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MEDICINES, POISONS AND THERAPEUTIC GOODS REGULATION 2008

Table of Provisions

CHAPTER 1--PRELIMINARY

1 Name of regulation

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

PART 2.2--RELATIONSHIP WITH REGISTRATION LAWS

20 Medicines authorisations subject to Health Practitioner Regulation National Law (ACT)

21 Medicines authorisations subject to Veterinary Practice Act 2018

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),

31 Authorisation conditions for prescribing medicines—Act, s 44 (1) (b) and (2)

31A Variation of authorisation condition during Commonwealth special arrangement

32 Additional requirements for prescribing controlled medicines 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

Division 3.4.3--Standing orders for walk-in centre

77 Authorisation of CHO to issue standing orders for supply and administration of medicines at

78 Particulars for CHO standing orders for supply and administration of medicines at walk-in

PART 3.5--MEDICINES SUPPLY AUTHORITIES GENERALLY

80 Cancellation of invalid supply

81 Information for CHO about monitored medicines supplied on supply authorities—Act, s 31

CHAPTER 4--SUPPLYING MEDICINES

PART 4.1--PRELIMINARY

100 Overview of supply authorisations for medicines

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

Division 4.2.1--Sch 1 medicines supply authorisations

110 Authorisation under sch 1 to supply medicines—

Division 4.2.2--Dispensing medicines

120 Authorisation conditions for dispensing medicines—Act, s 44 (1) (b) and (2)

120A Variation of authorisation condition for dispensing medicines during Commonwealth special

