Licence or permit application

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 form's screen. If you do save your partially completed application, you can return to it at a later time to complete it.

What would be considered "manufacturing" activities?

If your organisation intends to change items containing scheduled substances (even if it’s simply removing individual items from original packaging) prior to on-supply to external people/organisations, then it would be considered manufacturing.

It would be necessary to hold a poisons permit to obtain the following substances when they are Schedule 7 poisons:

•ACRYLONITRILE.•ARSENIC when it is a Schedule 7 poison.•BENZENE when it is a Schedule 7 poison.•CACODYLIC ACID when it is a Schedule 7 poison.•CYANIDES, METALLIC when they are Schedule 7 poisons.•DYES, including:◦AZO DYES◦BENZIDINE-BASED AZO DYES◦BENZIDINE-CONGENER (3-3’-DISTRIBUTED) AZO DYES◦OTHER DYES THAT COULD RELEASE CARCINOGENIC AMINES•1,2-DIBROMO-3-CHLOROPROPANE.•4-DIMETHYLAMINOAZOBENZENE.•FLUOROACETAMIDE when it is a Schedule 7 poison.•FLUOROACETIC ACID (commonly known as “1080”) except when included in ready-to-use bait products that are registered by the APVMA.•HYDROCYANIC ACID when it is a Schedule 7 poison.•4,4’-METHYLENEBIS[2-CHLOROANILINE].•NICOTINE for human use when it is a Schedule 7 poison.•STRYCHNINE when it is a Schedule 7 poison.•THALLIUM when it is a Schedule 7 poison.•VINYL CHLORIDE when it is a Schedule 7 poison.

What if I only want to obtain a substance in a very low concentration?

Any substance that is listed in Schedules 2, 3 and 4, but which is at a concentration less than 10mg/L or 10mg/kg would not be scheduled (refer to paragraph 1 (2) (j) of the SUSMP). So if you wanted to obtain a Schedule 2, 3 or 4 substance that was already in a product at this low concentration, it would not require you to hold a licence or a permit. However, if you wanted to obtain the substance at a higher concentration, you would still require a licence or a permit (even if you intended to dilute it after you obtained it). Additionally, any substance that is listed in any schedule, from Schedule 2 to 8 which is within an in-vitro diagnostic and analytical preparations containing 0.001 per cent or less of the substance would not be considered to be scheduled (so would not require a licence or a permit to be obtained) (Refer to the listing of “in-vitro diagnostic and analytical preparations” within Appendix A of the SUSMP).

What are Schedule 2 substances?

Schedule 2 substances are those that are available for a pharmacy customer to self-select from the shelf in a pharmacy in Victoria. The customer would not necessarily need to ask a pharmacy staff member to select the product. The top of their label should includes the words "PHARMACY MEDICINE"
A list of all Schedule 2 substances is available in the Standard for Uniform Scheduling of Medicines and Poisons (SUSMP). The SUSMP may be downloaded from a webpage that is accessible via a link below the list of schedule substance groups (on the current section of this form).

What are Schedule 3 substances?

Schedule 3 products are those that are available over-the-counter to a pharmacy customer if the customer asked the pharmacist for the product in a Victorian pharmacy. The top of their label should includes the words "PHARMACIST ONLY MEDICINE"
A list of all Schedule 3 substances is available in the Standard for Uniform Scheduling of Medicines and Poisons (SUSMP). The SUSMP may be downloaded from a webpage that is accessible via a link below the list of schedule substance groups (on the current section of this form).

What are Schedule 4 substances?

Schedule 4 substances are those that are available to an individual consumer on prescription from a health practitioner, such as a medical practitioner. When being supplied to a consumer, the top of their label normally includes the words "PRESCRIPTION ONLY MEDICINE"
A list of all Schedule 4 substances is available in the Standard for Uniform Scheduling of Medicines and Poisons (SUSMP). The SUSMP may be downloaded from a webpage that is accessible via a link below the list of schedule substance groups (on the current section of this form).

What are drugs of dependence in Schedule 4?

