Queensland Subordinate Legislation as Made

PUBLIC HEALTH (MEDICINAL CANNABIS) REGULATION 2017

- Made under the Public Health (Medicinal Cannabis) Act 2016
- As at 24 February 2017
- Reg 15 of 2017

TABLE OF PROVISIONS

   PART 1 - INTRODUCTION

           Division 1 - Preliminary

   1.      Short title
   2.      Commencement
   3.      Definitions

           Division 2 - General provisions

   4.      Compliance with code, guideline, protocol or standard
   5.      Language of documents

   PART 2 - MANUFACTURING APPROVALS AND WHOLESALING APPROVALS

           Division 1 - Preliminary

   6.      Definitions for part
   7.      Consistency with Commonwealth law
   8.      Evidentiary aids

           Division 2 - Application for approvals

              Subdivision 1 - Preliminary

   9.      Suitability of person to hold approval
   10.     Approved form

              Subdivision 2 - Particular provisions for application for manufacturing approval

   11.     Purpose of subdivision
   12.     Who may apply for manufacturing approval
   13.     Criteria for grant or renewal of manufacturing approval

              Subdivision 3 - Particular provisions for application for wholesaling approval

   14.     Purpose of subdivision
   15.     Who may apply for wholesaling approval
   16.     Criteria for grant or renewal of wholesaling approval

              Subdivision 4 - Process for deciding applications

   17.     Decision on application for approval
   18.     Chief executive may require information or documents
   19.     Chief executive may extend period for decision for complex application
   20.     Failure to decide application

           Division 3 - Grant of approvals

              Subdivision 1 - Conditions, term and transfer

   21.     Standard conditions for manufacturing approvals
   22.     Standard conditions for wholesaling approvals
   23.     Additional or varied conditions for approvals
   24.     Term of approvals
   25.     Transfer of approvals prohibited

              Subdivision 2 - Form of approvals

   26.     Form of manufacturing approval
   27.     Form of wholesaling approval

           Division 4 - Amendment, replacement and renewal of approvals

              Subdivision 1 - Preliminary

   28.     Making applications
   29.     Process for deciding application

              Subdivision 2 - Amendment

   30.     Application by holder to amend approval
   31.     Minor amendment of approval by chief executive

              Subdivision 3 - Replacement

   32.     Application for replacement of approval
   33.     Criteria for deciding replacement application

              Subdivision 4 - Renewal

   34.     Application for renewal of approval
   35.     Approval taken to be in force while renewal application considered

           Division 5 - Return and surrender of approvals

   36.     Return of instrument of approval

           Division 6 - Authority under approvals

   37.     Manufacturing approval does not grant authority to manufacture
   38.     Authority under wholesaling approval

           Division 7 - Particular provisions for wholesaling approvals

   39.     Wholesaling code
   40.     Wholesaler to give invoice when wholesaling medicinal cannabis
   41.     Automatic grant, renewal, variation, suspension, cancellation and surrender of wholesaling approval

           Division 8 - Administrative action

   42.     Definition for division
   43.     Grounds for action to be taken
   44.     Show cause notice
   45.     Representations about show cause notices
   46.     Ending show cause process without further action
   47.     Decision to take administrative action
   48.     Immediate administrative action

           Division 9 - Offences

   49.     Offence for false or misleading statements or documents
   50.     Offence for failure to comply with approval conditions

   PART 3 - OTHER DEALINGS WITH MEDICINAL CANNABIS

           Division 1 - Medicinal cannabis approvals, dispensing approvals and clinical trial approvals

   51.     Standard conditions for medicinal cannabis approvals—Act, s 34(1)
   52.     Standard conditions for dispensing approvals—Act, s 34(1)
   53.     Standard conditions for clinical trial approvals—Act, s 34(1)

           Division 2 - Patient-class prescribers

   54.     Prescribed specialist medical practitioners—Act, s 52(1)(a)
   55.     Prescribed classes of patients—Act, s 52(2)(a)
   56.     Prescribed medicinal cannabis—Act, s 52(2)(b)
   57.     Conditions for patient-class prescribers—Act, s 52(1)(b)

           Division 3 - Restricted access patients

   58.     Prescribed persons—Act, s 61(7), definition prescribed person

           Division 4 - Authorised ways and eligible persons

              Subdivision 1 - Preliminary

   59.     Definitions for division
   60.     Eligible persons and authorised ways—Act, s 68

              Subdivision 2 - Hospital staff

   61.     Dosage conditions do not apply to authorised hospital staff members
   62.     Authority ends when relevant patient leaves hospital
   63.     Use of patient-supplied medicinal cannabis
   64.     Hospital doctors
   65.     Enrolled nurses
   66.     Registered nurses
   67.     Pharmacists
   68.     Pharmacy technicians

