. No. 54, 2010 |
|
ad. No. 39, 2006 |
|
|
|
am. No. 54, 2010 |
|
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 |
|
|
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am. No. 39, 2006; No. 38, 2009 |
|
ad. No. 39, 2006 |
|
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ad. No. 6, 1996 |
|
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ad. No. 39, 2006 |
|
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am. No. 6, 1996; No. 39, 2006 |
|
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am. No. 24, 2002; Nos. 38 and 76, 2009 |
|
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ad. No. 6, 1996 |
|
|
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am. No. 24, 2002; No. 39, 2006; Nos. 38 and 76, 2009; Nos. 54 and 141, 2010 |
|
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; Nos. 54 and 141, 2010 |
|
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am. No. 76, 1993; No. 76, 2009 |
|
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am. No. 54, 2010 |
|
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am. No. 6, 1996; No. 24, 2002; No. 39, 2003; No. 39, 2006; No. 76, 2009; Nos. 54 and 141, 2010 |
|
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ad. No. 6, 1996 |
|
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am. No. 24, 2002; No. 54, 2010 |
|
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; No. 54, 2010 |
|
|
ad. No. 54, 2010 |
|
|
am. No. 204, 1991; No. 76, 1993; No. 6, 1996; No. 34, 1998; No. 24, 2002; No. 54, 2010 |
|
|
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 |
Table A
Application, saving or transitional provisions
Therapeutic Goods Amendment Act (No. 2) 2000 (No. 56, 2000)
Schedule 1
5 Application
The amendment of section 30 of the Therapeutic Goods Act 1989 by this Schedule applies to directions given, and requirements made, of persons after the commencement of the amendment.
Therapeutic Goods Amendment Act (No. 3) 2000 (No. 120, 2000)
Schedule 1
4 Saving
(1) Regulations in force for the purposes of subsection 18(1) of the Therapeutic Goods Act 1989 immediately before the commencement of the amendment of that subsection made by this Schedule have effect, after that commencement, as if they had been made for the purposes of that subsection after that commencement.
(2) Subitem (1) does not prevent the amendment or repeal of the regulations.
6 Application
Conditions specified in regulations made for the purposes of subsection 19(1A) of the Therapeutic Goods Act 1989 apply to an approval for the purpose mentioned in paragraph 19(1)(b) of that Act granted before or after the commencement of subsection 19(1A).
8 Application
Conditions specified in regulations made for the purposes of subsection 19(4A) of the Therapeutic Goods Act 1989 apply to an approval for the purpose mentioned in paragraph 19(1)(b) of that Act granted before or after the commencement of subsection 19(4A).
10 Application
Subsection 19(5B) of the Therapeutic Goods Act 1989 applies to an authority given under subsection 19(5) of that Act before or after the commencement of subsection 19(5B).
17 Application
(1) Subsections 31B(1) and (2) of the Therapeutic Goods Act 1989 apply to an approval granted under subsection 19(1) of that Act before or after the commencement of section 31B of that Act.
(2) Subsection 31B(3) of the Therapeutic Goods Act 1989 applies to an authority given under subsection 19(5) of that Act before or after the commencement of section 31B of that Act.
Therapeutic Goods Amendment Act 2001 (No. 14, 2001)
Schedule 1
36 Application of amendments
(1) The amendments made by this Schedule do not apply, and the Therapeutic Goods Act 1989 as in force immediately before the commencement of this Schedule continues to apply, in relation to any application made under that Act, before that commencement, for listing of therapeutic goods.
(2) However, the amendment made by item 5 of this Schedule applies, after that commencement, to therapeutic goods that were listed before that commencement.
(3) The amendment made by item 31 of this Schedule applies, after that commencement, to medicines listed under section 26A before that commencement.
Australia New Zealand Food Authority Amendment Act 2001 (No. 81, 2001)
2(6) In this section:
Australia New Zealand Joint Food Standards Agreement means the Agreement between the Government of Australia and the Government of New Zealand Establishing a System for the Development of Joint Food Standards, signed at Wellington on 5 December 1995.
