Contents

Chapter 1--Preliminary                                                                                                        1

1............ Short title [see Note 1] ....................................................................... 1

2............ Commencement [see Note 1] .............................................................. 1

3............ Interpretation ...................................................................................... 1

3A......... Declaration--member of European Community .............................. 15

3B......... Declaration--country covered by non‑EC/EFTA MRA ................. 15

4............ Objects of Act .................................................................................. 15

5............ Act to bind Crown ............................................................................ 16

5A......... Application of the Criminal Code--extended geographical jurisdiction   16

6............ Operation of Act .............................................................................. 16

6AAA... Commonwealth consent to conferral of functions etc. on its officers and authorities by corresponding State laws .......................................................................................................... 17

6AAB... When duty imposed ......................................................................... 17

6AAC... Imposing duty under State law ......................................................... 19

6AAD... Conferral of jurisdiction on federal courts ........................................ 20

6AAE.... Consequences of State law conferring duty, function or power on Commonwealth officer or Commonwealth authority .......................................................................................................... 20

6B......... Review of certain decisions under State laws ................................... 21

6C......... Fees payable to Commonwealth under State laws ........................... 21

7............ Declaration that goods are/are not therapeutic goods ....................... 21

7A......... Authorised persons .......................................................................... 22

7B......... Kits ................................................................................................... 23

8............ Power to obtain information with respect to therapeutic goods ...... 23

9............ Arrangements with States etc. .......................................................... 24

Chapter 2--Australian Register of Therapeutic Goods                                  25

9A......... Australian Register of Therapeutic Goods ....................................... 25

9B......... When registrations or listings of medical devices are taken to be cancelled              26

9C......... Inspection of entries in Register ....................................................... 28

9D......... Variation of entries in Register ......................................................... 28

9E.......... Publication of list of goods on Register ............................................ 29

Chapter 3--Medicines and other therapeutic goods that are not medical devices                30

Part 3‑1--Standards                                                                                                             30

10.......... Determination of standards .............................................................. 30

10A....... Application of standards to medical devices .................................... 31

11.......... Date of effect of standards ............................................................... 31

12.......... Standards to be disallowable ............................................................. 31

13.......... Special provisions relating to standards ........................................... 31

14.......... Criminal offences for importing, supplying or exporting goods that do not comply with standards      33

14A....... Civil penalties for importing, supplying or exporting goods that do not comply with standards           37

14B....... Application of Customs Act 1901 .................................................... 38

15.......... Criminal offences relating to breaching a condition of a consent ...... 39

15AA.... Civil penalty relating to breaching a condition of a consent ............. 40

Part 3‑2--Registration and listing of therapeutic goods                                  41

Division 1--Preliminary                                                                                             41

15A....... Application of this Part to medical devices ...................................... 41

16.......... Therapeutic goods and gazetted groups ........................................... 43

18.......... Exempt goods ................................................................................... 44

18A....... Exemption because of emergency ..................................................... 44

19.......... Exemptions for special and experimental uses ................................. 48

19A....... Exemptions where unavailability etc. of therapeutic goods ............. 50

19B....... Criminal offences relating to registration or listing etc. of imported, exported, manufactured and supplied therapeutic goods ................................................................................................. 52

19C....... Notice required to adduce evidence in support of exception under subsection 19B(6)            56

19D....... Civil penalties relating to registration or listing etc. of imported, exported, manufactured and supplied therapeutic goods ................................................................................................. 58

20.......... Criminal offences relating to notifying the Secretary and to importing goods exempt under section 18A               60

5>20A....... Civil penalty relating to the importation, exportation, manufacture or supply of sponsored goods without proper notification ........................................................................................ 61

21.......... Offence relating to wholesale supply ............................................... 62

21A....... General criminal offences relating to this Part .................................. 62

21B....... General civil penalties relating to this Part ....................................... 67

22.......... General offences relating to this Part ................................................ 69

22AA.... Civil penalty for breaching a condition of an exemption .................. 71

