Please resolve the following issues before proceeding
Click on an issue to go directly to the related section of the form.
errors found:
warnings found:
Change fee
Finalised submission date

Basic information

Licence or permit - Change or review form
Fields marked with * are required
How long will this form take to complete?
The length of time it takes to complete this form may vary depending on how complicated your application is. Simple applications may take 5 minutes, and more complicated applications may take 30 minutes or more.
You can save a partially completed application by clicking the link that states “Save For Later” in the top right hand corner of the screen. After saving, you can return to the application at a later time to complete it.

Do you know what type of licence or permit to apply for?

There are three main types of licences or permits that you can apply for: •A permit for health services•A permit for other purposes (such as research or industrial purposes)•A licence to supply by wholesale (and possibly manufacture)
Do you know which of these main three types of licences or permits to apply for?

Select which type of licence/permit to apply for

Does your organisation intend to carry out manufacturing activities with the substances?
What would be considered "manufacturing" activities?

Questions to determine what to apply for

Would individual items containing scheduled substances that your organisation intends to obtain ever need to be opened from their original, individual packaging by your organisation and then used or changed in some way by your organisation?
Would the scheduled items ever need to be administered to a human being by your organisation?
Would your organisation ever need to supply the scheduled substances to persons or organisations external to your organisation (other than for the purposes of waste removal)?

Health service permit confirmation

Based on your answers, it seems that your organisation may need to apply for a health service permit
To proceed to apply for a health service permit, please confirm that you understand the following points:
If you would like to provide general information in free-text regarding what you would like to apply for (in less than 300 characters), you may do so here. This is optional.

Permit for various purposes (including industry and research) - Confirmation

Based on your answers, it seems that your organisation may need to apply for a permit for purposes such as industry, research, education or advice.
To proceed to apply for such a permit please confirm that you understand the following information:
If you would like to provide general information in free-text regarding what you would like to apply for (in less than 300 characters), you may do so here. This is optional.

Licence to supply - Confirmation

Based on your answers, it seems that your organisation may need to apply for a licence to supply scheduled substances.
To proceed to apply for such a licence please confirm that you understand the following information:
Does your organisation intend to store any of the scheduled substances itself on premises that it owns or formally rents? (It is not necessary for a licence holder to store goods that it intends to supply itself if it can arrange for another “third party” licence holder to store the goods on its behalf).
If you would like to provide general information in free-text regarding what you would like to apply for (in less than 300 characters), you may do so here. This is optional.
CHANGES:

Licence / permit identification

What is the eight digit number of the licence / permit that is to be reviewed and/or changed?
(You can find this number, beginning with "2" at the top of the licence/permit document).
(If you would like to make changes to more than one licence / permit, please make a separate application for each individual licence / permit.
Does condition “(d)” on the existing licence state the following?
(d) The holder of this licence must not possess, store or hold the poisons or controlled substances named in the licence. Then either: •The licence holder may only direct sale or supply.Or: •Sale or supply must be by indent only.
Please confirm the following (or change the information provided above):

Name & address currently stated on licence / permit

Provide the name of the organisation that is currently stated on the existing licence / permit document.
Organisation's name
Provide the following details of the address currently stated on the first page of the existing licence / permit document.
Victorian street address
Victorian suburb / town
Victorian post code

What is changing? (if anything)

What would be considered "manufacturing" activities?
If you would like to provide general information in free-text regarding why you are completing this form (in less than 800 characters), you may do so here. This is optional.
Note that if you would like to apply to make a change to any element on the licence/permit document, you must select one of the relevant options above (i.e. you should not simply describe the change in this text-box without selecting one of the options above).

Possible multiple sites

Are there any additional sites listed AFTER the first page, at condition (d) on the existing permit document (and that are to remain on the permit)?

Contact person

What is the name of the main contact person from the organisation for the purpose of this form?
First name
Surname

Email address used for invoicing

Email address for invoicing
(This will be the main email address where the Department will send invoices for payment, yearly renewal notices and any other important correspondence).

Contact details for this form

Main contact phone number
Should the email address that the Department could contact your organisation on in relation to this particular form be the same as the email address provided in the section directly above? (i.e. should it be the same as the email to be used for invoicing?)
Main contact email address for this form
(The email address you provide directly above does not necessarily need to be the same email address that your organisation uses to be sent invoices from the Department for payment and for renewal notices.
However, if you specifically want to change the email address that your organisation uses to be sent invoices for payment and for renewal notices, please select the option of “Email address used for invoicing” on the menu further above.)
Secondary contact phone number
Secondary contact email address

Health service uses

Licence or permit - Change or review form
Fields marked with * are required

What would be the best way to describe the broad type of new or existing health services provided by your organisation (only one option may be selected).

Which new or existing general health services are provided? (Note that both a general practice clinic and a hospital cannot be selected at the same time)

Would your organisation require any substances obtained using the health service permit for any purposes other than for the administration to patients, or supply to patients?
(For example, Schedule 4 substances may be required by your organisation if it were to conduct its own analysis of its patients’ pathology samples)
Would the other purposes that the scheduled substances would be required for ONLY be pathology services provided by your organisation?
Please complete the "Uses" section of this form for only those activities relating to using scheduled substances for any purposes other than for the administration to patients, or the supply to patients, or for pathology services.
Are the other purposes that the scheduled substances would be required for (excluding pathology services) NEW, or are they CHANGING?
Please complete the "Uses" section of this form for only those NEW activities relating to using scheduled substances for any purposes other than for the administration to patients, or the supply to patients, or for pathology services.

Day surgery (not part of a hospital)

What new or existing day surgery service(s) would be provided?
(More than one may be selected, but do not select any that would not actually be provided.)

What new or existing specialised service(s) would be provided?
(More than one may be selected)

Confirm that your organisation either:
Enter the non-emergency patient transport licence held by your organisation
/

Over-night patient accommodation beds for patients

Would your organisation provide over-night patient accommodation beds for patients?
How many over-night patient accommodation beds would your organisation provide? (If your organisation is to use multiple sites with this single permit, then indicate the number of beds on the site that has the highest number of beds)

Substance change(s)

Licence or permit - Change or review form
Fields marked with * are required

Substance change options

What substance change(s) are to be made? (More than one option may be selected if necessary)

Standard medicines for specialised health services

You have indicated that the health services provided would include vaccination services.
Ordinarily, the scheduled medicines required for vaccination services would include vaccines approved to be used by nurse immunisers, as well as adrenaline necessary for the treatment of anaphylactic reactions.
Vaccines approved to be used by nurse immunisers include that for influenza, as well as those for diphtheria, haemophilus influenzae type b, hepatitis A, hepatitis B, human papillomavirus, measles, meningococcus, mumps, pertussis, polio, rotavirus, rubella, streptococcus pneumoniae, tetanus and varicella.
You have indicated that the health services provided would include cosmetic medical services.
Ordinarily, the scheduled items required for cosmetic medical services would include botulinum toxins, and hyaluronic acid and its polymers, as well as adrenaline necessary for the treatment of anaphylactic reactions.
You have indicated that the health services provided would include non-emergency patient transport services. Ordinarily, the scheduled medicines required for non-emergency patient transport services would include •The Schedule 4 medicines methoxyflurane and salbutamol•The Schedule 3 medicines glucagon, glyceryl trinitrate and salbutamol•The Schedule 2 medicine aspirin
Would the medicines indicated above be the ones to be included on the permit?
What medicines would be required to be part of the permit?
If your organisation intends to obtain any schedule 4 medicines that are in addition to those mentioned above, the following health professionals cannot lawfully initiate the administration of any of those additional schedule 4 medicines:
Nurse immunisers
Ambulance transport attendants or ambulance officers working under a non-emergency patient transport (NEPT) licence
Only another authorised practitioner, such as a medical practitioner, may initiate the administration of the additional schedule 4 medicines.
Please complete the next main section below (entitled “Select substance(s)”) to select the substances to be included on the health service permit that are in addition to those mentioned above.
If your organisation intends to obtain any schedule 4 medicines that are in addition to those mentioned above, the following health professionals cannot lawfully initiate the administration of any of those additional schedule 4 medicines:
Nurse immunisers
Ambulance transport attendants or ambulance officers working under a non-emergency patient transport (NEPT) licence
Only another authorised practitioner, such as a medical practitioner, may initiate the administration of the additional schedule 4 medicines.
Please complete the next main section below (entitled “Select substance(s)”) to select the substances to be included on the health service permit that are in addition to those mentioned above.
Select which limited selection of scheduled medicines from those mentioned above would be required to be part of the health service permit:

ADDING new substance(s) options

Should new individual substances or new groups of substances be added to the licence/permit (or both)?