Health and Aged Care Legislation Amendment (Application of Criminal Code) Act 2001 (No. 111, 2001)
(1) Each amendment made by this Act applies to acts and omissions that take place after the amendment commences.
(2) For the purposes of this section, if an act or omission is alleged to have taken place between 2 dates, one before and one on or after the day on which a particular amendment commences, the act or omission is alleged to have taken place before the amendment commences.
Therapeutic Goods Amendment (Medical Devices) Act 2002 (No. 24, 2002)
Schedule 1
38 Transitional for publication of list of goods on Register
The first list published under section 9E of the Therapeutic Goods Act 1989 after the commencement of this Schedule must be published within 12 months after the last list published under section 33 of the Therapeutic Goods Act 1989.
46 Saving of existing registrations and listings
(1) Despite the repeal of section 17 of the Therapeutic Goods Act 1989 by item 45, any therapeutic goods that, immediately before the commencement of this Schedule, were included in the Register are taken to be included in the Register after that commencement.
(2) Despite the repeal of subsection 17(5) of the Therapeutic Goods Act 1989, any notices that were in force immediately before the commencement of this Schedule, are taken to have been made under section 9A after that commencement.
55 Saving of existing requests for inspection or variation of the Register
(1) A request for a copy of an entry in the Register under section 32 of the Therapeutic Goods Act 1989:
(a) that was made before the commencement of this Schedule; and
(b) that was not dealt with before that commencement;
is taken, after that commencement, to be a request made under section 9C of the Therapeutic Goods Act 1989 as in force after that commencement.
(2) A request for a variation of an entry in the Register under section 32 of the Therapeutic Goods Act 1989:
(a) that was made before the commencement of this Schedule; and
(b) that was not dealt with before that commencement;
is taken, after that commencement, to be a request made under section 9D of the Therapeutic Goods Act 1989 as in force after that commencement.
Therapeutic Goods and Other Legislation Amendment Act 2002 (No. 56, 2002)
Schedule 3
20 Application
(1) The amendment made by item 12 applies in relation to applications made on or after the commencement of that item.
(2) The amendment made by item 18 applies in relation to applications for licences made on or after the commencement of that item.
(3) Paragraph 40(4)(a) of the Therapeutic Goods Act 1989 as amended by this Schedule applies in relation to a request made under that paragraph on or after the commencement of this item, even if the licence to which the request relates was granted before that commencement.
21 Transitional
(1) An approval of a body as an approved conformity assessment body that was in force under the Therapeutic Goods Act 1989 immediately before the commencement time has effect after the commencement time as if it were an approval of the body by the Secretary in writing for the purposes of the definition of EC/EFTA attestation of conformity in subsection 3(1) of the Therapeutic Goods Act 1989 as in force after the commencement time.
(2) In subitem (1):
commencement time means the time at which this item commences.
Therapeutic Goods Amendment Act (No. 1) 2003 (No. 39, 2003)
Schedule 1
41 Saving provisions
(1) The repeal of subsections 30(6) and (7) of the Therapeutic Goods Act 1989 does not affect the application, after the commencement of this item, of paragraph 30(6)(b) and subsection 30(7) of that Act in relation to a requirement imposed under paragraph 30(6)(a) of that Act before that commencement.
(2) The repeal of section 30A of the Therapeutic Goods Act 1989 does not affect the application, after the commencement of this item, of subsections 30A(3) and (4) of that Act in relation to a requirement imposed under subsection 30A(2) of that Act before that commencement.
(3) The repeal of section 30B of the Therapeutic Goods Act 1989 does not affect the application, after the commencement of this item, of subsections 30B(3), (4) and (5) of that Act in relation to a requirement imposed under subsection 30B(2) of that Act before that commencement.
55 Saving provision
The repeal and substitution of subsection 40(1) of the Therapeutic Goods Act 1989 does not affect the application, after the commencement of this item, of any condition that:
(a) was imposed on a licence under that subsection; and
(b) was in force immediately before that commencement.
