The Pharmaceutical Benefits Scheme (PBS) is an Australian Government program that benefits you and all Australians by subsidising medicines to make them more affordable. This means you can get access to lifesaving medicines when you need them most.

The PBS is governed by the National Health Act 1953. Details about the Minister for Health are available on the Department of Health and Aged Care website.

Top of page

How is the PBS Schedule released?

The PBS is released in the form of an online schedule and is updated on the first day of every month. You can access the schedule by visiting the PBS website. You can view the latest news on updates and changes by visiting Latest News section on the PBS website. By subscribing to the website you will receive an email notification of any updates to the site.

You can also access the schedule information in PDF and various other downloadable formats available from the Publications and Downloads sections.

Who is eligible to receive benefits under the PBS?

If you are an Australian Resident and you hold a current Medicare card then you are eligible to receive benefits under the PBS. The Australian Government has also set up a Reciprocal Health Care Agreement (RHCA) with certain countries, designed to give visitors from particular countries the benefits of the PBS.

Australia currently has RHCAs with the United Kingdom, Ireland, New Zealand, Malta, Italy, Sweden, the Netherlands, Finland, Norway, Belgium and Slovenia.

If you are visiting from one of these countries and want to claim the PBS benefits, simply show your passport when lodging a prescription. Alternatively, you can obtain a Reciprocal Health Care Agreement Card (RHCAC) from Services Australia. Please note that if you are a visitor from the Republic of Ireland and New Zealand, you are not eligible for the RHCAC.

For more information please see the PBS Eligibility section.

Can I collect PBS medicine from a pharmacy for someone else?

Yes, you can collect medicine for someone else. You will need to give the pharmacist:

The person’s Medicare card details
The person’s current concession and/or Department of Veterans' Affairs (DVA) health card details if they have one
The person’s PBS Safety Net entitlement or concession card details if they have one.

If you are not able to show these details you may have to pay full price for the medicine.

I am a pharmacist, where can I check a patient’s DVA file number or Medicare number?

You can call 13 22 90 to check the patient’s Department of Veterans' Affairs (DVA) file number or Medicare number, but you must obtain the patient’s consent first.

What are special numbers?

When a pharmacist submits a prescription, they are required to supply a valid Medicare number so they can claim reimbursement from Services Australia. There are special categories where a corresponding special number is issued when you cannot provide your Medicare number. The special number is written in place of the Medicare number on the claim form.

There are six different categories that have a special number issued:

Emergency situations
Visitors covered by the Reciprocal Health Care Agreement (RHCA)
Patients who a doctor considers to be entitled to the PBS
Patients who a pharmacist considers to be entitled to the PBS
Urgent clinical need situations
Seemingly valid Medicare cards

Numbers can be obtained from Services Australia.

For additional information please visit the Explanatory Notes section.

Top of page

Am I a General or a Concessional Patient? And what does it mean to the cost of my medicines?

You will receive medicines under the PBS as either a general or concessional patient. This status will determine which co-payment level you are required to pay for PBS prescriptions.

If you are a concessional patient you will have one of the following cards:

Pensioner Concession Card
Australian Seniors Health Card
Health Care Card
Department of Veterans' Affairs (DVA) Gold, Orange, or White Card

Please note that your Seniors Cards issued in some states and territories, are not considered to be a PBS Concession Card.

Centrelink is responsible for the provision and administration of your Pensioner Concession Card, the Australian Seniors Health Card and Health Care Cards.

The Department of Veterans' Affairs (DVA) is responsible for the provision and administration or the DVA Gold, White, and Orange Cards. There is also a DVA Pension Card, which entitles you to PBS medicines at a concessional rate (but not RPBS medicines).

You are a general patient if you do not hold any of the mentioned cards, and will not receive PBS or RPBS medicines at the concessional rate.

For more information on patient charges and patient co-payments please visit the Explanatory Notes section.

How does the TGA classify medicines?

