1 Title

2 Commencement

3 Object

4 Purpose of Parts 1 to 5

5 Overview of Parts 1 to 5

6 Interpretation

7 Crown exemption for products specified by Minister

8 Parts 1 to 5 bind the Crown

9 Rules and Orders have force of law

10 Effect of this subpart and subpart 3

11 When Rules and Orders come into force

12 Involvement of Finance Minister in making certain Rules

13 Meaning of Rule and Order in this subpart

14 Publication of Rules, Orders, and compilations on Internet site

15 Correction of Rules, Orders, and compilations on Internet site

16 Status of Rules, Orders, and compilations published on Internet site

17 Hard copies of Rules and Orders

18 No copyright in Rules and Orders

19 Presenting Rules and Orders

20 Presenting explanatory statements

21 Explanation of sections 22 to 27

22 Rules and Orders to be disallowed in whole only

23 Notice of motion to disallow Rule or Order

24 How and when Rule or Order disallowed

25 Lapse of notice of motion to disallow Rule or Order

26 Giving notice when Rule or Order disallowed

27 Effect of failure to table in, or disallowance by, Australian Parliament

28 Definitions of terms used primarily in subparts 1 to 3

29 Jurisdiction extended to conduct in Australia

30 Six-year time limit for bringing summary offences

31 Sentencing guidelines for offences involving harm

32 Strict liability offences

33 Alternative verdicts

34 Notice required to adduce evidence for certain defences

35 Certificates to provide evidence of certain matters

36 Application for civil penalty

37 Imposition of civil penalty

38 When and how civil penalty proceedings brought

39 Civil penalty proceedings in New Zealand after proceedings in Australia for civil penalty

40 Criminal proceedings in New Zealand after criminal proceedings in Australia

41 Relationship between concurrent civil penalty proceedings and criminal proceedings

42 One penalty only rule

43 Effect of withdrawal or discontinuation of proceedings on limitation period

44 Restriction on use of evidence given in civil penalty proceedings

45 Abuse of process jurisdiction not affected

46 Criminal liability of executive officers

47 Liability of executive officers to civil penalty

48 How to establish whether executive officer took all reasonable steps

49 Notice required to adduce evidence

50 Manufacture without manufacturing licence or correct manufacturing licence

51 Breaching conditions of manufacturing licence

52 Manufacture, import, export, or supply without product licence or correct product licence

53 Breaching conditions of product licence

54 Breaching conditions of special purpose approval or requirements of exemption

55 Import, export, or supply of product that does not conform to applicable standards

56 Breaching conditions of authorisation not to conform to applicable standards

57 Breaching conditions of conformity assessment certificate

58 Manufacturer supplying or exporting therapeutic product to which conformity assessment procedures not applied

59 Other persons supplying or exporting products to which conformity assessment procedures not applied

60 Purpose

61 Meaning of circumstances

62 Publishing or broadcasting proscribed advertisements

63 Advertisements for which approval required

64 Advertisements containing restricted representations

65 Advertising in breach of direction by Authority

66 Failing to comply with information requirement notice

67 Guidelines for setting penalty levels relating to advertising offences and civil penalties

68 Dealing with counterfeit products

69 Relief from liability in civil penalty proceedings relating to counterfeit products

70 Setting out false product licence number

71 Falsely representing that product is subject to product licence

72 Claiming to supply when product cannot be lawfully supplied

73 Notifying Authority if product subject to actual or proposed tampering

74 False or misleading statements in applications

75 False or misleading statements in declarations relating to conformity assessment procedures

76 Product licence holders failing to give adverse effect information

77 References to information include references to documents

78 Applicants, holders, and former holders failing to comply with information requirement notice

79 Applicants, holders, and former holders giving false or misleading information

80 Persons exempt from requirement to hold product licence failing to comply with information requirement notice

81 Self-incrimination not ground for refusing to supply information

82 Persons exempt from requirement to hold product licence giving false or misleading information

83 Ex-applicant for product licence failing to comply with information requirement notice

