Medicines, Poisons and Therapeutic Goods Regulation 2008 (ACT)

Medicines, Poisons and Therapeutic Goods Regulation 2008   

SL2008-42

made under the

Medicines, Poisons and Therapeutic Goods Act 2008

Republication No 55

Effective:  26 November 2025

Republication date: 26 November 2025

Last amendment made by A2025‑33

About this republication

The republished law

This is a republication of the Medicines, Poisons and Therapeutic Goods Regulation 2008, made under the Medicines, Poisons and Therapeutic Goods Act 2008 (including any amendment made under the Legislation Act 2001, part 11.3 (Editorial changes)) as in force on 26 November 2025.  It also includes any commencement, amendment, repeal or expiry affecting this republished law to 26 November 2025. 

The legislation history and amendment history of the republished law are set out in endnotes 3 and 4.

Kinds of republications

The Parliamentary Counsel’s Office prepares 2 kinds of republications of ACT laws (see the ACT legislation register at type="disc">

authorised republications to which the Legislation Act 2001 applies

unauthorised republications.

The status of this republication appears on the bottom of each page.

Editorial changes

The Legislation Act 2001, part 11.3 authorises the Parliamentary Counsel to make editorial amendments and other changes of a formal nature when preparing a law for republication. Editorial changes do not change the effect of the law, but have effect as if they had been made by an Act commencing on the republication date (see Legislation Act 2001, s 115 and s 117). The changes are made if the Parliamentary Counsel considers they are desirable to bring the law into line, or more closely into line, with current legislative drafting practice.

This republication includes amendments made under part 11.3 (see endnote 1).

Uncommenced provisions and amendments

If a provision of the republished law has not commenced, the symbol  U  appears immediately before the provision heading.  Any uncommenced amendments that affect this republished law are accessible on the ACT legislation register ( For more information, see the home page for this law on the register.

Modifications

If a provision of the republished law is affected by a current modification, the symbol  M  appears immediately before the provision heading.  The text of the modifying provision appears in the endnotes.  For the legal status of modifications, see the Legislation Act 2001, section 95.

Penalties

At the republication date, the value of a penalty unit for an offence against this law is $160 for an individual and $810 for a corporation (see Legislation Act 2001, s 133).

Medicines, Poisons and Therapeutic Goods Regulation 2008

made under the

Medicines, Poisons and Therapeutic Goods Act 2008

Contents

Page

Chapter 1  Preliminary

1            Name of regulation  2

3            Dictionary  2

4            Notes  2

5Offences against regulation—application of Criminal Code etc 3

6            Overview of things to which medicines and poisons standard does not apply   3

Chapter 2  Medicines—authorisations generally

Part 2.1    Overview of medicines authorisations

10          General overview of authorisations for medicines  4

11          Overview of medicines authorisations under this regulation                  5

12          General overview of authorisation conditions for medicines                  7

Part 2.2    Relationship with registration laws

20          Medicines authorisations subject to Health Practitioner Regulation National Law (ACT) restrictions  9

21Medicines authorisations subject to Veterinary Practice Act 2018 restrictions 9

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) and (3) (b)  10

31          Authorisation conditions for prescribing medicines—Act, s 44 (1) (b) and (2) (b)        11

31A         Variation of authorisation condition during Commonwealth special arrangement period 13

32          Additional requirements for prescribing controlled medicines for human use 14

Division 3.1.2           Prescriptions

40          General requirements for written prescriptions  15

41          Particulars for prescriptions  15

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) 18

51          Authorisation conditions for issuing requisitions for medicines—Act, s 44 (1) (b) and (2) (b)     18

Division 3.2.2           Requisitions

55          General requirements for written requisitions  19

56          Particulars for requisitions  19

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 (2) (a) 20

61          Authorisation conditions for issuing purchase orders for medicines—Act, s 44 (1) (b) and (2) (b)  20

Division 3.3.2           Purchase orders

62          General requirements for medicines purchase orders—Act, s 38 (2) (c)   21

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 emergencies—Act, s 42 (b)  22

71          Authorisation of CHO to issue standing orders for administration of medicines for public health matters—Act, s 42 (b)  22

72          Particulars for CHO standing orders for administration of medicines for public health matters    22

Division 3.4.2           Standing orders for institutions

75          Authorisation of doctors to issue standing orders for administration of medicines at institutions—Act, s 42 (b)  23

76          Particulars for standing orders for administration of medicines at institutions 24

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 walk-in centre—Act, s 42 (b)  25

78          Particulars for CHO standing orders for supply and administration of medicines at walk-in centre  25

Part 3.5    Medicines supply authorities generally

80          Cancellation of invalid supply authorities—Act, s 30 (2) (d)                 27

81          Information for CHO about monitored medicines supplied on supply authorities—Act, s 31 (1) (b) and (4), def required information  27

Chapter 4  Supplying medicines

Part 4.1    Preliminary

100         Overview of supply authorisations for medicines  29

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—Act, s 26 (1) (b) and (2) (b) 30

Division 4.2.2           Dispensing medicines

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

120A        Variation of authorisation condition for dispensing medicines during Commonwealth special arrangement period  32

121         How medicines are dispensed  33

122         Noting changes to prescriptions on oral direction of prescriber—Act, s 27 (2) (b) (ii)    35

123         Labelling dispensed medicines—Act, s 60 (1) (c) (i) and (2) (c) (i)         35

124         Marking dispensed prescriptions  36

125         Recording dispensing of medicines  38

Division 4.2.3           Supplying medicines on requisitions

130         Authorisation conditions for supplying medicines on requisitions—Act, s 44 (1) (b) and (2) (b)   39

131         Supplying medicines on requisitions  39

132         Labelling medicines supplied on requisition—Act, s 60 (1) (c) (i) and (2) (c) (i)  40

133         Marking filled requisitions  41

134         Recording supply of medicines on requisitions  42

Division 4.2.4           Supplying medicines on purchase orders

140         Authorisation conditions for supplying medicines on purchase orders—Act, s 44 (1) (b) and (2) (b)  42

141         Supplying medicines on purchase orders  43

142         Recording supply of medicines on purchase orders  44

Division 4.2.5           Supplying medicines on standing orders

150         Authorisation conditions for supplying medicines on standing orders—Act, s 44 (1) (b) and (2) (b)  45

151         Supplying medicines on standing orders  46

152         Labelling medicines supplied on standing order—Act, s 60 (1) (c) (i) and (2) (c) (i)      46

153         Recording supply of medicines on standing orders  47

Division 4.2.6           Supplying medicines during consultations

160         Authorisation conditions for supplying medicines during consultations—Act, s 44 (1) (b) and (2) (b)  48

161         Labelling medicines supplied during consultations  49

162         Recording medicines supplied during consultations  50

163         Additional requirements for supplying controlled medicines for human use during consultations 50

164         Information for CHO about monitored medicines supplied during consultations—Act, s 31 (2) (b) and (4), def required information  51