Add individual substances

Select which individual substances should be added.
The highest schedule that the substance belongs to will be stated next to the substance name.
Substance
Schedule
Schedule 2 Schedule 3 Schedule 4 Schedule 4 Schedule 4 drug of dependence Schedule 7 Schedule 7 - listed-regulated Schedule 8 Schedule 9
What would the cyanide be used for?
What if I only want to obtain a substance in a very low concentration?
The total holding quantity for individual Schedule 8 or 9 substances selected above, in milligrams, is:

Add whole groups of substances

Select which whole groups of substances are to be included on the licence/permit
What are Schedule 2 substances?
What are Schedule 3 substances?
Should the licence/permit inlcude Schedule 3 pseudoephedrine (ie: a drug of dependence within Schedule 3)
What are Schedule 4 substances?
Should the Schedule 4 substances include all drugs of dependence?
.
What are drugs of dependence in Schedule 4?
What are Schedule 7 substances?
Should the Schedule 7 substances include listed-regulated Schedule 7 substances?
.
What are lsted-regulated Schedule 7 substances?
What are Schedule 8 substances?
What are Schedule 9 substances?
What should the maximum holding quantity of all Schedule 8 or 9 substances be? (in milligrams)
What about Schedule 9 substances?
What about substances within Schedules 5, 6 or 10?

Confirm drug(s) of dependence addition

You have selected one or more drugs of dependence. These may include some Schedule 4 substances, all Schedule 8 substances and all Schedule 9 substances. Drugs of dependence carry risks for possible theft, illicit use and can cause significant harm and possibly death in people when mis-used. Your organisation should carry out due diligence on any staff member that it intends to allow access to any drug of dependence. Due diligence would ensure that the person: •Has not committed a drug related crime;•Does not have a drug dependency or has not used recreational drugs; and•Has the knowledge or practical skills necessary for the safe, secure and responsible handling of the substances.
Does your organisation want to proceed to include drugs of dependence with the application?
What would “due diligence” include?
To proceed to remove drugs of dependence from this application, un-select from your selections above any of the following substances that are marked as: •Any Schedle 4 drugs of dependence•Any Schedule 8 substances•Any Schedule 9 substances•Schedule 3 pseudoephedrine

Other agency requirements

You have indicated that substances(s) related to cannabis are to be included with the application. These substances may include cannabidiol, dronabinol, nabiximols, synthetic cannabinomimetics, tetrahydrocannabinol or cannabis itself.
Would your organisation ever need to obtain any substances related to cannabis in the foreseeable future? (Such substances may include cannabidiol, dronabinol, nabiximols, synthetic cannabinomimetics, tetrahydrocannabinol or cannabis itself.)
Would your organisation ever need to obtain the Schedule 4 substance cannabidiol in the foreseeable future? (Cannabidiol is related to cannabis.)
Would your organisation conduct any manufacturing activites on substances related to cannabis? (or would it even conduct any cultivation activities for cannabis?)
If your organisation would like to conduct any manufacturing activities on any substances related to cannabis (or even to cultivate cannabis), your organisation may need to apply for a separate licence from the Commonwealth Office of Drug Control. Please contact the Office of Drug Control to ask whether or not your organisation would need such a separate licence by phone (02) 6232 8740. (You can also visit the relevant website: https://www.odc.gov.au/).
Would your organisation conduct any research on substances related to cannabis (which could include activities such as the separation of cannabis and cannabis resin)?
If your organisation would like to conduct any research on substances related to cannabis (which could include activities such as the separation of cannabis and cannabis resin), then your organisation may need to apply for separate authorisation to conduct such research from the Commonwealth Office of Drug Control. Please contact the Office of Drug Control to ask whether or not your organisation would need such separate authorisation by phone (02) 6232 8740. (You can also visit the relevant website: https://www.odc.gov.au/).
Would your organisation ever import any substances related to cannabis from outside Australia?
To import substances related to cannabis from outside Australia, your organisation may need to apply for a separate import licence. Further information regarding an import licence should be obtained from the Commonwealth Office of Drug Control (Ph: (02) 6232 8740).
Please send an email to the Victorian Department of Health and Human Services (via medicinal.cannabis@dhhs.vic.gov.au), and in the email provide: •Identifying information for your organisation including:- Your organisation’s name, - Your organisation’s Victorian address- The tracking code associated with the application (found in the top right hand corner of this screen)•Answers to the following questions regarding the products containing substances related to cannabis that your organisation intends to import from outside Australia:1. What are the details of the types of products that would be imported? 2. Where and from whom would the products be imported? 3. What would be the volumes to be imported? 4. What would be the distribution channels?•A scanned copy of a current Commonwealth licence issued to your organisation to import substances related to cannabis, or provide advice that your organisation is in the process of applying for such a licence (if, after contacting the Commonwealth Office of Drug Control, your organisation has been advised that it requires such a licence).
Please send an email to the Victorian Department of Health and Human Services (via medicinal.cannabis@dhhs.vic.gov.au), and in the email provide: •Identifying information for your organisation including:- Your organisation’s name, - Your organisation’s Victorian address- The tracking code associated with the application (found in the top right hand corner of this screen)•Answers to the following questions regarding the products containing substances related to cannabis that your organisation intends to import from outside Australia:1. What are the details of the types of products that would be imported? 2. Where and from whom would the products be imported? 3. What would be the volumes to be imported?•A scanned copy of a current Commonwealth licence issued to your organisation to import substances related to cannabis, or provide advice that your organisation is in the process of applying for such a licence (if, after contacting the Commonwealth Office of Drug Control, your organisation has been advised that it requires such a licence).
Please be aware that your organisation may be contacted by the Victorian Office of Medicinal Cannabis in the future to provide your organisation’s transaction records involving any substances related to cannabis. For further information on what transactions always need to be recorded, and what details must be retained in records, refer to the main section that will appear later on in this form entitled “Records”.

Possible independent security assessment

Would your organisation ever need to store more than a total holding quantity of 2 grams of all Schedule 9 substance(s)?
Would your organisation ever need to store more than a total holding quantity of 10 grams of all Schedule 8 substance(s)? (10 grams of pure Schedule 8 oxycodone would equate to 100 packs of oxycodone 5mg (Endone®) tablets, where each pack contained 20 tablets)
As the quantity exceeds the limit above, your organisation would need a security assessment report for the storage premises from an independent security advisor. If your organisation already holds such an assessment that is relevant to the current premises, it may not be necessary to obtain a new assessment. The report must: •Specifically provide an assessment as to whether the immediate storage facility to be used to store Schedule 8 or 9 substances provides at least as much equivalent security as that which is indicated in Regulation 74 from the Victorian Drugs, Poisons and Controlled Substances Regulations.•Provide a judgement regarding whether or not the overall premises would be suitable for the handling and storage of Schedule 8 or 9 substances.Your organisation will need to provide the Department with a copy of the report. If it wishes to, your organisation may source its own independent security advisor, but it must be confirmed the the advisor: •Is independent of the organisation that holds the licence;•Has experience in reviewing the security of premises to be used for storing pharmaceuticals (such as those of pharmacies, hospitals or pharmaceutical wholesalers); and•Is registered as a security advisor with Victoria Police. (For more information about Victoria Police registrations, see this webpage: https://www.police.vic.gov.au/register-licence-registration-and-permit-holders
The Department also has a list of security advisors that have been used in the past.
Confirm that your organisation:
Please arrange to have a copy of the report passed on to a Departmental officer when one visits the premises of your organisation as part of the licence application process.
Once it is ready, a copy of the report will need to be provided to tbe Department as part of the application process.

REMOVING substance(s) options

Should individual substances or groups of substances be removed from the licence/permit (or both)?

Remove individual substances

Select which individual substances should be removed.
The highest schedule that the substance belongs to will be stated next to the substance name.
Substance
Schedule
Schedule 2 Schedule 3 Schedule 4 Schedule 4 Schedule 4 drug of dependence Schedule 7 Schedule 7 - listed-regulated Schedule 8 Schedule 9
What would the cyanide be used for?

Remove whole groups of substances

Select which whole groups of substances are to be removed from the licence/permit
What are Schedule 2 substances?
What are Schedule 3 substances?
Within Schedule 3, should only pseudoephedrine be removed from the licence/permit? (Pseudoephedrine is a drug of dependence within Schedule 3)
What are Schedule 4 substances?
Within Schedule 4, should only drugs of dependence be removed from the licence/permit?
.
What are drugs of dependence in Schedule 4?
What are Schedule 7 substances?
Within Schedule 7, should only listed-regulated Schedule 7 substances be removed from the licence/permit?
.
What are lsted-regulated Schedule 7 substances?
What are Schedule 8 substances?
What are Schedule 9 substances?

Change QUANTITIES of Schedule 8 or 9 substances

What should change?
What should the NEW maximum holding quantity of all Schedule 8 or 9 substances be? (in milligrams)

Change QUANTITY of INDIVIDUAL Schedule 8 or 9 substance(s)

Select which existing indiviual Schedule 8 or 9 substance(s) should have their maximum holding quantity changed, then enter the NEW maximum holding quantity for that substance.
The highest schedule that the substance belongs to will be stated next to the substance name.
Substance
Schedule
Schedule 2 Schedule 3 Schedule 4 Schedule 4 Schedule 4 drug of dependence Schedule 7 Schedule 7 - listed-regulated Schedule 8 Schedule 9
What would the cyanide be used for?
What if I only want to obtain a substance in a very low concentration?
The total holding quantity for individual Schedule 8 or 9 substances selected above, in milligrams, is:

Reason for change

Briefly describe why the new substance(s) are required when they have not been needed in the past.
For example, if the change(s) are required for a new research trial, please provide a summary of the purpose of the trial.
(Describe in less than 600 characters).
Briefly describe why the existing quantit(ies) are required to be changed.
For example, if the change(s) are required for a new research trial, please provide a summary of the purpose of the trial.
(Describe in less than 600 characters).
Briefly describe why the new substance(s) are required when they have not been needed in the past, and why the existing quantit(ies) are required to be changed.
For example, if the change(s) are required for a new research trial, please provide a summary of the purpose of the trial.
(Describe in less than 600 characters).
Please also explain why it has been requested that all Schedule 9 substances be added. Schedule 9 substances are substances that have a very high risk for abuse and misuse, so their possession is prohibited by law except when required for legitimate research or analytical purposes. Therefore, most organisations specify individual Schedule 9 substances to be added, and it is very unusual for an organisation to request that all Schedule 9 substances be added.