84 Ex-applicant for product licence giving false or misleading information

85 Failing to comply with recovery notice

86 Relief from civil liability for failing to comply with recovery notice

87 Export or supply of therapeutic products subject to recovery notice

88 Identifying sponsor when required to do so

89 Authority may issue non-compliance notice

90 Authority may withdraw non-compliance notice

91 Date by which monetary penalty must be paid

92 Amount and payment of monetary penalty

93 Non-compliance notice is bar to proceedings unless not paid by due date

94 Payment of monetary penalty not admission of guilt or liability

95 Regulations prescribing form of non-compliance notice

96 Giving enforceable undertaking

97 Consequence of breach of enforceable undertaking

98 Definition of terms used primarily in subparts 4 and 5

99 Appointment of authorised officers

100 Issue of identity cards to authorised officers

101 Searches for monitoring purposes

102 Entry and search on serious public health grounds without search warrant

103 Searches at request of manufacturer

104 Search warrant to seize evidential material

105 Powers under search warrant

106 Assistance with searches

107 Authorised officers to show identity card on request

108 Announcement before entry

109 Details of warrant to be given to occupier

110 Occupier entitled to be present during search

111 Use of electronic equipment

112 Copies of documents seized to be provided

113 Receipts for things seized

114 Return and retention of things seized

115 Order to retain things seized

116 Forfeiture on conviction or imposition of civil penalty

117 Samples for testing or analysis

118 Analysis and testing of samples in accordance with Rules and Orders

119 Evidence of analysis

120 Cost of testing and analysis

121 Offences relating to search and seizure

122 Disclosure of information

123 Right to inspect therapeutic products imported or for export

124 Non-compliant therapeutic products held at customs controlled area

125 Special provisions relating to consignments

126 Relationship with Customs and Excise Act 1996

127 Therapeutic products protected by Australian patents

128 Definitions of terms used primarily in this Part

129 Purpose and overview

130 Who may apply for merits review

131 What happens if Rules provide for internal review

132 When Authority not required to give reasons

133 No application if review already sought in Australia

134 Application for merits review does not affect decision

135 Establishment and constitution of Review Tribunal

136 Members of Review Tribunal not personally liable

137 Fees for Review Tribunal members

138 Parties to proceedings

139 Procedure of Review Tribunal

140 Decision by majority

141 Powers and decisions of Review Tribunal

142 Matters remitted to Authority for reconsideration

143 New information received by Review Tribunal

144 Transfer of proceedings to Australian Review Tribunal

145 Proceedings transferred from Australian Review Tribunal

146 Effect of decision by Review Tribunals

147 Appeal on question of law

148 Stating case for High Court

149 Application of subpart

150 Availability of judicial review

151 Effect of orders made in judicial review proceedings

152 Stay of judicial review proceedings

153 Determination of stay proceedings

154 Authority subject to Ombudsmen Act 1975 and to Australian Ombudsman Act

155 Co-operation between Ombudsmen

156 New Zealand Ombudsman transferring complaints to Australian Ombudsman

157 Australian Ombudsman transferring complaints to New Zealand Ombudsman

158 Refusal to deal with complaints investigated by Australian Ombudsman

159 Immunity for Australian Ombudsman and others

160 Other protections for Australian Ombudsman and others

161 Authority subject to Privacy Act 1993 and to Australian Privacy Act

162 Modification of information privacy principle 11

163 Co-operation between Privacy Commissioners

164 New Zealand Privacy Commissioner transferring complaints to Australia

165 Australian Privacy Commissioner transferring complaints to New Zealand

166 Taking no action on complaints dealt with by Australian Privacy Commissioner

167 Immunity for Australian Privacy Commissioner and others

168 Other protections for Australian Privacy Commissioner and others

169 Extended immunity for New Zealand Privacy Commissioner

170 Application of Official Information Act 1982

171 Application of Privacy Act 1993

172 Release of therapeutic product information to World Health Organisation

173 Release of therapeutic product information to New Zealand and Australian authorities with therapeutic product functions

