Use This Document As a Step-By-Step Guide To

Use this document as a step-by-step guide to:

-Apply for a licence or a permit to obtain (and/or supply) a scheduled substance in Victoria

-Apply to make changes to an existing Victorian licence or a permit (to obtain (and/or supply) a scheduled substance)

This document is not intended to be printed out.

Please be aware that there are fees involved for most applications, and there is an application process that may take several weeks.

Select what you would like to apply for from the menu below.

Navigate through this document via hyperlinks (marked in blue) - by holding the “Control” key on your keyboard, and then clicking on the hyperlink.

If you would like to carry out more than one action, come back to this menu after carrying out the first action.

For a new licence or permit
1. Apply for a new licence or permitto obtain a scheduled substance
For existing licences and permits
2.Apply to update apoisons control planfor an existing licence or permit
3.Apply to makes changes to the responsible person(s) on an existing licence or permit
4.Apply to have scheduled substance(s) added or removed or change the quantities of substances on an existing licence or permit
5.Apply to change the premises of an existing licence or to change the primary premises of an existing permit
6.Apply to change the postal address of an existing licence or permit
7.Apply to add campuses to an existing permit, or make changes to the campuses that are already present on an existing permit
8.Apply to change the legal ownership or the name of an existing licence or permit
9.Notify the Department that an existing licence or permit is to be cancelled

1.Apply for a new licence or permit to obtain a scheduled substance

You have indicated that an application is to be made for a new licence or permit to obtain a scheduled substance.

It is recommended that you complete the steps below (starting with step 1.01and continue to subsequent steps unless directed otherwise) to guide you to which licence or permit to apply for.

However, if you are already completely sure about which licence or permit to apply for, and you need no guidance, click on the link directly below this paragraph of writing, which will take you back to the main webpage, and which includes a list of all types of licences and permits that may be applied for (under the section entitled “Application forms and poison control plans” towards the bottom of the screen). You may then click on the licence or permit that you want to apply for, and will be taken to a screen that includes all forms to be completed.

If you would like to go back to the main menu of this document, please click here;

otherwise proceed below.

1.01 Is your organisation replacing the operations of another organisation that holds an existing Victorian licence or a permit?

Yes → Go to step 8.01

No → Go to step1.02

1.02 Is your organisation intending to carry out any of its operations within the Australian state of Victoria?

Yes →Go tostep 1.03

No → The Victorian Department of Health may only issue licences or permits to carry out operations inVictoria. To apply for a similar authorisation in another territory, please contact the appropriate authority from that territory. A list of contact details for health authorities of other Australian states may be found at the following web-page:

1.03 Would the products containing scheduled substances that need to be obtained by your organisation ever need to be opened from the original packaging by your organisation and then used or changed in some way by your organisation?

Yes→ Go to step 1.04

No → Go to step 1.10

1.04 Would the scheduled substances ever need to be administered to a human being by your organisation?

Yes → Go to step1.29

No → Go to step 1.05

1.05 Would the scheduled substances ever need to be supplied to persons or organisations external to your organisation (aside from for the purposes of waste removal)?

Yes → Go to step 1.06

No → Go to step 1.17

1.06 Would the scheduled substances that would be supplied to other persons or organisations be changed in some way prior to supply?

Yes → Go to step1.07

No → This answer may appear to conflict with your answer from step 1.03; nonetheless, go to step 1.10

1.07 Manufacturing licence

You have indicated that scheduled substances may be changed in some way by your organisation prior to supply. Based on your answers, it seems that your organisationmay need to apply for a licence to manufacture and supply scheduled substance(s).

Bear in mind that:

▪A licence to manufacture and supply scheduled substance(s) only allows the licence holder to supply scheduled substance(s) to authorised customers, which may include:

-Other persons or organisations holding a current licence or a current permit

-Authorised health practitioners, including registered medical practitioners, registered pharmacists working in approved pharmacies, registered dental practitioners and registered veterinary practitioners.

-Some other authorised persons that are specified in Regulation 5 of the current Victorian Drugs, Poisons and Controlled Substances Regulations.

The current Victorian Drugs, Poisons and Controlled Substances Regulations may be downloaded from the following web-page (from the “Related sites” menu on the lower right hand side of the screen, and clicking on the link stating “Drugs, Poisons and Controlled Substances Regulations 2006”):

▪An individual authorised health practitioner (for example, a medical practitioner) is able to lawfully supply a scheduled medicine that he/she has labelled for an individual patient under his/her care in the lawful practice of his/her professional in Victoria without having to hold a manufacturing licence to do so.

▪It is not necessary to hold a licence or permit to lawfully manufacture and supply a Schedule 5 substance or a Schedule 6 substance from Victoria.

(For your information, all Schedule 5 and 6 substances are listed within the current Australian Standard of Uniform Scheduling of Medicines and Poisons document, which may be down-loaded from the following web-page, by clicking on the link under the section entitled “Electronic version of the SUSMP” in the lower part of the web-page:

)

If you would like to go back to the previous questions, please click on the following link -1.03; otherwise proceed.