121 How medicines are dispensed

122 Noting changes to prescriptions on oral direction of prescriber—Act, s 27

123 Labelling dispensed medicines—Act, s 60 (1) (c) (i) and (2) (c)

124 Marking dispensed prescriptions

125 Recording dispensing of medicines

Division 4.2.3--Supplying medicines on requisitions

130 Authorisation conditions for supplying medicines on requisitions—Act, s 44 (1)

131 Supplying medicines on requisitions

132 Labelling medicines supplied on requisition—Act, s 60 (1) (c) (i) and

133 Marking filled requisitions

134 Recording supply of medicines on requisitions

Division 4.2.4--Supplying medicines on purchase orders

140 Authorisation conditions for supplying medicines on purchase orders—Act, s 44

141 Supplying medicines on purchase orders

142 Recording supply of medicines on purchase orders

Division 4.2.5--Supplying medicines on standing orders

150 Authorisation conditions for supplying medicines on standing orders—Act, s 44

151 Supplying medicines on standing orders

152 Labelling medicines supplied on standing order—Act, s 60 (1) (c) (i) and

153 Recording supply of medicines on standing orders

Division 4.2.6--Supplying medicines during consultations

160 Authorisation conditions for supplying medicines during consultations—Act, s 44 (1)

161 Labelling medicines supplied during consultations

162 Recording medicines supplied during consultations

163 Additional requirements for supplying controlled medicines for human use during

164 Information for CHO about monitored medicines supplied during consultations—Act, s 31

Division 4.2.7--Selling pseudoephedrine by retail

170 Meaning of retail sale—div 4.2.7

171 Authorisation conditions for retail sale of pseudoephedrine—Act,

172 Requirement to tell buyer about pseudoephedrine sales record

173 Required information for pseudoephedrine sales records

174 Failure to amend pseudoephedrine sales record

175 Pseudoephedrine sales record—decision by CHO

Division 4.2.8--Supplying pharmacist only medicines

180 Authorisation conditions for supply of pharmacist only medicines—Act,

PART 4.3--AUTHORISATION TO SUPPLY WITHOUT PRESCRIPTION IN EMERGENCIES

250 Meaning of designated prescription only medicine—pt

251 Authorisation to supply certain medicines without prescription in

252 Authorisation conditions for supplying of certain medicines without prescription in

253 Labelling medicines supplied without prescription in emergencies—Act, s 60 (1)

254 Recording medicines supplied without prescription in emergencies

PART 4.3A--AUTHORISATION TO SUPPLY CERTAIN MEDICINES WITHOUT PRESCRIPTION--CONTINUED DISPENSING

255 Authorisation to supply certain medicines without prescription by approved

256 Labelling certain medicines supplied without prescription by approved

PART 4.4--AUTHORISATION TO SUPPLY MEDICINES FOR DISPOSAL

260 Authorisation to supply medicines to pharmacists for disposal—Act,

261 Authorisation to supply medicines to commercial disposal operators for disposal—Act, s

PART 4.5--WHOLESALE SUPPLY OF MEDICINES UNDER CORRESPONDING LAWS

270 Conditions for wholesalers supplying medicines under corresponding laws—Act,

CHAPTER 5--ADMINISTERING MEDICINES

PART 5.1--AUTHORISATIONS FOR HEALTH-RELATED OCCUPATIONS

350 Authorisation under sch 1 for people in health-related occupations to administer

351 Authorisation conditions for administration of medicines at institutions by people in

352 Authorisation for pharmacist and intern pharmacist to administer vaccine without

353 Authorisation for nurse or midwife to administer vaccine without prescription—Act,

PART 5.2--OTHER ADMINISTRATION AUTHORISATIONS

360 Authorisation for self-administration etc of medicines—Act, s 37 (2) (b)

361 Authorisation for administration of medicines by assistants—Act,

CHAPTER 6--OBTAINING AND POSSESSING MEDICINES

370 Authorisation under sch 1 to obtain and possess medicines—Act,

371 Authorisation to obtain and possess medicines for certain personal use-related

CHAPTER 7--MANUFACTURING MEDICINES

380 Authorisation under sch 1 to manufacture medicines—Act, s 33 (b)

CHAPTER 8--DISCARDING MEDICINES

390 Discarding controlled medicines—Act, s 34 (1) (a)

CHAPTER 9--OTHER MEDICINES AUTHORISATIONS

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

400 Authorisations to deliver medicines under supply authorities—Act,

401 Authorisations for commercial disposal operators—Act, s 26 (1) (b) and

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

410 Authorisations to supply and administer adrenaline and salbutamol—Act,

PART 9.3--MEDICINES AUTHORISATIONS FOR CORRECTIONS FUNCTIONS

420 Authorisations for CYP authorised people—Act, s 26 (1) (b),

421 Authorisations for corrections officers—Act, s 26 (1) (b),

422 Authorisations for court and police cell custodians—Act, s 26 (1) (b),

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

430 Authorisations for non-controlled medicines research and education—Act,

431 Authorisation conditions for non-controlled medicines research and education—Act,

PART 9.5--AUTHORISATIONS UNDER MEDICINES LICENCES

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

440 Authorisations under controlled medicines research and education program licences—Act,

441 Authorisation condition for controlled medicines research and education program

Division 9.5.2--First-aid kit licence authorisations

450 Authorisations under first-aid kit licences—Act,

451 Authorisation condition for first-aid kit licences—Act, s 44 (1) (b) and

Division 9.5.3--Wholesalers licence authorisations

460 Authorisations under medicines wholesalers licences—Act,

461 Authorisation conditions for medicines wholesalers licences—Act,

Division 9.5.4--Opioid dependency treatment licence authorisations

470 Authorisations under opioid dependency treatment licences—Act,

471 Authorisation condition for opioid dependency treatment licences—Act,

Division 9.5.5--Pharmacy medicines rural communities licences

480 Authorisations under pharmacy medicines rural communities licences—Act,

481 Authorisation conditions for pharmacy medicines rural communities licences—Act,

PART 9.6--AUTHORISATIONS FOR ENDORSED HEALTH PRACTITIONERS

490 Authorisations for endorsed health practitioners—Act,

CHAPTER 10--PACKAGING AND LABELLING OF MEDICINES GENERALLY

500 When pharmacy medicines and pharmacist only medicines to be supplied in

501 Packaging of supplied manufacturer's packs of medicines—Act,

502 Labelling of supplied manufacturer's packs of medicines—Act,

CHAPTER 11--STORAGE OF MEDICINES

PART 11.1--PRELIMINARY

510 Meaning of prescribed person—ch 11

511 Meaning of key—ch 11

PART 11.2--STORAGE REQUIREMENTS FOR MEDICINES GENERALLY

515 Storage of medicines generally—Act, s 61 (b) and

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

520 Storage of medicines other than controlled medicines in community pharmacies—Act,

521 Storage of medicines other than controlled medicines by other people—Act,

522 Storage of pharmacy medicines by pharmacy medicines rural communities

PART 11.4--ADDITIONAL STORAGE REQUIREMENTS FOR CONTROLLED MEDICINES

530 Meaning of personal custody—pt 11.4

531 Storage of controlled medicines by wholesalers licence-holders—Act, s 61

532 Storage of controlled medicines for certain health-related occupations—Act,

533 Storage of controlled medicines by certain other prescribed people—Act,

533A Storage of buprenorphine or methadone by opioid dependency treatment licence-holders