Division 4.2.7           Selling pseudoephedrine by retail

170         Meaning of retail sale—div 4.2.7  52

171         Authorisation conditions for retail sale of pseudoephedrine—Act, s 44 (1) (b) and (2) (b)        52

172         Requirement to tell buyer about pseudoephedrine sales record           53

173         Required information for pseudoephedrine sales records                   54

174         Failure to amend pseudoephedrine sales record  56

175         Pseudoephedrine sales record—decision by CHO  56

Division 4.2.8           Supplying pharmacist only medicines

180         Authorisation conditions for supply of pharmacist only medicines—Act, s 44 (1) (b) and (2) (b)  57

Part 4.3    Authorisation to supply without prescription in emergencies

250         Meaning of designated prescription only medicine—pt 4.3                  58

251         Authorisation to supply certain medicines without prescription in emergencies—Act, s 26 (1) (b)  58

252         Authorisation conditions for supplying of certain medicines without prescription in emergencies—Act, s 44 (1) (b) and (2) (b)  59

253         Labelling medicines supplied without prescription in emergencies—Act, s 60 (1) (c) (i) and (2) (c) (i)  60

254         Recording medicines supplied without prescription in emergencies       61

Part 4.3A   Authorisation to supply certain medicines without prescription—continued dispensing

255         Authorisation to supply certain medicines without prescription by approved pharmacist––Act, s 185 (1) (g)  62

256         Labelling certain medicines supplied without prescription by approved pharmacist––Act, s 185 (1) (j)  62

Part 4.4    Authorisation to supply medicines for disposal

260         Authorisation to supply medicines to pharmacists for disposal—Act, s 26 (1) (b)        64

261         Authorisation to supply medicines to commercial disposal operators for disposal—Act, s 26 (1) (b)  64

Part 4.5    Wholesale supply of medicines under corresponding laws

270         Conditions for wholesalers supplying medicines under corresponding laws—Act, s 20 (4) (c)    65

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 medicines—Act, s 37 (1) (b) and (3) (b)  66

351         Authorisation conditions for administration of medicines at institutions by people in health-related occupations—Act, s 44 (1) (b) and (2) (b)  66

352         Authorisation for pharmacist and intern pharmacist to administer vaccine without prescription—Act, s 37 (1) (b)  68

353         Authorisation for nurse or midwife to administer vaccine without prescription—Act, s 37 (1) (b)  69

Part 5.2    Other administration authorisations

360         Authorisation for self-administration etc of medicines—Act, s 37 (2) (b) and (3) (b)     70

361         Authorisation for administration of medicines by assistants—Act, s 37 (1) (b)   71

Chapter 6  Obtaining and possessing medicines

370         Authorisation under sch 1 to obtain and possess medicines—Act, s 35 (1) (b), (2) (b) and s 36 (b)  72

371         Authorisation to obtain and possess medicines for certain personal use-related dealings—Act, s 35 (1) (b), (2) (b) and s 36 (b)  72

Chapter 7  Manufacturing medicines

380         Authorisation under sch 1 to manufacture medicines—Act, s 33 (b)       73

Chapter 8  Discarding medicines

390         Discarding controlled medicines—Act, s 34 (1) (a)  74

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, s 26 (1) (b), (2) (b), s 35 (1) (b), (2) (b) and s 36 (b)  75

401         Authorisations for commercial disposal operators—Act, s 26 (1) (b) and (2) (b), s 35 (1) (b) and (2) (b) and s 36 (b)  76

Part 9.2    Emergency supply and administration of adrenaline, naloxone and salbutamol

410         Authorisations to supply and administer adrenaline, naloxone and salbutamol—Act, s 26 (1) (b) and s 37 (1) (b)  77

Part 9.3    Medicines authorisations for corrections functions

420         Authorisations for CYP authorised people—Act, s 26 (1) (b), s 35 (1) (b), (2) (b), s 36 (b) and s 37 (1) (b)  78

421         Authorisations for corrections officers—Act, s 26 (1) (b), s 35 (1) (b), (2) (b), s 36 (b) and s 37 (1) (b)  78

422         Authorisations for court and police cell custodians—Act, s 26 (1) (b), s 35 (1) (b), (2) (b), s 36 (b) and s 37 (1) (b)  79

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, s 26 (1) and (2) (b)  81

431         Authorisation conditions for non-controlled medicines research and education—Act, s 44 (1) (b) and (2) (b)  83

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, s 20 (1) (a)  84

441         Authorisation condition for controlled medicines research and education program licences—Act, s 44 (1) (b) and (2) (b)  85

Division 9.5.2           First-aid kit licence authorisations

450         Authorisations under first-aid kit licences—Act, s 20 (1) (a)                 86

451         Authorisation condition for first-aid kit licences—Act, s 44 (1) (b) and (2) (b) 87

Division 9.5.3           Wholesalers licence authorisations

460         Authorisations under medicines wholesalers licences—Act, s 20 (1) (a)   87

461         Authorisation conditions for medicines wholesalers licences—Act, s 44 (1) (b) and (2) (b)       88

Division 9.5.4           Opioid dependency treatment licence authorisations

470         Authorisations under opioid dependency treatment licences—Act, s 20 (1) (a)  89

471         Authorisation condition for opioid dependency treatment licences—Act, s 44 (1) (b) and (2) (b) 90

Division 9.5.5           Pharmacy medicines rural communities licences

480         Authorisations under pharmacy medicines rural communities licences—Act, s 20 (1) (a)        91

481         Authorisation conditions for pharmacy medicines rural communities licences—Act, s 44 (1) (b) and (2) (b)  92

Part 9.6    Medicines authorisations for health practitioners

490         Authorisations for endorsed health practitioners—Act, s 20 (1) (d)        94

490A        Authorisations for health practitioners to deal with medicines with CHO approval—Act, s 20 (1) (c)  94

Chapter 10Packaging and labelling of medicines generally

500         When pharmacy medicines and pharmacist only medicines to be supplied in manufacturer’s packs—Act, s 59 (1) (c) (i) and (2) (c) (i)  96

501         Packaging of supplied manufacturer’s packs of medicines—Act, s 59 (1) (c) (i) and (2) (c) (i)    96

502         Labelling of supplied manufacturer’s packs of medicines—Act, s 60 (1) (c) (i) and (2) (c) (i)     97

Chapter 11 Storage of medicines

Part 11.1   Preliminary

510         Meaning of prescribed person—ch 11  98

511         Meaning of key—ch 11  99

Part 11.2   Storage requirements for medicines generally

515         Storage of medicines generally—Act, s 61 (b) and (c)  100

Part 11.3   Additional storage requirements for medicines other than controlled medicines

520         Storage of medicines other than controlled medicines in community pharmacies—Act, s 61 (b) and (c)  101

521         Storage of medicines other than controlled medicines by other people—Act, s 61 (b) and (c)    101

522         Storage of pharmacy medicines by pharmacy medicines rural communities licence-holders—Act, s 61 (b) and (c)  102

Part 11.4   Additional storage requirements for controlled medicines

530         Meaning of personal custody—pt 11.4  103

531         Storage of controlled medicines by wholesalers licence‑holders—Act, s 61 (b) and (c)  103

532         Storage of controlled medicines for certain health-related occupations—Act, s 61 (b) and (c)    104

533         Storage of controlled medicines by certain other prescribed people—Act, s 61 (b) and (c)       106

533A        Storage of buprenorphine or methadone by opioid dependency treatment licence-holders etc—Act, s 61 (b) and (c)  108