Drugs of dependence are substances that have a risk for abuse, misuse and physical or psychological dependence. Within Schedule 4, they include: pseudoephedrine, testosterone, phentermine and benzodiazepines (including clonazepam, diazepam, flurazepam, lorazepam, midazolam, nitrazepam, oxazepam and temazepam). This is not a complete list. A complete list is found in Schedule 11 of the Victorian Drugs, Poisons and Controlled Substances Act.

If you would like to include only some Schedule 4 drugs of dependence with this application, in the “Select substance(s)” section (further above), you can select “Some individual substances, as well as some groups of substances”. Then you can select individual drugs of dependence in the “Add individual substances” section, and in this “Add whole groups of substances” section you can select “No” to adding all Schedule 4 drugs of dependence.

What are Schedule 7 substances?

Schedule 7 substances are chemicals available only to specialised or authorised users who have the skills necessary to handle them safely. The top of their label may includes the words "DANGEROUS POISON", however that is not always the case.
A list of all Schedule 7 substances is available in the Standard for Uniform Scheduling of Medicines and Poisons (SUSMP). The SUSMP may be downloaded from a webpage that is accessible via a link below the list of schedule substance groups (on the current section of this form).

What are lsted-regulated Schedule 7 substances?

Schedule 7 substances that cannot be sold by retail (ie: listed-regulated Schedule 7 substances) are very dangerous chemicals that may only be obtained by those that hold a poisons licence or permit. They include: acrylonitrile, arsenic, benzene, benzidine-based azo dyes, cacohylic acid, cyanides (metallic), dibromo-3-chloropropane, 4-dimehtylaminoazobenzene, fluoroacetamide, fluoroacetic acid (concentrated form), hydrocyanic acid, 4,4’-methylenebis[2-chloroaniline], sytrchnine, thallium and vinyl chloride.

What are Schedule 8 substances?

Schedule 8 substances are those that have a high risk for abuse, misuse and physical or psychological dependence, so require specialised restrictions of manufacture, supply, distribution, possession and use. They are certainly only available to a consumer on prescription from a health practitioner, such as a medical practitioner. When being supplied to an individual consumer, the top of their label normally includes the words "CONTROLLED DRUG"
A list of all Schedule 8 substances is available in the Standard for Uniform Scheduling of Medicines and Poisons (SUSMP). The SUSMP may be downloaded from a webpage that is accessible via a link below the list of schedule substance groups (on the current section of this form).

If you would like to include only some Schedule 8 substances with this application, in the “Select substance(s)” section (further above), you can select “Some individual substances, as well as some groups of substances”. Then you can select individual Schedule 8 substances in the “Add individual substances” section; and in this “Add whole groups of substances” section you do not have to select to add all “Schedule 8 substances”, but you can select groups within other schedules if you want.

What are Schedule 9 substances?

Schedule 9 substances are substances that have a very high risk for abuse and mis-use, so they should not be available for use to individual consumers at all.
Their manufacture, possession, sale and use is prohibited by law except when required for legitimate medical or scientific research, or for legitimate analytical, teaching or training purposes. They are classed according to the phrase "PROHIBITED SUBSTANCES".
A list of all Schedule 9 substances is available in the Standard for Uniform Scheduling of Medicines and Poisons (SUSMP). The SUSMP may be downloaded from a webpage that is accessible via a link below the list of schedule substance groups (on the current section of this form).

If you would like to include only some Schedule 9 substances with this application, in the “Select substance(s)” section (further above), you can select “Some individual substances, as well as some groups of substances”. Then you can select individual Schedule 9 substances in the “Add individual substances” section; and in this “Add whole groups of substances” section you do not have to select to add all “Schedule 9 substances”, but you can select groups within other schedules if you want.

What about Schedule 9 substances?

Within the Standard for the Uniform Schedule of Medicines and Poisons (SUSMP), Schedule 9 substances are classified as “Prohibited”. (Schedule 9 includes such substances as heroin). The SUSMP indicates that they are substances which “may be abused or misused, the manufacture, possession, sale or use of which should be prohibited by law except when required for medical or scientific research, or for analytical, teaching or training purposes with approval of Commonwealth and/or State or Territory Health Authorities.”
Because these substances should only be used for medical or scientific research, or for analytical, teaching or training purposes (i.e. not “health” purposes), an organisation in Victoria wishing to obtain and use them should apply for a separate permit that is not a health service permit, but is a permit for other purposes (that may involve the organisation performing research or industrial activities).