22A....... Criminal offences for false statements in applications for registration 71

22B....... Civil penalty for false statements in applications for registration ... 72

Division 2--Registration and listing                                                                    73

23.......... Applications generally ...................................................................... 73

24.......... Applications for registration ............................................................ 73

24A....... When evaluation fee due for payment .............................................. 74

24B....... Payment of evaluation fee by instalments ........................................ 74

24C....... Recovery of evaluation fee ............................................................... 75

24D....... Reduction of evaluation fee where evaluation not completed within prescribed period          75

24E........ Deemed refusal of application .......................................................... 76

25.......... Evaluation and registration of therapeutic goods .............................. 76

25A....... When the Secretary must not use protected information ................. 80

25B....... Registration of therapeutic device to which EC/EFTA attestation of conformity applies      81

26.......... Listing of therapeutic goods ............................................................. 82

26AA.... Listing of therapeutic device to which EC/EFTA attestation of conformity applies               85

26A....... Listing of certain medicines .............................................................. 86

26B....... Certificates required in relation to patents ....................................... 89

26BA.... Approved form for notices ............................................................... 90

26C....... Certificates required in relation to patent infringement proceedings 90

26D....... Requirements for interlocutory injunction ....................................... 92

27.......... Registration or listing number ........................................................... 94

28.......... Conditions of registration or listing .................................................. 94

29.......... Duration of registration or listing ..................................................... 97

29A....... Criminal offence for failing to notify adverse effects etc. of goods .. 97

29AA.... Civil penalty for failing to notify adverse effects etc. of goods ....... 98

29B....... Notification of adverse effects etc. where application withdrawn or lapses            98

29C....... Civil penalties for failing to notify adverse effects etc. where application withdrawn or lapses             99

30.......... Cancellation of registration or listing .............................................. 100

30C....... Consultation with Gene Technology Regulator ............................. 103

30D....... Secretary may seek advice about classes of GM products ............ 103

30E........ Secretary to take advice into account ............................................. 104

Division 2A--Public notification and recovery of therapeutic goods 105

30EA..... Public notification and recovery of therapeutic goods ................... 105

30EB..... Publication of requirements ............................................................ 107

30EC..... Criminal offences for non‑compliance with requirements .............. 107

30ECA.. Civil penalty for non‑compliance with requirements ..................... 108

30ED..... Power of cancellation unaffected .................................................... 108

Division 3--General                                                                                                   109

30F........ Criminal offences for goods exempt under section 18A not conforming to standards etc.       109

30FA..... Civil penalty for goods exempt under section 18A not conforming to standards etc.              111

30G....... Disposal of unused goods exempt under section 18A .................... 111

30H....... Record for goods exempt under section 18A .................................. 112

31.......... Secretary may require information ................................................. 113

31AAA. Civil penalty for providing false or misleading information in relation to medicines listed under section 26A       115

5>31A....... Secretary may require information etc. about goods exempt under section 18         116

5>31AA.... Secretary may require information etc. about goods exempt under section 18A      117

5>31B....... Secretary may require information relating to approvals and authorities under section 19      118

5>31C....... Criminal offence for failing to give information or documents sought under section 31A, 31AA or 31B                119

5>31D....... False or misleading information ...................................................... 119

31E........ False or misleading documents ....................................................... 120

31F........ Self‑incrimination ............................................................................ 121

Part 3‑3--Manufacturing of therapeutic goods                                                  122

33A....... Application of this Part to medical devices .................................... 122

34.......... Exempt goods and exempt persons ................................................ 122

35.......... Criminal offences relating to manufacturing therapeutic goods ...... 122

35A....... Civil penalties relating to manufacturing therapeutic goods ........... 125

35B....... Criminal offences relating to breaching a condition of a licence ...... 126

35C....... Civil penalty relating to breaching a condition of a licence ............. 127

36.......... Manufacturing principles ............................................................... 127

37.......... Application for licence ................................................................... 128