Uses in research / industry

Licence or permit - Change or review form
Fields marked with * are required
Use have indicated in the "Health service uses" section that substances obtained using the permit may be used for purposes other than for the administration to patients, or the supply to patients, or for pathology services; and you have indicated that these uses are either NEW, or they are CHANGING.
So please complete this section ONLY for the the use of scheduled substances that DO NOT involve administration to patients, or supply to patients, or pathology services.
Use have indicated in the "Manufacturing" section that substances obtained using the licence may be used for laboratory purposes; and you have indicated that these purposes are either NEW or they are CHANGING.
So please complete this section ONLY for the the laboratory use of scheduled substances obtained using the icence.

Tasks

What NEW task(s) would substances be used for?
(other than for administration or supply to patients, or for pathology purposes).
What task(s) would the NEW substance(s) be used for?
Would the administration of scheduled substances to animals ALWAYS be carried out by a registered veterinary practitioner, or under the personal supervision of a registered veterinary practitioner?
Would the purpose of all the task(s) that the substance(s) would be used for be for the health services of animals?
To conduct any such administration of substances to animals and/or to conduct any euthenisation of research animals (before or after such administration), your organisation would need to hold either a: •a Scientific Procedures Premise Licenceor•a Scientific Procedures Fieldwork LicenceThese licences are issued by the Agriculture portfolio of the Department of Jobs, Precincts and Regions. Confirm that your organisation either:
Would the scheduled substances obtained using the permit ever need to be administered to a live human being by your organisation?
What does “administer” mean?
Would scheduled substances ever need to be supplied to any person by your organisation for the purpose of that human being to later consume the substance (ie: to later swallow, inject or apply to his/her body)?
Would the substances obtained via the poisons permit ONLY be used to administer/supply to people (for the purpose of those people to consume the substances)?
Would a Schedule 8 or 9 substance be administered to any person? Or would a Schedule 8 or 9 substance be supplied to any person for the purpose of that person to later consume?

Overall purpose

Select the best description of the general purpose of all the task(s) that the new substance(s) would be used for from the following options:

Name or ownership

Licence or permit - Change or review form
Fields marked with * are required

Name or ownership change options

What should change?
Note that: •The "trading name" may include the name of a specific area of the organisation that uses the licence / permit);•If the Australian Company Number (ACN) or the Australian Business Number (ABN) is to change, then you must select to change the legal entity.

Legal entity

Does the NEW owner hold either an Australian Company Number (ACN) and/or an Australian Business Number (ABN)?
Select that the NEW owner has an ACN and/or an ABN, and then enter the corresponding numbers for the organisation
Enter the name(s) of the director(s) of the organisation
First name
Surname
Has the NEW owner been found guilty of any indictable offence in the past ten years?
Please indicate the details of the indictable offence(s)
Date(s)
Offence(s)
Court(s)
Penalty(ies)

Trading name / Specific area of organisation

Would the NEW organisation also use a trading name that is different to the legal name entered above OR would the licence/permit only be used by one specific area of the new organisation?

Possible staff, procedures or facilities changes

With the change, would there be any significant changes to any of the following: •Staff that are involved in any activites relating to scheduled substances?•Procedures followed by any such staff?•Facilities or equipment used by such staff in these activities?

Address

Licence or permit - Change or review form
Fields marked with * are required
Applicant details (name of this section for new apps) (And it become visible only after a type of licence/permit was selected)

Organisation's identifying details

Does the organisation also use a trading name that is different to the legal name entered above OR would the licence/permit only be used by one specific area of the organisation?
Does the organisation hold either an Australian Company Number (ACN) or an Australian Business Number (ABN)?
Select that the organisation has an ACN and/or an ABN, and then enter the corresponding numbers for the organisation
Enter the name(s) of the director(s) of the organisation
First name
Surname

Legal history of the applicant

Has the applicant been found guilty of any indictable offence in the past ten years?
Please indicate the details of the indictable offence(s)
Date(s)
Offence(s)
Court(s)
Penalty(ies)

Person completing form

What is your name? (ie: the person completing this form)
First name
Surname

Contact details

Main contact phone number
Main contact email address
Secondary contact phone number
Secondary contact email address
CHANGES:

Address change options

What address(es) should change?

Possible additional site(s) change(s)

Is it intended that scheduled substances may be stored over-night at more than one Victorian location that have separate addresses, and that are owned, or formally rented by the organisation?
Would the physical site address change(s) apply to only the principle site listed on the permit, or could the change(s) apply to additional site(s) associated with the permit? (There will always be one site address listed on the first page of any permit, and if there are additional sites that are part of the same permit (also used to store scheduled substances), the additional sites address(es) will be listed on the second, or subsequent page(s) of the permit document).
What would the site address change(s) apply to?
Note that, like the principle site, any additional site must be: •A site where the licence / permit holder may store scheduled substances (for example stored over-night) and•A site that is owned or formally rented by the licence / permit holder (so the licence / permit holder would have control over the security of the site).
Can scheduled substances be stored over-night at a location that is not owned or is not formally rented by the organisation that would hold the licence/permit?

Address change

Provide the following details for the NEW Victorian address of the premises where scheduled substances may be stored, and which would be owned or formally rented by the licence / permit holder:
Provide the following details for the NEW Victorian address of the PRIMARY premises where scheduled substances may be stored, and which would be owned or formally rented by the licence / permit holder:
Provide the following details for the NEW street address of the organisation’s location in Victoria (ie: not where scheduled substances are stored)
Victorian street address
Victorian suburb / town
Victorian post code
Can scheduled substances be stored over-night at a location that is not owned or is not formally rented by the organisation that would hold the licence/permit?
Can the address be a residential premises?
Would any part of the premises at the location specified above occupied and utilised by any organisation(s) other than the licence / permit holder?
Would more than 75% of the premises at the location specified above occupied and utilised by the licence / permit holder?

Possible independent security assessment

Would your organisation ever need to store more than a total holding quantity of 2 grams of all Schedule 9 substance(s)?
Would your organisation ever need to store more than a total holding quantity of 10 grams of all Schedule 8 substance(s)? (10 grams of pure Schedule 8 oxycodone would equate to 100 packs of oxycodone 5mg (Endone®) tablets, where each pack contained 20 tablets)
As the quantity exceeds the limit above, your organisation would need a security assessment report for the proposed storage premises from an independent security advisor. If your organisation already holds such an assessment that is relevant to the current premises, it may not be necessary to obtain a new assessment. The report would need to provide a judgement regarding whether or not the premises would be suitable for the storage of Schedule 8 or 9 substances. Your organisation will need to provide the Department with a copy of the report. If it wishes to, your organisation may source its own independent security advisor, but it must be confirmed the the advisor: •Is independent of the organisation that holds the licence;•Has experiencing in reviewing the security of premises to be used for storing pharmaceuticals (such as those of pharmacies, hospitals or pharmaceutical wholesalers); and•Is registered as a security advisor with Victoria Police. (For more information about Victoria Police regiistrations, see this webpage: http://www.police.vic.gov.au/content.asp?Document_ID=37739
The Department also has a list of security advisors that have been used in the past.
Confirm that your organisation:
Please arrange to have a copy of the report passed on to a Departmental officer when one visits the premises of your organisation as part of the licence application process.
Once it is ready, a copy of the report will need to be provided to tbe Department as part of the application process.

Postal address change

Would the NEW postal address for the organisation be different to the NEW address of the physical premises?
Would the NEW postal address for the organisation be different to the NEW address of the PRINCIPLE site?
Provide the following details for the NEW postal address:
Street address
Suburb / Town
Post Code

Additional sites

Licence or permit - Change or review form
Fields marked with * are required

Additional site change options

In the section to make changes to the “Address”, you have indicated that changes are to be made to sites that are additional to the principle site.
If this is not the case, please go back to that section to change that answer.
What additional site change(s) are to be made? (Both options may be selected if necessary)

ADDING new site(s)

For the question in the table directly below this text, answer the following question - Would any part of the premises at the additional location be occupied and utilised by any organisation(s) other than the permit holder? (ie: "Are there other organisations at this site?")

New site

Are there other organisations at this site?
Would more than 75% of the premises at this location be occupied and utilised by the permit holder?

Additional site(s) compliance

Also note that a standard condition on a permit that includes additional sites is that scheduled substances will only be purchased at the primary premises.

REMOVING existing site(s)

Site to be removed

Responsible person

Licence or permit - Change or review form
Fields marked with * are required
What is a responsible person listed on a licence/permit?

Responsible person change options

What responsible person change(s) are to be made?

