Commonwealth Consolidated Regulations

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NARCOTIC DRUGS REGULATION 2016

- made under the Narcotic Drugs Act 1967

TABLE OF PROVISIONS

   PART 1--PRELIMINARY

   1.      Name  
   3.      Authority  
   4.      Definitions  
   4A.     Prescription of substances  
   4B.     Permitted supply  

   PART 2--MEDICINAL CANNABIS LICENCES AND PERMITS

           Division 1--Medicinal cannabis licences and permits

   5.      Application for medicinal cannabis licence--information requirements  
   6.      Application for medicinal cannabis licence--document requirements  
   7.      Application fee for medicinal cannabis licences  
   7A.     Application for medicinal cannabis licence--general grounds for refusal of licence  
   7B.     Matters to be specified in a medicinal cannabis licence--persons prescribed  
   8.      Application for medicinal cannabis permit--information requirements  
   9.      Application for medicinal cannabis permit--document requirements  
   10.     Application fee for medicinal cannabis permit  
   11.     Application for medicinal cannabis permit--particular grounds for refusal of permit  

           Division 3--Conditions of medicinal cannabis licences

   17.     Condition that medicinal cannabis licence holder must only use seeds, cultivars or other genetic material of cannabis plants obtained from legitimate sources  
   17A.    Condition that medicinal cannabis licence holder must give information relating to activities authorised by licence if requested  
   17B.    Condition that medicinal cannabis licence holder must retain records  
   17C.    Condition that medicinal cannabis licence holder must notify emergency services  
   17D.    Condition that medicinal cannabis licence holder must notify Secretary of certain information  
   17E.    Condition that medicinal cannabis licence holder must operate in accordance with risk management plan and standard operating procedures  
   17F.    Condition that medicinal cannabis licence holder must maintain system of security  
   18.     Condition that medicinal cannabis licence holder employ or engage suitable staff  
   19.     Condition that medicinal cannabis licence holder be party to certain contracts  
   20.     Condition that medicinal cannabis licence holder notify the Secretary of certain matters  

           Division 4--Variation, suspension and surrender of medicinal cannabis licences and medicinal cannabis permits

              Subdivision A--Variation of medicinal cannabis licences and medicinal cannabis permits

   21.     Circumstances in which medicinal cannabis licences and medicinal cannabis permits must not be varied  
   22.     Application for variation of medicinal cannabis licences and medicinal cannabis permits--information requirements  
   23.     Application for variation of medicinal cannabis licences and medicinal cannabis permits--document requirements  
   24.     Application fee for variation of medicinal cannabis licences and medicinal cannabis permits  

              Subdivision B--Suspension of medicinal cannabis licences and medicinal cannabis permits

   25.     Suspension of medicinal cannabis licences and medicinal cannabis permits  
   26.     Secretary may suspend medicinal cannabis licences and medicinal cannabis permits  
   27.     Secretary may permit specified activities to occur during suspension of medicinal cannabis licences  
   27A.    Secretary may permit specified activities to occur during suspension of medicinal cannabis permits  
   28.     Secretary to notify of proposed suspension of medicinal cannabis licences and medicinal cannabis permits  
   29.     Effect of suspension of medicinal cannabis licences  
   29A.    Effect of suspension of medicinal cannabis permits  
   30.     Revocation of suspension of medicinal cannabis licences and medicinal cannabis permits  
   31.     Matters not affected by suspension of medicinal cannabis licences and medicinal cannabis permits  
   32.     Offence and civil penalty--breach of condition of permitted activity during suspension of licence or permit  

              Subdivision C--Surrender of medicinal cannabis licences and medicinal cannabis permits

   33.     Surrender of medicinal cannabis licences and medicinal cannabis permits  
   34.     Licence holder may surrender medicinal cannabis licences and medicinal cannabis permits  

   PART 3--LICENSING THE MANUFACTURING OF NARCOTIC DRUGS

           Division 1--Manufacture licences and permits

   35.     Application for manufacture licence--information requirements  
   36.     Application for manufacture licence--document requirements  
   36A.    Application for manufacture licence--general grounds for refusal of licence  
   37.     Matters to be specified in a manufacture licence--persons prescribed  
   38.     Application for manufacture permit--information requirements  

           Division 2--Conditions of manufacture licences

   39.     Condition that manufacture licence holder employ or engage suitable staff  
   40.     Condition that manufacture licence holder notify the Secretary of certain matters  

           Division 3--Variation, suspension and surrender of manufacture licences and manufacture permits

              Subdivision A--Variation of manufacture licences and permits

   41.     Circumstances in which a manufacture licence or manufacture permit must not be varied  
   42.     Application for variation of manufacture licence or permit--information requirements  
   43.     Application for variation of manufacture licence or permit--document requirements  

              Subdivision B--Suspension of manufacture licences and permits

   44.     Suspension of manufacture licences and permits  
   45.     Secretary may suspend manufacture licences and permits  
   46.     Secretary to notify of proposed suspension of manufacture licence or permit  
   47.     Effect of suspension of manufacture licences  
   47A.    Effect of suspension of manufacture permit  
   48.     Revocation of suspension of manufacture licence or permit  
   49.     Matters not affected by suspension of manufacture licence or permit  

              Subdivision C--Surrender of manufacture licences and permits

   50.     Surrender of manufacture licences and permits  
   51.     Licence holder may surrender manufacture licence or permit  

   PART 4--REVIEW OF DECISIONS

   52.     Reviewable decisions  

   PART 5--OTHER MATTERS

           Division 1--Inspection fees

   54.     Inspection fees  

           Division 1A--Charges

   54A.    Classes of medicinal cannabis licences for the purposes of charge  
   54B.    Payment of charge  
   54C.    Recovery of charge  

           Division 2--Other matters

   55.     Secretary to notify States and Territories of certain matters  
   56.     Modification of operation of Chapters 2 and 3 of the Act  

   PART 6--APPLICATION, SAVING AND TRANSITIONAL PROVISIONS

   57.     Application provisions relating to the Narcotic Drugs Amendment (Cannabis) Regulations 2018  
   58.     Application provisions relating to the Narcotic Drugs Amendment (Review Recommendations) Regulations 2019  
   59.     Application provisions relating to the Narcotic Drugs Amendment (Fees) Regulations 2020  
   60.     Application provisions relating to the Narcotic Drugs Amendment (Cannabis-Related Manufacture Licences and Permits) Regulations 2020  
   61.     Application provisions relating to the Narcotic Drugs Amendment (Fees) Regulations 2021  
   62.     Application provisions relating to the Narcotic Drugs Amendment (Medicinal Cannabis) Regulations 2021  
   63.     Application of amendments of the Narcotic Drugs Amendment (Fees) Regulations 2023  
           SCHEDULE 1 Application fees


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