60 Application provision
Subsection 40(4) of the Therapeutic Goods Act 1989 as amended by this Act, and subsection 40(5) of that Act, apply to any licence in force after the commencement of this item, whether or not the licence was granted after that commencement.
US Free Trade Agreement Implementation Act 2004 (No. 120, 2004)
Schedule 7
7 Application of amendments
(1) The amendments made by this Schedule apply to applications for registration or listing under section 23 of the Therapeutic Goods Act 1989 made on or after the day on which this Schedule commences.
(2) The amendments made by item 6 apply to legal proceedings commenced on or after the day on which this Schedule commences.
Financial Framework Legislation Amendment Act 2005 (No. 8, 2005)
4 Saving of matters in Part 2 of Schedule 1
(1) If:
(a) a decision or action is taken or another thing is made, given or done; and
(b) the thing is taken, made, given or done under a provision of a Part 2 Act that had effect immediately before the commencement of this Act;
then the thing has the corresponding effect, for the purposes of the Part 2 Act as amended by this Act, as if it had been taken, made, given or done under the Part 2 Act as so amended.
(2) In this section:
Part 2 Act means an Act that is amended by an item in Part 2 of Schedule 1.
Schedule 1
496 Saving provision--Finance Minister's determinations
If a determination under subsection 20(1) of the Financial Management and Accountability Act 1997 is in force immediately before the commencement of this item, the determination continues in force as if it were made under subsection 20(1) of that Act as amended by this Act.
Therapeutic Goods Amendment Act (No. 2) 2006 (No. 2, 2006)
Schedule 1
15 Application
The amendments made by this Schedule apply to applications for registration or listing of therapeutic goods that are made on or after the day on which this Schedule commences.
Therapeutic Goods Amendment (Repeal of Ministerial responsibility for approval of RU486) Act 2006 (No. 5, 2006)
The purpose of this Act is to remove the responsibility for approval of RU486 from the Minister and to provide responsibility for approval of RU486 to the Therapeutic Goods Administration.
Therapeutic Goods Legislation Amendment (Annual Charges) Act 2008 (No. 96, 2008)
Schedule 1
3 Application
(1) The amendment made by item 1 applies in relation to the financial year beginning on 1 July 2009 and all later financial years (regardless of whether the registration, listing or inclusion in the Register of the therapeutic goods, or whether the licence, commenced before, on or after 1 July 2009).
(2) The amendment made by item 2 applies for the purposes of working out whether a person is exempt from liability to pay annual registration charge, annual listing charge or annual charge for inclusion in the Register for the financial year beginning on 1 July 2009 and all later financial years.
Therapeutic Goods Amendment (Medical Devices and Other Measures) Act 2009 (No. 38, 2009)
Schedule 2
4 Application
(1) The amendment made by item 1 applies in relation to an exemption made on or after the commencement of that item.
(2) The amendment made by item 2 applies in relation to a revocation or variation made on or after the commencement of that item (whether the exemption was made before, on or after that commencement).
Schedule 3
23 Application and transitional
(1) The amendments of section 38 of the Therapeutic Goods Act 1989 made by this Schedule apply in relation to applications for licences made on or after the commencement of this item.
(2) The amendments of sections 40 and 41 of the Therapeutic Goods Act 1989 made by this Schedule apply in relation to licences granted before, on or after the commencement of this item.
(3) The amendments of section 41EC of the Therapeutic Goods Act 1989 made by this Schedule apply in relation to applications for conformity assessment certificates made on or after the commencement of this item.
(4) The amendment of section 41EG of the Therapeutic Goods Act 1989 made by this Schedule applies in relation to notices given on or after the commencement of this item.
(5) The amendment of section 41EJ of the Therapeutic Goods Act 1989 made by this Schedule applies in relation to conformity assessment certificates issued before, on or after the commencement of this item.
(6) The amendments of section 41ET of the Therapeutic Goods Act 1989 made by this Schedule apply in relation to conformity assessment certificates issued before, on or after the commencement of this item.