New Responsible Person

Qualification(s)

Enter at least one of the following for the NEW responsible person applicant:
Enter the registration number with AHPRA (the Australian Health Practitioner Regulation Agency) for a medical practitioner, or a nurse, or pharmacist, or a dental practitioner, or a podiatrist, or an optometrist, or a midwife.
Enter the four digit Veterinary Practitioners Board of Victoria registration number of one of the organisaion's veterinary practitioners.
Enter the following details of the qualification (If more than one relevant qualification is held, enter what you believe to be the most relevant)
Name of the qualification (for example, Bachelor of Science etc)
Name of the institution that provided the qualification
Is there any other appropriate person within the organisation with relevant qualifications so that he/she could be nominated as a new responsible person?
Please indicate what relevant experience the person has had in the preceding twelve years. The experience does not need to cover the entire twelve years, but at least five of the years from the twelve year period should include such experience. The five years do not need to be consecutive.
Year beginning role
No yr(s) in role
Place of employment
Role
Tasks (which included the handling and recording of scheduled substances)
blank bbbbbbbbb
Total number of years of experience

Name

Enter the following details for the NEW responsible person applicant (the new applicant relating to the qualification(s) that you have entered directly above).
First name
Middle name (not required if none)
Surname
Current role within the organisation

Legal history

Does this responsible person applicant declare to have been found guilty of any indictable offence in the past ten years?
Please indicate the details of the indictable offence(s)
Date(s)
Offence(s)
Court(s)
Penalty(ies)

Possible replacement of existing person(s)

Please select if the new person is:
Enter the name(s) of the existing responsible person(s) to be replaced.
First name
Surname
i. . (You can find the name(s) of the existing responsible person(s) listed on the first page of the
.....licence/permit document.)

Signature of this responsible person applicant

Will this responsible person applicant also be the same person that signs this entire form prior to submission (in a later section of this form)?
This responsible person applicant must sign below to declare that the information that has been supplied above on this form about him/her is true and correct in every particular and that this declaration is made in the knowledge that a person making a false declaration is liable to prosecution under Section 49 of the Drugs, Poisons and Controlled Substances Act 1981.
Please sign electronically here
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Removing responsible person(s)

Enter the name(s) of the existing responsible person(s) to be removed.
First name
Surname
i. . (You can find the name(s) of the existing responsible person(s) listed on the first page of the
.....licence/permit document.)
Provide the name of at least one existing responsible person that is to remain listed on the licence/permit.
First name
Surname

Existing substances

Licence or permit - Change or review form
Fields marked with * are required

What substances are currently listed?

Select which existing schedules of substances are currently included on licence(s) / permit used by the organisation, and which you would like to continue being part of the licence(s) / permit. (More than one may be selected)
What are Schedule 2 substances?
What are Schedule 3 substances?
Should the licence/permit inlcude Schedule 3 pseudoephedrine (ie: a drug of dependence within Schedule 3)
What are Schedule 4 substances?
Are there any limitations on the range of existing Schedule 4 substances included on the licence/permit?
.
What are drugs of dependence in Schedule 4?
What are Schedule 7 substances?
Are there any limitations on the range of Schedule 7 substances included on the licence?
.
Do the Schedule 7 substances listed on the licence include any of the following: •arsenic, •benzene, •cyanides (metallic), Or any of the following: •acrylonitrile, cacohylic acid, sytrchnine, thallium, vinyl chloride, fluoroacetic acid (concentrated form);Or any of the following: •benzidine-based azo dyes (or any dyes that could release carcinogenic amines), dibromo-3-chloropropane, 4-dimehtylaminoazobenzene, fluoroacetamide, hydrocyanic acid, 4,4’-methylenebis (2-chloroaniline) or nicotine for human use.(Note that these are all Schedule 7 substances that cannot be sold by retail, or “listed-regulated Schedule 7 substances”)
Aside from any of the substances listed above (in the question directly above), are any other additional Schedule 7 substances listed on the licence?
What are lsted-regulated Schedule 7 substances?
What are Schedule 8 substances?
What are Schedule 9 substances?
What should the maximum holding quantity of all Schedule 8 or 9 substances be? (in milligrams)

Confirm drug(s) of dependence inclusion

You have indicated that one or more drugs of dependence are currently included on the licence / permit. These may include some Schedule 4 substances, all Schedule 8 substances and all Schedule 9 substances. Drugs of dependence carry risks for possible theft, illicit use and can cause significant harm and possibly death in people when mis-used. Your organisation should carry out due diligence on any staff member that it intends to allow access to any drug of dependence. Due diligence would ensure that the person: •Has not committed a drug related crime;•Does not have a drug dependency or has not used recreational drugs; and•Has the knowledge or practical skills necessary for the safe, secure and responsible handling of the substances.
Does your organisation want to continue to include all the drugs of dependence that have been part of its licence / permit?
What would “due diligence” include?
To proceed to remove specific existing drugs of dependence from the licence / permit, please nominate the drugs to be removed by the followoing: •1. Select that "Substances" are to be changed in the main menu of this form;•2. in the "Substance change(s)" section, select to "remove substance(s) from the licence/permit", then complete the subsequent section for removing specific substanes.

COMPLIANCE VERIFICATION sections of this form

Licence or permit - Change or review form
Fields marked with * are required
All of the remaining sections of this form constitutes your organisation's licence/permit compliance verification.

Manufacturing

Licence or permit - Change or review form
Fields marked with * are required
You have indicated in the "Basic Information" section that your organisation is applying for a supply licence which includes manufacturing activities.
You have indicated in the "Basic Information" section that individual items containing scheduled substances that your organisation intends to obtain may need to be opened from their original, individual packaging by your organisation, and may also then need to be supplied to persons or organisations external to your organisation (other than for the purposes of waste removal).
Such activities would be considered to be manufacturing (ie: changing items, even if it’s simply removing them from original packaging prior to on-supply to external people/organisations).
If your organisation intends to cultivate (grow) a plant that would produce a narcotic, your organisation would need to apply for a cultivation authority to do so lawfully (separate to this application).
If so: •For poppies (to produce opioids), please email alkaloid.poppies@ecodev.vic.gov.au; or call: 136 186.•For cannabis, please call (02) 6232 8433.

Extent of manufacturing

What extent of manufacturing would be conducted?

Human / animal products

Would your organisation produce any products intended to be administered to a person or an animal by an end-user?
What does “administer” mean?
Scheduled products that are administered to people or animals are normally known as therapeutic goods.
Would the products be intended for people or animals? (or could some be intended for people, and some for animals?) (more than one may be selected)
Human therapeutic products should only be produced on premises that have been issued with a licence from the Australian Therapeutic Goods Administration (TGA) for the manufacture of those products.
Confirm that your organisation either:
Enter the TGA manufacturing licence number for the premises
MI -
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Would any of the products containing scheduled substances that your organisation produces, which are intended to be used for animals be mixed in stockfeed by your organisation prior to being supplied to any customers?
Would any of the animal products that your organisation produces (which are not mixed in stockfeed) be intended for therapeutic purposes in animals?
Would any of the animal products that your organisation produces be intended for therapeutic purposes in animals?
Therapeutic veterinary products not mixed in stockfeed must be registered with the Australian Pesticides and Veterinary Medicines Authority (APVMA).
Indicate if the therapeutic veterinary products that your organisation intends to produce:
Additionally, many therapeutic veterinary products should only be produced on premises that have been issued with a licence from the Australian Pesticides and Veterinary Medicines Authority (APVMA) for the manufacture of those products. Some therapeutic veterinary products that are listed, reserved or exempt by the APVMA may not need to be produced on premises with an APVMA manufacturing licence.
Confirm one of the following:

Agricultural products

Would your organisation produce any agricultural products in Schedules 2, 3, 4, 7, 8 or 9?
(Most agricultural products would be in Schedules 5, 6 or 7, or would be unscheduled - as Victorian poisons licences do not include Schedule 5 or 6 substances, it would be most likely that only licence applications that include Schedule 7 substances could include agricultural products).
Some agricultural products may need to be registered with the Australian Pesticides and Veterinary Medicines Authority (APVMA).
Click the buton above (saying "What is an 'agricultural product?") to refer to the APVMA web-site for more information on whether your agricultural product(s) need to be registered with the APVMA. Indicate if there are any agricultural products that your organisation intends to produce which require APVMA registration:

Other products

Would your organisation produce any products to be included on the licence other than those described above (ie: any products that are not human / animal products, and which are not agricultural products)?

Quality manufacturing systems

Laboratory activities

Would your organisation carry out laboratory activities using the scheduled substances it obtains using the licence (for example, for quality control procedures)? (Note: If your organisation would only obtain substances for laboratory activities using a separate poisons permit (not a poisons licence), then the answer to this question should be “no”)
Please complete the "Uses" section of this form for ONLY those laboratory activities that use scheduled substances obtained using the licence
Would the laboratory activities be NEW or are they CHANGING?
Please complete the "Uses" section of this form for ONLY those laboratory activities that use scheduled substances obtained using the licence

Health practitioner activities

Licence or permit - Change or review form
Fields marked with * are required

Health practitioner basics for using Schedule 2, 3, 4 & 8 medicines

You have indicated in the "Uses" section of this form that scheduled substances may be administered to people (or supplied to a person for the purpose of that person to later consume).
The administration of scheduled substances to people or the supply of such substances for people to consume may only be lawfully carried out by certain registered health practitioners.
In these cases, scheduled substances would be referred to as medicines.
What does “administer” and “supply” mean in the context of medicines, and how are they different?
Confirm that your organisation understands the following points:
What is an “un-dispensed” schedule 4 or 8 medicine?