CHAPTER 12--CONTROLLED MEDICINES REGISTERS

540 Keeping of controlled medicines registers by certain people—Act,

541 Keeping of controlled medicines registers by first-aid kit holders—Act,

542 Form of controlled medicines registers—Act, s 49 (1) (b) and (2)

543 Making entries in controlled medicines

544 Prescribed witnesses for administration of controlled medicines—Act, s 53 (a) and

545 Prescribed witnesses for discarding of controlled medicines—Act, s 54 (a)

546 Changes etc to entries in controlled medicines registers—Act,

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

PART 13.1--CONTROLLED MEDICINES APPROVALS

Division 13.1.1--Preliminary

550 Meaning of controlled medicines approval

551 Meaning of designated prescriber—pt 13.1

Division 13.1.2--Standing controlled medicines approvals

555 Standing approval to prescribe controlled medicines for hospital in-patient or patient

556 Standing approval to prescribe controlled medicines for short-term

556A Controlled medicines to which standing approvals do not apply

557 Standing interim approval to prescribe buprenorphine and methadone for patients of

Division 13.1.3--Chief health officer controlled medicines approvals

560 Applications for CHO controlled medicines approvals

561 Requirements for CHO controlled medicines approval applications

562 CHO decision on applications to prescribe controlled medicines

563 Restrictions on CHO power to approve applications for approvals

564 Term of CHO controlled medicines approvals

565 Applications for review of unfavourable CHO decisions for approvals

566 Medicines advisory committee—referred applications and review of unfavourable CHO

567 Amendment and revocation of controlled medicines approvals

568 Application for review of amendment and revocation on CHO initiative

569 Medicines advisory committee—review of amendment or revocation on CHO initiative

570 Conditional controlled medicines approvals

571 Form of CHO controlled medicines approvals

572 When controlled medicines approvals etc take effect

573 Medicines advisory committee—recommendations to CHO

574 Guidelines for CHO decisions on applications

575 Controlled medicines prescribing standards

Division 13.1.4--Endorsements to treat drug-dependency

580 Meaning of endorsement—div 13.1.4

581 Applications for CHO endorsement to treat drug-dependency

582 CHO decisions on applications for endorsement to treat

583 Form of CHO endorsements to treat drug-dependency

584 Medicines advisory committee—review of CHO decisions to refuse endorsements to treat

PART 13.2--APPENDIX D MEDICINES APPROVALS

588 Modification of medicines and poisons standard—Act, s 15 (1), def

589 Meaning of ACT listed appendix D medicine

590 Meaning of appendix D medicines approval

591 Standing approval to prescribe ACT listed appendix D medicines

592 Applications for CHO approval to prescribe appendix D medicines

593 CHO decisions on applications to prescribe appendix D

594 Form of CHO appendix D medicines approvals

CHAPTER 14--MEDICINES LICENCES

PART 14.1--MEDICINES LICENCES GENERALLY

600 Medicines licences that may be issued—Act, s 78 (2)

PART 14.2--CONTROLLED MEDICINES RESEARCH AND EDUCATION PROGRAM LICENCES

605 Applications for controlled medicines research and education program

606 Restrictions on issuing of controlled medicines research and education program

607 Additional information for controlled medicines research and education program

PART 14.3--FIRST-AID KIT LICENCES

610 Applications for first-aid kit licences

611 Restrictions on issuing of first-aid kit licences—Act, s 85 (1)

612 Additional information for first-aid kit licences—Act,

PART 14.4--MEDICINES WHOLESALERS LICENCES

615 Applications for medicines wholesalers licences

616 Restrictions on issuing of medicines wholesalers licences—Act,

617 Additional information for medicines wholesalers licences—Act,

PART 14.5--OPIOID DEPENDENCY TREATMENT LICENCES

620 Applications for opioid dependency treatment licences

621 Restriction on issuing of opioid dependency treatment licences—Act,

622 Witnessing not required for administration under opioid dependency treatment

PART 14.6--PHARMACY MEDICINES RURAL COMMUNITIES LICENCES

