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:

Fee ($)

Pending licence/permit last six digits

Finalised submission date

Substances

Licence or permit application

Fields marked with * are required

Select substance(s)

Would your organisation require individual substances to be included on its licence/permit, or whole groups of substances (or both)?

Individual substances

Groups of substances

Some individual substances, as well as some groups of substances

Add individual substances

Select which individual substances should be included.
The highest schedule that the substance belongs to will be stated next to the substance name.

Add individual substance(s)

	Substance	Schedule
		Substance HSP *	Substance Non-HSP permit *	Substance Licence *		Schedule 2	Schedule 3	Schedule 4	Schedule 4	Schedule 4 drug of dependence	Schedule 7	Schedule 7 - listed-regulated	Schedule 8	Schedule 9	S2 addition	S3 addition	S4 addition	S4 addition 2	S4DD addition	S7 addition	S7LR addition	S8 addition	S9 addition	Cannabis Addition	Nitrous Addition	Last Column Unselected	What would the cyanide be used for? Electroplating Mining: Dissolving metals from ores Other	What should the maximum holding quantity of this substance be? (in milligrams) *

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:

Confirm drug(s) of dependence addition

Please explain why it has been requested that ALL Schedule 9 substances be included.
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.

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?

Yes

Confirm that your organisation carries due diligence on its staff members that it intends on allowing access to any drugs of dependence.
Your organisation may or may not be asked to provide evidence that it has carried out due diligence. *

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

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)?

Yes

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)

Yes

As the quantity exceeds the limit above, your organisation would need to obtain a security assessment report for the proposed storage premises from an independent security advisor.
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 is applying for 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:

Already holds an independent security assessment report for the storage of Schedule 8 or 9 substances on its premises.

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.

Intends to hold an independent security assessment report for the storage of Schedule 8 or 9 substances on its premises within the next six weeks.

Enter the date within the next six weeks upon which it is anticipated that your organisation will obtain an independent security assessment report for the storage of Schedule 8 or 9 substances on its premises. *

Once it is ready, a copy of the report will need to be provided to tbe Department as part of the application process.

S4DD

S7LR

Applicant details

Licence or permit application

Fields marked with * are required

Organisation's identifying details

What is the name of the applicant (ie: the legal name of the organisation) *

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?

Yes - there is a different trading name, or only a specific area of the organisation would use the licence/permit

Enter the trading name, or the name of the specific area of the organisation would use the licence/permit *

Does the organisation hold either an Australian Company Number (ACN) or an Australian Business Number (ABN)?

Yes

Select that the organisation has an ACN and/or an ABN, and then enter the corresponding numbers for the organisation

ACN

Australian company number (ACN) *

ABN

Australian business number (ABN) *

Enter the name(s) of the director(s) of the organisation

First name	Surname
First name *	Surname *

Legal history of the applicant

Has the applicant been found guilty of any indictable offence in the past ten years?

Yes

Please indicate the details of the indictable offence(s)

Date(s)

Offence(s)

Court(s)

Penalty(ies)

Possible taking over of operations of an existing licence/permit holder

Select here if your organisation is making this application in order to replace an existing licence/permit that has been held by a different organisation (i.e. your organisation is taking over the premiess and operations of another organisation).

Please provide the name of the organisation that currently holds a licence/permit which your organisation is replacing.
(The name of the organisation holding the licence/permit will be stated near the top of the licence/permit document).

If you know what it is, please provide the eight digit number of the licence / permit belonging to the organisation that your organisation is replacing.

(You can find this number, beginning with "2" at the top of the licence/permit document).

First two digits

Remaining six digits

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?

Yes - there are change(s) in one or more of these things.

Please describe these changes *

Contact person

What is the name of the main contact person from the organisation for the purpose of this application?

First name

Surname

Confirm that this contact person has been granted authorisation to provide information on behalf of the organisation. *

Contact details

Main contact phone number

Main contact email address

Future correspondence will be sent to this email address (including invoices for initial payment and each yearly renewal). After a licence/permit is issued, this contact email address can be changed by completing the online form to change a licence/permit.

Select here if you would like to provide an additional contact phone number and/or email address

Secondary contact phone number

Secondary contact email address

Additional sites

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?

Yes

Why is it necessary that substances need to be stored in more than one location? (Explain in less than 110 characters, but more than 10 characters) *

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

Provide the following details for the Victorian address of the premises where scheduled substances may be stored, and which would be owned or formally rented by the applicant:

Provide the following details for the Victorian address of the PRIMARY premises where scheduled substances may be stored, and which would be owned or formally rented by the applicant:

Provide the following details of the 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?