What about Schedule 10 substances?

Schedule 5 and 6 substancesIt is not necessary to hold a Victorian licence or permit to be in the lawful possession, or to supply substances within Schedules 5 or 6 of the Standard for the Uniform Schedule of Medicines and Poisons.
(See Sections 13(4), 13(4A), 13(4B) and 13(4C) of the Victorian Drugs, Poisons and Controlled Substances Act.) Schedule 10 substancesWithin the Standard for the Uniform Schedule of Medicines and Poisons, substances that are present in circumstances specified in Schedule 10 are classified as “of such danger to health as to warrant prohibition of sale, supply and use - Substances which are prohibited for the purpose or purposes listed for each poison.”
Therefore, it’s extremely unlikely that the Department would issue a licence or permit to allow an organisation to obtain any substance that is present in a circumstance specified in Schedule 10.
Note that Schedule 10 generally only lists substances in specific circumstances. So, the prohibition on such a substance would only apply to that circumstance. For example, hydrogen peroxide is listed in Schedule 10 when in certain circumstances for teeth whitening preparations. So, if hydrogen peroxide is not present in such a teeth whitening preparation, it would not be in Schedule 10, and the prohibition under Schedule 10 would not apply to it.
If you would like to contact the Department about this, you may send an email to the Department.

What would “due diligence” include?

An organisation may conduct the following to carry out due diligence on a staff member it intends to allow access to drugs of dependence: •A review of a national police check for the person to ensure they have not committed a drug related crime. This is very important for staff members that are intended to have access to any Schedule 8 or Schedule 9 substances.•Contacting available references associated with any of the person’s previous work history.•A review of the person’s work history. The person should have accumulated many hours of practical work experience in safely, securely and responsibly handling similarly risky substances.•A review of the person’s education and skills. The person should have had education and training to equip him/her with the knowledge and practical skills necessary for the safe, secure and responsible handling of drugs of dependence (as well as any other dangerous substances that he/she may be handling). However, while some qualifications may confirm a person’s understanding of matters such as theoretical chemistry, they may not confirm that the person is competent in the safe, secure and responsible handling of dangerous substances in a practical setting. Similarly, just because a person holds a formal qualification, it would not mean that there is no need for the person to undergo a police record check.•Requesting that a person undergo physiological testing (such as blood, urine or saliva testing) to determine whether or not the person may be using drugs illicitly. While the Department has suggested that a licence/permit holder may consider such drug testing, such testing is entirely optional to gain information about a person, and the Department does not endorse any specific test to be carried out.•A review of any other information that the licence/permit holder may have in relation to the person. The more relevant information that an organisation knows about a person working for it, the better. While the Department does not endorse an organisation gaining access to a person’s private and confidential information without the person’s consent, an organisation should use judgment on whether or not it has sufficient information about a person to be able to adequately determine whether or not the person is suitable and competent enough to have access to drugs of dependence.

What does “administer” mean?

To administer means to introduce a substance to a person’s body in some way. The following are some (but not all) ways that a substance may be administered: •Giving a person a single dose of an oral medicine and then watching the person swallow the dose in front of you;•Injecting a person with a substance;•Applying a substance to a person’s skin.

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?

No - Only a location that your organisation owns or formally rents (and therefore has control over security) may be used to store the organisation’s scheduled substances over-night.
It’s possible that specific room(s) within a larger building may be formally rented (or owned) by your organisation (and other organisation(s) may utilise other rooms in the building). Therefore, your organisation will be responsible for the security of the specific room(s) that it rents/owns, and its room(s) must not be used by any other organisation. In that case, the specific room number(s)/name(s) within the larger building must be identified on this form when a new location is proposed to be added.

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?