              Subdivision 3 - State analysts and trainee State analysts

   69.     Manufacture of medicinal cannabis

           Division 5 - Offences

   70.     Misuse of written instruction for medicinal cannabis
   71.     Unsafe disposal or use of medicinal cannabis

           Division 6 - Medicinal cannabis management plans

   72.     Additional matters to be dealt with in medicinal cannabis management plans—Act s 70(4)

   PART 4 - LAWFUL DIRECTIONS

           Division 1 - Lawful directions generally

   73.     Preventing fraudulent lawful directions

           Division 2 - Prescriptions

              Subdivision 1 - Prescriptions generally

   74.     Prescriptions for medicinal cannabis
   75.     Form of prescriptions
   76.     Content of prescriptions

              Subdivision 2 - Paper prescriptions

   77.     Paper prescriptions generated by computer
   78.     Electronic communication of paper prescriptions

              Subdivision 3 - Electronic prescriptions

   79.     Electronic prescriptions

   PART 5 - DISPENSING MEDICINAL CANNABIS

           Division 1 - Packaging and labelling

   80.     Packaging
   81.     Labelling generally
   82.     Labelling by pharmacist
   83.     Labelling by single-patient prescribers and patient-class prescribers
   84.     Warnings to be printed on labels
   85.     Chief executive may approve alternative packaging or labelling
   86.     Restriction on using contaminated packages
   87.     Restriction on selling in second-hand packages

           Division 2 - Dispensing

   88.     When medicinal cannabis must not be dispensed
   89.     Dealing with prescriptions
   90.     Issuing, selling or supplying medicinal cannabis after expiry date

           Division 3 - Advertising medicinal cannabis

   91.     Advertising medicinal cannabis

   PART 6 - RECORD-KEEPING

           Division 1 - Record-keeping generally

   92.     Records may be made and kept electronically
   93.     Recording information on paper
   94.     Keeping information
   95.     Record to be made on day of transaction
   96.     Stocktake
   97.     Discrepancy to be immediately reported to chief executive
   98.     Records not to be changed but may be corrected
   99.     False, misleading or incomplete entries

           Division 2 - Record-keeping by particular doctors

   100.    Particular doctors to record transactions involving medicinal cannabis

           Division 3 - Record-keeping by pharmacists

   101.    Definition for division
   102.    Pharmacists to record transactions involving medicinal cannabis in controlled drugs record
   103.    Entries to be made in controlled drugs record
   104.    Pharmacist to keep documents

           Division 4 - Record-keeping by wholesalers

   105.    Records of transactions to be kept by wholesalers

           Division 5 - Record-keeping by hospitals and nursing homes

              Subdivision 1 - Preliminary

   106.    Definitions for division

              Subdivision 2 - Hospitals and nursing homes with multiple storage points

   107.    Application of subdivision
   108.    Main issue book
   109.    Details to be recorded in main issue book
   110.    Ward book
   111.    Details to be recorded in ward book when medicinal cannabis obtained into unit
   112.    Details to be recorded in ward book when medicinal cannabis administered in unit
   113.    Transfer vouchers may be used for medicinal cannabis in certain cases
   114.    Main issue book and ward book as 1 book

              Subdivision 3 - Hospitals and nursing homes with 1 storage point

   115.    Application of subdivision
   116.    Single storage book
   117.    Details to be recorded in single storage book when medicinal cannabis deposited
   118.    Details to be recorded in single storage book when medicinal cannabis administered

              Subdivision 4 - Other provisions about record-keeping by hospitals and nursing homes

   119.    Responsibility for checking accuracy of records at hospitals and nursing homes

   PART 7 - TRANSPORTATION AND DELIVERY OF MEDICINAL CANNABIS

   120.    Definitions for part
   121.    Sending and delivering medicinal cannabis
   122.    Delivery of medicinal cannabis
   123.    Sending medicinal cannabis by carrier

   PART 8 - STORAGE OF MEDICINAL CANNABIS

   124.    Relevant person must comply with standard

   PART 9 - NOTIFICATION AND REPORTING

   125.    Definition for part
   126.    Single-patient prescribers
   127.    Patient-class prescribers

   PART 10 - TRANSITIONAL PROVISIONS

   128.    Definitions for part
   129.    Existing licence to manufacture medicinal cannabis
   130.    Existing application for controlled drug manufacturer licence
   131.    Existing licence to wholesale medicinal cannabis
   132.    Existing application for controlled drug wholesaler licence
           SCHEDULE 1
           SCHEDULE 2