(7) Paragraph 41ET(1)(c) of the Therapeutic Goods Act 1989, as in force immediately before the commencement of this item, continues to apply on and after that commencement in relation to a notice given before that commencement.
(8) Subsection 41JA(1A) of the Therapeutic Goods Act 1989 applies in relation to applications for conformity assessment certificates made on or after the commencement of this item.
(9) Subsection 41JA(1C) of the Therapeutic Goods Act 1989 applies in relation to conformity assessment certificates issued before, on or after the commencement of this item.
Schedule 4
20 Application and transitional
(1) If:
(a) immediately before the commencement of this item, therapeutic goods were registered goods or listed goods; and
(b) at a particular time within the period of 12 months beginning on the day on which this item commences:
(i) a standard referred to in paragraph (c) or (d) of the definition of standard in subsection 3(1) of the Therapeutic Goods Act 1989 (as amended by this Act) would, apart from this subitem, apply to the goods; and
(ii) the goods do not conform with that standard;
then that standard is taken not to apply to the goods at that time.
(2) To avoid doubt, paragraph (a) of the definition of standard in subsection 3(1) of the Therapeutic Goods Act 1989 (as amended by this Act) applies in relation to orders made under section 10 of the Therapeutic Goods Act 1989 before, on or after the commencement of this item.
(3) An order in force under paragraph 13(7)(c) of the Therapeutic Goods Act 1989 immediately before the commencement of this item has effect, on and after that commencement, as if it were an order in force under subsection 13(5) of that Act.
Schedule 5
3 Application
The amendment made by item 2 applies in relation to information held by the Department on or after the commencement of this item (regardless of whether the information came into existence before, on or after that commencement).
Schedule 6
12 Saving and transitional
(1) A notice in force under section 42DC of the Therapeutic Goods Act 1989 immediately before the commencement of this item has effect, on and after that commencement, as if it were a notice given and in force under section 42DKB of that Act.
(2) Regulations in force for the purposes of subsection 42DD(1) of the Therapeutic Goods Act 1989 immediately before the commencement of this item continue in force on and after that commencement as if they were regulations in force for the purposes of section 42DD of that Act.
Therapeutic Goods Amendment (2009 Measures No. 1)
Act 2009
(No. 76, 2009)
Schedule 1
7 Application
The amendment made by item 2 applies in relation to therapeutic goods included in the Register before, on or after the commencement of that item.
Schedule 2
25 Application and transitional--amendments made by this Schedule
(1) The amendments made by items 4 to 7 apply in relation to applications for licences made on or after the commencement of those items.
(2) The amendments made by items 8 to 11 apply in relation to applications for licences:
(a) made on or after the commencement of those items; and
(b) made before the commencement of those items that have not been decided by the Secretary before that commencement.
(3) In relation to an application covered by paragraph (2)(b) of this item, paragraph 38(1)(a) of the Therapeutic Goods Act 1989 applies on and after the commencement of this item as if the application was in respect of the one or more manufacturing sites constituted by the manufacturing premises the subject of the application.
(4) The amendments made by items 13 to 22 apply in relation to licences granted before, on or after the commencement of those items.
26 Transitional--existing licences
(1) This item applies to a licence that:
(a) was in force under Part 3-3 of the Therapeutic Goods Act 1989 immediately before the commencement of this item; or
(b) was suspended under that Part immediately before that commencement.
(2) The Therapeutic Goods Act 1989 applies in relation to the licence on and after that commencement as if the licence covered the one or more manufacturing sites constituted by the manufacturing premises to which the licence related immediately before that commencement.
(3) Subitem (2) is subject to section 38B of the Therapeutic Goods Act 1989 (about splitting multi-site licences).