No - Only a location that your organisation owns or formally rents (and therefore has control over security) may be used to store the organisation’s scheduled substances over-night.
It’s possible that specific room(s) within a larger building may be formally rented (or owned) by your organisation (and other organisation(s) may utilise other rooms in the building). Therefore, your organisation will be responsible for the security of the specific room(s) that it rents/owns, and its room(s) must not be used by any other organisation. In that case, the specific room number(s)/name(s) within the larger building must be identified on this form when a new location is proposed to be added.

Can the address be a residential premises?

The Department cannot provide any certainty that it would approve any licence/permit application, particularly when a residential premises has been nominated for a site where scheduled substances would be stored.
The Department strongly advises against applicants from nominating residential premises and/or carrying out any alterations to a residential premises in an attempt to try to make them more suitable.
There are a number of risks associated with all scheduled substances obtained using a licence/permit that make storage of the substances at residential premises quite inappropriate.

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

A responsible person listed on a licence/permit is someone engaged by the licence/permit holder that: •Will have a regular involvement, and/or regularly oversee the handling of scheduled items 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.•Will be available to answer any questions relating to the licence/permitAt least one responsible person must be listed on a licence/permit, and more than one may be listed if desired.

What does “administer” mean?

To administer means to introduce a substance to a person/animal's body in some way. The following are some (but not all) ways that a substance may be administered: •Giving a person/animal a single dose of an oral medicine for that person/animal to swallow;•Injecting a person/animal with a substance;•Applying a substance to the external part of a person/animal’s body.

What does “administer” and “supply” mean in the context of health services, and how are they different?

To administer means to introduce a substance to a person’s body in some way. The following are some (but not all) ways that a substance may be administered:
- Giving a person a single dose of an oral medicine and then watching the person swallow the dose in front of you;
- Injecting a person with a substance;
- Applying a substance to a person’s skin. To supply means to dispense a quantity of a medicine to a patient so that the patient can carry the substance away and consume it elsewhere by him/herself (eg: in his/her own home). In this circumstance, the medicine must have a dispensing label completed on its packaging.
It is unlawful for a nurse that is not a nurse practitioner or who does not have a rural and isolated practice endorsement to make a decision to supply a patient with a Schedule 4 or 8 medicine, and to complete the dispensing label of such a medicine.

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

An “un-dispensed” Schedule 4 or 8 medicine is one that has NOT been affixed with a label by a health practitioner that may lawfully do so, where the label would indicate that the medicine is only to be used by a specific patient. “Un-dispensed” medicines are those normally found within imprest cupboards and may potentially be used for any patient.

Would "therapeutic need" apply to Schedule 4 products when used for cosmetic purposes?

Yes.
Considering the following registered uses of Schedule 4 dermal injectable products in Australia: •Botox® (botulinum toxin) is registered in Australia to be used for a number of therapeutic purposes. One of its registered uses is for the temporary improvement in the appearance of upper facial rhytides (glabellar lines, crow’s feet and forehead lines) in adults.•Restylane® (containing hyaluronic acid) is registered to be used in Australia as a space-occupying supplement for the intercellular matrix of connective tissue to correct cutaneous contour deformities of the skin.The above-mentioned uses are likely to fulfil the definition of “therapeutic use” in the Interpretation section of the SUSMP, which includes: •influencing, inhibiting or modifying a physiological process in human beings;(Aging and skin changes over time would be physiological processes).•the modification of parts of the anatomy in human beings.

What is a “nurse”? And what if it’s an enrolled nurse?

Any reference to a “nurse” without any other endorsement on this form means either:
- a registered nurse (ie: under AHPRA) or
- an enrolled nurse (ie: under AHPRA) other than an enrolled nurse who has a notation on his or her registration indicating that he or she is not qualified to administer medication. (AHPRA = The Australian Health Practitioner Regulation Agency)

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

An “un-dispensed” Schedule 4 or 8 medicine is one that has NOT been affixed with a label by a health practitioner that may lawfully do so (such as a pharmacist), where the label would indicate that the medicine is only to be used by a specific patient. “Un-dispensed” medicines are those normally found within imprest cupboards and may potentially be used for any patient.

What does it mean to “supply” to patients?