Is any part of the premises at the location specified above occupied and utilised by any organisation(s) other than the applicant?

Yes

Is more than 75% of the premises at the location specified above occupied and utilised by the applicant?

Yes - More than 75% of the premises at the address is occupied by the applicant.

Confirm that any scheduled substances that are obtained via the licence/permit would be secured by the applicant so that they cannot be accessed by representatives of other organisations that occupy parts of the premises. *

Identify the exact parts of the premises where the applicant would store scheduled substances (ie: floor and/or room number(s)). These parts of the premises should be occupied and utilised solely by the applicant (so representatives of other organisations should not have access these parts of the premises). *

Would the postal address for the applicant be different to the address provided above?

Yes - Postal address different to that above

No - Same address as above

Provide the following details for the postal address:

Street address

Suburb / Town

Post Code

Additional sites

Licence or permit application

Fields marked with * are required

Additional site details

You have indicated in the "Applicant details" section, under the "Additional sites" seb-section that it is 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.
If this is not the case, please go back to that section to change that answer.
If that is the case, please enter the following details of additional site(s) to be added, where scheduled substances may be stored, and which would be owned or formally rented by the applicant.

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 applicant? (ie: "Are there other organisations at this site?")

Additional site

Victorian street address *

Suburb / town *

Postcode

Are there other organisations at this site?

Yes

Would more than 75% of the premises at this location be occupied and utilised by the permit applicant?

Yes

Confirm that any scheduled substances that are obtained via the permit would be secured by the permit applicant so that the substances cannot be accessed by representatives of other organisations that occupy parts of the premises. *

Identify the exact parts of the premises where the permit applicant would store scheduled substances (ie: floor and/or room number(s)). These parts of the premises should be occupied and utilised solely by the permit applicant (so representatives of other organisations should not have access these parts of the premises). *

Additional site(s) compliance

Confirm that all sites will comply with all the standard requirements that are being confirmed elsewhere on this form. *

Confirm that none of the additional site(s) (listed above) would be supplied with any Schedule 8 or 9 substances unless the site(s) have compliant storage facilities for Schedule 8 or 9 substances on their premises (as described in the “Storage and access” section of this form). *

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.

Responsible person

Licence or permit application

Fields marked with * are required

Please confirm that your organisation understands that a responsible person listed on a licence/permit must be someone engaged by the licence/permit holder that: •Will have a regular involvement, and/or regularly oversee the handling of products associated with the licence/permit; •Will be able to periodically review the procedures of the licence/permit holder to ensure they are being carried out in compliance with Drugs and Poisons legislation and with conditions of the licence/permit; and•Will be available to answer any questions relating to the licence/permit. *

What is a responsible person listed on a licence/permit?

Responsible Person

Qualification(s)

Enter at least one of the following for the responsible person applicant:

Australian health practitioner registration (in a relevant discipline)

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.

First three letters of the registration number *

Final ten numbers of the AHPRA registration number . . . . . ..... . . . . .....................................................

Final ten numbers of the AHPRA registration number . . . . . ..... . . . . ..................................................... *

Enter the four digit Veterinary Practitioners Registration Board of Victoria registration number of one of the organisation's veterinary practitioners

Final ten numbers of the AHPRA registration number . . . . . ..... . . . . ..................................................... *

A qualification that included significant studies in chemistry and/or human health

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

Confirm that you understand that you may or may not be asked to provide a copy, or an official record of the qualification. *

The person to be nominated does not have either of the above qualifications

Is there any other appropriate person within the organisation with relevant qualifications so that he/she could be nominated as a new responsible person?

Yes

Confirm that the person to be nominated as a new responsible person on the licence/permit has recently had at least five years experience and proven training in the handling and recording of scheduled substances, similar to those on the licence/permit. *

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.

Select here if you would like to supplement this responsible person application with some of the person's recent experience

	Year beginning role	No yr(s) in role	Place of employment	Role	Tasks (which included the handling and recording of scheduled substances)
			Number of year(s) in role *	Number of years in role0 *	Place of employment *	Role *	Tasks *

blank bbbbbbbbb

Total number of years of experience

Click here to continue

Name

Enter the following details for the responsible person 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?

Yes

Please indicate the details of the indictable offence(s)

Date(s)

Offence(s)

Court(s)

Penalty(ies)

Possible different contact details

The following contact details have been provided in the "Applicant details" section of this form: •Email address: •Phone number:
Will the responsible person being nominated in this section of the form be DIRECTLY contactable using both of these contact details?