38.......... Grant of licence ............................................................................... 129

39.......... Term of licence ............................................................................... 131

40.......... Conditions of licences ..................................................................... 132

41.......... Revocation and suspension of licences ........................................... 134

41A....... Publication of list of manufacturers etc. ......................................... 136

Chapter 4--Medical devices                                                                                         137

Part 4‑1--Introduction                                                                                                       137

Division 1--Overview of this Chapter                                                             137

41B....... General ............................................................................................ 137

41BA.... Requirements for medical devices (Parts 4‑2 and 4‑3) ................... 137

41BB..... Administrative processes (Parts 4‑4 to 4‑10) ................................ 137

41BC..... Enforcement (Part 4‑11) ................................................................. 138

Division 2--Interpretation                                                                                      139

41BD.... What is a medical device ................................................................. 139

41BE..... Kinds of medical devices ................................................................ 140

41BF..... System or procedure packs ............................................................ 141

41BG.... Manufacturers of medical devices .................................................. 141

41BH.... Meaning of compliance with essential principles ........................... 142

41BI...... Meaning of non‑application of conformity assessment procedures 142

Division 3--Application provisions                                                                    144

41BJ...... Application of this Chapter to medical devices covered by Part 3‑2 144

41BK.... Application of the Criminal Code .................................................. 144

Part 4‑2--Essential principles and medical device standards                    145

41C....... What this Part is about ................................................................... 145

Division 1--Essential principles                                                                          146

41CA.... Essential principles ......................................................................... 146

Division 2--Medical device standards                                                             147

41CB..... Medical device standards ................................................................ 147

41CC..... Content of medical device standards .............................................. 147

41CD.... Inconsistencies between medical device standards ......................... 148

Part 4‑3--Conformity assessment procedures                                                    149

41D....... What this Part is about ................................................................... 149

Division 1--Conformity assessment procedures                                       150

41DA.... Conformity assessment procedures ............................................... 150

41DB.... Medical device classifications ......................................................... 151

Division 2--Conformity assessment standards                                           152

41DC.... Conformity assessment standards .................................................. 152

41DD.... Content of conformity assessment standards ................................ 152

41DE..... Inconsistencies between conformity assessment standards ........... 153

Part 4‑4--Conformity assessment certificates                                                    154

41E........ What this Part is about ................................................................... 154

Division 1--Issuing conformity assessment certificates                        155

41EA..... When conformity assessment certificates are required ................... 155

41EB..... Applications ................................................................................... 155

41EC..... Considering applications ................................................................ 156

41ED..... Time for making decisions on applications .................................... 158

41EE..... Procedure following making a decision whether to issue certificate 158

41EF..... Duration of certificate ..................................................................... 159

41EG..... Lapsing of applications .................................................................. 159

41EH..... Treating applications as having been refused ................................. 160

41EI...... Criminal offences for making a false statement .............................. 160

41EIA... Civil penalty for making a false statement ..................................... 161

Division 2--Conditions                                                                                             162

41EJ...... Automatic conditions on conformity assessment certificates ........ 162

41EK..... Conditions imposed when conformity assessment certificates are issued               163

41EL..... Conditions imposed after issuing a conformity assessment certificate 164

Division 3--Suspension of conformity assessment certificates          165

41EM.... Suspension of conformity assessment certificates ......................... 165

41EN..... Notice of proposed suspension ...................................................... 165

41EO..... Duration of suspension .................................................................. 166

41EP..... Revocation of suspension ............................................................... 166

41EQ..... Powers of revocation of conformity assessment certificates unaffected 167

Division 4--Revocation of conformity assessment certificates          168

41ER..... Automatic revocation of conformity assessment certificates ......... 168

41ES...... Immediate revocation of conformity assessment certificates ......... 168

41ET..... Revocation of conformity assessment certificates after notice of proposed revocation          168

41EU..... Limiting revocation of conformity assessment certificates to some medical devices of a particular kind                169

