Australian Capital Territory Numbered Regulations

MEDICINES, POISONS AND THERAPEUTIC GOODS REGULATION 2008 (NO 42 OF 2008)

- made under the Medicines, Poisons and Therapeutic Goods Act 2008

TABLE OF PROVISIONS

CHAPTER 1--PRELIMINARY

   1.      Name of regulation  
   2.       Commencement  
   3.      Dictionary  
   4.      Notes  
   5.      Offences against regulation—application of Criminal Code etc  
   6.      Overview of things to which medicines and poisons standard does not  

CHAPTER 2--MEDICINES—AUTHORISATIONS GENERALLY

   PART 2.1--OVERVIEW OF MEDICINES AUTHORISATIONS

   10.     General overview of authorisations for medicines  
   11.     Overview of medicines authorisations under this regulation  
   12.      General overview of authorisation conditions for medicines  

   PART 2.2--RELATIONSHIP WITH HEALTH PROFESSIONALS ACT

   20.     Medicines authorisations subject to Health Professionals Act  

CHAPTER 3--MEDICINES—SUPPLY AUTHORITIES

   PART 3.1--PRESCRIBING MEDICINES

           Division 3.1.1--Authorisation to prescribe medicines

   30.     Authorisation under sch 1 to prescribe medicines—Act, s 40 (1) (b), (2) (b)  
   31.     Authorisation conditions for prescribing medicines—Act, s 44 (1) (b) and (2)  
   32.     Additional requirements for prescribing controlled medicines for human  
   33.     Additional requirements for designated appendix D medicines prescriptions for human  

           Division 3.1.2--Prescriptions

   40.     General requirements for written prescriptions  
   41.     Particulars for prescriptions  

   PART 3.2--REQUISITIONING MEDICINES

           Division 3.2.1--Authorisation to issue requisitions

   50.     Authorisation under sch 1 to issue requisitions for medicines—Act, s 41 (b)  
   51.     Authorisation conditions for issuing requisitions for medicines—Act, s 44 (1) (b)  

           Division 3.2.2--Requisitions

   55.     General requirements for written requisitions  
   56.     Particulars for requisitions  

   PART 3.3--MEDICINES PURCHASE ORDERS

           Division 3.3.1--Authorisation to issue purchase orders

   60.     Authorisation under sch 1 to issue purchase orders for medicines—Act, s 38 (1) (b) and  
   61.     Authorisation conditions for issuing purchase orders for medicines—Act, s 44 (1)  

           Division 3.3.2--Purchase orders

   62.     General requirements for medicines purchase orders—Act, s 38 (2)  

   PART 3.4--STANDING ORDERS FOR MEDICINES

           Division 3.4.1--CHO standing orders

   70.     Authorisation of CHO to issue standing orders for supply of medicines in public health  
   71.     Authorisation of CHO to issue standing orders for administration of medicines for public  
   72.     Particulars for CHO standing orders for administration of medicines for public health  

           Division 3.4.2--Standing orders for institutions

   75.     Authorisation of doctors to issue standing orders for administration of medicines at  
   76.     Particulars for standing orders for administration of medicines at  

   PART 3.5--MEDICINES SUPPLY AUTHORITIES GENERALLY

   80.     Cancellation of invalid supply  
   81.     Information for CHO about controlled medicines supplied on supply  

CHAPTER 4--SUPPLYING MEDICINES

   PART 4.1--PRELIMINARY

   PART 4.2--MEDICINES--SUPPLY AUTHORISATIONS UNDER SCH 1

           Division 4.2.1--Sch 1 medicines supply authorisations

           Division 4.2.2--Dispensing medicines

           Division 4.2.3--Supplying medicines on requisitions

           Division 4.2.4--Supplying medicines on purchase orders

           Division 4.2.5--Supplying medicines on standing orders

           Division 4.2.6--Supplying medicines during consultations

           Division 4.2.7--Selling pseudoephedrine by retail

           Division 4.2.8--Supplying pharmacist only medicines

   PART 4.3--AUTHORISATION TO SUPPLY WITHOUT PRESCRIPTION IN EMERGENCIES

   PART 4.4--AUTHORISATION TO SUPPLY MEDICINES FOR DISPOSAL

   PART 4.5--WHOLESALE SUPPLY OF MEDICINES UNDER CORRESPONDING LAWS

CHAPTER 5--ADMINISTERING MEDICINES

   PART 5.1--AUTHORISATIONS FOR HEALTH-RELATED OCCUPATIONS

   PART 5.2--OTHER ADMINISTRATION AUTHORISATIONS

CHAPTER 6--OBTAINING AND POSSESSING MEDICINES

CHAPTER 7--MANUFACTURING MEDICINES

CHAPTER 8--DISCARDING MEDICINES

CHAPTER 9--OTHER MEDICINES AUTHORISATIONS

   PART 9.1--AUTHORISATIONS FOR DELIVERY PEOPLE AND COMMERCIAL DISPOSAL OPERATORS

   PART 9.2--EMERGENCY SUPPLY AND ADMINISTRATION OF ADRENALINE AND SALBUTAMOL

   PART 9.3--MEDICINES AUTHORISATIONS FOR CORRECTIONS FUNCTIONS

   PART 9.4--AUTHORISATIONS FOR MEDICINES RESEARCH AND EDUCATION PROGRAM PURPOSES OTHER THAN CONTROLLED MEDICINES

   PART 9.5--AUTHORISATIONS UNDER MEDICINES LICENCES

           Division 9.5.1--Controlled medicines research and education program licence authorisations