(4) If section 38B of the Therapeutic Goods Act 1989 does not apply in relation to the licence, that Act applies in relation to the licence on and after the commencement of this item as if:
(a) the licence authorised the holder of the licence, at the manufacturing site constituted by the manufacturing premises to which the licence related immediately before that commencement, to carry out the steps in the manufacture of therapeutic goods that the licence allowed the holder to carry out immediately before that commencement; and
(b) that authorisation were an authorisation referred to in subsection 38(2B) of that Act.
(5) Subitem (4) does not prevent the variation of that authorisation under section 40A or 40B of the Therapeutic Goods Act 1989.
Note: A contravention of that authorisation may lead to the licence being revoked or suspended: see paragraph 41(1)(ea) of the Therapeutic Goods Act 1989.
Schedule 3
16 Application
(1) The amendments made by items 1 to 9 apply in relation to the registration or listing of therapeutic goods before, on or after the commencement of those items.
(2) The amendments made by items 10 and 11 apply in relation to conformity assessment certificates issued before, on or after the commencement of those items.
(3) The amendments made by items 12 and 13 apply in relation to the inclusion of a kind of medical device in the Register before, on or after the commencement of those items.
Schedule 5
5 Application
The amendments made by items 1 and 2 apply in relation to applications for listings made on or after the commencement of those items.
Schedule 6
14 Saving and transitional
(1) The amendment made by item 1 does not affect the validity of an order made under section 10 of the Therapeutic Goods Act 1989 before the commencement of this item.
(2) The repeal of section 11 of the Therapeutic Goods Act 1989 by this Schedule does not apply to an order made under section 10 of that Act before the commencement of this item.
(3) The amendment made by item 8 does not affect the validity of an order made under section 41CB of the Therapeutic Goods Act 1989 before the commencement of this item.
(4) Subsection 41CB(2) of the Therapeutic Goods Act 1989, as in force immediately before the commencement of this item, continues to apply on and after that commencement in relation to an order made under section 41CB of that Act before that commencement.
Conformity assessment standards
(5) The amendment made by item 11 does not affect the validity of an order made under section 41DC of the Therapeutic Goods Act 1989 before the commencement of this item.
(6) Subsection 41DC(3) of the Therapeutic Goods Act 1989, as in force immediately before the commencement of this item, continues to apply on and after that commencement in relation to an order made under section 41DC of that Act before that commencement.
Schedule 7
26 Application--listings of medicines
The amendments made by items 5 to 10 apply in relation to applications for listings of medicines made on or after the commencement of those items.
27 Application--revocation of cancellation of registration or listing upon request
The amendment made by item 14 applies in relation to cancellations occurring before, on or after the commencement of that item.
28 Saving--device nomenclature codes
Despite the amendment made by item 22, regulations in force for the purposes of subsection 41BE(3) of the Therapeutic Goods Act 1989 immediately before the commencement of this item continue in force, after that commencement, until the first determination made under that subsection (as inserted by this Act) takes effect.
56 Saving--Therapeutic Goods Advertising Code
(1) Despite the amendment made by item 29, the Therapeutic Goods Advertising Code as in force immediately before the commencement of this item continues in force, after that commencement, until the first instrument made under section 42BAA of the Therapeutic Goods Act 1989, as inserted by this Act, takes effect.
(2) Despite the amendment made by item 52, regulations in force for the purposes of section 42DD of the Therapeutic Goods Act 1989 immediately before the commencement of this item continue in force, after that commencement, until the first instrument made under section 42BAA of the Therapeutic Goods Act 1989, as inserted by this Act, takes effect.
(3) Despite the amendment made by item 54, regulations in force for the purposes of paragraph 42DF(4)(c) of the Therapeutic Goods Act 1989 immediately before the commencement of this item continue in force, after that commencement, until the first instrument made under section 42BAA of the Therapeutic Goods Act 1989, as inserted by this Act, takes effect.
57 Application and transitional--registration or listing conditions
(1) Subsection 28(1) of the Therapeutic Goods Act 1989, as inserted by this Act, applies in relation to the registration or listing of therapeutic goods occurring before, on or after the commencement of this item.