41EV..... Publication of revocation etc. of conformity assessment certificates 170

41EW.... Date of effect of revocation etc. of conformity assessment certificates   170

Part 4‑5--Including medical devices in the Register                                       171

41F........ What this Part is about ................................................................... 171

Division 1--Including medical devices in the Register                          172

41FA..... What this Division is about ............................................................ 172

41FB..... How this Division works ............................................................... 173

Subdivision A--Applications                                                                                  173

41FC..... Applications ................................................................................... 173

41FD..... Matters to be certified .................................................................... 174

41FE..... Criminal offences for making a false statement .............................. 175

41FEA.. Civil penalty for making a false statement ..................................... 176

Subdivision B--Including kinds of medical devices in the Register              177

41FF..... Obligation to include kinds of medical devices in the Register ....... 177

41FG..... Notification of unsuccessful applications ...................................... 177

Subdivision C--Auditing of applications                                                             178

41FH..... Selecting applications for auditing .................................................. 178

41FI...... Auditing of applications ................................................................. 178

41FJ...... Procedure following audits ............................................................. 179

41FK..... Lapsing of applications .................................................................. 179

Subdivision D--Miscellaneous                                                                              180

41FL..... Device number ................................................................................ 180

41FM.... Duration of inclusion in the Register .............................................. 180

Division 2--Conditions                                                                                             181

41FN..... Conditions applying automatically ................................................ 181

41FO..... Conditions imposed when kinds of medical devices are included in the Register     183

41FP..... Conditions imposed after kinds of medical devices are included in the Register      184

Part 4‑6--Suspension and cancellation from the Register                           185

Division 1--Suspension from the Register                                                    185

Subdivision A--General power of suspension                                                    185

41G....... What this Part is about ................................................................... 185

41GA.... Suspension of kinds of medical devices from the Register ............. 185

41GB.... Notice of proposed suspension must be given in certain cases ...... 186

41GC.... Duration of suspension .................................................................. 186

41GD.... Revocation of suspension ............................................................... 187

41GE..... Treating applications for revocation as having been refused .......... 188

Subdivision B--Suspension as a result of suspension under Part 4‑4          188

41GF..... Suspension of kinds of medical devices from the Register ............. 188

41GG.... Duration of suspension .................................................................. 189

41GH.... Revocation of suspension ............................................................... 189

Subdivision C--Effect of suspension                                                                    189

41GI...... Effect of suspension ....................................................................... 189

41GJ..... Powers of cancellation from Register unaffected ............................ 190

Division 2--Cancellation of entries from the Register                           191

41GK.... Automatic cancellation of entries of kinds of medical devices from the Register     191

41GL..... Immediate cancellation of entries of kinds of medical devices from the Register     191

41GM... Cancellation of entries of kinds of medical devices from the Register after section 41JA notice             192

41GN.... Cancellation of entries of kinds of medical devices from the Register after notice of proposed cancellation           193

41GO.... Limiting cancellation of entries from Register to some medical devices of a particular kind    194

41GP..... Publication of cancellation of entry from Register ......................... 194

41GQ.... Date of effect of cancellation of entries from Register ................... 195

Part 4‑7--Exempting medical devices from inclusion in the Register   196

41H....... What this Part is about ................................................................... 196

41HA.... Devices exempted from inclusion in the Register ........................... 196

41HB.... Exemptions for special and experimental uses ............................... 197

41HC.... Exemptions for medical practitioners ............................................. 198

Part 4‑8--Obtaining information                                                                                 200

41J........ What this Part is about ................................................................... 200

Division 1--Information relating to compliance with requirements and other matters                 201

41JA..... Secretary may require information ................................................. 201

41JB...... Complying with the Secretary's requirements ............................... 202

41JBA... Civil penalty for giving false or misleading information in purported compliance with a notice             203

41JC...... Self‑incrimination ............................................................................ 204

Division 2--Information relating to medical devices covered by exemptions    205

41JD..... Secretary may require information etc. about devices exempted under section 41HA from inclusion in the Register ........................................................................................................ 205