Chapter 12 Controlled medicines registers

540         Keeping of controlled medicines registers by certain people—Act, s 48 (a) and s 50 (1) (b) and (2) (b)  110

541         Keeping of controlled medicines registers by first-aid kit holders—Act, s 48 (a) and s 50 (1) (b) and (2) (b)  112

542         Form of controlled medicines registers—Act, s 49 (1) (b) and (2) (b)     113

543         Making entries in controlled medicines registers—Act, s 51 (1) (b)       113

544         Prescribed witnesses for administration of controlled medicines—Act, s 53 (a) and (b)  115

545         Prescribed witnesses for discarding of controlled medicines—Act, s 54 (a) and (b)     115

546         Changes etc to entries in controlled medicines registers—Act, s 55 (2) (b) 116

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  118

551         Meaning of designated prescriber—pt 13.1  118

Division 13.1.2         Standing controlled medicines approvals

555         Standing approval to prescribe controlled medicines for hospital in‑patient or patient discharge 119

556         Standing approval to prescribe controlled medicines for short-term treatment   119

556A        Controlled medicines to which standing approvals do not apply           120

557         Standing interim approval to prescribe buprenorphine and methadone for patients of certain institutions  120

Division 13.1.3         Chief health officer controlled medicines approvals

560         Applications for CHO controlled medicines approvals  122

561         Requirements for CHO controlled medicines approval applications      123

562         CHO decision on applications to prescribe controlled medicines          124

563         Restrictions on CHO power to approve applications for approvals       124

564         Term of CHO controlled medicines approvals  126

565         Applications for review of unfavourable CHO decisions for approvals     126

566         Medicines advisory committee—referred applications and review of unfavourable CHO decisions  127

567         Amendment and revocation of controlled medicines approvals           128

568         Application for review of amendment and revocation on CHO initiative   129

569         Medicines advisory committee—review of amendment or revocation on CHO initiative 130

570         Conditional controlled medicines approvals  130

571         Form of CHO controlled medicines approvals  131

572         When controlled medicines approvals etc take effect  132

573         Medicines advisory committee—recommendations to CHO               132

574         Guidelines for CHO decisions on applications  132

575         Controlled medicines prescribing standards  133

Division 13.1.4         Endorsements to treat drug‑dependency

580         Meaning of endorsement—div 13.1.4  133

581         Applications for CHO endorsement to treat drug‑dependency            134

582         CHO decisions on applications for endorsement to treat drug‑dependency 134

583         Form of CHO endorsements to treat drug-dependency  135

584         Medicines advisory committee—review of CHO decisions to refuse endorsements to treat drug-dependency  135

Part 13.2   Appendix D medicines approvals

588         Modification of medicines and poisons standard—Act, s 15 (1), def medicines and poisons standard  137

589         Meaning of ACT listed appendix D medicine  137

590         Meaning of appendix D medicines approval  137

591         Standing approval to prescribe ACT listed appendix D medicines        137

592         Applications for CHO approval to prescribe appendix D medicines       138

593         CHO decisions on applications to prescribe appendix D medicines       138

594         Form of CHO appendix D medicines approvals  139

Chapter 14 Medicines licences

Part 14.1   Medicines licences generally

600         Medicines licences that may be issued—Act, s 78 (2)  141

Part 14.2   Controlled medicines research and education program licences

605         Applications for controlled medicines research and education program licences        142

606         Restrictions on issuing of controlled medicines research and education program licences—Act, s 85 (1) (a)  143

607         Additional information for controlled medicines research and education program licences—Act, s 88 (1) (k)  143

Part 14.3   First-aid kit licences

610         Applications for first-aid kit licences  145

611         Restrictions on issuing of first-aid kit licences—Act, s 85 (1) (a)          146

612         Additional information for first-aid kit licences—Act, s 88 (1) (k)           146

Part 14.4   Medicines wholesalers licences

615         Applications for medicines wholesalers licences  148

616         Restrictions on issuing of medicines wholesalers licences—Act, s 85 (1) (a) 148

617         Additional information for medicines wholesalers licences—Act, s 88 (1) (k) 149

Part 14.5   Opioid dependency treatment licences

620         Applications for opioid dependency treatment licences  150

621         Restriction on issuing of opioid dependency treatment licences—Act, s 85 (1) (a)       150

622         Witnessing not required for administration under opioid dependency treatment licence—Act, s190 (1) (a)  150

Part 14.6   Pharmacy medicines rural communities licences

625         Applications for pharmacy medicines rural communities licences        151

626         Restrictions on issuing of pharmacy medicines rural communities licences—Act, s 85 (1) (a)     151

Chapter 15 Medicines—other provisions

Part 15.1   Opioid dependency treatment

630         Guidelines for treatment of opioid dependency  152

631         Minister may exempt certain people dealing with buprenorphine or methadone from Act—Act, s 190 (1) (b)  152

Part 15.2   Medicines advisory committee

635         Medicines advisory committee—membership  154

636         Medicines advisory committee—term of appointments  155

637         Medicines advisory committee—conditions of appointments              155

638         Medicines advisory committee—time and place of meetings              155

639         Medicines advisory committee—presiding member  156

640         Medicines advisory committee—quorum  156

641         Medicines advisory committee—voting  156

642         Medicines advisory committee—conduct of meetings  156

643         Medicines advisory committee—disclosure of interests by members    157

644         Medicines advisory committee—ending appointments  159

Part 15.3   Other medicines provisions

650         Advertising controlled medicines—Act, s 66 (3) (b)  161

651         Advertising other medicines  161

652         Prescribed institutions—Act, dict, def institution, par (b)  162

Chapter 16 Low and moderate harm poisons

Part 16.1   Preliminary

660         Meaning of relevant law—ch 16  163

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) and (2) (b)   164

662         Authorisation condition for supplying low and moderate harm poisons—Act, s 44 (1) (b) and (2) (b)  164

Part 16.3   Authorisation to manufacture low and moderate harm poisons

663         Authorisation to manufacture low and moderate harm poisons—Act, s 33 (b)   165

664         Authorisation condition for manufacturing low and moderate harm poisons—Act, s 44 (1) (b) and (2) (b)  165

Part 16.4   Packaging and labelling of low and moderate harm poisons

665         Packaging of supplied manufacturer’s packs of low and moderate harm poisons—Act, s 59 (1) (c) (i) and (2) (c) (i)  166

666         Labelling of supplied manufacturer’s packs of low and moderate harm poisons—Act, s 60 (1) (c) (i) and (2) (c) (i)  166

Chapter 17Dangerous poisons authorisations

Part 17.1   Overview of dangerous poisons authorisations

670         General overview of authorisations for dangerous poisons                167

671         Overview of dangerous poisons authorisations under this regulation    168

672         General overview of authorisation conditions for dangerous poisons    168

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, s 20 (1) (a)     170

676         Authorisation conditions for dangerous poisons manufacturers licences—Act, s 44 (1) (b) and (2) (b)  171

Division 17.2.2         Dangerous poisons—research and education program licence authorisations

680         Authorisations under dangerous poisons research and education program licences—Act, s 20 (1) (a)  173

681         Authorisation condition for dangerous poisons research and education program licences—Act, s 44 (1) (b) and (2) (b)  174