625 Applications for pharmacy medicines rural communities licences

626 Restrictions on issuing of pharmacy medicines rural communities licences—Act,

CHAPTER 15--MEDICINES—OTHER PROVISIONS

PART 15.1--OPIOID DEPENDENCY TREATMENT

630 Guidelines for treatment of opioid dependency

631 Minister may exempt certain people dealing with buprenorphine or methadone from

PART 15.2--MEDICINES ADVISORY COMMITTEE

635 Medicines advisory committee—membership

636 Medicines advisory committee—term of appointments

637 Medicines advisory committee—conditions of appointments

638 Medicines advisory committee—time and place of meetings

639 Medicines advisory committee—presiding member

640 Medicines advisory committee—quorum

641 Medicines advisory committee—voting

642 Medicines advisory committee—conduct of meetings

643 Medicines advisory committee—disclosure of interests by members

644 Medicines advisory committee—ending appointments

PART 15.3--OTHER MEDICINES PROVISIONS

650 Advertising controlled medicines—Act, s 66 (3) (b)

651 Advertising other medicines

652 Prescribed institutions—Act, dict, def institution,

CHAPTER 16--LOW AND MODERATE HARM POISONS

PART 16.1--PRELIMINARY

660 Meaning of relevant law—ch 16

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

661 Authorisation to supply low and moderate harm poisons—Act, s 26 (1) (b)

662 Authorisation condition for supplying low and moderate harm poisons—Act,

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

663 Authorisation to manufacture low and moderate harm poisons—Act,

664 Authorisation condition for manufacturing low and moderate harm poisons—Act,

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

665 Packaging of supplied manufacturer's packs of low and moderate harm

666 Labelling of supplied manufacturer's packs of low and moderate harm

CHAPTER 17--DANGEROUS POISONS AUTHORISATIONS

PART 17.1--OVERVIEW OF DANGEROUS POISONS AUTHORISATIONS

670 General overview of authorisations for dangerous poisons

671 Overview of dangerous poisons authorisations under this regulation

PART 17.2--AUTHORISATIONS UNDER DANGEROUS POISONS LICENCES

Division 17.2.1--Dangerous poisons manufacturers licence authorisations

675 Authorisations under dangerous poisons manufacturers licences—Act,

676 Authorisation conditions for dangerous poisons manufacturers licences—Act,

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

680 Authorisations under dangerous poisons research and education program licences—Act,

681 Authorisation condition for dangerous poisons research and education program

Division 17.2.3--Dangerous poisons suppliers licence authorisations

685 Authorisations under dangerous poisons suppliers licences—Act,

686 Authorisation conditions for dangerous poisons suppliers licences—Act,

PART 17.3--OTHER DANGEROUS POISONS AUTHORISATIONS

Division 17.3.1--Authorisations for manufacturing etc purposes

690 Manufacturing etc authorisations for dangerous poisons—Act,

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

692 Authorisations to deliver dangerous poisons under purchase orders—Act,

693 Authorisation to supply dangerous poisons to commercial disposal operator for

694 Authorisations for commercial disposal operators—Act, s 26 (1) (b) and

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

695 Authorisations for dangerous poisons research and education—Act, s 26 (1) and

696 Authorisation conditions for dangerous poisons research and education—Act,

CHAPTER 18--DANGEROUS POISONS LICENCES

PART 18.1--DANGEROUS POISONS LICENCES GENERALLY

700 Dangerous poisons licences that may be issued—Act,

PART 18.2--DANGEROUS POISONS MANUFACTURERS LICENCES

705 Applications for dangerous poisons manufacturers licences

706 Restrictions on issuing of dangerous poisons manufacturers licences—Act,

707 Additional information for dangerous poisons manufacturers licences—Act,

PART 18.3--DANGEROUS POISONS RESEARCH AND EDUCATION PROGRAM LICENCES

710 Applications for dangerous poisons research and education program

711 Restrictions on issuing of dangerous poisons research and education program

712 Additional information for dangerous poisons research and education licences—Act,

PART 18.4--DANGEROUS POISONS SUPPLIERS LICENCES

