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MEDICINES, POISONS AND THERAPEUTIC GOODS ACT 2022 - As at 21 March 2024 - Act 73 of 2022

- As at 21 March 2024 - Act 73 of 2022

Table of Provisions

CHAPTER 1 - PRELIMINARY

  • 1 Name of Act
  • 2 Commencement
  • 3 Objects of Act
  • 4 Definitions
  • 5 Meaning of "supply" and "wholesale supply"
  • 6 Meaning of "NSW Poisons Schedules"
  • 7 Effect of classification of substances

CHAPTER 2 - REGULATION OF SUPPLY, PRESCRIPTIONS AND OTHER ACTIVITIES

PART 2.1 - INTRODUCTION

  • 8 Application of Chapter
  • 9 Authorisation of activities under other laws
  • 10 Authorisation of activities by regulations
  • 11 Regulations about application of Parts 2.2-2.6
  • 12 Regulations may prohibit or restrict authorised activities

PART 2.2 - WHOLESALE SUPPLY

PART 2.3 - OBTAINING WHOLESALE SUPPLY

Note

PART 2.4 - NON-WHOLESALE SUPPLY

  • 27 Application of Part
  • 28 Offence--unauthorised non-wholesale supply
  • 29 Non-wholesale supply by health practitioners and veterinary practitioners
  • 30 Non-wholesale supply by pharmacists in pharmacies
  • 31 Non-wholesale supply by pharmacists in hospitals
  • 32 Non-wholesale supply by pharmacists in managed correctional centres
  • 33 Non-wholesale supply by carers
  • 34 Non-wholesale supply by State Vaccine Centre

PART 2.5 - PRESCRIPTIONS

  • 35 Application of Part
  • 36 Offence--unauthorised issue of prescription
  • 37 Prescriptions issued by health practitioners and veterinary practitioners

PART 2.6 - CLINICAL TRIALS

  • 38 Application of Part
  • 39 Authorisation of clinical trials

PART 2.7 - OFFENCES

  • 40 Offence--loss or theft of Schedule 4D or 8 substances
  • 41 Offence--possessing Schedule 7 substances for domestic use
  • 42 Offences--automatic machines for supplying certain therapeutic goods
  • 43 Offence--supplying certain therapeutic goods at houses or in public places
  • 44 Offence--administration or non-wholesale supply of unregistered or unlisted therapeutic goods
  • 45 Offence--supply of expired therapeutic goods
  • 46 Offence--dispensing or compounding scheduled substances on prescription
  • 47 Offence--obtaining scheduled substances by false representation
  • 48 Defence for delivering or transporting substances

PART 2.8 - RESTRICTION ORDERS

  • 49 Health Secretary may make restriction orders
  • 50 Grounds on which restriction orders may be made
  • 51 Making restriction orders
  • 52 Restriction orders for health practitioners
  • 53 Review of restriction orders

PART 2.9 - MISCELLANEOUS

  • 54 Regulations about scheduled substances used for cosmetic purposes
  • 55 Regulations about activities involving certain therapeutic goods and preparations

CHAPTER 3 - LICENCES, APPROVALS AND OTHER AUTHORISATIONS

PART 3.1 - INTRODUCTION

  • 56 Application of Chapter

PART 3.2 - LICENCES FOR WHOLESALE SUPPLY AND OBTAINING WHOLESALE SUPPLY OF CERTAIN THERAPEUTIC GOODS

Division 1 - Granting of wholesaler licences and obtain licences

  • 57 Wholesaler licences and obtain licences
  • 58 Grounds for granting licence
  • 59 Application for licence
  • 60 Conditions of licence
  • 61 Variation of licence
  • 62 Annual fee for licence

Division 2 - Suspension or cancellation of wholesaler licences and obtain licences

  • 63 Mandatory grounds for suspension or cancellation of licence
  • 64 Discretionary grounds for suspension or cancellation of licence
  • 65 Submissions about suspension or cancellation of licence on discretionary grounds
  • 66 Notice of suspension or cancellation of licence

PART 3.3 - APPROVALS FOR SUPPLY AND PRESCRIPTION OF CERTAIN THERAPEUTIC GOODS BY HEALTH PRACTITIONERS

  • 67 Application of Part
  • 68 Granting of approval
  • 69 Offence--supplying or issuing prescriptions for therapeutic goods without approval
  • 70 Application for approval
  • 71 Conditions of approval
  • 72 Variation of approval
  • 73 Suspension or revocation of approval