Health practitioner(s) initiating administration or supply of Schedule 4 or 8s

In many organisations, only medical practitioners authorise the administration or make a decision to supply Schedule 4 or 8 medicines. However, in some organisations, other types of health practitioners may do so. Would the only health practitioners that authorise the administration or make a decision to supply Schedule 4 or 8 medicines in your organisation be medical practitioners?
Select from the list below which types of health practitioners may authorise the administration or make a decision to supply Schedule 4 or 8 medicines used at your organisastion. (More than one type of health practitioner may be selected, but do no select any that would not actually make these decisions at your health service). After you select a health practitioner, please also confirm that the other information that will appear is understood via clicking on the button in the column marked as "Confirm understanding". The other information relates to limitations on the medicines that may lawfully be involved.
x
Administration? (Can initiate some Schedule 4 or 8 administration?)
x
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Supply? (Can initiate some Schedule 4 or 8 supply?)
x┌Select from here
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│
┌Confirm understanding
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Practitioner type
A
S
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Medicines involved:
Authority
Medical practitioner √ √
Any within their scope of practice Section 13 of the DPCS Act Medical practitioners are registered with AHPRA
Nurse without an endorsement below X X
What is a “nurse”? And what if it’s an enrolled nurse?
Nurse immuniser √ X
Secretarial approval. Nurses are registered with AHPRA
Nurse with compliant advanced life support training √ X
Secretarial approval. Nurses are registered with AHPRA
Nurse practitioner √ √
Any within their scope of practice Ministerial approval. Nurses are registered with AHPRA
Nurse working under the rural and isolated practice framework √ √
Ministerial approval. Nurses are registered with AHPRA
Nurse that may work in accordance with a standing order policy √ X
Individual health service policy. Individual health service policy.
Midwife without an endorsement √ X
Secretarial approval. Midwives are registered with AHPRA
Endorsed midwife √ √
Ministerial approval. Midwives are registered with AHPRA
Personal care assistant X X
What is an “un-dispensed” schedule 4 or 8 medicine?
Pharmacist Pharmacist without an endorsement X X
Pharmacist with immuniser endorsement, working for a hospital √ X
Secretarial approval. Pharmacists are registered with AHPRA
Dental practitioner √ √
Any within their scope of practice Section 13 of the DPCS Act Dental practitioners are registered with AHPRA
Veterinary practitioner √ √
Any within their scope of practice Section 13 of the DPCS Act Registered with the Veterinary Practitioners Board of Victoria
Podiatrist without an endorsement √ X
Products containing 2% or less of either lignocaine or prilocaine Regulation 7(1)(16) Podiatrists are registered with AHPRA
Endorsed podiatrist √ √
Ministerial approval. Podiatrists are registered with AHPRA
Optometrist without an endorsement √ X
Eye preparations containing tropicamide, cyclopentolate, pilocarpine, physostigmine or synthetic cocaine Regulation 7(1)(15) Optometrists are registered with AHPRA
Endorsed optometrist √ √
Ministerial approval. Optometrsits are registered with AHPRA
Orthoptist √ X
Local anaesthetics (such as lignocaine, amethocaine, oxybuprocaine and proxymetacaine) and/or cycloplegics (such as atropine, cyclopentolate, homatropine and tropicamide) in topical ophthalmic preparations. Regulation 7(1)(22) Orthoptists are registered with the Orthoptists Board of Australia
Dental hygienist, dental therapist or oral health therapist √ X
Any of the following required for dental care: adrenaline, articaine, felypressin, lignocaine, mepivacaine, prilocaine, therapeutic mercury or demeclocycline and triamcinolone (in combination for topical use) Regulation 7(1)(21). Dental hygienist, dental therapist and oral health therapist are registered with the Dental Board of Australia
Nurse, ambulance officer or ambulance transport attendant working under a non-emergency patient transport (NEPT) licence √ X
Regulation 7(1)(24) NEPT Regulations and Clinical Practice Protocols. NEPT providers (and their staff) are registered by the Private Hospitals, DHHS
Types of persons allowed to administer a Covid-19 vaccine √ X
Victorian Government endorsement
Aboriginal and Torres Strait Islander health practitioner √ X
Victorian Government endorsement
What if I believe a health practitioner type has authorisation to administer/supply but has not been included in the list above?
Your hospital has conditions for standing orders on its health service permit.
Some health services find that they no longer utilise standing orders, so may wish to remove them from their permit.
Does your hospital intend to continue with a policy for standing orders?
•The hospital should have a committee (such as a “Drugs and Therapeutics Committee") to consider its medicine use policies, which includes a chairperson.•The hospital should document:A. Establishment and membership of the committee (including the terms and conditions of appointment, resignations, removals and other vacancies)B. Quorum and proceedingsC. Co-opted membersD. Sub-committeesE. Functions of the Committee•The hospital should have criteria to be considered before a proposed standing order may be approved by the committee (which includes the need and the outcome expected, as well as clinical evidence).•The committee should define the qualifications and credentials required by a nurse who is to be authorised to implement a standing order. Education should also be provided to relevant new and existing nursing staff.•Action should be taken to ensure that nurses that are not suitably authorised do not carry out standing orders (for example, a list of authorised nurses will be maintained).•Standing orders should only be implemented in designated areas of the hospital.•All medical officers at your hospital should be informed that their patients may be subjected to standing orders (and it would be advisable that they confirm that they understand this in writing)•If medical practitioner wishes for particular patients to be excluded from being subjected to standing orders, those patients should be clearly identified.•Standing orders should be validated (for example, by being signed by the Director of Nursing and the Director of Medical Services)•Updated versions of standing orders should be given a new version number (which may also include an expiry date)•Any variations from earlier versions of standing orders should be clearly identified in new versions, and unauthorised alterations to standing orders should be prevented.•A senior staff member should be responsible for the ongoing management of standing orders.•If a standing order is carried out on a patient, precise details of the administration should be recorded.•Copies of records for standing orders that have been carried out on patients should be collated and reviewed each month by a clinical quality committee.
You have indicated in the list above that nurse(s) working under the rural and isolated practice framework may initiate administration of, or may supply scheduled medicines in your health service.
Note that while such nurses may supply to their individual patients, they do not have the lawful authority to prescribe medicines.
Please either confirm the following, or un-select the option above for nurse(s) working under the rural and isolated practice framework.

No other persons can initiate administration or supply of Schedule 4 or 8s

Supplying Schedule 4 or 8s

You have selected health practitioner(s) that have the lawful ability to supply Schedule 4 or 8 medicines to patients. Is it intended that such supply to patients will take place?
In addition to initiating the administering medicines to animals, veterinary practitioners also have the lawful ability to dispense a Schedule 4 or 8 medicine to a specific animal.
After dispensing a medicine to a specific animal, a carer of the animal (such as a veterinary nurse or an animal’s owner) may then administer that dispensed medicine to the animal.
Is it intended that any veterinary practitioner(s) at your organisation will carry out such dispensing of animal medicines?
What does it mean to “supply” to patients?

Possible verbal administration instructions

You have selected health practitioner(s) that have the lawful ability to provide verbal instriuctions for another practitioner to carry out administration.
(Practitioners that may provide such instructions are medical practitioners, dental practitioners, nurse practitioners, authorised midwives, authorised optmetrists or authorised podiatrists).
Is it intended that such verbal instructions would ever be provided at your health service?

Possible hospital

Is there a registered pharmacy from which pharmacists work on your hospital’s premises?
Is the pharmacy operated by the same organisation that holds the health service permit for the hospital?
Aside from distributing scheduled medicines to storage facilities throughout the hospital organisation, and supplying dispensed scheduled medicines to patients, do pharmacists working in the pharmacy make other supply of scheduled medicines? (for example, to external organisations, or to individual health practitioners that may not even work at the hospital)?
Bear in mind that scheduled medicines from a hospital pharmacy should only be supplied for health service purposes, and not for any non-health service purposes (in compliance with Section 20(3A)(b) of the current Victorian, Drugs, Poisons and Controlled Substances Act).