(2) Subsection 28(2B) of the Therapeutic Goods Act 1989, as inserted by this Act, applies in relation to the registration or listing of therapeutic goods occurring on or after the commencement of this item.
(3) Conditions in force under subsection 28(1) of the Therapeutic Goods Act 1989 immediately before the commencement of this item continue in force, on and after that commencement, as if they had been imposed, on that commencement, under subsection 28(2B) of the Therapeutic Goods Act 1989.
(4) Subitem (3) does not prevent the variation or removal of the conditions under subsection 28(3) of the Therapeutic Goods Act 1989 on or after the commencement of this item.
(5) The amendment made by item 31 applies in relation to:
(a) conditions imposed under subsection 28(2B) of the Therapeutic Goods Act 1989 on or after the commencement of that item (including because of subitem (3)); and
(b) conditions imposed under subsection 28(3) of the Therapeutic Goods Act 1989 before, on or after the commencement of that item.
(6) The amendment made by item 34 applies in relation to the registration or listing of therapeutic goods occurring before, on or after the commencement of that item.
(7) The amendment made by item 36 applies in relation to the listing of medicine occurring before, on or after the commencement of that item.
(8) This item does not affect the conditions to which the registration or listing of therapeutic goods is subject before the commencement of this item.
58 Application--information gathering
(1) The amendments made by items 38 and 40 apply in relation to periods beginning before, on or after the commencement of those items.
(2) The amendment made by item 41 applies in relation to things occurring before, on or after the commencement of that item.
(3) Regulations in force for the purposes of subsection 41JA(2) of the Therapeutic Goods Act 1989 immediately before the commencement of this item continue in force for the purposes of that subsection on and after that commencement.
59 Application--advertisements
The amendments made by items 44 to 50 apply in relation to advertisements published or broadcast on or after the commencement of those items.
Therapeutic Goods Amendment (2009 Measures No. 2)
Act 2009
(No. 96,
2009)
Schedule 1
13 Saving and transitional
(1) The amendment made by item 10 does not affect the validity of an instrument made under paragraph 52D(2)(a) or (b) of the Therapeutic Goods Act 1989 before the commencement of that item.
(2) If:
(a) on or after 1 January 2010 and before the commencement of this item, the Committee referred to in section 52B of the Therapeutic Goods Act 1989 had proposed an amendment of the current Poisons Standard; and
(b) before that commencement, that Committee had not amended the current Poisons Standard as a result of that proposal;
then the Secretary must have regard to that proposal in relation to making the first instrument under subsection 52D(2) of that Act on or after that commencement.
(3) If:
(a) on or after 1 January 2010 and before the commencement of this item, an application was made to the Committee referred to in section 52B of the Therapeutic Goods Act 1989 for an amendment of the current Poisons Standard; and
(b) the application had not been refused by that Committee before that commencement; and
(c) before that commencement, that Committee had not proposed an amendment of the current Poisons Standard as a result of the application;
then the application has effect on and after that commencement as if it were an application made to the Secretary in accordance with section 52EAA of that Act.
Schedule 2
4 Application
The amendments made by items 2 and 3 apply in relation to applications made after the day on which the first instrument made under section 41BEA of the Therapeutic Goods Act 1989 takes effect.
Note: Section 12 of the Legislative Instruments Act 2003 deals with when a legislative instrument takes effect.
Schedule 3
7 Application and saving
(1) The amendments made by items 2 and 5 apply in relation to advertisements occurring on or after the commencement of those items.
(2) The amendment made by item 3 applies in relation to applications made on or after the commencement of that item.
(3) The amendment made by item 4 does not affect the validity of a request made under subsection 30D(1) of the Therapeutic Goods Act 1989 before the commencement of that item.
10 Application
The amendment made by item 8 applies in relation to applications for the registration or listing of medicine made on or after the commencement of this Part.
Therapeutic Goods
Amendment (2009 Measures No. 3) Act 2010
(No. 54, 2010)
Schedule 1
58 Application--licences
The amendment made by item 31 applies in relation to licences granted before, on or after the commencement of that item.