This form was designed in May 2021. If you are completing this form after May 2021, it’s possible that additional types of health practitioners may have since gained authorisation to administer and/or supply Schedule 4 or 8 medicines within Victoria. If you believe that is the case, you should verify such a belief by reading information available on the Victorian Medicines and Poisons Regulation website.
If you have found new information available on the Medicines and Poisons Regulation website (i.e. a webpage created after May 2021) to verify the belief that an additional type of health practitioner has gained authorisation to administer and/or supply Schedule 4 or 8 medicines, then please email Victorian Medicines and Poisons Regulation for further instructions on how to proceed. In the email, please provide the link to the new webpage (i.e. a webpage created after May 2021) that you have found that you believe verifies this belief. Victorian Medicines and Poisons Regulation may be contacted on dpcs@health.vic.gov.au. (Note that while there was a tentative proposal in May 2021 for private first aid providers to possess some Schedule 4 medicines for the purpose of administration, this proposal had not yet been reviewed or endorsed in May 2021. Either way, the proposal was that private first aid providers would not require a Victorian health service permit in order to possess the Schedule 4 medicines, but would only require a First Aid Licence issued by the Private Hospitals area of the Department of Health. For more information about this, please contact the Private Hospitals area via privatehospitals@dhhs.vic.gov.au).

What does it mean to “supply” to patients?

To supply to a patient means to dispense a quantity of a medicine to a patient so that the patient can carry the substance away and consume it elsewhere by him/herself (for example, in his/her own home). In this circumstance, the medicine must have a dispensing label completed on its packaging.

What does “administer” mean?

This section of the form asks that your organisation verifies that its customers have lawful authorisation to receive and be in possession of the scheduled substances that they have ordered. It’s feasible that your organisation may engage a third party to carry out a process to determine the authorisation of customers to receive and possess the substances. However, this form still refers to your organisation in ensuring this verification because: •The third party would still be representing your organisation when doing so (i.e. the third party would be acting as an agent, or a representative of your organisation).•Your organisation will still have ultimate responsibility for who it supplies. •If supply were to be made to an unauthorised customer, your organisation will be held to account by the Department (as your organisation’s name is on the licence), and a third party that your organisation may have been mistakenly relying on will not necessarily be held to account by the Department).Consequently, your organisation should be completely confident that any third party it engages to determine customer authority is completely accurate in its verification process. Additionally, even if your organisation engages a third party to establish customer authority, your organisation should be well aware of what specific authorisations need to be verified for different types of customers. If your organisation were to carry out random checks to ensure the third party is carrying out adequate verification procedures, your organisation would need a basis upon which to carry out such random checks. Consequently, this form also refers to your organisation in ensuring customer verification for this additional reason.

What does “administer” mean?

To administer means to introduce a substance to a person/animal's body in some way. The following are some (but not all) ways that a substance may be administered: •Giving a person/animal a single dose of an oral medicine for that person/animal to swallow;•Injecting a person/animal with a substance;•Applying a substance to the external part of a person/animal’s body.

What might quantities inconsistent with the activities of a business include?

Such a request may include a single unusually large order, repeated orders for small quantities that add up to an unusually large quantity or orders for products that are atypical for the type of customer involved. This is especially relevant if your organisation was being asked to supply an exceptionally large quantity of products that could be used in the illicit drug trade to a customer that is unlikely to ever need such a quantity in their lawful activities. For example, it may appear unusual for a small pharmacy to order a crate full of a single Schedule 8 product, when it has never ordered such a large quantity ever before.

What does “administer” mean?

To administer means to introduce a substance to a person’s body in some way. The following are some (but not all) ways that a substance may be administered:
- Giving a person a single dose of an oral medicine and then watching the person swallow the dose in front of you;
- Injecting a person with a substance;
- Applying a substance to a person’s skin.

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

An “un-dispensed” Schedule 4 medicine is one that has NOT been affixed with a label by a health practitioner that may lawfully do so, where the label would indicate that the medicine is only to be used by a specific patient. “Un-dispensed” medicines are those normally found within imprest cupboards and may potentially be used for any patient.

What are drugs of dependence?