Authorised supply

Licence or permit - Change or review form
Fields marked with * are required

Possible third party storage

Does your organisation intend to ever use a third party storage company to store, on behalf of your organisation, any of the scheduled goods that your organisation intends to supply? (ie: so these products would not be stored on your organisation’s premises prior to supply)
Confirm that prior to using any third party storage company to store, on behalf of your organisation, any of the scheduled goods that your organisation intends to supply:

Customer authorisation

What types of customers would your organisation supply with scheduled substances?
(More than one may be selected, but do not select any that would not actually be supplied.)
What types of customers external to your hospital would your hospital pharmacy supply with scheduled substances?
(More than one may be selected, but do not select any that would not actually be supplied.)
This section refers to verification of customer authorisation.
What if my organisation engages a third party to determine customer authorisation?
Select which health practitioner(s) would be supplied:
Would any podiatrists that your organisation supplies have an additional endorsement with their registration to become authorised to obtain a wider range of substances?
Would any optometrists that your organisation supplies have an additional endorsement with their registration to become authorised to obtain a wider range of substances?
Confirm by selecting the check-box below that your organisation verifies that the health practitioners you have selected above are registered in Australia prior to supplying any scheduled medicines to them by checking relevant practitioners registration on the web-site of the Australian Health Practitioner Regulation Agency (AHPRA) (bearing in mind that this should be done for all such new customers, and routinely for such existing customers. Registrations must be renewed by health practitioners annually.) It is also advisable to see if the suburb/town where the health practitioner would like the goods to be delivered to matches the suburb/town on the health practitioner’s AHPRA registration as being his/her principle place of practice. While it’s certainly possible for a health practitioner to practice from more than one location, licence holders may need to discuss that with health practitioner customers to reduce the likelihood of a false customer account being used. The relevant AHPRA web-page may be accessed by the link directly below the check-box below.
AHPRA registration does not need to be verified for veterinary practitioners, as they are not registered with AHPRA (but are instead registered with the Viictorian Veterinary Practitioners Board)
AHPRA registration does not need to be verified for orthoptists as they are not registered with AHPRA (but are instead registered with the Australian Orthoptic Board)
Confirm by selecting the check-box below that your organisation verifies that the following endorsed practitioner(s) have an endorsement on their AHPRA registration prior to any supply:
•Nurse practitioners (ie: not just regular nurses)
•Endorsed midwives (ie: not just regular midwives)
•Endorsed podiatrists (ie: not just regular podiatrists)
•Endorsed optometrists (ie: not just regular optometrists)
Which other types of other persons or organisations may be supplied?

No other persons or organisations can be supplied

Other supply requirements

Would your organisation ever order the supply of any substances intended to be ultimately administered to a person by an end-user? (Any such items would be considered “therapeutic goods”)
What does “administer” mean?
Please indicate what type of non-therapeutic goods would be supplied?
(More than one answer may be selected, but at least one must be selected)
Please describe what other purpose the supplied goods would be used for (which would not involve therapeutic use). (Describe in at least 15 characters, but less than 300 characters)
Does your organisation intend to supply human therapeutic goods to customers located outside Australia?
What might quantities inconsistent with the activities of a business include?
What does “administer” mean?

Storage and access

Licence or permit - Change or review form
Fields marked with * are required

Schedule 2, 3 or 4 storage

What storage facilities may be used to store any Schedule 2, 3 or 4 substances?
(More than one may be selected, but do not select any that would not actually be used.)
Please confirm the following regarding the emergency trolley using a tamper-evident seal:
What types of portable container(s) may be used for any Schedule 2, 3 or 4 substances?
(More than one may be selected, but do not select any that would not actually be used.)
During operating hours, while the container holding emergency medicines is not under the direct, constant supervision of an authorised staff member, would it be placed within one of the locked storage facilities (from the list further above)?
Please confirm the following regarding the container holding emergency medicines:
Note that schedule 4 medicines that have been dispensed to an aged care resident (including those within a dose administration aid that includes the resident’s name) should be stored in a lockable storage facility.
However, the question above does not relate to such dispensed medicines. The question above relates to un-dispensed medicines.
What is an “un-dispensed” schedule 4 medicine?
In accordance with the above confirmation point, it is recommended that wholesalers store scheduled products in storage facilities that are separate from those that may store unscheduled products.
However, while there are significant risks involved in mixing scheduled and unscheduled products: •Some wholesalers store unscheduled therapeutic products intended for internal use with Schedule 2, 3 or 4 products. Although, if the schedule 2, 3 or 4 products include any drugs of dependence, then the unscheduled products should not account for more than 50% of all goods stored in the single storage facility.(Unscheduled therapeutic products intended for internal use would include tablets, capsules or injections).•Any other unscheduled products (i.e. not intended for internal therapeutic use) should not be stored in the same storage facility as Schedule 2, 3 or 4 drugs of dependence. In considering to store other unscheduled products with Schedule 2, 3 or 4 that are not drugs of dependence, then the unscheduled products should not account for more than 50% of all goods stored in the single storage facility.
What are drugs of dependence?
In accordance with the above confirmation point, it is recommended that wholesalers store scheduled products in storage facilities that are separate from those that may store unscheduled products.
However, while there are significant risks involved in mixing scheduled and unscheduled products: •Some wholesalers store unscheduled therapeutic products intended for internal use with Schedule 2, 3 or 4 products that are not drugs of dependence.(Unscheduled therapeutic products intended for internal use would include tablets, capsules or injections).•In considering to store other unscheduled products (i.e. not intended for internal therapeutic use) with Schedule 2, 3 or 4 products that are not drugs of dependence, then the unscheduled products should not account for more than 50% of all goods stored in the single storage facility.

Schedule 7 storage

What storage facilities may be used to store Schedule 7 substances obtained using the permit?
(More than one may be selected, but do not select any that would not actually used.)
What storage facilities may be used to store listed-regulated Schedule 7 substances?
(More than one may be selected, but do not select any that would not actually be used.)
What are listed-regulated Schedule 7 substances?

Schedule 8 or 9 storage

What is the best way to describe the facility(ies) that would be used to store any Schedule 8 or 9 substances?
(More than one may be selected, but do not select any that would not actually be used.)
You have selected a safe (above) as well another type of storage facility (such as a vault). It's quite uncommon for organisations to have both a safe as well as another type of storage facility for Schedule 8 or 9 substances.
Please confirm that any storage facility that you have selected from the options above (for storing Schedule 8 or 9 substances) would use no less security than each of the four points listed below:
Please confirm that any storage facility that you have selected from the options above (for storing Schedule 8 or 9 substances) would be able to provide a level of security that is not less than the level provided by a facility that would comply with each of the four points listed below:
The following expert advice has been provided regarding how a facility for the storage of Schedule 8/9 substances would be "securely attached" so it would likely withstand attack by hand tools for 30 minutes or power tools for 5 minutes: •The storage facility should be bolted to a concrete or brick wall/floor (i.e. a “hard core” wall/floor). So, the facility should not simply be attached to something like a laminated benchtop.•When attached to a hard core wall, the storage facility should be secured by use of FOUR Loxin or Dyna Bolts (each 10mm by 50mm minimum).•If a metal/steel “safe stand” is being used (i.e. so a safe is at waist height, rather than on the floor, when it cannot be attached to a wall compliantly), then the safe stand must be securely attached (i.e. using four Loxin/Dyna Bolts) both to the safe itself, and securely attached to the floor (e.g. a concrete floor, using four Loxin/Dyna Bolts).•Nonetheless, it is possible for the facility to be attached to a stud and plaster wall, or a hollow block wall. In this case, the storage facility should be secured by use of FOUR 10mm coach bolts through the stud in the wall and through a 3mm mild steel backing plate. This backing must, at minimum, be the same size as the back of the storage facility.•Alternatively, if a storage facility weighed over 350kg, it would be considered to be so heavy that it would be securely attached.
Note that if an organisation were to consider using a very large facility to be the immediate storage facility for Schedule 8/9 substances (such as an entire room or an entire building), then, to comply with point 4 (above), the entire room/building must not be used to store any items other than Schedule 8 or 9 substances; or possibly Schedule 4 drugs of dependence (if any). Many organisations may find it to be very impractical to have an entire room/building that cannot be used to store anything other than these few items (and may consequently choose to use a smaller safe as the immediate storage facility for Schedule 8 or 9 substances).
If your organisation intends to use a facility for the storage of Schedule 8/9 substances where it may not be so obvious that the facility meets the four requirements listed above (e.g. not a common, compliant drug safe), you will likely need an assessment from an independent, professional security advisor to confirm that the storage facility provides no less security than that specified in these points.
How could I arrange an assessment from an independent security advisor?
The following points are recommendations for using electronic storing and recording cabinet(s) for storing Schedule 8 medicines.
If your organisations chooses not to follow any of these recommendations, it should do so under its own internal advice from a security consultant (and possibly a legal consultant). It’s possible that the such advice may take a risk / benefit analysis of your organisation’s systems for electronic storing and recording cabinet(s). Your organisation should bear in mind that if Schedule 8 medicines are stolen from the facility and the medicines subsequently are involved in a person's injury or death, then your organisation may need to explain whether or not the steps it took to prevent the incident were adequate.
Please confirm that your organisation understands each of these recommendations:
Note that schedule 8 medicines that have been dispensed to an aged care resident (including those within a dose administration aid that includes the resident’s name) should be stored in a lockable facility that is firmly fixed to a floor or wall, however this doesn’t necessarily have to be a compliant safe or vault.
However, the question above does not relate to such dispensed medicines. The question above relates to un-dispensed medicines.
What is an “un-dispensed” schedule 8 medicine?