174 Release of therapeutic product information to other national authorities with therapeutic product functions

175 Release of therapeutic product information relating to product tampering and law enforcement

176 Release of therapeutic product information required to be provided

177 Release of therapeutic product information in accordance with international co-operative arrangements

178 Release of therapeutic product information to public

179 Protection against action if lawfully making information available

180 Purpose of sections 181 to 184

181 Definition of protected active ingredient information

182 Periods when protected active ingredient information may not normally be disclosed

183 Limited circumstances in which protected active ingredient information may be disclosed

184 Continuation of protections under Medicines Act 1981

185 Protection against action for use by Authority of information

186 Management of Authority's records

187 Definitions of terms used primarily in this Part

188 Overview of Ministerial Council

189 Overview of Board

190 Parliament's expectations of Board

191 Restrictions on Minister's discretion to appoint

192 Vacancies in membership of Board and flaws in appointment

193 Effect of flaws in Board processes

194 Overview of Managing Director

195 Overview of Authority

196 Authority to provide information to Minister

197 Authority to comply with request for information from Finance Minister

198 Authority to comply with request for information by Secretary to the Treasury

199 Authority to comply with directions of Ministerial Council

200 Review of operations and performance

201 Employees and others not to disclose Authority information

202 Employees not to misuse position

203 Application of sections 204 to 207

204 General protection from liability

205 Immunities

206 Indemnities

207 Insurance

208 Immunity for Authority

209 Application of Health and Safety in Employment Act 1992

210 Seal of Authority

211 Signature of Managing Director

212 Restriction on borrowing, etc

213 Restriction on giving guarantees and indemnities

214 Restriction on use of derivative transactions

215 Banking

216 Restriction on acquiring securities

217 Restriction on Authority's involvement in other entities

218 Subsidiaries not to do what Authority cannot or must not do

219 Aligning accounting periods of subsidiaries

220 Banking and accounting for trust money

221 Investment of trust money

222 Exemption of Authority from income tax

223 Authority's input tax under Goods and Services Tax Act 1985

224 Overview

225 Obligation to prepare statement of intent

226 Board to ensure Authority complies with statement of intent

227 Direction by Ministerial Council to amend statement of intent

228 Amendments to statement of intent

229 Statement of intent to be presented to House of Representatives and be published

230 Obligation to prepare annual report

231 Annual report to be presented to House of Representatives and be published

232 Auditor-General is auditor of Authority

233 Obligation to keep accounting records

234 Offence of failing to keep accounting records

235 Offences relating to reporting

236 What Board member must do if interested in matter

237 How disclosures of interest are made

238 Permission to act despite being interested in matter

239 Consequences of failing to comply with section 236

240 Authority may avoid some acts done in breach of conflict of interest rules

241 Duties apply regardless of where senior officer located

242 Duty to act with honesty and integrity

243 Duty to comply with Acts and Rules

244 Duty of care, diligence, and skill

245 Duties of good faith, etc

246 Duty not to misuse information

247 Offences relating to failure to comply with certain duties

248 Requirement to provide information in connection with criminal proceedings

249 Application for civil penalty

250 Imposition of civil penalty

251 When and how civil penalty proceedings brought

252 Authority involvement in proceedings

253 Relief from liability in civil penalty proceedings under section 249

254 Requirement to provide information in connection with civil penalty proceedings

255 Disqualification for breach of duty

256 Application to quash or amend disqualification order

257 Effect of disqualification under Australian Act

258 Compensation order

259 When application for compensation order may be made

260 Others involved in breach of certain senior officer duties

261 Defence to rely on information and advice

262 Relief from civil liability

263 Restriction on use of evidence given in proceedings for civil penalty

264 Civil penalty proceedings in New Zealand after proceedings in Australia for pecuniary penalty

265 Criminal proceedings in New Zealand after criminal proceedings in Australia

266 Relationship between concurrent civil penalty proceedings and criminal proceedings

267 Effect of withdrawal or discontinuation of proceedings on limitation period