715 Applications for dangerous poisons suppliers licences

716 Restrictions on issuing of dangerous poisons suppliers licences—Act,

717 Additional information for dangerous poisons suppliers licences—Act,

CHAPTER 19--DANGEROUS POISONS—OTHER PROVISIONS

PART 19.1--DANGEROUS POISONS PURCHASE ORDERS

720 Supplying dangerous poisons on purchase orders

721 General requirements for dangerous poisons purchase orders—Act,

722 Recording supply of dangerous poisons

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

725 Conditions for wholesalers supplying dangerous poisons under corresponding laws—Act,

PART 19.3--PACKAGING AND LABELLING OF DANGEROUS POISONS

730 Meaning of relevant law—pt 19.3

731 Packaging of supplied manufacturer's packs of dangerous poisons—Act, s 59 (1)

732 Labelling of supplied manufacturer's packs of dangerous poisons—Act, s 60 (1)

PART 19.4--STORAGE OF DANGEROUS POISONS

735 Storage of dangerous poisons—Act, s 61 (b) and (c)

PART 19.5--DANGEROUS POISONS REGISTERS

740 Keeping of dangerous poisons registers by certain people—Act, s 48 and s 50

741 Form of dangerous poisons registers—Act, s 49 (1) (b)

742 Making entries in dangerous poisons

743 Prescribed witnesses for discarding of dangerous poisons—Act, s 54 (a) and

744 Changes to entries in dangerous poisons registers—Act, s 55 (2)

CHAPTER 20--PAINTS

750 Manufacture, supply and use of paints containing white lead—Act, s 70 (1) (b), (2) (b)

751 Manufacture, supply and use of paints for certain purposes—Act, s 71 (1) and

752 Manufacture, supply and use of paints for toys—Act,

753 Manufacture, supply and use of paints containing pesticides—Act, s 73 (b)

CHAPTER 21--PROHIBITED AND SCHEDULE 10 SUBSTANCES

PART 21.1--PRELIMINARY

760 Meaning of prohibited substance—ch 21

761 Prohibited substances licences—Act, s 78 (2)

PART 21.2--PROHIBITED SUBSTANCES RESEARCH AND EDUCATION PROGRAM LICENCES

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

765 Applications for prohibited substances research and education program

766 Restrictions on issuing of prohibited substances research and education program

767 Additional information for prohibited substances research program and education

Division 21.2.2--Prohibited substances research and education program authorisations

768 Authorisations under prohibited substances research and education program licences—Act,

769 Authorisation condition for prohibited substances research and education program

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

770 Approvals of dealings for prohibited substances research and education program

771 Authorisation condition for approval-holders—Act, s 44 (1) (b) and (2)

772 General requirements for prohibited substances purchase orders—Act, s 38 (2)

773 Recording supply of prohibited substances on purchase orders

774 Information for CHO about supplied prohibited substances research and education program

PART 21.3--PROHIBITED SUBSTANCES REGISTERS

775 Keeping of prohibited substances registers by certain people—Act, s 48 and s

777 Making entries in prohibited substances

778 Prescribed witnesses for discarding of prohibited substances—Act, s 54 (a) and

779 Changes to entries in prohibited substances registers—Act, s 55 (2)

CHAPTER 22--THERAPEUTIC GOODS

800 Definitions—ch 22

801 Prescribed regulated therapeutic goods—Act, s 14, def regulated therapeutic

802 Authorisation to supply optical devices—Act, s 74 (1) (b) and (2)

803 Authorisation conditions for supplying optical devices—Act, s 75 (1)

CHAPTER 23--NOTIFICATION AND REVIEW OF DECISIONS

850 Meaning of reviewable decision—ch 23

851 Reviewable decision notices

852 Applications for review

CHAPTER 24--MISCELLANEOUS

860 Supply etc of certain declared substances by public employee exercising functions under

861 Dealings with regulated substances and regulated therapeutic goods by public employees

861A Dealings with regulated substances and regulated therapeutic goods by public employees

862 Certain containers not to be used for human-use substances—Act,

863 Disapplication of Legislation Act, s 47 (6)

864 Exemption of piper methysticum (kava)—Act, s 190 (1) (a)

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