41JE...... Secretary may require information relating to approvals under section 41HB         206

5>41JF...... Secretary may require information relating to authorities under section 41HC        207

5>41JG..... Criminal offences for failing to give information or documents sought under this Division     207

41JH..... False or misleading information ...................................................... 208

41JI....... False or misleading documents ....................................................... 208

41JJ....... Self‑incrimination ............................................................................ 209

Part 4‑9--Public notification and recovery of medical devices                  210

41K....... What this Part is about ................................................................... 210

41KA.... Public notification and recovery of medical devices ....................... 210

41KB.... Publication of requirements ............................................................ 212

41KC.... Criminal offences for failing to comply with requirements relating to a kind of medical device              212

41KCA. Civil penalty for failing to comply with requirements relating to a kind of medical device     213

41KD.... Powers of suspension and cancellation unaffected ......................... 213

Part 4‑10--Assessment fees                                                                                          214

41L........ What this Part is about ................................................................... 214

41LA..... Assessment fees ............................................................................. 214

41LB..... When assessment fee due for payment .......................................... 215

41LC..... Payment of assessment fee by instalments .................................... 215

41LD..... Recovery of assessment fee ............................................................ 215

41LE..... Reduction of conformity assessment fee where decision not made within prescribed period                 215

Part 4‑11--Offences and civil penalty provisions relating to medical devices          217

41M...... What this Part is about ................................................................... 217

Division 1--Non‑compliance with essential principles                            218

41MA... Criminal offences for importing, supplying or exporting a medical device that does not comply with essential principles ........................................................................................ 218

41MAA Civil penalties for importing, supplying or exporting a medical device that does not comply with essential principles ........................................................................................................ 221

41MB... Exceptions ...................................................................................... 222

41MC... Criminal offences relating to breaching a condition of a consent .... 223

41MCA Civil penalty relating to breaching a condition of a consent ........... 224

41MD... Treating medical devices as prohibited imports or exports ............ 224

Division 2--Failure to apply conformity assessment procedures      225

41ME.... Criminal offences for failing to apply conformity assessment procedures--manufacturers    225

41MEA. Civil penalties for failing to apply conformity assessment procedures--manufacturers         227

41MF.... Criminal offences for failing to apply conformity assessment procedures--sponsors            228

41MG... Exceptions ...................................................................................... 229

41MH... Criminal offence for making false statements in declarations ......... 230

41MHA Civil penalty for making false statements in declarations .............. 230

Division 3--Medical devices not included in the Register and related matters               231

41MI..... Criminal offences for importing, exporting, supplying or manufacturing a medical device not included in the Register ........................................................................................................ 231

41MIA.. Notice required to adduce evidence in support of exception under subsection 41MI(7)         233

41MIB.. Civil penalty for importing, exporting, supplying or manufacturing a medical device not included in the Register ........................................................................................................ 235

41MJ.... Treating medical devices as prohibited imports or exports ............ 236

41MK... Wholesale supply of medical devices not included in the Register 236

41ML.... False advertising about medical devices .......................................... 236

41MLA. Civil penalty for making misrepresentations about medical devices 237

41MM.. Claims about arranging supplies of medical devices not included in the Register     237

41MN... Criminal offences relating to breaches of conditions ...................... 237

41MNA Civil penalties for breaching conditions .......................................... 240

Division 4--Other offences and civil penalty provisions                        241

41MO... Criminal offences for misusing medical devices exempted for special or experimental uses    241

41MP.... Criminal offence for failing to notify adverse events etc. ............... 243

41MPA. Civil penalty for failing to notify adverse events etc. .................... 245

41MPB. Relief from liability for contraventions for failing to notify adverse events etc.      246

41MQ... Notification of adverse events etc. where application withdrawn or lapses            247

41MR... Civil penalties for failing to notify adverse effects etc. where application withdrawn or lapses             247