PART 3.4 - OPIOID TREATMENT PROGRAM

  • 74 Registration in Opioid Treatment Program
  • 75 Offence--supplying, dispensing or issuing prescriptions for certain scheduled substances without OTP registration

PART 3.5 - AUTHORITIES FOR DRUG MISUSE AND TRAFFICKING ACT 1985

  • 76 Granting of DMT authority
  • 77 Application for DMT authority
  • 78 Duration of DMT authority
  • 79 Conditions of DMT authority
  • 80 Variation of DMT authority
  • 81 Suspension or revocation of DMT authority

PART 3.6 - MISCELLANEOUS

Division 1 - Investigation of applications for licences, approvals and DMT authorities

  • 82 Application of Division
  • 83 Information about applications for licences, approvals and DMT authorities
  • 84 Investigation of applications for licences, approvals and DMT authorities

Division 2 - Fees

  • 85 Fees for licences, approvals, OTP registrations and DMT authorities

CHAPTER 4 - APPLICATION OF COMMONWEALTH THERAPEUTIC GOODS LAWS

  • 86 Application of Commonwealth therapeutic goods laws
  • 87 Functions of Commonwealth Minister, Commonwealth Secretary and others
  • 88 Application of Commonwealth administrative laws
  • 89 Application of Commonwealth criminal laws
  • 90 Functions of Commonwealth officers and authorities relating to offences
  • 91 No double jeopardy for offences against applied provisions
  • 92 Commonwealth may keep fees paid to Commonwealth Secretary

CHAPTER 5 - INVESTIGATION FUNCTIONS

PART 5.1 - INFORMATION GATHERING

  • 93 Application of Part
  • 94 Powers to require information and records
  • 95 Power to require answers
  • 96 Recording of evidence
  • 97 Power to require name and address
  • 98 Privilege against self-incrimination not affected

PART 5.2 - ENTERING PREMISES

  • 99 Powers to enter premises
  • 100 Search warrants
  • 101 Powers permitted to be exercised on premises
  • 102 Power to require name and address
  • 103 Requiring assistance
  • 104 Use of force

PART 5.3 - SEIZED THINGS

  • 105 Definition
  • 106 Release of seized things
  • 107 Forfeiture of seized things by order
  • 108 Forfeiture of seized things with consent
  • 109 Order for expenses to be paid
  • 110 Storage of and interference with seized things
  • 111 Disposal of forfeited things

PART 5.4 - MISCELLANEOUS

  • 112 Offence--contravention of requirement made by authorised officer
  • 113 Variation or revocation of notices
  • 114 Destruction of things surrendered by enforcement agencies

CHAPTER 6 - ENFORCEMENT

PART 6.1 - COMPLIANCE NOTICES

  • 115 Compliance notices
  • 116 Review of compliance notices

PART 6.2 - OFFENCES AND PENALTIES

  • 117 Maximum penalty for Tier 1, 2, 3, 4 and 5 offences
  • 118 Contraventions by corporations
  • 119 Continuing offences
  • 120 Proceedings for offences
  • 121 Penalty notices
  • 122 Protection from personal liability
  • 123 Exclusion of civil liability of State and State authorities

PART 6.3 - EVIDENTIARY MATTERS

  • 124 Certificates issued by Health Secretary
  • 125 Certificates issued by analysts
  • 126 Presumptions

CHAPTER 7 - ADMINISTRATION

PART 7.1 - REGULATORY ADVISORY COMMITTEE AND CLINICAL ADVISORY COMMITTEE

  • 127 Regulatory Advisory Committee
  • 128 Clinical Advisory Committee
  • 129 Information required from Health Care Complaints Commission and certain health practitioner bodies
  • 130 Subcommittees

PART 7.2 - AUTHORISED OFFICERS

  • 131 Appointment of authorised officers
  • 132 Police officers taken to be authorised officers
  • 133 Functions of authorised officers
  • 134 Certificate of authority for authorised officers
  • 135 Use of assistants
  • 136 Offences--obstruction or impersonation

PART 7.3 - ANALYSTS AND ANALYSES

  • 137 Appointment of analysts
  • 138 Conduct of analyses
  • 139 Offence--use of analysis for trade purposes or advertisement

PART 7.4 - ORDERS BY HEALTH SECRETARY

Division 1 - Public health risk authorisation orders

  • 140 Health Secretary may make public health risk authorisation orders
  • 141 Duration of public health risk authorisation orders
  • 142 Effect of public health risk authorisation orders

Division 2 - Supply prohibition orders

  • 143 Health Secretary may make supply prohibition orders

CHAPTER 8 - MISCELLANEOUS

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