59 Transitional--exempt biologicals
(1) This item applies in relation to a class of biologicals that, immediately before the commencement of this item, was covered by an exemption of the kind referred to in paragraph 18(1)(c) of the Therapeutic Goods Act 1989.
(2) At the commencement of this item, there is taken to be an exemption (the transitional exemption) in force under subsection 32CA(2) of that Act covering that class of biologicals.
(3) Subject to this item, the transitional exemption ceases to be in force at the end of the period (the transitional period) of 3 years beginning on the day this item commences.
(4) If:
(a) before the end of the period of 18 months beginning on the day this item commences, a person makes an application in accordance with section 32DA or 32DD of that Act to include in the Register a biological included in that class; and
(b) before the end of the transitional period, the person has not been notified of the Secretary's decision on the application;
the transitional exemption, in relation to that biological, continues in force past the end of the transitional period until the person is notified of the Secretary's decision on the application.
(5) If:
(a) before the end of the transitional period, a person makes an application in accordance with section 32DA or 32DD of that Act to include in the Register a biological included in that class; and
(b) before the end of that period, the person is notified of the Secretary's decision on the application;
the transitional exemption, in relation to that biological, ceases to be in force immediately after that notification.
60 Transitional regulations
The Governor-General may make regulations prescribing matters of a transitional nature (including prescribing any saving or application provisions) relating to the amendments made by this Schedule.
Schedule 2
15 Application
The amendment made by item 14 applies in relation to anything done or omitted to be done on or after the commencement of that item.
16 Saving
Despite the repeal of provisions of the Therapeutic Goods Act 1989 made by items 1, 2, 4 to 8 and 10 to 13, those provisions (as in force immediately before the commencement of those items) continue to apply on and after that commencement in relation to anything done or omitted to be done before that commencement.
Schedule 3
3 Application
The amendments made by items 1 and 2 apply in relation to therapeutic goods, and kinds of medical devices, included in the Register before, on or after the commencement of those items.
Schedule 4
6 Application
(1) The amendments made by items 1 to 5 apply in relation to notices given on or after the commencement of those items.
(2) Paragraphs 31(1)(ac) and (2)(ac) of the Therapeutic Goods Act 1989, as inserted by this Act, apply in relation to the registration or listing of therapeutic goods occurring before, on or after the commencement of this item.
Schedule 5
2 Application
The amendment made by item 1 applies in relation to an annual registration charge, an annual listing charge, an annual charge for inclusion in the Register or an annual licensing charge that becomes payable on or after the day on which that item commences.
Schedule 6
20 Application
(1) The amendment made by item 3 applies in relation to requests made on or after the commencement of that item.
(2) The amendments made by items 4 and 5 apply in relation to advertisements published or broadcast on or after the commencement of those items.
(3) The amendments made by items 8 to 15 and 17 to 19 apply in relation to requests made to the Minister to reconsider decisions, where the requests are made on or after the commencement of those items (regardless of whether the decisions were made before, on or after that commencement).
Therapeutic Goods Amendment (2010 Measures No. 1)
Act 2010
(No. 141
, 2010)
Schedule 1A
10 Application
(1) Paragraph 23(2)(ba) and subparagraph 25(1)(da)(i) of the Therapeutic Goods Act 1989, as inserted by this Act, apply in relation to applications for registration of medicine that are made after the day on which the first instrument made under subsection 3(2A) or (2B) of that Act takes effect.
(2) Subparagraph 25(1)(da)(ii) of the Therapeutic Goods Act 1989, as inserted by this Act, applies in relation to applications for registration of medicine that are made on or after the day on which the first instrument made under subsection 3(2A) or (2B) of that Act takes effect.
(3) Subparagraph 25(4)(d)(ia) of the Therapeutic Goods Act 1989, as inserted by this Act, applies on and after the day on which the first instrument made under subsection 3(2A) or (2B) of that Act takes effect (whether the application for registration was made before, on or after that day).