Drugs of dependence are substances that have a risk for abuse, misuse and physical or psychological dependence. They include all substances in Schedules 8 and 9. Within Schedule 4, they include: pseudoephedrine, testosterone, phentermine and benzodiazepines (including clonazepam, diazepam, flurazepam, lorazepam, midazolam, nitrazepam, oxazepam and temazepam). This is not a complete list. A complete list is found in Schedule 11 of the Victorian Drugs, Poisons and Controlled Substances Act.

What are listed-regulated Schedule 7 substances?

Listed-regulated Schedule 7 substances include: acrylonitrile, arsenic, benzene, benzidine-based azo dyes, cacohylic acid, cyanides (metallic), dibromo-3-chloropropane, 4-dimehtylaminoazobenzene, fluoroacetamide, fluoroacetic acid (concentrated form), hydrocyanic acid, 4,4’-methylenebis[2-chloroaniline], nicotine for human use, sytrchnine, thallium and vinyl chloride.

How can I ensure that the facility is "securely attached" so it would likely withstand attack by hand tools for 30 minutes or power tools for 5 minutes?

Expert advice indicates that being ‘securely attached’ is satisfied by - •For a hard core wall: The storage facility is secured by use of four Loxin or Dyna Bolts (each 10mm by 50mm minimum).•For a stuff and plaster wall, or for a hollow block wall: The storage facility is secured by use of four 10mm coach bolts through 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 is securely attached.

How could I arrange an assessment from an independent security advisor?

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 specified on this form for a licence/permit, you will likely need an assessment from an independent, professional 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.
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 may hold the licence/permit;•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

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

An “un-dispensed” Schedule 8 medicine is one that has NOT been affixed with a label by a health practitioner that may lawfully do so, where the label would indicate that the medicine is only to be used by a specific patient. “Un-dispensed” medicines are those normally found within imprest safes and may potentially be used for any patient.

What are drugs of dependence?

Drugs of dependence are substances that have a risk for abuse, misuse and physical or psychological dependence. They include all substances in Schedules 8 and 9. Within Schedule 4, they include: pseudoephedrine, testosterone, phentermine and benzodiazepines (including clonazepam, diazepam, flurazepam, lorazepam, midazolam, nitrazepam, oxazepam and temazepam). This is not a complete list. A complete list is found in Schedule 11 of the Victorian Drugs, Poisons and Controlled Substances Act.

What would “due diligence” include?

An organisation may conduct the following to carry out due diligence on a staff member it intends to allow access to drugs of dependence: •A review of a national police check for the person to ensure they have not committed a drug related crime. This is very important for staff members that are intended to have access to any Schedule 8 or Schedule 9 substances.•Contacting available references associated with any of the person’s previous work history.•A review of the person’s work history. The person should have accumulated many hours of practical work experience in safely, securely and responsibly handling similarly risky substances.•A review of the person’s education and skills. The person should have had education and training to equip him/her with the knowledge and practical skills necessary for the safe, secure and responsible handling of drugs of dependence (as well as any other dangerous substances that he/she may be handling). However, while some qualifications may confirm a person’s understanding of matters such as theoretical chemistry, they may not confirm that the person is competent in the safe, secure and responsible handling of dangerous substances in a practical setting. Similarly, just because a person holds a formal qualification, it would not mean that there is no need for the person to undergo a police record check.•Requesting that a person undergo physiological testing (such as blood, urine or saliva testing) to determine whether or not the person may be using drugs illicitly. While the Department has suggested that a licence/permit holder may consider such drug testing, such testing is entirely optional to gain information about a person, and the Department does not endorse any specific test to be carried out.•A review of any other information that the licence/permit holder may have in relation to the person. The more relevant information that an organisation knows about a person working for it, the better. While the Department does not endorse an organisation gaining access to a person’s private and confidential information without the person’s consent, an organisation should use judgment on whether or not it has sufficient information about a person to be able to adequately determine whether or not the person is suitable and competent enough to have access to drugs of dependence.

What does “administer” mean?

To administer means to introduce a substance to a person/animal's body in some way. The following are some (but not all) ways that a substance may be administered: •Giving a person/animal a single dose of an oral medicine for that person/animal to swallow;•Injecting a person/animal with a substance;•Applying a substance to the external part of a person/animal’s body.