Chapter 5--Advertising, counterfeit therapeutic goods and product tampering      249

Part 5‑1--Advertising and generic information                                                  249

Division 1--Preliminary                                                                                           249

42AA.... This Part not to apply to advertisements directed at health professionals etc.       249

42AB.... This Part not to apply to advertisements for goods not for human use   250

42AC.... This Part not to apply to advertisements for exported goods ....... 250

42B....... Definitions ...................................................................................... 250

Division 2--Therapeutic goods advertisements for which an approval is required         253

42BA.... Application of Division .................................................................. 253

42C....... Offences relating to publication of advertisements ........................ 253

Division 3--General provisions about advertising therapeutic goods 256

42DA.... Application of Division .................................................................. 256

42DB.... Definitions ...................................................................................... 256

42DC.... Certain representations not to be published or broadcast .............. 256

42DD.... Restricted representations .............................................................. 256

42DE..... Applications for approval of use of restricted representation ....... 257

42DF..... Approval of use of restricted representation ................................. 257

42DG.... Notice of approval or refusal .......................................................... 257

42DH.... Variation of conditions of approval ................................................ 258

42DI...... Withdrawal of approval .................................................................. 258

42DJ..... Prohibited and required representations ......................................... 259

42DK.... Use of restricted or prohibited representations .............................. 259

42DL..... Advertising offences ....................................................................... 260

42DM... Compliance with Code ................................................................... 262

Division 4--Generic information about ingredients or components of therapeutic goods           263

42DN.... Application of Division .................................................................. 263

42DO.... Compliance with the Code ............................................................. 263

42DP..... Offences--publication of generic information ................................ 263

Part 5‑2--Counterfeit therapeutic goods                                                                264

42E........ Offence of dealing with counterfeit therapeutic goods ................... 264

42EA..... Civil penalty relating to dealing with counterfeit therapeutic goods 265

42EB..... Relief from liability for certain contraventions relating to dealing with counterfeit therapeutic goods    265

42F........ Customs treatment of counterfeit therapeutic goods ..................... 266

Part 5‑3--Product tampering                                                                                         267

42T....... Notifying of actual or potential tampering ..................................... 267

42U....... Meaning of actual or potential tampering etc. ................................ 268

42V....... Recovery of therapeutic goods because of actual or potential tampering                 268

42VA.... Civil penalty relating to the recovery of therapeutic goods because of actual or potential tampering     270

42VB..... Relief from liability for contraventions relating to the recovery of therapeutic goods because of actual or potential tampering ........................................................................................ 271

42W...... Supply etc. of therapeutic goods that are subject to recovery requirements            271

42X....... Saving of other laws ........................................................................ 272

Chapter 5A--Enforcement                                                                                             273

Part 5A‑1--Civil penalties                                                                                              273

Division 1--Obtaining an order for a civil penalty                                     273

42Y....... Federal Court may order person to pay pecuniary penalty for contravening civil penalty provision     273

42YA.... What is a civil penalty provision? ................................................... 274

42YB..... Meaning of penalty unit ................................................................. 274

42YC..... Persons involved in contravening civil penalty provision .............. 274

42YD.... Recovery of a pecuniary penalty ................................................... 274

42YE..... Gathering information for application for pecuniary penalty ........ 275

Division 2--Civil penalty proceedings and criminal proceedings     276

42YF..... Civil proceedings after criminal proceedings .................................. 276

42YG.... Criminal proceedings during civil proceedings ................................ 276

42YH.... Criminal proceedings after civil proceedings .................................. 276

42YI...... Evidence given in proceedings for civil penalty not admissible in criminal proceedings          276

Part 5A‑2--Infringement notices                                                                                278

42YJ...... Infringement notices in respect of offences .................................... 278

42YK.... Infringement notices in respect of civil penalty provisions ........... 278

Part 5A‑3--Enforceable undertakings                                                                     279

42YL..... Enforcement of undertakings .......................................................... 279