To continue applying for a licence to manufacture and supply scheduled substance(s), please complete the following steps:

1.07Would the scheduled substances that are to be manufactured and supplied include any Schedule 8 or 9 substances?

(For your information, all Schedule 8 and 9 substances are listed within the current Australian Standard of Uniform Scheduling of Medicines and Poisons document, which may be down-loaded from the following web-page, by clicking on the link under the section entitled “Electronic version of the SUSMP” in the lower part of the web-page:

)

Yes → Go to step 1.09

No → Go to step 1.08

1.08 Is there only one scheduled substance that would be manufactured and supplied, and is that substance fluoroacetic acid (or “1080”)?

Yes → Go to step 1.35

No → Go to step 1.46

1.09 Would the scheduled substances that are to be supplied also include any substances from Schedules 2, 3, 4 or 7?

Yes → Go to step 1.49

No → Go to step 1.52

1.10 Supply licence

You have indicated that scheduled substances would not be opened from their original packaging by your organisation.

Based on your answers, it seems that your organisation may need to apply for a licence to supply scheduled substance(s).

If you would like to go back to the previous question, please click on the following link -1.03; otherwise proceed.

Bear in mind that:

▪A licence to supply scheduled substance(s) only allows the licence holder to supply scheduled substance(s) to authorised customers, which may include:

-Other persons or organisations holding a current licence or a current permit

-Some other authorised persons that are specified in Regulation 5 of the current Victorian Drugs, Poisons and Controlled Substances Regulations.

▪It is not necessary to hold a licence or permit to lawfully supply a Schedule 5 substance or a Schedule 6 substance fromVictoria.

)

If you would like to go back to the previous question, please click on the following link -1.03; otherwise proceed.

To continue applying for a licence to supply scheduled substance(s), please complete the following steps:

1.10Would the scheduled substances that are to be supplied ONLY include Schedule 7 substances?

(For your information, all Schedule 7 substances are listed within the current Australian Standard of Uniform Scheduling of Medicines and Poisons document, which may be down-loaded from the following web-page, by clicking on the link under the section entitled “Electronic version of the SUSMP” in the lower part of the web-page:

Yes → Go to step 1.11

No → Go to step 1.13

1.11 Would Scheduled 7 substances that are to be supplied include any of the following (which is a list of listed-regulated Schedule 7 substances):

Acrylonitrile

Arseinc

Benzene

Benzidine-based azo dyes

Cacodylic acid

Metallic cyanides

1,2-Dibromo-3-chloropropane

4-Dimethylaminoazobenzene

Fluoroacetic acid

Hydrocyanic acid

4-4’-Methylenebis[2-chloroaniline]

Nicotine

2-Nitrotoluene for cosmetic use

Strychnine

Thallium

Vinyl chloride

Yes → Go to step 1.13

No → Go to step 1.12

1.12 Would the Scheduled 7 substances that are to be on supplied only be supplied to individual people, or may it also be supplied to organisations?

If it may be supplied organisations OR individual people

→Go to step 1.13

If it would ONLY be supplied to individual people:

→It is not necessary to hold a licence to lawfully supply a Schedule 7 substance that is not a listed-regulated Schedule 7 substance by retail.

If your organisation does not intend to only supply a Schedule 7 substances that are not a listed-regulated Schedule 7 substance by retail then → Go to step 1.13

If you would like to go back to the main menu, click here

1.13 Would your organisation always direct the supply of the scheduled substances via a third party supplier (and so your organisation would never actually be in physical possession of the substances)?

Yes (my organisation would NEVER be in physical possession)

→ Go to step 1.14

No (my organisation would be in physical possession of the substances always, or at least some times) → Go to step 1.15

1.14 Would the scheduled substances that your organisation intends to direct the supply of include both Schedule 8 substances, and any substances from Schedules 2, 3, 4 or 7?

(For your information, a document sets out substances as they are listed in different schedules is the current Australian Standard of Uniform Scheduling of Medicines and Poisons document, which may be down-loaded from the following web-page, by clicking on the link under the section entitled “Electronic version of the SUSMP” in the lower part of the web-page:

Yes → Go to step 1.67

No (my organisation would only direct the supply of EITHER Schedule 8 substances OR of any substances from Schedules 2, 3, 4 or 7) →

→Go to step 1.64

1.15 Would the scheduled substances that are to be supplied include any Schedule 8 substances?

)

Yes → Go to step 1.16

No → Go to step 1.55

1.16 Would the scheduled substances that are to be supplied also include any substances from Schedules 2, 3, 4 or 7?

Yes → Go to step1.58

No → Go to step 1.61

1.17 Research or industrial permit

You have indicated that scheduled substances may be used by your organisation for some purpose other than health services, and not supplied (aside from for the purposes of waste removal).