What would “due diligence” include?

An organisation may conduct the following to carry out due diligence on a staff member it intends to allow access to drugs of dependence: •A review of a national police check for the person to ensure they have not committed a drug related crime. This is very important for staff members that are intended to have access to any Schedule 8 or Schedule 9 substances.•Contacting available references associated with any of the person’s previous work history.•A review of the person’s work history. The person should have accumulated many hours of practical work experience in safely, securely and responsibly handling similarly risky substances.•A review of the person’s education and skills. The person should have had education and training to equip him/her with the knowledge and practical skills necessary for the safe, secure and responsible handling of drugs of dependence (as well as any other dangerous substances that he/she may be handling). However, while some qualifications may confirm a person’s understanding of matters such as theoretical chemistry, they may not confirm that the person is competent in the safe, secure and responsible handling of dangerous substances in a practical setting. Similarly, just because a person holds a formal qualification, it would not mean that there is no need for the person to undergo a police record check.•Requesting that a person undergo physiological testing (such as blood, urine or saliva testing) to determine whether or not the person may be using drugs illicitly. While the Department has suggested that a licence/permit holder may consider such drug testing, such testing is entirely optional to gain information about a person, and the Department does not endorse any specific test to be carried out.•A review of any other information that the licence/permit holder may have in relation to the person. The more relevant information that an organisation knows about a person working for it, the better. While the Department does not endorse an organisation gaining access to a person’s private and confidential information without the person’s consent, an organisation should use judgment on whether or not it has sufficient information about a person to be able to adequately determine whether or not the person is suitable and competent enough to have access to drugs of dependence.

What are “starter packs”?

Starter packs are small product packs that provide consumers a few days supply of a therapeutic good. Normally, health practitioners supply their patients with such packs when patients initiate therapy so that patients can begin therapy immediately and can judge whether they can tolerate therapy using only a small quantity.

What are drugs of dependence?

Drugs of dependence are substances that have a risk for abuse, misuse and physical or psychological dependence.
They include all substances in Schedules 8 and 9. Within Schedule 4, they include: pseudoephedrine, testosterone, phentermine and benzodiazepines (including clonazepam, diazepam, flurazepam, lorazepam, midazolam, nitrazepam, oxazepam and temazepam). This is not a complete list. A complete list is found in Schedule 11 of the Victorian Drugs, Poisons and Controlled Substances Act.

What are drugs of dependence?

Drugs of dependence are substances that have a risk for abuse, misuse and physical or psychological dependence. They include all substances in Schedules 8 and 9. Within Schedule 4, they include: pseudoephedrine, testosterone, phentermine and benzodiazepines (including clonazepam, diazepam, flurazepam, lorazepam, midazolam, nitrazepam, oxazepam and temazepam). This is not a complete list. A complete list is found in Schedule 11 of the Victorian Drugs, Poisons and Controlled Substances Act.

What is a “transaction”?

A transaction would include any usage of a scheduled substance, any transfer within an organisation or any destruction.

What is a “transaction”?

A transaction would include any administration or supply to a patient with a scheduled medicine, any other usage, any transfer within an organisation, or any destruction.

What is a “transaction”?

A transaction would include the supply or destruction of a product containing a scheduled substance. It would also include the manufacture of such a product (for those licence holders that conduct manufacturing).

What are the “primary” records?

“Primary” records would be relevant where records may be duplicated in more than one place, or in more than one system. For example, some organisations like to keep both electronic and hand-written versions of records. In such a case, the “primary” record is the official record, and the original record that is made.
Drugs and Poisons legislation does not require anyone to keep duplicate or multiple versions of records. Only primary records are required.

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

An “un-dispensed” Schedule 8 medicine is one that has NOT been affixed with a label by a health practitioner that may lawfully do so, where the label would indicate that the medicine is only to be used by a specific patient. “Un-dispensed” medicines are those normally found within imprest cupboards and may potentially be used for any patient.

What are drugs of dependence?