Yes - This responsible person will be DIRECTLY contactable using BOTH of the above contact details

No - One of both of the above contact details will be different for this responsible person

Please select the contact details that will be different for this responsible person (both may be selected):

Phone number

Email address

Signature of this responsible person applicant

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

COMPLIANCE VERIFICATION sections of this form

Licence or permit application

Fields marked with * are required

All of the remaining sections of this form constitutes your organisation’s licence/permit compliance verification.

Health practitioner activities

Licence or permit application

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:

There is nothing in Victorian Drugs, Poisons and Controlled Substances legislation to prevent any health practitioners registered with the Australian Health Practitioner Regulation Agency (AHPRA) in medical, dental, nursing & midwifery, optometry or podiatry practice to initiate the administration of a Schedule 2 or 3 medicine providing the administration complies with that health practitioner’s scope of practice. To obtain information about a health practitioner’s scope of practice, contact the individual registration board of the health practitioner. *

Nurses registered with AHPRA could potentially carry out the administration of Schedule 4 or 8 medicines on the order of another authorised health practitioner providing that: •an administration order has been provided by a health practitioner that can lawfully provide such an order (as outlined in the next confirmation point); and•the administration complies with the scope of practice of the nurse carrying out the administration;

Some health practitioners have the lawful authority to make a decision to administer an un-dispensed Schedule 4 or 8 medicine to a patient (ie: authorise administration), and may also subsequently carry out that administration him/herself.
Some health practitioners may also lawfully make a decision to supply a Schedule 4 or 8 medicine to a patient (i.e. so the patient may then take that medicine to their own home). Prior to supply, these health practitioners must either complete a dispensing label for the medicines themselves, or prepare a prescription for a pharmacist to dispense the medicine.
However, some health practitioners may only lawfully authorise administration, and may not lawfully supply. More information regarding health practitioners that may authorise administration or may make a decision to supply Schedule 4 or 8 medicines is in the next section (further below).
Additionally, in accordance with Part 8 of the DPCS Regulations, a relevant health practitioner must not supply or authorise administration of a Schedule 4 or 8 medicine to a patient unless: •that patient is under the practitioner's care; and•the practitioner has taken all reasonable steps to ensure a therapeutic need exists for the medicine. *

What is an “un-dispensed” schedule 4 or 8 medicine?

In the "Health Service Uses" section of this form, you have indicated that cosmetic medical procedures involving skin penetration may be carried out. With that in mind, please complete the following:

Confirm that your organisation understands that when first considering to treat a patient with a Schedule 4 dermal injectable product, a medical practitioner should use the following method (or use a method that is of no lesser clinical standard) to ensure that he/she has taken all reasonable steps to establish that a therapeutic need exists for the Schedule 4 product: •Carry out a face-to-face consultation with the patient, where a direct physical examination of the patient may be necessary;•Assess the patient’s condition, based on the history and clinical signs and appropriate examination;•Communicate with the patient to:◦Establish the patient’s current physical state and past medical history, and current or recent use of medications, including non-prescription medications;◦Ensure that there is sufficient clinical justification for the proposed treatment;◦Ensure that the proposed treatment is not contra-indicated;•Accept responsibility for evaluating information used in assessment and treatment;•Make appropriate arrangements to follow the progress of the patient and inform the patient’s general practitioner or other relevant practitioners;•Keep an appropriate record of the consultation;•Keep colleagues well informed when sharing the care of patients.If a medical practitioner were to use a different method to establish a therapeutic need, then he/she may need to demonstrate how that method was of no lesser clinical standard to that described above. This would be especially pertinent if an adverse incident were to occur involving dermal injectable products. *

The above point refers to "therapeutic need". Would this apply to products that would be used for cosmetic purposes?

Please enter the name and contact telephone number of the medical practitioner(s) that your organisation intends to receive orders from to carry out the administration of Schedule 4 dermal injectable products:

First name	Surname	Phone number
First name *	Surname *

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?

Yes – ONLY medical practitioner(s) would authorise administration or make a decision to supply Schedule 4s or 8s

No – Other health practitioner(s) may do so (possibly in addition to 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.

Administration? (Can initiate some Schedule 4 or 8 administration?)