Chapter 6--Administration                                                                                             280

Part 6‑1--Payment of charges                                                                                      280

43.......... By whom charges payable .............................................................. 280

44.......... Time for payment of charges .......................................................... 280

45.......... Therapeutic Goods Administration Account ................................. 281

Part 6‑2--Entry, searches and warrants                                                                 283

45A....... Definitions ...................................................................................... 283

46.......... Searches to monitor compliance with Act ...................................... 284

46A....... Searches of certain premises to monitor compliance with Act ....... 284

46B....... Searches and seizures on public health grounds ............................. 285

47.......... Searches and seizures related to offences and civil penalty provisions 286

48.......... General powers of authorised persons in relation to premises ...... 287

48A....... Details of warrant to be given to occupier etc. ............................... 288

48B....... Announcement before entry ........................................................... 288

48C....... Use of electronic equipment at premises ........................................ 289

48D....... Compensation for damage to electronic equipment ........................ 290

48E........ Copies of seized things to be provided .......................................... 291

48F........ Occupier entitled to be present during search ................................ 291

48G....... Receipts for things seized under warrant ....................................... 292

48H....... Retention of seized things .............................................................. 292

48J........ Magistrate may permit a thing to be retained ................................. 293

49.......... Monitoring warrants ....................................................................... 293

50.......... Offence and civil penalty provision related warrants ..................... 294

51.......... Offence and civil penalty provision related warrants by telephone 295

51A....... Searches at request of manufacturer ............................................... 297

51B....... Offences relating to warrants .......................................................... 297

52.......... Identity cards .................................................................................. 297

Part 6‑3--National Drugs and Poisons Schedule Committee                     299

52A....... Definitions ...................................................................................... 299

52B....... Establishment and constitution of Committee ............................... 299

52C....... Functions of Committee ................................................................. 300

52D....... Poisons Standard ............................................................................ 300

52E........ Matters to be taken into account in exercising powers .................. 301

52EA..... Poisons Standard--validation etc. .................................................. 302

52EB..... Compensation for acquisition of property ..................................... 303

Part 6‑4--Complementary medicines                                                                       305

52F........ Definitions ...................................................................................... 305

52G....... Establishment and constitution of Committee ............................... 305

Chapter 7--Miscellaneous                                                                                             306

53.......... Retention of material on withdrawal of application ....................... 306

53A....... Alternative verdicts for various offences ........................................ 306

54.......... Offences and forfeiture ................................................................... 307

54AA.... Offences for contravening conditions or requirements imposed under the regulations            308

54AB.... Criminal offence for damaging etc. documents ............................... 309

54AC.... Civil penalty for damaging etc. documents ..................................... 309

54A....... Time for bringing prosecutions ....................................................... 309

54B....... Application of this Act to an executive officer of a body corporate 309

54C....... Establishing whether an executive officer took reasonable steps to prevent the commission of an offence or the contravention of a civil penalty provision ...................................... 310

55.......... Conduct by directors, servants and agents ..................................... 311

56.......... Judicial notice ................................................................................. 312

56A....... Certificates to provide evidence of certain matters ........................ 312

57.......... Delegation ....................................................................................... 314

58.......... Export certifications ....................................................................... 316

59.......... Fees ................................................................................................. 316

60.......... Review of decisions ........................................................................ 317

60A....... New information on review--discretion to remit ........................... 319

61.......... Release of information .................................................................... 321

62.......... Consequential amendments ............................................................ 326

63.......... Regulations ..................................................................................... 326

Chapter 8--Repeal and transitional provisions                                                  329

64.......... Interpretation .................................................................................. 329

65.......... Repeal ............................................................................................. 329

66.......... Transitional arrangements for goods required to be registered or listed .. 329

67.......... Transitional provision for therapeutic goods for export only ........ 331

68.......... Transitional arrangements for Part 3‑3 ........................................... 331

69.......... Continuation of standards and requirements .................................. 332

Schedule--Consequential Amendments                                                   &