New South Wales Consolidated Acts

MEDICINES, POISONS AND THERAPEUTIC GOODS ACT 2022

- As at 21 March 2024 
- Act 73 of 2022 

TABLE OF PROVISIONS

           Long Title

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

   13.     Application of Part
   14.     Offence--unauthorised wholesale supply
   15.     Wholesale supply by licensed wholesalers
   16.     Wholesale supply of Schedule 7 substances
   17.     Wholesale supply by public health entities
   18.     Wholesale supply between pharmacists
   19.     Return of wholesale supply

   PART 2.3 - OBTAINING WHOLESALE SUPPLY
   Note

   20.     Application of Part
   21.     Obtaining wholesale supply by health practitioners and others
   22.     Obtaining wholesale supply by public health entities
   23.     Obtaining wholesale supply in residential aged care facilities
   24.     Obtaining wholesale supply in correctional centres and detention centres
   25.     Obtaining wholesale supply by licence holders
   26.     Obtaining wholesale supply of Schedule 7 substances

   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

   144.    Health Secretary may recover fees and charges
   145.    Service of documents
   146.    Disclosure of information
   147.    Act to bind Crown
   148.    Review of Act
   149.    Regulations
   150.    Specific regulation-making powers
   151.    Repeals
           SCHEDULE 1
           SCHEDULE 2
           SCHEDULE 3
           SCHEDULE 4
           SCHEDULE 5