Based on your answers, it seems that your organisation may need to apply for an industrial or research permit to use scheduled substance(s).

If you would like to go back to the previous question, please click on the following link - 1.05; otherwise proceed.

Bear in mind that:

▪It is not necessary to hold a licence or permit to lawfully obtain a Schedule 5 substance or a Schedule 6 substance within Victoria.

▪It is not necessary to hold a poisons licence or permit to lawfully obtain a Schedule 7 substance that is not a listed-regulated Schedule 7 substances within Victoria.

So, it would be necessary to hold a licence or permit to lawfully obtain the following when they are Schedule 7 substances:

Acrylonitrile

Arseinc

Benzene

Benzidine-based azo dyes

Cacodylic acid

Metallic cyanides

1,2-Dibromo-3-chloropropane

4-Dimethylaminoazobenzene

Fluoroacetic acid

Hydrocyanic acid

4-4’-Methylenebis[2-chloroaniline]

Nicotine

2-Nitrotoluene for cosmetic use

Strychnine

Thallium

Vinyl chloride

▪It’s possible to obtain small, single-pack quantities of Schedule 2 and Schedule 3 medicines from a registered pharmacist working in an approved pharmacy, and no poisons permit is required to obtain these medicines in such a way.

▪(For your information, a document sets out substances as they are listed in different schedules is the current Australian Standard of Uniform Scheduling of Medicines and Poisons document, which may be down-loaded from the following web-page, by clicking on the link under the section entitled “Electronic version of the SUSMP” in the lower part of the web-page:

)

If you would like to go back to the previous question, please click on the following link - 1.05; otherwise proceed.

To continue applying for an industrial or research permit to use scheduled substance(s), please complete the following steps (and continue to subsequent steps unless directed otherwise):

1.17Download and complete electronically the following form (found in the web-link directly at the bottom of this step), and in doing so, in question 12 on page 2 of the form, select the option “Purchase or Obtain Poisons or Controlled Substances for use for Industrial, Educational, Advisory or Research Purposes”

After completing the form, print out the completed version and then arrange for the printed copy to the signed.

1.18 Download and complete electronically the following form (found in the web-link directly at the bottom of this step) to nominate a responsible person for the permit.

More than one responsible person may be nominated for a permit, but an individual form must be completed for each individual person.

After completing the form(s), print out the completed version and then arrange for the printed copy to the signed.

1.19 Download, complete and then print the following template, bearing in mind that sample answers have been placed after some questions in the plan (so in completing the template, delete any information in the sample answers that do not apply).

1.20 Would the scheduled substances that are to be used include any Schedule 8 or 9 substances?

)

Yes → Go to step 1.21

No → Go to step 1.24

1.21 Ensure that your organisation has a storage facility to allow the lawful storage of Schedule 8 or 9 substances, which complies with Sub-regulation 35(1) of the current Drugs, Poisons and Controlled Substances Regulations.

Most organisations comply with Sub-Regulation 35(1) by storing Schedule 8 or 9 substances in a compliant vault or safe. The walls of a compliant facility are constructed of at least a mild steel plate, with at least 10 mm in thickness. A compliant facility must be securely attached to a wall or floor in such a manner that it will resist attack by hand tools for 30 minutes or power tools for 5 minutes.

(For you information, the current Victorian Drugs, Poisons and Controlled Substances Regulations may be downloaded from the following web-page (from the “Related sites” menu on the lower right hand side of the screen, and clicking on the link stating “Drugs, Poisons and Controlled Substances Regulations 2006”):

)

1.22 Download, complete and then print the following template, bearing in mind that sample answers have been placed after some questions in the plan (so in completing the template, delete any information in the sample answers that do not apply).

1.23 Arrange payment for the application by either:

▪Preparing a cheque made out to the Department of Health;

▪ Including a written request in the blank space at the bottom of the first page of the printed application form for an invoice requesting payment to be sent out.

The fee for such a permit application which includes Schedule 8 or 9 substances (along with other schedules) is stated in the column titled “New Fee”, and in the row titled “Permit 8, 9” in the table found on the second page of the document that can be downloaded from the following link:

Go to step 1.25

1.24 Arrange payment for the application by either:

▪Preparing a cheque made out to the Department of Health;

▪ Including a written request in the blank space at the bottom of the first page of the printed application form for an invoice requesting payment to be sent out.

The fee for such a permit application which does not include any Schedule 8 or 9 substances is stated in the column titled “New Fee”, and in the row titled “Permit 2, 3, 4, 7” in the table found on the second page of the document that can be downloaded from the following link:

Go to step 1.25

1.25 Would the scheduled substances included on the proposed individual permit need to be stored overnight at more than one location that have separate addresses and that are owned or formally rented by your organisation?

Yes → Go to step 1.26

No → Go to step 1.27

1.26 Download, complete and then print the following template, bearing in mind that sample answers have been placed after some questions in the plan (so in completing the template, delete any information in the sample answers that do not apply).