Division 17.2.3         Dangerous poisons suppliers licence authorisations

685         Authorisations under dangerous poisons suppliers licences—Act, s 20 (1) (b)  175

686         Authorisation conditions for dangerous poisons suppliers licences—Act, s 44 (1) (b) and (2) (b) 176

Part 17.3   Other dangerous poisons authorisations

Division 17.3.1         Authorisations for manufacturing etc purposes

690         Manufacturing etc authorisations for dangerous poisons—Act, s 20 (2) (a) 178

Division 17.3.2         Authorisations for delivery people and commercial disposal operators

692         Authorisations to deliver dangerous poisons under purchase orders—Act, s 26 (1) (b) and (2) (b), s 35 (1) (b), (2) (b) and s 36 (b)  179

693         Authorisation to supply dangerous poisons to commercial disposal operator for disposal—Act, s 26 (1) (b)  180

694         Authorisations for commercial disposal operators—Act, s 26 (1) (b) and (2) (b), s 35 (1) (b) and (2) (b) and s 36 (b)  180

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 (2) (b)        181

696         Authorisation conditions for dangerous poisons research and education—Act, s 44 (1) (b) and (2) (b)  182

Chapter 18 Dangerous poisons licences

Part 18.1   Dangerous poisons licences generally

700        Dangerous poisons licences that may be issued—Act, s 78 (2)           183

Part 18.2   Dangerous poisons manufacturers licences

705         Applications for dangerous poisons manufacturers licences               184

706         Restrictions on issuing of dangerous poisons manufacturers licences—Act, s 85 (1) (a)         185

707        Additional information for dangerous poisons manufacturers licences—Act, s 88 (1) (k) 185

Part 18.3   Dangerous poisons research and education program licences

710         Applications for dangerous poisons research and education program licences  186

711         Restrictions on issuing of dangerous poisons research and education program licences—Act, s 85 (1) (a)  187

712         Additional information for dangerous poisons research and education licences—Act, s 88 (1) (k)  187

Part 18.4   Dangerous poisons suppliers licences

715         Applications for dangerous poisons suppliers licences  189

716         Restrictions on issuing of dangerous poisons suppliers licences—Act, s 85 (1) (a)      190

717         Additional information for dangerous poisons suppliers licences—Act, s 88 (1) (k)      190

Chapter 19 Dangerous poisons—other provisions

Part 19.1   Dangerous poisons purchase orders

720         Supplying dangerous poisons on purchase orders  191

721         General requirements for dangerous poisons purchase orders—Act, s 38 (2) (c)       192

722         Recording supply of dangerous poisons  192

Part 19.2   Wholesale supply of dangerous poisons under corresponding laws

725         Conditions for wholesalers supplying dangerous poisons under corresponding laws—Act, s 20 (4) (c)  193

Part 19.3   Packaging and labelling of dangerous poisons

730         Meaning of relevant law—pt 19.3  194

731         Packaging of supplied manufacturer’s packs of dangerous poisons—Act, s 59 (1) (c) (i) and (2) (c) (i)  194

732         Labelling of supplied manufacturer’s packs of dangerous poisons—Act, s 60 (1) (c) (i) and (2) (c) (i)  195

Part 19.4   Storage of dangerous poisons

735         Storage of dangerous poisons—Act, s 61 (b) and (c)  196

Part 19.5   Dangerous poisons registers

740         Keeping of dangerous poisons registers by certain people—Act, s 48 and s 50 (1) (b) and (2) (b)  197

741         Form of dangerous poisons registers—Act, s 49 (1) (b)  198

742         Making entries in dangerous poisons registers—Act, s 51 (1) (b)         198

743         Prescribed witnesses for discarding of dangerous poisons—Act, s 54 (a) and (b)       198

744         Changes to entries in dangerous poisons registers—Act, s 55 (2) (b)     199

Chapter 20Paints

750         Manufacture, supply and use of paints containing white lead—Act, s 70 (1) (b), (2) (b) and (3) (b)  200

751         Manufacture, supply and use of first group paints for certain purposes—Act, s 71 (1)    200

751A        Manufacture, supply and use of paints or tinters for certain purposes—Act, s 71 (3)    201

752         Manufacture, supply and use of paints for toys—Act, s 72 (b)            201

753         Manufacture, supply and use of paints containing pesticides—Act, s 73 (b) 201

Chapter 21 Prohibited and schedule 10 substances

Part 21.1   Preliminary

760         Meaning of prohibited substance—ch 21  202

761         Prohibited substances licences—Act, s 78 (2)  202

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 licences       203

766         Restrictions on issuing of prohibited substances research and education program licences—Act, s 85 (1) (a)  204

767         Additional information for prohibited substances research program and education licences—Act, s 88 (1) (k)  205

Division 21.2.2         Prohibited substances research and education program authorisations

768         Authorisations under prohibited substances research and education program licences—Act, s 20 (1) (a)  205

769         Authorisation condition for prohibited substances research and education program licences—Act, s 44 (1) (b) and (2) (b)  206

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

770        Approvals of dealings for prohibited substances research and education program licences—Act, s 20 (1) (c)  207

771         Authorisation condition for approval-holders—Act, s 44 (1) (b) and (2) (b) 208

772         General requirements for prohibited substances purchase orders—Act, s 38 (2) (c)    208

773         Recording supply of prohibited substances on purchase orders          209

774         Information for CHO about supplied prohibited substances research and education program licences—Act, s 31 (1) (a) (ii), (1) (b), (2) (a) (ii), (2) (b) and (4)  209

Part 21.3   Prohibited substances registers

775         Keeping of prohibited substances registers by certain people—Act, s 48 and s 50 (1) (b) and (2) (b)  211

776         Form of prohibited substances registers—Act, s 49 (1) (b)                211

777        Making entries in prohibited substances registers—Act, s 51 (1) (b)     212

778         Prescribed witnesses for discarding of prohibited substances—Act, s 54 (a) and (b)     212

779         Changes to entries in prohibited substances registers—Act, s 55 (2) (b) 213

Chapter 22 Therapeutic goods

800         Definitions—ch 22  214

801         Prescribed regulated therapeutic goods—Act, s 14, def regulated therapeutic good, par (b)    214

802         Authorisation to supply optical devices—Act, s 74 (1) (b) and (2) (b)     214

803         Authorisation conditions for supplying optical devices—Act, s 75 (1) (b)  215

Chapter 23 Notification and review of decisions

850         Meaning of reviewable decision—ch 23  216

851         Reviewable decision notices  217

852         Applications for review  218

Chapter 24 Miscellaneous

860         Supply etc of certain declared substances by public employee exercising functions under Act—Act, s 26 (1) (b) etc  219

861         Dealings with regulated substances and regulated therapeutic goods by public employees under chief health officer permit—Act, s 20 (1) (a) etc  220

861A        Dealings with regulated substances and regulated therapeutic goods by public employees under director‑general authorisation—Act, s 20 (1) (d) and s 22 (1) (d)         221

862         Certain containers not to be used for human-use substances—Act, s 63 (1) (b)         222

863Disapplication of Legislation Act, s 47 (6) 222

864         Exemption of piper methysticum (kava)—Act, s 190 (1) (a)               224

Schedule 1 Medicines—health-related occupations authorisations       226

Part 1.1    Ambulance services and officers  226

Part 1.2    Dentists, dental hygienists, dental therapists and oral health therapists        227