(4) Subsection 25AA(1) of the Therapeutic Goods Act 1989, as inserted by this Act, applies in relation to medicine included in the Register on or after the day on which the first instrument made under subsection 3(2A) or (2B) of that Act takes effect (where the notification (in relation to the medicine) referred to in subparagraph 25(4)(d)(ia) of that Act also occurred on or after that day).
Note: Section 12 of the Legislative Instruments Act 2003 deals with when a legislative instrument takes effect.
Schedule 2
7 Application
(1) The amendments made by items 1A to 1D apply in relation to requests made on or after the commencement of those items.
(2) The amendment made by item 1E applies in relation to applications for registration made on or after the commencement of that item.
(3) The amendments made by items 1 and 2 apply in relation to applications for listings made on or after the commencement of those items.
(4) The amendment made by item 6A applies in relation to a notice given on or after the commencement of that item (whether the application or request was made before, on or after that commencement).
21 Application
(1) The amendments made by items 8 and 9 apply in relation to applications for listings made on or after the commencement of those items.
(2) The amendments made by items 10 to 15 apply in relation to notices given on or after the commencement of those items.
(2A) The amendment made by item 15A applies in relation to notices given on or after the commencement of that item.
(3) The amendments made by items 16 and 17 apply in relation to applications made on or after the commencement of those items.
(4) The amendments made by items 18 and 19 apply in relation to initial decisions made on or after the commencement of those items.
Acts Interpretation Amendment Act 2011 (No. 46, 2011)
Schedule 3
10 Saving--appointments
The amendments made by Schedule 2 do not affect the validity of an appointment that was made under an Act before the commencement of this item and that was in force immediately before that commencement.
11 Transitional regulations
The Governor-General may make regulations prescribing matters of a transitional nature (including prescribing any saving or application provisions) relating to the amendments and repeals made by Schedules 1 and 2.
Therapeutic Goods Amendment (2011 Measures No. 1)
Act 2011
(No. 77, 2011)
Schedule 1
6 Application
(1) The amendment made by item 1 applies in relation to requests made on or after the commencement of that item.
(2) The amendments made by items 2 to 4 apply in relation to applications made under section 23 of the Therapeutic Goods Act 1989 on or after the commencement of those items.
(3) The amendment made by item 5 applies in relation to notices given on or after the commencement of that item.
7 Transitional--approved forms
An approval in force under subsection 9D(6) of the Therapeutic Goods Act 1989 immediately before the commencement of this item continues in force on and after that commencement as if it were an approval in force under paragraph 9D(6)(a) of that Act.
8 Transitional--registration or listing conditions
(1) If:
(a) on or after the day on which this item commences, the first instrument made under subsection 28(2) of the principal Act takes effect; and
(b) immediately before that first instrument takes effect, a condition on the registration or listing of therapeutic goods was in force under subsection 28(2B) of the principal Act; and
(c) either:
(i) if that condition was in force because of subitem 57(3) of Schedule 7 to the amending Act--that condition was imposed in writing under subsection 28(1) of the principal Act (as in force at any time before 25 January 2010) and was described as a standard condition; or
(ii) in any other case--that condition was imposed by notice in writing under subsection 28(2B) of the principal Act and was described as a standard condition;
then that condition ceases to be in force at the time that first instrument takes effect.
Note 1: If, immediately before that first instrument takes effect, multiple conditions on the registration or listing of therapeutic goods were in force under subsection 28(2B) of the principal Act, this item has a separate application in relation to each of those conditions.
Note 2: Section 12 of the Legislative Instruments Act 2003 deals with when a legislative instrument takes effect.
(2) Subitem 57(1) of Schedule 7 to the amending Act is subject to an instrument under subsection 28(2) of the principal Act providing that specified conditions apply only to a specified class of therapeutic goods that are registered or listed on or after that instrument takes effect.
(3) In this item:
amending Act means the Therapeutic Goods Amendment (2009 Measures No. 1) Act 2009.
principal Act means the Therapeutic Goods Act 1989.