           Division 9.5.2--First-aid kit licence authorisations

           Division 9.5.3--Wholesalers licence authorisations

           Division 9.5.4--Opioid dependency treatment licence authorisations

           Division 9.5.5--Pharmacy medicines rural communities licences

CHAPTER 10--PACKAGING AND LABELLING OF MEDICINES GENERALLY

CHAPTER 11--STORAGE OF MEDICINES

   PART 11.1--PRELIMINARY

   PART 11.2--STORAGE REQUIREMENTS FOR MEDICINES GENERALLY

   PART 11.3--ADDITIONAL STORAGE REQUIREMENTS FOR MEDICINES OTHER THAN CONTROLLED MEDICINES

   PART 11.4--ADDITIONAL STORAGE REQUIREMENTS FOR CONTROLLED MEDICINES

CHAPTER 12--CONTROLLED MEDICINES REGISTERS

CHAPTER 13--CONTROLLED MEDICINES AND APPENDIX D MEDICINES APPROVALS FOR HUMAN USE

   PART 13.1--CONTROLLED MEDICINES APPROVALS

           Division 13.1.1--Preliminary

           Division 13.1.2--Standing controlled medicines approvals

           Division 13.1.3--Chief health officer controlled medicines approvals

           Division 13.1.4--Endorsements to treat drug-dependency

   PART 13.2--APPENDIX D MEDICINES APPROVALS

CHAPTER 14--MEDICINES LICENCES

   PART 14.1--MEDICINES LICENCES GENERALLY

   PART 14.2--CONTROLLED MEDICINES RESEARCH AND EDUCATION PROGRAM LICENCES

   PART 14.3--FIRST-AID KIT LICENCES

   PART 14.4--MEDICINES WHOLESALERS LICENCES

   PART 14.5--OPIOID DEPENDENCY TREATMENT LICENCES

   PART 14.6--PHARMACY MEDICINES RURAL COMMUNITIES LICENCES

CHAPTER 15--MEDICINES—OTHER PROVISIONS

   PART 15.1--OPIOID DEPENDENCY TREATMENT GUIDELINES

   PART 15.2--MEDICINES ADVISORY COMMITTEE

   PART 15.3--OTHER MEDICINES PROVISIONS

CHAPTER 16--LOW AND MODERATE HARM POISONS

   PART 16.1--PRELIMINARY

   PART 16.2--AUTHORISATION TO SUPPLY LOW AND MODERATE HARM POISONS

   PART 16.3--AUTHORISATION TO MANUFACTURE LOW AND MODERATE HARM POISONS

   PART 16.4--PACKAGING AND LABELLING OF LOW AND MODERATE HARM POISONS

CHAPTER 17--DANGEROUS POISONS AUTHORISATIONS

   PART 17.1--OVERVIEW OF DANGEROUS POISONS AUTHORISATIONS

   PART 17.2--AUTHORISATIONS UNDER DANGEROUS POISONS LICENCES

           Division 17.2.1--Dangerous poisons manufacturers licence authorisations

           Division 17.2.2--Dangerous poisons—research and education program licence authorisations

           Division 17.2.3--Dangerous poisons suppliers licence authorisations

   PART 17.3--OTHER DANGEROUS POISONS AUTHORISATIONS

           Division 17.3.1--Authorisations for manufacturing etc purposes

           Division 17.3.2--Authorisations for delivery people and commercial disposal operators

           Division 17.3.3--Authorisations for dangerous poisons research and education programs by scientifically qualified people

CHAPTER 18--DANGEROUS POISONS LICENCES

   PART 18.1--DANGEROUS POISONS LICENCES GENERALLY

   PART 18.2--DANGEROUS POISONS MANUFACTURERS LICENCES

   PART 18.3--DANGEROUS POISONS RESEARCH AND EDUCATION PROGRAM LICENCES

   PART 18.4--DANGEROUS POISONS SUPPLIERS LICENCES

CHAPTER 19--DANGEROUS POISONS—OTHER PROVISIONS

   PART 19.1--DANGEROUS POISONS PURCHASE ORDERS

   PART 19.2--WHOLESALE SUPPLY OF DANGEROUS POISONS UNDER CORRESPONDING LAWS

   PART 19.3--PACKAGING AND LABELLING OF DANGEROUS POISONS

   PART 19.4--STORAGE OF DANGEROUS POISONS

   PART 19.5--DANGEROUS POISONS REGISTERS

CHAPTER 20--PAINTS

CHAPTER 21--PROHIBITED AND APPENDIX C SUBSTANCES

   PART 21.1--PRELIMINARY

   PART 21.2--PROHIBITED SUBSTANCES RESEARCH AND EDUCATION PROGRAM LICENCES

           Division 21.2.1--Issue of prohibited substances research and education program licences

           Division 21.2.2--Prohibited substances research and education program authorisations

           Division 21.2.3--Other provisions—prohibited substances research and education program licences

   PART 21.3--PROHIBITED SUBSTANCES REGISTERS

CHAPTER 22--THERAPEUTIC GOODS

CHAPTER 23--NOTIFICATION AND REVIEW OF DECISIONS

CHAPTER 24--MISCELLANEOUS

CHAPTER 30--TRANSITIONAL
           SCHEDULE 1
           SCHEDULE 2
           SCHEDULE 3
           SCHEDULE 4
           SCHEDULE 5
           SCHEDULE 6
           DICTIONARY
           ENDNOTES