Part 1.3    Doctors  230

Part 1.4    Health practitioners at institutions  232

Part 1.4A   Medical radiation practitioners  233

Part 1.5    Midwives  234

Part 1.6    Nurses  236

Part 1.7    Opioid dependency treatment centres operated by Territory 238

Part 1.8    Optometrists  239

Part 1.9    Pharmacists and employees  240

Part 1.10   Podiatrists  243

Part 1.11   Residential care facilities  244

Part 1.12   Sales representatives for medicines manufacturers and wholesalers    246

Part 1.13   Veterinary practitioners and employees  247

Schedule 3 ACT listed appendix D medicines—standing approvals      249

Part 3.1    Approval conditions  249

3.1          Definitions—sch 3  249

Part 3.2    Standing approvals for ACT listed appendix D medicines 251

Schedule 4 Dangerous poisons—manufacturing etc authorisations     255

Schedule 5 Requirements for storage receptacles                258

Part 5.1    Medicines cabinets  258

5.1          Medicines cabinets—general requirements  258

5.2          Medicines cabinets—body requirements  258

5.3          Medicines cabinets—door requirements  258

5.4          Medicines cabinets—lock requirements  259

5.5          Medicines cabinets—mounting requirements  259

Part 5.2    Safes, strong rooms and vaults  260

5.6          Requirements for safes  260

5.7          Requirements for strong rooms  260

5.8          Requirements for vaults  260

Dictionary261

Endnotes

1            About the endnotes  273

2            Abbreviation key  273

3            Legislation history  274

4            Amendment history  282

5            Earlier republications  297

Medicines, Poisons and Therapeutic Goods Regulation 2008

made under the

Medicines, Poisons and Therapeutic Goods Act 2008

Chapter 1Preliminary

1. Name of regulation

   This regulation is the Medicines, Poisons and Therapeutic Goods Regulation 2008.

2. Dictionary

   The dictionary at the end of this regulation is part of this regulation.

   Note 1The dictionary at the end of this regulation defines certain terms used in this regulation, and includes references (signpost definitions) to other terms defined elsewhere.

   For example, the signpost definition ‘young detainee—see the Children and Young People Act 2008, section 95.’ means that the term ‘young detainee’ is defined in that section and the definition applies to this regulation.

   Note 2A definition in the dictionary (including a signpost definition) applies to the entire regulation unless the definition, or another provision of the regulation, provides otherwise or the contrary intention otherwise appears (see Legislation Act, s 155 and s 156 (1)).

3. Notes

   A note included in this regulation is explanatory and is not part of this regulation.

   NoteSee the Legislation Act, s 127 (1), (4) and (5) for the legal status of notes.

4. Offences against regulation—application of Criminal Code etc

   Other legislation applies in relation to offences against this regulation.

   Note 1Criminal Code

   The Criminal Code, ch 2 applies to all offences against this regulation (see Code, pt 2.1).

   The chapter sets out the general principles of criminal responsibility (including burdens of proof and general defences), and defines terms used for offences to which the Code applies (eg conduct, intention, recklessness and strict liability).

   Note 2Penalty units

   The Legislation Act, s 133 deals with the meaning of offence penalties that are expressed in penalty units.

5. Overview of things to which medicines and poisons standard does not apply

   (1)The medicines and poisons standard applies to regulated substances (see the Act, pt 3.1 and s 17).

   (2)However, the medicines and poisons standard sets out the following things to which it does not apply (unless there is a contrary intention in the standard):

   (a)a substance in a preparation or product included in the standard, appendix A;

   (b)a substance and the reason for its entry in the standard, appendix B;

   (c)a substance to which the standard, appendix G applies;

   (d)certain low concentrations of substances included in the standard, schedules 1 to 6 if the substance is not also included in schedule 7 or 8;

   (e)certain impurities in pesticides.

Chapter 2Medicines—authorisations generally

Part 2.1Overview of medicines authorisations

1. General overview of authorisations for medicines

   (1)The Act requires that a person must not deal with a medicine in a particular way unless the person is authorised to deal with the medicine.

   Example

   the Act, s 35 is about obtaining certain substances (which include medicines)

   NoteThe Act, s 19 sets out when a person deals with a medicine.

   (2)The Act, section 20 sets out when a person is authorised to deal with a medicine.

   (3)This regulation authorises certain dealings with medicines.

   NoteAn authorisation is not required to deal with the following:

   ·     a substance excluded from the medicines and poisons standard by the standard;

   ·     a substance mentioned in the medicines and poisons standard, sch 2, 3, 4 or 8 if none of the schedules apply to the substance because of an exception in the standard (eg Aspirin in packets available from supermarkets).

   (4)An authorisation under this regulation may be subject to limitations.

   Examples—s (4)

   1     a health practitioner’s authorisation is subject to any condition or restriction to which the health practitioner is subject to under the Health Practitioner Regulation National Law (ACT) (see s 20)

   2     the authorisation of a person to prescribe a medicine is subject to any restriction included in sch 1 in relation to the person (see s 30 (1) (b))

   NoteFor the power to impose other restrictions, see the Act, ch 8.

1. Overview of medicines authorisations under this regulation

   (1)Medicines authorisations under this regulation that are specific to health-related occupations are given by the following provisions (and are set out in schedule 1):

   (a)section 30 (which is about authorisations under schedule 1 to prescribe medicines);

   (b)section 50 (which is about authorisations under schedule 1 to issue requisitions for medicines);

   (c)section 60 (which is about authorisations under schedule 1 to issue purchase orders for medicines);

   (d)section 110 (which is about authorisations under schedule 1 to supply medicines);

   NoteSupply includes dispense on prescription (see Act, s 24).

   (e)section 255 (which is about authorisation of approved pharmacists to supply certain medicines without prescription);

   (f)section 350 (which is about authorisations under schedule 1 for people in health-related occupations to administer medicines);

   (g)section 352 (which is about authorisation of pharmacists and intern pharmacists to administer vaccines without prescription);

   (h)section 370 (which is about authorisations under schedule 1 to obtain and possess medicines);

   (i)section 380 (which is about authorisations under schedule 1 to manufacture medicines).