Access

Authorised staff would only include registered health practitioners involved in administration or supply of Schedule 4 or 8 medicines. These may include pharmacists, nurses (including a nurse without any further endorsement), as well as medical practitioners.
For the pupose of ambulance services, authorised staff may include operational staff engaged by Ambulance Victoria within the meaning of the Victorian Ambulance Services Act 1986
For the pupose of first aid services, authorised staff may include members engaged by St John Ambulance Victoria that are recognised as being qualified to Advanced First Aid level.
For the purposes of administration of methoxyflurane, authorised staff may include lifeguards engaged by Life Saving Victoria and who hold a current Surf Life Saving Australia Pain Management Certificate and any administration of methoxyflurane is only in accordance with the current clinical protocols established by Surf Life Saving Australia.
These may also include other health practitioners verified in the table within the "Health practitioner activities" Section of this form (ie: under the sub-section "Health practitioner(s) initiating administration or supply of Schedule 4 or 8s").
For the purpose of administration of scheduled substances to people, authorised staff would only include registered health practitioners involved in administration or supply of Schedule 4 or 8 medicines, including pharmacists, nurses (including any nurse without a further endorsement), and others listed in the table within the "Health practitioner activities" Section of this form (ie: under the sub-section "Health practitioner(s) initiating administration or supply of Schedule 4 or 8s").
It’s also possible for these authorised staff members to directly supervise another staff member to carry out routine tasks, whereby the authorised staff member is in the same room as the other staff member to supervise that staff member. (For example, a pharmacist (an authorised staff member) may directly supervise a pharmacy technician (who may not be an authorised staff member) while the pharmacy technician checks the expiry dates of stock).
(It's also possible for authorised staff to include an authorised maintenance staff member ONLY for the purposes of receiving and securing bulk nitrous oxide gas cylinders in a lockable storage facility (ie: not for administering nitrous oxide). This would ONLY apply to bulk medical gases cylinders).
Personal care assistants should not have access to any un-dispensed medicines at all. For more information about un-dispensed medicines, refer to the sections further above relating to storage.
Authorised staff would be registered veterinary practitioners involved in veterinary administration or supply of Schedule 4 or 8 medicines.
Note that: •It’s possible for a person to be personally supervised by such a veterinary practitioner, but the authorised person will always be the veterinary practitioner;•It’s also possible for a veterinary practitioner to dispense a scheduled medicine for an animal. Then, any other person that is caring the animal could later administer that dispensed medicine to the animal when the veterinary practitioner is not present. For more information on dispensing a medicine, see the “Health practitioner activities” section of this form.
You have indicated in the "Health service uses" Section of this form that scheduled substances may be needed for additional purposes, other than for the administration to patients, or supply to patients. For only these additional purposes (not involving patients), authorised staff would not necessarily need to be registered health practitioners; however-
Authorised staff that may access any scheduled substance storage facility would only include those staff members that have a legitimate reason associated with their role to access the substances, and that have had education and training to equip him/her with the knowledge or practical skills necessary for the safe, secure and responsible handling of the substances.
It's recommended that relevant staff are trained in applicable aspects of: •The Victorian Compliance Code for Hazardous Substances. Please contact Work Safe Victoria for further information about this.•The National Code of Practice for the Storage and Handling of Workplace Dangerous Goods. Please contact Safe Work Australia for further information about this.
It is recommended that routine training and meetings are provided to all staff which includes quality and professional matters relating to your organisation’s activities. Additionally, it is recommended that material from the following sections of this form should be included in training:
•This "Storage and access" section; the "Records" section; the "Destruction" section
•The "Supply" section, the "Transfer or delivery" section;
•The "Code of good wholesaling practice" section;
•The "Uses" section;
•The "Additional sites" section;
You have indicated in the "Existing substances" section of this form that drugs of dependence would be part of the licence/permit.
Authorised staff that may access or transport drugs of dependence would only include staff members that have had due diligence carried out to ensure that they: •Have not committed a drug related crime; and•Do not have a drug dependency or has not used recreational drugs.
What are drugs of dependence?
What would “due diligence” include?
Would scheduled substances ever be taken to be used by your organisation away from a storage site? (for example, away from the site address specified in the "Applicant details" section of this form)

Temperature monitoring

Would your organisation supply any substances intended to be ultimately administered to a person or an animal by an end-user? (ie: including any raw ingredients and any final products) (Any such items would be considered “therapeutic goods”)
What does “administer” mean?
Note that some animal products, such as stockfeed, may not require temperature control. It would be best to refer to product information documentation to determine if such products require temperature control. Please confirm these points even if the animal products that your organisation stores do not require temperature control.
Please indicate what type of non-therapeutic goods would be supplied?
(More than one answer may be selected, but at least one must be selected)
Please describe what other purpose the supplied goods would be used for (which would not involve therapeutic use). (Describe in at least 15 characters, but less than 300 characters)

General security

What general security measures would apply to premises where scheduled substances would be stored?
(At least one option must be selected, but do not select any options that would not actually be used) (The first option is always required to be selected)

Transport

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Systems of transport

Would your organisation transport scheduled substances between its storage facilities?
(including between sites)
(including stock transferred from the pharmacy to a ward)
Confirm that when scheduled substances are transferred, a record is made at the location from where the items are sent from, which includes:
How are the scheduled substances transported when your organisation arranges for them to be transported?
(More than one answer may be selected, but do not select any that would not actually be used.)
(Your organisation should be aware of how products are delivered, even if your organisation merely directs a third party storage company to have them delivered).
Confirm that:
What would “due diligence” include?
Would staff members carrying out deliveries ever be company representatives that transport “starter-packs” to health practitioner customers?
Would your organisation utilise a “self storage” facility to store its starter packs?
(i.e. When using a “self storage” facility, your organisation would rent a secure storage area on the premises of another organisation to store its goods, where the secure area would be accessed only by representatives of your organisation).
What are “starter packs”?
What are drugs of dependence?

Cold chain

Would your organization ever arrange to have delivered any therapeutic goods requiring refrigeration?
(eg: delivery of products registered with the Australian Therapeutic Goods Administration to be stored at or below 8 degrees celsius)

Calling orders

Would your organisation ever allow any customers to attend your organisation’s premises to collect orders? (ie: such orders are known as “calling orders”, so your organisation would not transport the order to the customer’s premises.)
What are drugs of dependence?

Records and accountability

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Details in records

What is a “transaction”?
Confirm that the following details are recorded for all transactions involving scheduled substances, including each time a scheduled substance is:
used in manufacturing or associated activities,
supplied to a customer or destroyed;
used, transferred between storage facilities or destroyed;
administered to a patient, supplied to a patient, used in any other way, transferred between storage facilities or destroyed;
Confirm that the following three items are included in the details of the substance:
In the case of administration or supply of a scheduled medicine to a patient:
Note that it's permissible to have a single dedicated page that can be used to record all transactions of a particular type (for example, all transactions of a particular form and strength of a substance), and then those identical details (for example, the name, form and strength of the same substance) could simply be stated at the top of the page, and would not need to be repeated on the same page for each individual transaction.
Note that it's permissible to have a single dedicated page that can be used to record all transactions of a particular type (for example, all administration or supply to a particular patient), and then those identical details (for example, the patient's name and location) could simply be stated at the top of the page, and would not need to be repeated on the same page for each individual transaction.
Confirm that, in addition to the above items, the following details are recorded for all transactions involving Schedule 8 or 9 substances:
Note that for Schedule 8 medicines, it is also advisable (although not absolutely required by Victorian Drugs and Poisons legislation) for stock holding quantities remaining at the change over of shift to be checked by two authorised persons.

Making Schedule 8 or 9 records

What method is used to make the primary (or only) records for the transactions of Schedule 8 or 9 substances?
Confirm that the hand-written records for Schedule 8 or 9 substances are made in registers (or books) whereby:
Note that for Schedule 8 medicines, it is also advisable (although not absolutely required by Victorian Drugs and Poisons legislation) that when stock holding quantities of Schedule 8 medicines must be transcribed from one page to the next, or from one register to the next, the transcribed quantities should be checked and countersigned by two authorised persons.
What are the “primary” records?
What method(s) are used to make records for the transactions of Schedule 8 or 9 substances?
Confirm that the hand-written records for Schedule 8 or 9 substances are made in registers (or books) whereby:
Note that it is also advisable (although not absolutely required by Victorian Drugs and Poisons legislation) that when stock holding quantities of Schedule 8 or 9 substances must be transcribed from one page to the next, or from one register to the next, the transcribed quantities should be checked and countersigned by two authorised persons.
Note that the administration of a dispensed schedule 8 medicine to a resident of an age care facility should be recorded in accordance with the above requirements for Schedule 8 records ONLY IF the Schedule 8 medicine has NOT been dispensed into a dose administration aid that includes the resident’s name (so liquids, injections and loose tablets (not in a dose administration aid) should be recorded in accordance with the above requirements; however any tablets within a dose administration aid that includes the resident’s name should not need to be recorded in accordance with the above requirements for Schedule 8 records).
Further, the question above does not actually relate to any dispensed medicines. The question above relates to un-dispensed medicines.
What is an “un-dispensed” schedule 8 medicine?

Retaining records

Confirm that all scheduled substance transaction records:

Ordering substances

Note that anything known to contain a Schedule 9 substance (a prohibited substance) should only be obtained from people/organisations that are lawfully authorised to be in possession of them in the first place. An authorised organisation may include Victoria Police. However, a member of the general public is unlikely to be authorised. If you are obtaining a Schedule 9 substance from a wholesale licence holder, it’s possible for you to request that the wholesaling organisation provide you with a copy of its poisons licence prior to the supply.
The above points are particularly important for drugs of dependence. For this reason, it is advisable to only maintain minimal stock holding quantities of drugs of dependence.
What are drugs of dependence?