│

Supply? (Can initiate some Schedule 4 or 8 supply?)

x┌Select from here

│

┌Confirm understanding

↓		Practitioner type	A	S	↓
1	Medical practitioner	√	√	5	Any within their scope of practice	Section 13 of the DPCS Act Medical practitioners are registered with AHPRA
1	Nurse without an endorsement below	X	X		What is a “nurse”? And what if it’s an enrolled nurse?
1	Nurse immuniser	√	X	5		Secretarial approval. Nurses are registered with AHPRA
1	Nurse with compliant advanced life support training	√	X	5		Secretarial approval. Nurses are registered with AHPRA
1	Nurse practitioner	√	√	5	Any within their scope of practice	Ministerial approval. Nurses are registered with AHPRA
1	Nurse working under the rural and isolated practice framework	√	√	5		Ministerial approval. Nurses are registered with AHPRA
1	Midwife without an endorsement	√	X	5		Secretarial approval. Midwives are registered with AHPRA
1	Endorsed midwife	√	√	5		Ministerial approval. Midwives are registered with AHPRA
1	Personal care assistant	X	X		What is an “un-dispensed” schedule 4 or 8 medicine?
1	Pharmacist	Pharmacist without an endorsement	X	X
1	Pharmacist with immuniser endorsement, working for a hospital	√	X	5		Secretarial approval. Pharmacists are registered with AHPRA
1	Dental practitioner	√	√	5	Any within their scope of practice	Section 13 of the DPCS Act Dental practitioners are registered with AHPRA
1	Veterinary practitioner	√	√	5	Any within their scope of practice	Section 13 of the DPCS Act Registered with the Veterinary Practitioners Board of Victoria
1	Podiatrist without an endorsement	√	X	5	Products containing 2% or less of either lignocaine or prilocaine	Regulation 7(1)(16) Podiatrists are registered with AHPRA
1	Endorsed podiatrist	√	√	5		Ministerial approval. Podiatrists are registered with AHPRA
1	Optometrist without an endorsement	√	X	5	Eye preparations containing tropicamide, cyclopentolate, pilocarpine, physostigmine or synthetic cocaine	Regulation 7(1)(15) Optometrists are registered with AHPRA
1	Endorsed optometrist	√	√	5		Ministerial approval. Optometrsits are registered with AHPRA
1	Orthoptist	√	X	5	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
1	Dental hygienist, dental therapist or oral health therapist	√	X	5	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
1	Nurse, ambulance officer or ambulance transport attendant working under a non-emergency patient transport (NEPT) licence	√	X	5		Regulation 7(1)(24) NEPT Regulations and Clinical Practice Protocols. NEPT providers (and their staff) are registered by the Private Hospitals, DHHS
1	Types of persons allowed to administer a Covid-19 vaccine	√	X	5		Victorian Government endorsement
1	Aboriginal and Torres Strait Islander health practitioner	√	X	5		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?

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 medicines 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.

Confirm that your health service is in a remote location and *

Confirm that you health service is referred to on the Victorian Medicines and Poisons website for specific sites that may engage a nurse under the rural and isolated practice framework. *

Select here if all types of health practitioners that may initiate the administration or supply of Schedule 4 or 8 medicines at your organisastion have been selected from the list above (AND the button in the "Confirm Understanding" column for each that you have selected has also been clicked). (Selecting here will also clear all the other health practitioners that have not been selected above.
Unselecting this option will make all health practitioners that have not been selected re-appear). *

One selected correctly

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

Confirm that no persons other than the registered health practitioners confirmed in the above table will initiate the administration or the supply of any Schedule 4 or 8 medicines that have been obtained via the health service permit. *

Confirm that no persons other than medical practitioners will initiate the administration or the supply of any Schedule 4 or 8 medicines that have been obtained via the health service permit. *

Confirm that no persons other than registered health practitioners will carry out the administration of scheduled medicines that have been obtained via the health service permit. Such registered health practitioners may include nurses carrying out administration on the order of a health practitioner that may provide such an order (such as a medical practitioner).
Accordingly, there are limitations on which persons may access storage facilities of scheduled medicines that have been obtained via the health service permit (outlined in the "Storage and access" section of this form). *

In the table in the section above, you have indicated that your organisation would engage nurse immuniser(s) to initiate the administration of vaccines in accordance with the relevant secretarial approval. Confirm that your organisation would engage registered medical practitioner(s) to be available to provide advice to the nurse immuniser(s) on the use of the vaccines whenever administration is to take place. *

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?

Yes

Confirm that Schedule 4 or 8 medicines supplied to patients are packaged appropriately, and in compliance with Appendix L of the Standard for the Uniform Scheduling of Medicines and Poisons, are labelled with: •All letters being at least 1.5mm in height•The name of the patient•The date of supply•The name, address and telephone number of the place of supply•The name, strength, form and quantity of the medicine•The directions for use•The words “KEEP OUT OF REACH OF CHILDREN” in red with a white background and•If the medicine is for external use only, the words “POISON” or “FOR EXTERNAL USE ONLY” in red with a white background.