   (2)For other authorisations, see the following provisions:

   (a)section 70 (which is about authorisation of CHO to issue standing orders for supply of medicines in public health emergencies);

   (b)section 71 (which is about authorisation of CHO to issue standing orders for administration of medicines for public health matters);

   (c)section 75 (which is about authorisation of doctors to issue standing orders for administration of medicines at institutions);

   (d)section 77 (which is about authorisation of CHO to issue standing orders for supply and administration of medicines at walk-in centres);

   (e)section 251 (which is about authorisation to supply certain medicines without prescription in emergencies);

   (f)section 260 (which is about authorisation to supply medicines to pharmacists for disposal);

   (g)section 261 (which is about authorisation to supply medicines to commercial disposal operators for disposal);

   (h)section 360 (which is about authorisation for self‑administration of medicines);

   (i)section 361 (which is about authorisation for the administration of medicines by assistants);

   (j)section 371 (which is about authorisation to obtain and possess medicines for certain personal use-related dealings);

   (k)section 400 (which is about authorisation to deliver medicines under supply authorities);

   (l)section 401 (which is about authorisation for commercial disposal operators for disposal of medicines);

   (m)section 410 (which is about authorisation to supply and administer adrenaline, naloxone and salbutamol);

   (n)section 420 (which is about authorisations for CYP authorised people);

   (o)section 421 (which is about authorisations for corrections officers);

   (p)section 430 (which is about authorisations for non-controlled medicines research and education);

   (q)section 440 (which is about authorisations under controlled medicines research and education program licences);

   (r)section 450 (which is about authorisations under first-aid kit licences);

   (s)section 460 (which is about authorisations under medicines wholesalers licences);

   (t)section 470 (which is about authorisations under opioid dependency treatment licences);

   (u)section 480 (which is about authorisations under pharmacy medicines rural communities licences);

   (v)section 490 (which is about authorisations for endorsed health practitioners);

   (w)section 490A (which is about authorisation of health practitioners for certain dealings approved by CHO).

2. General overview of authorisation conditions for medicines

   (1)The Act, section 44 requires a person who is authorised to deal with a medicine to comply with any condition to which the authorisation is subject.

   Example

   Section 31 sets out the authorisation conditions for an authorised person to prescribe a medicine.

   (2)The conditions are additional to other restrictions on an authorised person’s authority to deal with a medicine.

   Example—s (2)

   Sch 1 limits the prescription by eligible midwives of medicines that are listed on the pharmaceutical benefits scheme (see sch 1, part 1.5) to eligible midwives who hold a particular authority.

   NoteConditions may also be imposed under other provisions of the Act including, for example, s 89 which sets out conditions on licences.

Part 2.2Relationship with registration laws

1. Medicines authorisations subject to Health Practitioner Regulation National Law (ACT) restrictions

   A health practitioner’s authorisation under the Act to deal with a medicine is subject to any condition or other restriction to which the health practitioner is subject under the Health Practitioner Regulation National Law (ACT).

   Example

   Section 31 places conditions on the prescribing of medicines by a health practitioner authorised to prescribe the medicines.  If a particular health practitioner’s registration under the Health Practitioner Regulation National Law (ACT) is subject to the condition or restriction that the person may not prescribe certain medicines, the health practitioner’s authorisation under the Medicines, Poisons and Therapeutic Goods Act 2008 to prescribe medicines is also subject to that condition or restriction.

   NoteA reference to an Act includes a reference to the statutory instruments made or in force under the Act, including any regulation (see Legislation Act, s 104).

2. Medicines authorisations subject to Veterinary Practice Act 2018 restrictions

   A veterinary practitioner’s authorisation under the Act to deal with a medicine is subject to any condition or other restriction to which the veterinary practitioner is subject under the Veterinary Practice Act 2018.

Chapter 3Medicines—supply authorities

Part 3.1Prescribing medicines

Division 3.1.1           Authorisation to prescribe medicines

1. Authorisation under sch 1 to prescribe medicines—Act, s 40 (1) (b), (2) (b) and (3) (b)

   (1)A person mentioned in schedule 1, column 2 is authorised to prescribe a medicine if—

   (a)prescribing the medicine is included in the schedule, column 3 in relation to the person; and

   (b)the prescribing is consistent with any restriction for the prescribing mentioned in the schedule, column 3; and

   (c)if the prescription is a self-prescription of the medicine—

   (i)the person is not a trainee dentist, trainee nurse practitioner, intern doctor or person training to be an eligible midwife; or

   (ii)the medicine is not a restricted medicine.

   (2)In this section:

   restricted medicine means—

   (a)an anabolic steroid; or

   (b)an appendix D medicine; or

   (c)a monitored medicine.

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

   (1)A prescriber’s authorisation under section 30 to prescribe a medicine is subject to the following conditions:

   (a)the medicine is prescribed in accordance with the Act, section 7 (Appropriate prescription and supply of medicines);

   (b)if the prescription is a written prescription—

   (i)the prescription complies with section 40 (General requirements for written prescriptions); and

   (ii)the prescription (other than a national residential medication chart prescription) includes the particulars mentioned in section 41 on the front of the prescription; and

   (iii)if the prescription is a national residential medication chart prescription in a national residential medication chart––the chart includes the particulars mentioned in section 41; and

   (iv)if the prescription is faxed by a prescriber to a pharmacist—the prescriber sends the original prescription to the pharmacist not later than 7 days after the prescriber faxes the prescription to the pharmacist;

   Note 1For the endorsement of faxed prescriptions, see s 41 (1) (l).

   Note 2Pharmacist does not include an intern pharmacist (see dict).

   (c)if the prescription is an oral prescription—

   (i)the prescriber believes on reasonable grounds that giving an oral prescription for the medicine is reasonably necessary for the patient’s treatment; and

   (ii)if the prescription is for an unusual or dangerous dose of a medicine—the prescription includes a statement telling the person who is to dispense or administer the medicine that the prescription is for an unusual or dangerous dose; and

   (iii)the prescription includes the particulars mentioned in section 41; and

   (iv)the prescriber sends a written prescription for the medicine to the pharmacist not later than 24 hours after the prescriber gives the oral prescription to the pharmacist;

   NoteFor the endorsement of written prescriptions confirming oral prescriptions, see s 41 (1) (m).

   (d)if the medicine is a controlled medicine for human use—

   (i)the prescriber complies with the additional requirements under section 32 for prescribing a controlled medicine; and

   (ii)if the controlled medicines approval is an oral approval—the prescriber sends the chief health officer a written application for the approval in accordance with section 561 (Requirements for CHO controlled medicines approval applications) not later than 7 days after the day the oral approval is given;

   (e)if the medicine is an appendix D medicine—

   (i)the prescriber has an appendix D medicines approval to prescribe the medicine; and

   (ii)the prescriber complies with each condition (if any) of the approval (including any conditions in schedule 3, part 3.2, column 4 in relation to the medicine).

   (2)In this section:

   national residential medication chart means a medication chart within the meaning of the National Health (Pharmaceutical Benefits) Regulations 2017 (Cwlth), section 41 (4), as in force from time to time.

   NoteThe National Health (Pharmaceutical Benefits) Regulations 2017 (Cwlth) does not need to be notified under the Legislation Act because s 47 (6) does not apply (see s 863).

31AVariation of authorisation condition during Commonwealth special arrangement period

(1)This section applies to a prescriber of a prescription if—

(a)the prescription is faxed by the prescriber to a pharmacist; and

(b)the prescription is for the supply of a medicine in accordance with a Commonwealth special arrangement; and

(c)the Commonwealth special arrangement requires the prescriber to keep the original of the prescription.

(2)The prescriber is not required to send the original of the prescription  under section 31 (1) (b) (iv).

(3)In this section:

Commonwealth special arrangement means a special arrangement made under the National Health Act 1953 (Cwlth), section 100, as in force from time to time.

NoteCommonwealth special arrangements are accessible at type="1">

Additional requirements for prescribing controlled medicines for human use

The following are the additional requirements for prescribing a controlled medicine for human use:

(a)the prescriber has a controlled medicines approval to prescribe the medicine;

NoteFor controlled medicines approvals, see pt 13.1.

