Drugs, Poisons and Controlled Substances Amendment (Schedule 9 Poisons) Regulations 2022 (Vic)

Drugs, Poisons and Controlled Substances Amendment (Schedule 9 Poisons) Regulations 2022

S.R. No. 96/2022

table of provisions

Regulation  Page

1Objective

2Authorising provisions

3Commencement

4Principal Regulations

5Objectives

6Definitions

7Regulation 13 substituted

8General Schedule 9 permit

9Regulation 15 substituted

10New Division 3 inserted in Part 2

11Issuing prescription for Schedule 4, 8 or 9 poison—registered medical practitioner

12Sale or supply of Schedule 4, 8 or 9 poison—registered medical practitioner

13Wholesale supply of Schedule 9 poison by pharmacist to another pharmacist

14Sale of supply of Schedule 9 poison by pharmacist

15Authorising administration of Schedule 4, 8 or 9 poison—registered medical practitioner

16Administration of Schedule 4, 8 or 9 poison—registered medical practitioner

17Regulation 101 substituted

18Schedule 2 amended

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Endnotes

statutory rules 2022

S.R. No. 96/2022

Drugs, Poisons and Controlled Substances Act 1981

Drugs, Poisons and Controlled Substances Amendment (Schedule 9 Poisons) Regulations 2022

The Governor in Council makes the following Regulations:

Dated: 27 September 2022

Responsible Minister:

MARY-ANNE THOMAS
Minister for Health

SAMUAL WALLACE

Clerk of the Executive Council

1Objective

The objective of these Regulations is to amend the Drugs, Poisons and Controlled Substances Regulations 2017—

(a)to restrict the circumstances in which Schedule 9 permits are issued to a registered medical practitioner or dentist; and

(b)to only allow veterinary practitioners and dentists to apply for a general Schedule 9 permit; and

(c)to make minor and consequential amendments; and

(d)to update the prescribed form used by registered medical practitioners to apply for a Schedule 9 permit.

2Authorising provisions

These Regulations are made under sections 129 and 132 of the Drugs, Poisons and Controlled Substances Act 1981.

3Commencement

These Regulations come into operation on 27 September 2022.

4Principal Regulations

In these Regulations, the Drugs, Poisons and Controlled Substances Regulations 2017[1] are called the Principal Regulations.

5Objectives

In regulation 1(b) of the Principal Regulations, after "fees" insert "and other matters".

6Definitions

In regulation 5(1) of the Principal Regulations insert the following definition—

"human research ethics committee means a committee—

(a)that has notified its existence to the Australian Health Ethics Committee established under the National Health and Medical Research Council Act 1992 of the Commonwealth; and

(b)to which the NHMRC (within the meaning of that Act) has allocated a code to denote the NHMRC's registration of the committee as a human research ethics committee; and

(c)whose registration referred to in paragraph (b) is in force;".

7Regulation 13 substituted

For regulation 13 of the Principal Regulations substitute—

"13   Application for general Schedule 9 permit

A veterinary practitioner or dentist may apply to the Secretary for a general Schedule 9 permit.".

8General Schedule 9 permit

(1)For regulation 14(2) of the Principal Regulations substitute—

"(2)The Secretary must not issue a general Schedule 9 permit to a dentist unless the Secretary is satisfied that—

(a)a human clinical trial has been approved by a human research ethics committee; and

(b)the activity to be authorised by the permit is to be undertaken for the purposes of that trial.".

(2)After regulation 14(3) of the Principal Regulations insert—

"(3A)Without limiting subregulation (3), when issuing a general Schedule 9 permit to a dentist, the Secretary must include a condition that the activity is only authorised to be undertaken for the purposes of the human clinical trial specified in the condition.".

9Regulation 15 substituted

For regulation 15 of the Principal Regulations substitute—

"15   General Schedule 9 permit is not limited to specific animals

A general Schedule 9 permit granted to a veterinary practitioner is not restricted to the administration of a Schedule 9 poison to a specific animal.".

10New Division 3 inserted in Part 2

After regulation 15 of the Principal Regulations insert—

"Division 3—Schedule 9 permit

15ADocuments to accompany application for Schedule 9 permit

(1)Subject to subregulation (2), an application under section 33A of the Act must be accompanied by the following—

(a)a copy of a document issued by a human research ethics committee approving the human clinical trial in relation to which the application is made; and

(b)a copy of the protocol for that trial; and

(c)for each patient in respect of whom the application is made, a copy of a consent form relating to that trial that is signed by the patient.

(2)An application under section 33A of the Act need not be accompanied by a document that has previously accompanied a different application made under that section.

15BSchedule 9 permits issued for clinical trials only

(1)The Secretary must not issue a Schedule 9 permit under section 33B of the Act authorising a medical practitioner to administer, supply or prescribe a Schedule 9 poison to a person unless the Secretary is satisfied that—

(a)a human clinical trial has been approved by a human research ethics committee; and

(b)the activity to be authorised by the permit is to be undertaken for the purposes of that trial.

(2)When issuing a Schedule 9 permit under section 33B of the Act, the Secretary must impose a condition under section 33B(2)(b) of the Act that the administration, supply or prescription of the Schedule 9 poison is only authorised to be undertaken for the purposes of the human clinical trial specified in the condition.".

11Issuing prescription for Schedule 4, 8 or 9 poison—registered medical practitioner

In regulation 17(g) of the Principal Regulations omit "a general Schedule 9 permit, or".