Drugs of dependence are substances that have a risk for abuse, misuse and physical or psychological dependence.
They include all substances in Schedules 8 and 9. Within Schedule 4, they include: pseudoephedrine, testosterone, phentermine and benzodiazepines (including clonazepam, diazepam, flurazepam, lorazepam, midazolam, nitrazepam, oxazepam and temazepam). This is not a complete list. A complete list is found in Schedule 11 of the Victorian Drugs, Poisons and Controlled Substances Act.

What are "cytotoxic" drugs?

Cytotoxic drugs (sometimes known as antineoplastics) contain substances which are toxic to cells so are used to treat cancer. The ability of these substances to damage and kill cells creates potential risks to those who handle them during the course of their work. Further information regarding the handling of these substances is available from Worksafe Victoria.

What sort of things should the risk assessment take into consideration, and what should some key aspects of the plan include?

The security risk assessment could take into consideration:
- The quantity of all medicines being held on the premises
- The location on the premises at which medicines are stored
- Electronic security systems, lighting, entry and exit points, and premises layout.
- All possible ways in which medicines could be lost or stolen at all different locations in which they may be held on the premises (including temporary holding locations) and during transport.
- Methods used for the accountability of medicines being held on the premises.
- All past incidents involving medicines being lost or stolen from the organisation (if any) Key aspects of the security risk management plan should be that:
- Premises and systems should be designed to reduce the chance of medicines being lost or stolen, and internal standard operating procedure documents should be prepared so there is a written record of these systems. (Though, being documents internal to your organisation, it would not be necessary to submit the standard operating procedures to the Department of Health and Human Services).
- A manager should be appointed to take responsibility for security, including compliance with the plan
- The plan and procedures should be reviewed at least every 12 months (and updated if necessary)
- Regular training should be provided to all staff, and especially those that have access to medicines.
- Security audits and transaction audits should be carried out to ensure that the premises and the processes used comply with the plan.

What are drugs of dependence?

Drugs of dependence are substances that have a risk for abuse, misuse and physical or psychological dependence.
They include all substances in Schedules 8 and 9. Within Schedule 4, they include: pseudoephedrine, testosterone, phentermine and benzodiazepines (including clonazepam, diazepam, flurazepam, lorazepam, midazolam, nitrazepam, oxazepam and temazepam). This is not a complete list. A complete list is found in Schedule 11 of the Victorian Drugs, Poisons and Controlled Substances Act.

Who should sign this application?

Someone that can fully represent the organisation should sign this application. This may include an owner of the organisation, a director of the organisation, a manager of the organisation, or anyone that has been granted authorisatsion to fully represent the organisastion.

What happens after I submit this form? How long do I need to wait after submitting the form?

As mentioned on this page, normally it is necessary for a Departmental officer to visit a premises associated with an application.
Normally, within three working days after: •the application form is successfully submittedand•the application fee is paidthe applicant should expect to be contacted by an officer to arrange a mutually convenient time to conduct an inspection. In conducting an inspection, an officer may identify matters that require action from the applicant to achieve compliance before the application can proceed. The length of time it takes to act on such matters is entirely dependent on the applicant (and the Department has no control over this).
(For example, if a storage facility intended to be used as part of an application involving storage did not use a locking device, an officer will likely request that the applicant install a locking device onto the facility. In such a case, the Department will then want confirmation that a locking device has been installed. The length of time it takes to install the locking device, and provide confirmation of its installation will be dependent on the applicant, and the Department has no control over how long that will take the applicant to complete). After any such matters that require action from the applicant to achieve compliance have been acted upon, the length of time it takes the Department for final processing of the application can vary.
Normally, this final processing is carried out within two to three weeks after receiving confirmation from the applicant that any matters that required action to achieve compliance have been acted upon. However, this final processing time can sometimes be extended out to additional weeks during periods when the Department receives a very large number of applications around the same time. Also bear in mind that, under Sections 19(3)(b) and 19(5) of the Victorian Drugs, Poisons and Controlled Substances Act, the Department must be satisfied that an applicant is fit and proper, and that an applicant’s premises is suitable, sanitary and adequately equipped to conduct its proposed activities before the Department can issue a licence or permit. The Department may be unable to issue a licence or a permit if an applicant is unable to adequately demonstrate this.

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

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