(b)if the approval is for a particular form of the medicine—the prescription is for the form of the medicine approved or a bioequivalent form;

NoteBioequivalent—see the dictionary.

(c)if the approval is for a particular strength of the medicine—the prescription is for the strength approved or a weaker strength;

(d)if the approval is for a particular quantity of the medicine—the prescription is for not more than the quantity approved;

(e)the prescriber complies with each condition (if any) of the approval;

(f)if the controlled medicine is dronabinol for human use—

(i)the prescriber also has an authorisation under the Therapeutic Goods Act 1989 (Cwlth), section 19 to supply the medicine; and

(ii)the prescriber complies with each condition (if any) of the authorisation.

Example—par (b)

If a slow release form of a medicine is approved, the prescriber is not authorised to prescribe an immediate release form of the medicine.

Example—par (c) and par (d)

If a doctor is given an approval to prescribe 25 morphine 20mg capsules, the doctor may prescribe 5 20mg capsules and 10 15mg capsules.  Later, if the approval is still in force, the doctor may prescribe not more than 10 morphine capsules of any strength up to and including 20mg.

Division 3.1.2           Prescriptions

NoteA prescription may provide for a medicine to be dispensed or administered (see Act, dict, def prescription).

1. General requirements for written prescriptions

   A written prescription for a medicine must—

   (a)be signed by the prescriber; and

   NoteThe prescription must be signed with the prescriber’s usual signature (see Act, dict, def signs).

   (b)if the prescriber amends the prescription—be initialled and dated beside the amendment by the prescriber; and

   (c)be written in terms and symbols used in ordinary professional practice; and

   (d)if the prescription is for an unusual or dangerous dose—include the prescriber’s initials beside an underlined reference to the dose.

   NoteWritten includes in electronic form (see Act, dict).

2. Particulars for prescriptions

   (1)A prescription must include the following particulars:

   (a)the prescriber’s name, professional qualifications and business address and telephone number;

   (b)the date the prescription is given;

   (c)the medicine, and the form, strength and quantity of the medicine, to be dispensed or administered under the prescription;

   (d)the name, date of birth and address of the person for whom the medicine is prescribed;

   (e)directions about the use of the medicine, including the dose and regimen of the medicine, that are adequate to allow the medicine to be taken or administered safely;

   (f)the number of times the medicine may be dispensed or administered under the prescription;

   (g)if the prescription is for a controlled medicine for human use—

   (i)if the medicine is dronabinol—the relevant TGA authorisation particulars; and

   (ii)if the prescription is a repeat prescription—the period that must elapse between each dispensing or administration of the medicine;

   (h)if the prescriber is a dentist—the words ‘for dental treatment only’;

   (i)if the prescriber is an eligible midwife—the words ‘for midwifery use only’;

   (j)if the prescriber is an optometrist—the words ‘for optometry use only’;

   (k)if the prescriber is a veterinary practitioner—

   (i)the words ‘for animal treatment only’; and

   (ii)the species of the animal for which the medicine is to be dispensed; and

   (iii)if possible, a way of identifying the animal;

   (l)if the prescription is an original of a prescription that was faxed by a prescriber to a pharmacist—the prescription is endorsed with words to the effect that the prescription was faxed to a named pharmacy on a stated date;

   (m)if the prescription is a written prescription under section 31 (1) (c) (iv) (which is about oral prescriptions)—the prescription is endorsed with words to the effect that the prescription is a confirmation copy of an oral prescription issued to a named pharmacist on a stated date.

   (2)However, if the prescription is written for an in-patient at a hospital in the patient’s medical records, the prescription need not include the prescriber’s professional qualifications and business address and telephone number.

   Note 1Hospital means a public hospital, private hospital or day hospital and includes a body prescribed by regulation as a hospital (see Act, dict).

   Note 2A hospice is a hospital (see The Macquarie Dictionary, 4th ed).

   (3)Also, if the prescription is a national residential medication chart prescription, the prescription need not include either of the following:

   (a)the prescriber’s professional qualifications;

   (b)the quantity of the medicine to be dispensed or administered under the prescription.

   (4)In this section:

   relevant TGA authorisation particulars means the words ‘TGA authorisation’ followed by—

   (a)the identifying number for the authorisation; or

   (b)if no identifying number is given for the authorisation—the date of the approval.

Part 3.2Requisitioning medicines

Division 3.2.1           Authorisation to issue requisitions

1. Authorisation under sch 1 to issue requisitions for medicines—Act, s 41 (b)

   A person mentioned in schedule 1, column 2 is authorised to issue a requisition for a medicine if—

   (a)issuing the requisition is included in the schedule, column 3 in relation to the person; and

   (b)the issue of the requisition is consistent with any restriction for the issue of the requisition mentioned in the schedule, column 3.

2. Authorisation conditions for issuing requisitions for medicines—Act, s 44 (1) (b) and (2) (b)

   A person’s authorisation under section 50 to issue a requisition for a medicine is subject to the following conditions:

   (a)if the requisition is a written requisition—the requisition complies with section 55 (General requirements for written requisitions) and section 56 (Particulars for requisitions);

   (b)if the requisition is an oral requisition—

   (i)the person believes on reasonable grounds that issuing the requisition is reasonably necessary for the treatment of a person; and

   (ii)the quantity of the medicine requisitioned is not more than the amount reasonably necessary for the person’s treatment; and

   (iii)the requisition complies with section 56.

Division 3.2.2           Requisitions

1. General requirements for written requisitions

   A written requisition for a medicine must be—

   (a)signed by the person (the issuer) issuing the requisition; and

   NoteThe requisition must be signed with the issuer’s usual signature (see Act, dict, def signs).

   (b)if the issuer amends the requisition—initialled and dated by the issuer beside the amendment.

   NoteWritten includes in electronic form (see Act, dict).

2. Particulars for requisitions

   A requisition must include the following particulars:

   (a)the name of the person issuing the requisition;

   (b)the capacity in which the person is issuing the requisition;

   (c)the date the requisition is issued;

   (d)the medicine, and the form, strength and quantity of the medicine, to be supplied on the requisition;

   (e)the pharmacy or ward to which the medicine is to be supplied.

   NoteWard—see the Act, dictionary.

Part 3.3Medicines purchase orders

Division 3.3.1           Authorisation to issue purchase orders

1. Authorisation under sch 1 to issue purchase orders for medicines—Act, s 38 (1) (b) and (2) (a)

   A person mentioned in schedule 1, column 2 is authorised to issue a purchase order for a medicine if—

   (a)issuing the purchase order is included in the schedule, column 3 in relation to the person; and

   (b)the issue of the purchase order is consistent with any restriction for the issue of the purchase order mentioned in the schedule, column 3.

2. Authorisation conditions for issuing purchase orders for medicines—Act, s 44 (1) (b) and (2) (b)

   A person’s authorisation under section 60 to issue a purchase order for a medicine is subject to the following conditions:

   (a)the purchase order complies with section 62 (General requirements for medicines purchase orders—Act, s 38 (2) (c));

   NoteA purchase order must be in writing (see Act, dict, def purchase order).