268 Abuse of process jurisdiction not affected

269 Regulations providing for departures from the Scheme

270 Regulations for fees and charges for non-Scheme work

271 Transitional and savings regulations

272 General regulation-making power

273 Outline of transitional regime

274 Definitions of terms used in this subpart

275 Saving and application of former Act and former regulations

276 Prescribed fees and charges

277 Deemed grant of transitional approval

278 Duration of transitional approval

279 Deemed grant of transitional approval

280 Duration of transitional approval

281 Determination of pending notices for medicines and related products

282 Grant of transitional approval

283 Duration of transitional approval

284 Kinds of pending applications covered by sections 285 to 288

285 Pending applications on which evaluation work started by start date

286 Pending applications on which no evaluation work done by start date

287 Pending applications that lapse

288 Protection of confidential supporting information

289 Authorised prescribers

290 Medicine required by medical practitioner

291 Clinical trials covered by sections 292 to 294

292 Deemed grant of transitional approval

293 Duration of transitional approval

294 Request to modify clinical trial

295 Determination of pending application for approval of clinical trial

296 Grant of transitional approval

297 Duration of transitional approval

298 Kinds of existing licences covered by sections 299 and 300

299 Deemed grant of transitional approval

300 Duration of transitional approval

301 Kinds of pending applications covered by sections 302 to 304

302 Determination of pending applications

303 Grant of transitional approval

304 Duration of transitional approval

305 Deemed grant of transitional approval

306 Duration of transitional approval

307 Declaration of lawful supply

308 Information to be supplied by sponsor

309 Medical devices subject to existing approvals, etc

310 Medical device required by medical practitioner

311 Deemed grant of transitional approval

312 Duration of transitional approval

313 Declaration of lawful supply

314 Information to be supplied by sponsor

315 Dietary supplements subject to existing approvals, etc

316 Deemed grant transitional approval

317 Duration of transitional approval

318 Declaration of lawful supply

319 Information to be supplied by sponsor

320 Notice issued under section 36 of former Act before start date

321 Advertising

322 When section 323 applies

323 Appeals of decisions under former Act

324 Offences and breaches of former Act

325 Sections 50 to 76 do not apply to holders of transitional approvals

326 Barred proceedings

327 Pending proceedings

328 Transfer of Medsafe employees to Authority

329 Transfer does not break continuity of employment

330 No compensation for technical redundancy

331 Protection of status as contributor to Government Superannuation Fund

332 Purpose of sections 333 and 334

333 Health Sector (Transfers) Act 1993 amended

334 Agreement of Ministerial Council required for transfers

335 Consequential amendments relating to establishment of Authority

336 Other consequential amendments

337 Purpose

338 Outline

339 Interpretation

340 Application

341 Parts 6 and 7 to bind the Crown

342 Employees and employers

343 Outline of this subpart

344 Supplying scheduled medicines by wholesale: controlled activity

345 Regulations may authorise supplying scheduled medicines by wholesale

346 Licence may authorise supplying scheduled medicines by wholesale as fixed vendor or mobile vendor

347 Supplying scheduled medicines other than by wholesale: controlled activity

348 Prescriber may supply scheduled medicines other than by wholesale in limited circumstances

349 Pharmacist may supply scheduled medicines other than by wholesale in limited circumstances

350 Veterinarian may supply scheduled medicines other than by wholesale in limited circumstances

351 Employee working with prescriber may supply scheduled medicines other than by wholesale in limited circumstances

352 Employee working with pharmacist may supply scheduled medicines other than by wholesale in limited circumstances

353 Employee working with veterinarian may supply scheduled medicines other than by wholesale in limited circumstances

354 Deemed licence may authorise supply of scheduled medicines other than by wholesale in limited circumstances

355 Licence may authorise supply of pharmacy medicines other than by wholesale in limited circumstances

356 Regulations or standing order may authorise supply of scheduled medicines other than by wholesale

357 Supply of scheduled medicines to medicines control officer not supply other than by wholesale

358 Standing orders for supply of scheduled medicines

359 Supplying medicines by auction: controlled activity

360 Supplying scheduled medicines by vending machine: controlled activity

361 Dispensing medicines: controlled activity