Destruction

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Destruction requirements

Would any unwanted scheduled substances (even if they’re very infrequent) be destroyed by your organisation, or would they be sent away for destruction? (more than one may selected)
Are Schedule 8 or 9 substances destroyed by your organisation?
(Note that the exception to this rule is for a partially used tablet, lozenge or a vial of a previously sterile Schedule 8 substance, in which case a single authorised person, including a single nurse that is not a nurse practitioner may destroy the substance).
When sent away, to whom would the unwanted items be sent to? (more than one may be selected)
When being sent to waste companies, could any unwanted items be identified as being scheduled substances as they are being sent (for example, by a visible label, or by any other way)?

Destruction records

Note that it is not necessary for a registered pharmacist working in a pharmacy to make a record of the destruction of Schedule 2, 3 or 4 medicines. (See Sub-regulation 108(2) of the current Drugs, Poisons and Controlled Substances Regulations).
However, it is very strongly recommended that pharmacists make records of the destruction of Schedule 4 drugs of dependence.

Good Wholesaling Practice

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The Code of Good Wholesaling Practice for Medicines

Standards of the Code include (but are not limited to) the following:
Goods should be stored: •So that different products are segregated (to help avoid confusion of products) (See Section 4.1 of the Code) •Off the floor (See Section 4.2 of the Code)•So that equipment used to monitor the air temperature of the storage facilities and to alert staff of temperature breaches:- Should be automatic (See Sections 8.3 and 8.4 of the Code)
- Should be able to operate in the event of a power failure (See Section 8.3 of the Code)
- Should have their temperature calibration and alert/alarm functions checked at least annually (See Section 8.7 of the Code)
Goods requiring refrigeration: •As inward goods from suppliers, should be moved to a refrigerated storage facility as a matter of priority (See Sections 8.10 and 8.11 of the Code)•As outward goods to customers, should be handled to reduce the risk that the quality of the goods will be compromised (ie: taking into consideration the temperature of the area where the order is assembled, and the length of time that the goods requiring refrigeration spend in the area) (See Sections 8.12 of the Code)
There should be procedures in place for: •Customer complaints (See Sections 6.1 and 6.2 of the Code) •Return of goods from customers (See Section 6.3 of the Code) •Product recalls (See Sections 6.4 to 6.7 of the Code), and •Damaged stock and stock unsuitable for sale (See Sections 6.8 and 6.9 of the Code) •The handling of cytotoxic drugs, and spillage of any cytotoxic drugs (See Sections 3.5 and 4.6 of the Code)
What are "cytotoxic" drugs?
Standard operating procedures should be prepared, followed by staff and regularly reviewed (See Sections 7.8 to 7.15 of the Code).
Your organisation should carry out a security risk assessment and maintain a security risk management plan for the wholesale supply operation. (See Sections 9 of the Code) It would not be necessary to submit the security risk management plan to the Department of Health and Human Services, however it’s possible that officers from the Department may ask for copies.
What sort of things should the risk assessment take into consideration, and what should some key aspects of the plan include?
Unless your organisation intends on storing only small quantities of drugs of dependence (where a small quantity may be, for example, a single unit of up to five different products), then: •The organisation’s security risk management plan should comply with AS/NZS ISO 31000:2009 (ie: “Security Risk Management – Principles and Guidelines”) (See within Page 21 of the Code). •A security consultant should be engaged to assist in the preparation and regular review of the organisation’s security risk management plan to comply with AS/NZS ISO 31000:2009 (See within Page 21 of the Code).
What are drugs of dependence?
•An appropriate security consultant should be engaged if the organization stores any Schedule 8 or 9 substances.
•If your organisation intends on storing any drugs of dependence as raw materials, then it is recommended that these raw materials are stored in a safe or a vault. •Any safe or vault used, including any safe or vault used to store any Schedule 8 medicines should be fitted with:- An alarm- Seismic detectors- Video monitoring- A locking mechanism that:- Requires two persons for access (eg: requires two separate codes to be entered, where one of the two people knows one code, the other person knows the other code, and neither code is divulged to the other person. The same principle could potentially be applied by having two separate keys etc.- Is designed so that after access codes (or keys) are entered, there is a time delay before the storage facility opens.(For all these points, see within Section 10.13 of the code as well as Section 10.5 of the code.)Any safe or vault should also be located in an area out of public view (See within Section 10.6 of the Code)•If your organisation intends on storing any Schedule 3 or 4 drugs of dependence that are not raw materials, then these should be stored in a facility that allows rapid detection of theft and identification of the offenders (ie: a transparent lockable facility, such as a cage, and security cameras directly monitoring the facility) (See within Section 10.14 of the code)•Regular physical stock checks of the quantities of Schedule 3, 4 or 8 drugs of dependence should be conducted (See within Section 10.15 of the code)•Unwanted Schedule 3, 4 or 8 drugs of dependence should be removed for destruction as soon as possible (and should not be left on the premises for waste to accumulate) (See within Section 10.18 of the code)•It is recommended that any unwanted Schedule 3 or 4 drugs of dependence destroyed on your organisation’s premises are destroyed and recorded by two registered health practitioners (ie: in accordance with the requirements that would be in place for Schedule 8 medicines destroyed on your organisation’s premises) (See within Section 10.17 of the code)

Submission

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Fee

Based on the information you have provided, the following are significant details of this form submission:
Change incurring a fee (if any):
21 MA (a licence to manufacture S8s/S9s)
23 MP4 (a licence to manufacture S4s (and possibly S2s/S3s/S7s))
23 MP237 (a licence to manufacture S2s/S3s/S7s)
22 WA (a licence to store, supply, but not manufacture S8s/S9s)
24 WP4 (a licence to store, supply, but not manufacture S4s (and possibly S2s/S3s/S7s))
24 WP237 (a licence to store, supply, but not manufacture S2s/S3s/S7s)
22 WA Indent (a licence to direct supply by indent, but not store S8s/S9s)
24 WP4 Indent (a licence to direct supply by indent, but not store S4s (and possibly S2s/S3s/S7s))
24 WP237 Indent (a licence to direct supply by indent, but not store S2s/S3s/S7s)
25 Permit 2347 (a permit for research or other uses permit which does not include S8s/S9s)
25 Permit 8,9 (a permit for research or other uses which includes S8s/S9s (and possibly other substances))
27 Permit 8,9 (an industrial permit which includes S8s/S9s (and possibly other substances))
27 Permit 2347 (an industrial permit which does not include S8s/S9s)
29 HSP Type D (a health service permit with either –multiple sites (with beds) OR – a single site with more than 100 beds)
29 HSP Type C (a health service permit with either –multiple sites (with no beds) OR – a single site with 31 to 100 beds)
29 HSP Type B (a health service permit for either - a single site with 1 to 30 beds OR – a residential aged care facility)
29 HSP Type A (a health service permit for a single site with no over-night beds)
$
Fee until 30 June 2022
Please note that fees are increased on 1 July each year in line with the Victorian Government yearly indexation of fees. The fee displayed here is that which was in place when you began this form. If you began this form prior to 1 July in any year, and then completed the form after 1 July, the fee would have increased (so will be more than that displayed here).
To enable payment of the above fee, an invoice will be sent soon (normally within two working days) after the Department receives this completed form to the main email address that you have nominated on this form:
Please be aware that just because your organisation pays the above fee and completes this form, it does not guarantee that this application will be successful.
How will you pay....
An invoice will be sent soon after the Department receives this completed form (normally within two working days). The invoice will be sent to the main email address that you have nominated on this form:
For payments by cheque, please: •Prepare a cheque for the amount indicated directly above made out to the Department of Health and Human Services•Do not post the cheque until after this electronic form has been successfully submitted•Once this electronic application has been successfully submitted, place the cheque into an envelope together with a cover letter containing identifying information for this form. Identifying information would include: - The name of the organisation that is currently stated on the existing licence / permit document. ()- The tracking code for the application (found in the top right hand corner of this screen).- Any other identifying information that you think would be helpful •Post the sealed and stamped envelope to:Administration, Drugs and Poisons Regulation
Department of Health & Human Services
GPO Box 4541, Melbourne VIC 3001

Inspection preparedness

Often it is necessary for departmental officers to visit a licence/permit holder's premises associated with a proposed change.
A visit would generally involve inspecting: •Examples of records that would be made for transactions of scheduled substances;
•The general security on the premises; •Scheduled substance storage facilities;
•And accompanying temperature monitoring devices
Would your organisation be prepared for such an inspection immediately, or at a later date?

Cancellation

Further contact

Because you have not selected for any principal changes to be made (i.e. changes possible in the "Basic information" section of this form), it may not be necessary for a representative of the Department to contact your organisation in response to receiving this form. However, the Department will certainly keep a record of this completed form.
Representatives of the Department routinely contact licence/permit holders for compliance checks, so they would certainly refer to this completed form at that time.

Declaration

By signing in the space below, I declare that the information that has been supplied on thie form is true and correct in every particular and that this declaration is made in the knowledge that a person making a false declaration is liable to prosecution under Section 49 of the Drugs, Poisons and Controlled Substances Act 1981.
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After clicking the button above, you will submit your form to be reviewed by the Department of Health and Human Services. You will receive a message saying “Form Shared” and you will receive the tracking code for the submission. An officer from the Department will review the form. Once the form has been finalised you will receive an email that includes a PDF version of the finalised form.
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