12Sale or supply of Schedule 4, 8 or 9 poison—registered medical practitioner

In regulation 36(f) of the Principal Regulations omit "a general Schedule 9 permit, or".

13Wholesale supply of Schedule 9 poison by pharmacist to another pharmacist

For regulation 46 of the Principal Regulations substitute—

"46   Wholesale supply of Schedule 9 poison by pharmacist to another pharmacist

A pharmacist must not sell or supply a Schedule 9 poison to another pharmacist for use by the other pharmacist in the lawful practice of that pharmacist's profession unless the sale or supply is—

(a)sale or supply in accordance with an instruction from a registered medical practitioner who holds a Schedule 9 permit in which the Schedule 9 poison is specified; or

(b)sale or supply in accordance with an instruction from a dentist or veterinary practitioner who holds a general Schedule 9 permit in which the Schedule 9 poison is specified.".

14Sale of supply of Schedule 9 poison by pharmacist

For regulation 49(1) of the Principal Regulations substitute—

"(1)A pharmacist must not sell or supply a Schedule 9 poison unless—

(a)the sale or supply is in accordance with an instruction from a registered medical practitioner who holds a Schedule 9 permit in which the Schedule 9 poison is specified; or

(b)the sale or supply is in accordance with an instruction from a dentist or veterinary practitioner who holds a general Schedule 9 permit in which the Schedule 9 poison is specified; or

(c)subject to regulation 52, the sale or supply is in accordance with an original prescription of—

(i)a registered medical practitioner who holds a Schedule 9 permit in which the Schedule 9 poison is specified; or

(ii)a veterinary practitioner or dentist who holds a general Schedule 9 permit in which the Schedule 9 poison is specified.

Penalty: 100 penalty units.".

15Authorising administration of Schedule 4, 8 or 9 poison—registered medical practitioner

For regulation 78(g) of the Principal Regulations substitute—

"(g)in the case of a Schedule 9 poison, the practitioner holds a Schedule 9 permit that authorises the practitioner to supply or administer the poison.".

16Administration of Schedule 4, 8 or 9 poison—registered medical practitioner

In regulation 88(h) of the Principal Regulations omit "a general Schedule 9 permit, or".

17Regulation 101 substituted

For regulation 101 of the Principal Regulations substitute—

"101   Administration of Schedule 9 poison by pharmacist

A pharmacist must not administer a Schedule 9 poison except—

(a)in accordance with an authorisation that a registered medical practitioner or a dentist gave verbally under regulation 84(1)(a); or

(b)in accordance with an authorisation that a registered medical practitioner or a dentist gave—

(i)in writing under regulation 84(1)(b); and

(ii)not more than 6 months ago; or

(c)in accordance with the original prescription of a registered medical practitioner or dentist.

Penalty:100 penalty units.".

18Schedule 2 amended

For Form 2 in Schedule 2 to the Principal Regulations substitute—

"FORM 2

Regulation 128

Drugs, Poisons and Controlled Substances Regulations 2017

APPLICATION FOR PERMIT TO ADMINISTER, SUPPLY OR PRESCRIBE SCHEDULE 9 POISONS BY A REGISTERED MEDICAL PRACTITIONER FOR A CLINICAL TRIAL

Section 1:

Full name of patient participating in trial	Date of birth	Sex
Private address of patient	Postcode

Full name and qualifications of applying registered medical practitioner

Address of applying registered medical practitioner Postcode

Telephone and fax no. of applying registered medical practitioner

Name and address of site where patient is participating in the clinical trial

Section 2:

Schedule 9 poison(s) for which permit is requested:

POISON NAME PROPRIETARY NAME (if available) DOSE FORM DOSE PER UNIT EXPECTED MAXIMUM DAILY DOSE

Name and address of supplier

Is this product registered for therapeutic use? If Yes, in which countries?

Details of other treatment (if applicable)

Section 3: Details of clinical trial and human research ethics committee

Name and registration number of the clinical trial

Purpose of the clinical trial

Name of principal investigators of the clinical trial

Registry that the clinical trial is registered on

Date that clinical trial was registered on the registry

Sites for which the clinical trial approval has been granted in Victoria

Has the clinical trial received approval from a human research ethics committee?

Ethics approval number

Date ethics approval was granted

Date ethics approval expires

Name and registration number of the human research ethics committee that granted the ethics approval

Institution responsible for the human research ethics committee, if applicable

Signature of applying registered medical practitioner

Date".

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Endnotes

[1] Reg. 4: S.R. No. 29/2017, as amended by S.R. Nos 31/2018, 45/2018, 72/2018, 178/2018, 15/2020, 73/2020, 13/2021, 174/2021, 13/2022 and 16/2022.

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Penalty Units

These Regulations provide for penalties by reference to penalty units within the meaning of section 110 of the Sentencing Act 1991. The amount of the penalty is to be calculated, in accordance with section 7 of the Monetary Units Act 2004, by multiplying the number of penalty units applicable by the value of a penalty unit.

The value of a penalty unit for the financial year commencing 1 July 2022 is $184.92. The amount of the calculated penalty may be rounded to the nearest dollar.

The value of a penalty unit for future financial years is to be fixed by the Treasurer under section 5 of the Monetary Units Act 2004. The value of a penalty unit for a financial year must be published in the Government Gazette and a Victorian newspaper before 1 June in the preceding financial year.