362 Prescriber may dispense medicines in limited circumstances

363 Pharmacist may dispense medicines in course of pharmacy practice

364 Certain other persons associated with pharmacies may dispense medicines in limited circumstances

365 Veterinarian may dispense medicines in limited circumstances

366 Employee working with veterinarian may dispense medicines in limited circumstances

367 Regulations may authorise dispensing of medicines

368 Licence may authorise dispensing medicines by automated dispensing machine

369 Prescribing prescription medicines: controlled activity

370 Authorised prescriber may prescribe prescription medicines in limited circumstances

371 Designated prescriber may prescribe prescription medicines in limited circumstances

372 Veterinarian may prescribe prescription medicines in limited circumstances

373 Prescribing authorities to issue prescribing notice

374 Review of prescribing notice

375 Prescribing authority to make list available

376 Minister's powers in relation to prescribing authority's obligations under sections 373 to 375

377 Administering prescription medicines: controlled activity

378 Prescriber may administer prescription medicines in limited circumstances

379 Veterinarian may administer prescription medicines in limited circumstances

380 Person may administer prescription medicines in limited circumstances

381 Standing orders authorising administering of prescription and pharmacist-only medicines

382 Possessing prescription medicines: controlled activity

383 Reasonable excuse for possessing prescription medicines

384 Operating pharmacy: controlled activity

385 Outline of this subpart

386 Effect of certain instruments issued under this subpart

387 Minister may prohibit specific persons prescribing and exercising authority

388 Minister must have health authority or Veterinary Council recommendation to prohibit in certain circumstances

389 Medical Officer of Health may restrict prescribing and supplying to individual by restriction notice

390 Prescribing or supplying in contravention of restriction notice

391 Restricted individual procuring or attempting to procure in contravention of restriction notice

392 Review or appeal of restriction notice

393 Statement relating to dependency

394 Outline of this subpart

395 Who may apply

396 Form of application

397 Application must set out medicines to which it relates

398 Application must contain sufficient information

399 Granting of licence

400 Additional matter when granting licence to supply pharmacy medicines other than by wholesale

401 Refusal of licence

402 Licence to supply scheduled medicines by wholesale as fixed vendor

403 Licence to supply scheduled medicines by wholesale as mobile vendor

404 Licence to supply pharmacy medicines other than by wholesale

405 Licence to dispense medicines by using automated dispensing machine

406 Licence to operate pharmacy

407 Conditions of licence

408 Reasons for imposing conditions on licence

409 Complying with conditions on licence

410 Effect of false or misleading statement made in application for licence

411 Reasons for cancelling licence

412 Effect of charge or conviction on licence

413 Producing licence to court

414 Duration of licence

415 Superseding licence

416 Surrendering licence on ceasing controlled activity

417 Register of licences and records of licensing authority

418 Outline of this subpart

419 Meaning of holds an interest in pharmacy

420 Additional matters to be satisfied for pharmacy licence

421 Additional information required for pharmacy licence

422 Restrictions on companies being granted pharmacy licence

423 Licence and majority interest restrictions for persons

424 Exception for mortgagees in possession

425 Mandatory condition on pharmacy licence

426 Failure to comply with conditions on pharmacy licence

427 Prescriber restricted from holding interest in pharmacy

428 Prohibition on operating or holding of majority interest in more than 5 pharmacies

429 Offence for persons associated with pharmacies to take fee on prescriptions

430 Outline of this subpart

431 Security of medicines in pharmacy

432 Storage of scheduled medicine in person's possession or charge

433 Storage of scheduled medicine in unattended building or vehicle

434 Powers of Medical Officer of Health in respect of premises

435 Containers and packages when supplying and transporting medicine

436 Container for medicine in person's possession or charge

437 Packing and preparing medicines for use

438 Delivering medicines

439 Disposal of medicines

440 Records relating to supplying medicine

441 Providing information about records for supplying medicine

442 Offence to knowingly risk public health

443 Outline of this subpart

444 Interpretation

445 Medicines control officers

446 Identification cards

447 Powers of entry to inspect compliance

448 Entry on serious risk to public health ground

449 Issue of search warrants

450 Powers of entry with search warrant