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?

Yes

Confirm that Schedule 4 or 8 dispensed animal medicines are packaged appropriately, and in compliance with Appendix L of the Standard for the Uniform Scheduling of Medicines and Poisons, are labelled with: •All letters being at least 1.5mm in height•The species of the animal •The name of the animal’s carer (or owner)•The date of dispensing•The name, address and telephone number of the place of dispensing•The name, strength, form and quantity of the medicine•The directions for use•The words “FOR ANIMAL TREATMENT ONLY”•The words “KEEP OUT OF REACH OF CHILDREN” in red with a white background and•If the medicine is for external use only, the words “POISON” or “FOR EXTERNAL USE ONLY” in red with a white background.
Additionally, as a matter of good practice: •If there is more than one animal of the same species, or with the same carer, then include another unique identifier for the individual animal on the label

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?

Yes

Confirm that whenever any such verbal administration instructions are provided at your organisation: •Such verbal instructions would only be provided if the health practitioner providing the instructions believes an emergency exists (in accordance with Sub-regulations 84(1)(a), 85(1)(a) and 86(1)(a) of the the Victorian Drugs, Poisons and Controlled Substances Regulations);•Your organisation understands that it is advisable that: - The practitioner carrying out the administration (often a nurse/midwife) should record the instructions in patient records- The practitioner providing the verbal instructions should repeat the instructions to another practitioner (such as a second nurse/midwife).•Your organisastion understands that Sub-regulation 84(2), 85(2) and 86(2) of the Victorian Drugs, Poisons and Controlled Substances Regulations indicates that the practitioner providing the verbal instructions must as soon as practicable:- confirm those verbal instructions in writing; and- include them or provide them for inclusion in the treatment records of the patient concerned.

Confirm that your organisation understands that it is extremely unlikely that the administration of cosmetic dermal injectable products would be needed in an emergency. It is unlawful to administer any Schedule 4 products via a verbal order if an emergency does not exist.
(Cosmetic dermal injectable products include botulinum toxin (within Botox® and Dysport®) and hyaluronic acid polymers (within Restylane® and Juvederm®)).

Hospital pharmacy

Is there a registered pharmacy from which pharmacists work on your hospital’s premises?

Yes

Is the pharmacy operated by the same organisation that holds the health service permit for the hospital?

Yes

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)?

Yes

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).

Good Wholesaling Practice

Licence or permit application

Fields marked with * are required

The Code of Good Wholesaling Practice for Medicines

Confirm that your organisation understands that there are many standards under the Australia-wide Code of Good Wholesaling Practice for Medicines which should be followed (in addition to those mentioned elsewhere on this form).

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)

If you would like assistance, you can telephone Drugs and Poisons Regulation on 1300 364 545.

Basic information

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

Select which type of licence/permit to apply for

Questions to determine what to apply for

Health service permit confirmation

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

Licence to supply - Confirmation

Health service uses

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

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

Day surgery (not part of a hospital)

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

Over-night patient accommodation beds for patients

Substances

Standard medicines for specialised health services

Select substance(s)

Add individual substances

Add whole groups of substances

Confirm drug(s) of dependence addition

Other agency requirements

Possible independent security assessment

Uses in research / industry

Tasks

Overall purpose

Applicant details

Organisation's identifying details

Legal history of the applicant

Possible taking over of operations of an existing licence/permit holder

Contact person

Contact details

Additional sites

Address

Additional sites

Additional site details

Additional site

Additional site(s) compliance

Responsible person

Responsible Person

Qualification(s)

Name

Legal history

Possible different contact details

Signature of this responsible person applicant

COMPLIANCE VERIFICATION sections of this form

Manufacturing

Extent of manufacturing

Extent of manufacturing

Human / animal products

Agricultural products

Other products

Quality manufacturing systems

Laboratory activities

Health practitioner activities

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

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

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

Supplying Schedule 4 or 8s

Possible verbal administration instructions

Hospital pharmacy

Authorised supply

Possible third party storage

Customer authorisation

No other persons or organisations can be supplied

Other supply requirements

Storage and access

Schedule 2, 3 or 4 storage

Schedule 7 storage

Schedule 8 or 9 storage

Access

Temperature monitoring

General security

Transport

Systems of transport

Cold chain

Calling orders

Records and accountability

Details in records

Making Schedule 8 or 9 records

Retaining records

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