   (b)the person must, not later than 24 hours after the person receives the medicine, send the supplier a document signed by the person acknowledging receipt of the medicine.

   Example—document

   a copy of the supplier’s delivery docket signed by the buyer

1. Earlier republications

   Some earlier republications were not numbered.  The number in column 1 refers to the publication order.

   Since 12 September 2001 every authorised republication has been published in electronic pdf format on the ACT legislation register.  A selection of authorised republications have also been published in printed format.  These republications are marked with an asterisk (*) in column 1.  Electronic and printed versions of an authorised republication are identical.

Republication No and date	Effective	Last amendment made by	Republication for
R1 14 Feb 2009	14 Feb 2009– 5 June 2009	not amended	new regulation
R2 6 June 2009	6 June 2009– 16 Dec 2009	SL2009‑27	amendments by SL2009‑27
R3 17 Dec 2009	17 Dec 2009– 21 Jan 2010	A2009‑49	amendments by A2009‑49
R4 22 Jan 2010	22 Jan 2010– 31 Mar 2010	SL2010‑2	amendments by SL2010‑1 and SL2010‑2
R5 1 Apr 2010	1 Apr 2010– 10 May 2010	A2010‑10	commenced expiry
R6 11 May 2010	11 May 2010– 30 June 2010	SL2010‑16	amendments by SL2010‑16
R7 1 July 2010	1 July 2010– 22 Nov 2010	SL2010‑20	amendments by A2010‑10, SL2010‑16 and SL2010‑20
R8 23 Nov 2010	23 Nov 2010– 30 Nov 2010	SL2010‑45	amendments by SL2010‑45
R9 1 Dec 2010	1 Dec 2010– 20 Dec 2010	SL2010‑45	amendments by A2010‑43
R10 21 Dec 2010	21 Dec 2010– 11 Dec 2011	A2010‑50	amendments by A2010‑50
R11 12 Dec 2011	12 Dec 2011– 9 Feb 2012	A2011‑52	amendments by A2011‑52
R12 10 Feb 2012	10 Feb 2012– 12 Feb 2012	SL2012‑5	amendments by SL2012‑5
R13 13 Feb 2012	13 Feb 2012– 2 Aug 2012	SL2012‑5	expiry of provision (s 864)
R14 3 Aug 2013	3 Aug 2013– 25 Jan 2013	SL2012‑34	amendments by SL2012‑34
R15 26 Jan 2013	26 Jan 2013– 31 Aug 2013	SL2013-1	amendments by SL2013-1
R16 1 Sept 2013	1 Sept 2013– 4 Nov 2013	SL2013‑24	amendments by SL2013‑24
R17 5 Nov 2013	5 Nov 2013– 24 Nov 2013	SL2013-28	amendments by SL2013-28
R18 25 Nov 2013	25 Nov 2013– 25 Sept 2013	A2013-44	relocation of provisions from A2008‑26 and other amendments by A2013-44
R19 26 Sept 2014	26 Sept 2014– 30 Sept 2014	SL2014‑23	amendments by SL2014‑23
R20 1 Oct 2014	1 Oct 2014– 22 Oct 2014	SL2014‑23	amendments by SL2014‑23
R21 23 Oct 2014	23 Oct 2014– 21 May 2015	SL2014‑26	amendments by SL2014‑26
R22 22 May 2015	22 May 2015– 20 July 2015	SL2015‑19	amendments by SL2015‑19
R23 21 July 2015	21 July 2015– 23 Nov 2015	SL2015‑19	amendments by SL2015‑19
R24 24 Nov 2015	24 Nov 2015– 30 Nov 2015	SL2015‑36	amendments by SL2015‑36
R25 1 Dec 2015	1 Dec 2015– 8 Dec 2015	SL2015‑36	amendments by A2015‑29
R26 9 Dec 2015	9 Dec 2015– 29 Feb 2016	A2015‑50	amendments by A2015‑50
R27 1 Mar 2016	1 Mar 2016– 30 July 2016	SL2016‑5	amendments by A2015‑38 and SL2016‑5
R28 31 July 2016	31 July 2016– 28 Aug 2016	SL2016-16	amendments by SL2016-16
R29 29 Aug 2016	29 Aug 2016– 24 Aug 2017	SL2016‑16	amendments by A2016-7
R30 25 Aug 2017	25 Aug 2017– 14 June 2018	SL2017‑27	amendments by SL2017‑27
R31 15 June 2018	15 June 2018– 21 Nov 2018	A2018‑23	amendments by A2018‑23
R32 22 Nov 2018	22 Nov 2018– 20 Dec 2018	A2018‑42	amendments by A2018‑42
R33 21 Dec 2018	21 Dec 2018– 12 Sept 2019	A2018‑42	amendments by A2018‑32
R34 13 Sept 2019	13 Sept 2019– 20 Jan 2020	SL2019‑23	amendments by SL2019‑23
R35 21 Jan 2020	21 Jan 2020– 3 Apr 2020	SL2020‑3	amendments by SL2020‑3
R36 4 Apr 2020	4 Apr 2020– 7 Apr 2020	SL2020‑13	amendments by SL2020‑13
R37 8 Apr 2020	8 Apr 2020– 19 June 2020	A2020‑11	amendments by A2020‑11
R38 20 June 2020	20 June 2020– 26 June 2020	SL2020‑21	amendments by SL2020‑21
R39 27 June 2020	27 June 2020– 20 Aug 2020	SL2020‑24	amendments by SL2020‑24
R40 21 Aug 2020	21 Aug 2020– 9 Sept 2020	SL2020‑31	amendments by SL2020‑31
R41 10 Sept 2020	10 Sept 2020– 22 June 2021	SL2020‑39	amendments by SL2020‑39
R42 23 June 2021	23 June 2021– 17 Aug 2021	A2021‑12	amendments by A2021‑12
R43 18 Aug 2021	18 Aug 2021– 4 Nov 2021	SL2021‑19	amendments by SL2021‑19
R44 5 Nov 2021	5 Nov 2021– 30 Sept 2022	SL2021‑28	amendments by SL2021‑28
R45 1 Oct 2022	1 Oct 2022– 6 Apr 2023	SL2021‑28	expiry of provision (s 632)
R46 7 Apr 2023	7 Apr 2023– 2 July 2023	SL2023‑5	amendments by SL2023‑5
R47 3 July 2023	3 July 2023– 7 Aug 2023	A2023‑17	amendments by A2023‑17
R48 8 Aug 2023	8 Aug 2023– 29 Sept 2023	SL2023‑17	amendments by SL2023‑17
R49 30 Sept 2023	30 Sept 2023– 11 Dec 2023	SL2023‑17	expiry of provisions (pt 9.7)
R50 12 Dec 2023	12 Dec 2023– 9 July 2024	SL2023‑34	amendments by SL2023‑34
R51 10 July 2024	10 July 2024– 12 Dec 2024	A2024‑30	amendments by A2024‑30
R52 13 Dec 2024	13 Dec 2024– 11 June 2025	SL2024‑36	amendments by SL2024‑36
R53 12 June 2025	12 June 2025– 16 June 2025	SL2024‑36	amendments by SL2024‑36
R54 17 June 2025	17 June 2025– 25 Nov 2025	SL2025‑7	amendments by SL2025‑7