451 Occupier entitled to be present during search

452 Use of electronic equipment

453 Copies of documents seized to be provided

454 Disposal of property seized

455 Order to retain seized property

456 Analysis of sample

457 Analysis of samples and certificate of analyst

458 Evidence of analysis

459 Cost of analysis

460 Offence of wilfully obstructing

461 False or misleading statement, declaration, or answer

462 Director-General or Medical Officer of Health may require documents or records

463 Offence not to comply with requirement in section 462

464 Disclosure of information

465 Matters relating to information and summons

466 Service of documents

467 Contents of container presumed in proceedings

468 Certificate signed by licensing authority

469 Copies of documents or records in proceedings

470 Forfeiture on conviction

471 Notifying health authority or Veterinary Council of conviction

472 Strict liability

473 Liability of employer for act of employees

474 Liability of executive officers for acts of body corporate

475 Protection of persons acting in performance of functions under Parts 6 and 7

476 Outline of this subpart

477 Appeal against decision in respect of premises

478 Appeal against decision of licensing authority

479 Status of decision of licensing authority pending appeal

480 Proceedings before District Court

481 Appeal to High Court on question of law

482 Status of decision of District Court pending appeal

483 Procedure for appeal

484 No person may be deprived of right to appeal

485 Licensing authority to implement decision of Court

486 Outline of subpart

487 Interpretation

488 Restriction on xenotransplantation

489 Authorisation for particular xenotransplantation given by Minister

490 Authorisation given for xenotransplantation by Order in Council

491 Criteria for authority

492 Advice on applicability of criteria

493 Applications

494 No compensation

495 Enforcement powers

496 Director-General or Medical Officer of Health may require information relating to xenotransplantation

497 Offence not to comply with requirement to produce under section 496

498 Expiry of subpart

499 Regulations

500 Regulations designating health practitioners as designated prescribers

501 Regulations relating to prescribing notices and prescription medicines that designated prescribers may prescribe

502 Regulations designating health practitioners as authorised prescribers

503 Regulations relating to qualifications, training, and competence of prescribers and veterinarians when prescribing

504 Orders in Council providing for exemption from, or modifications of, restrictions on pharmacy ownership and operation

505 Minister may approve laboratory

506 Minister may appoint analyst in charge

507 Analyst in charge may authorise analyst

508 Advisory and technical committees

509 Statement of Director-General

510 Director-General may authorise Medical Officer of Health to issue notices and statements

511 Standard for Uniform Scheduling of Medicines and Poisons or SUSMP

512 Scheduled medicines

513 Ministerial notice declaring scheduled medicine

514 Ministerial notice departing from managing director's listing

515 Director-General to keep Internet register of declarations and departures

516 Evidence of SUSMP

517 How to refer to or specify medicines

518 Relationship with Misuse of Drugs Act 1975

519 Designated prescriber under former Act deemed to be designated prescriber

520 Standing orders issued under former Act

521 Application for licence to sell medicines by wholesale under former Act

522 Licence to sell any medicine by wholesale granted under former Act

523 Application for licence to sell any medicine by retail under former Act

524 Licence to sell medicines by retail granted under former Act

525 Application for licence to hawk medicines under former regulations

526 Licence to hawk medicines granted under former regulations

527 Application for licence to operate pharmacy under former Act

528 Licence to operate pharmacy granted under former Act

529 Other licences granted under former Act

530 Condition on deemed licence

531 Proceedings commenced under former Act

532 Appeal from decision under former Act

533 Officers appointed under former Act

534 No compensation for loss of office or appointment

535 Xenotransplantation

536 Approved laboratory under former Act

537 Analyst in charge under former Act

538 Repeal

539 Transitional and savings regulations

540 Expiry of section 539

541 Revocations

542 Validity of actions under former Act and regulations not affected

543 Medicines (Approved Laboratories and Analysts in Charge) Notice 2000 saved

544 Medicines (Standing Order) Regulations 2002 saved

545 Medicines (Designated Prescriber: Nurse Practitioners) Regulations 2005 saved

546 Medicines (Designated Prescriber: Optometrists) Regulations 2005 saved

547 Orders in Council made under section 96D(1) of former Act saved

548 Consequential amendments