The Therapeutic Goods Administration (TGA) classifies medicines in a scheduling system that determines where you can get your medicines:

Unscheduled: these items are not classified and you can purchase them without restriction (for example, at a supermarket)
Schedule 2 (S2): You can only purchase these medications at a pharmacy
Schedule 3 (S3): You can only purchase these medications from a pharmacy, where a pharmacist must personally hand you the medicine and give you an opportunity to seek advice on the medicine
Schedule 4 (S4): You can only purchase these medications with a prescription, this includes most items on the PBS
Schedule 8 (S8): These medicines are classified as drugs of dependence or addiction

S2 and S3 medicines are sometimes called ‘over-the-counter’ medicines.

S8 medications listed on the PBS have some restrictions which are different in some States and Territories; please contact your local State or Territory health authority for more information.

For more information please visit the Scheduling of Medicines & Poisons section in the TGA website.

Top of page

What is the Pharmaceutical Benefits Advisory Committee (PBAC)?

The Pharmaceutical Benefits Advisory Committee (PBAC) is an independent statutory body established under the National Health Act 1953 to make recommendations and give advice to the Minister about which drugs and medicinal preparations should be subsidised on the PBS.

The PBAC considers the medical effectiveness and cost-effectiveness of a proposed benefit compared to alternative therapies. The PBAC recommends maximum quantities and repeats, and may also recommend restrictions for medicines.

The PBAC has three cycles per year, each lasting approximately 17 weeks.

The PBAC consists of medical experts who meet several times a year and is not a permanent unit in the Department of Health and Aged Care. Because of its structure, the committee is best contacted by writing.

If you require information about applying for listing on the PBS; or would like to know the PBAC meeting dates, and the members of the PBAC; please see the PBAC section.

What are Unrestricted, Restricted, and Authority Required Items?

Medicines are referred to as items under the PBS. These medicines are supplied as an Unrestricted, Restricted or Authority Required item:

Unrestricted medicines under the PBS Schedule may be prescribed by your prescriber within their scope of practice at their discretion.
Restricted medicines listed in the schedule, are only prescribed if your condition meets the stated restrictions.
Authority Required (STREAMLINED) medicines are prescribed for specific conditions and do not need prior approval from Services Australia or the Department of Veterans' Affairs. Instead the process is streamlined by providing a four or five digit streamlined authority code.
Authority Required medicines are medicines that can only be prescribed by if prior approval is obtained from Services Australia or the Department of Veterans' Affairs as appropriate, by calling 1800 888 333 or 1800 552 580, respectively. Since 1 August 2003, your doctor can apply for authority for the majority of PBS medicines online at Services Australia.

Some items require authority in writing to be obtained from Services Australia. In some cases, your doctor will be required to provide further evidence in order for you to continue subsidised treatment.

Your pharmacist can check the validity of an authorised prescription by contacting Services Australia on 13 22 90 for PBS prescriptions and the Department of Veterans' Affairs on 13 32 54 for RPBS prescriptions.

The Department of Veterans' Affairs is able to approve any RPBS prescription requiring authorisation at a concessional price. Doctors can call 1800 552 580 to gain authority.

Top of page

What if I need an increased maximum quantity or more prescription repeats?

If your doctor needs to increase the maximum quantity or give you more repeats of your prescription, they can apply for authorisation in the normal way by contacting Services Australia or the Department of Veterans' Affairs as appropriate, unless otherwise stated in the current PBS schedule.

For more information please see the Information for Prescribers section.

What are the restrictions on PBS prescriptions?

You may only have up to three PBS items on PBS prescription; and only have one Authority Required item, including STREAMLINED authority items. A PBS prescription may only contain PBS items, and cannot contain non-PBS items.

If you would like more information please visit the Information for PBS Prescribers section.

What are the standards when writing PBS prescriptions?

Your prescriber must hold a valid PBS prescriber number to write a valid PBS prescription. This number can be obtained from Services Australia. The prescriptions must either be computer generated or handwritten. If handwritten, the prescription must be in an indelible form in the prescriber’s handwriting, and on standard PBS stationery. Paper sized 18x12cm is also appropriate.

All PBS prescriptions must contain the prescriber’s name and address; the patient’s name, address, and entitlement status; and endorsed PBS or RPBS. Prescriptions should completely identify the medicine being prescribed. The following should be defined:

Item
Form
Quantity
Dose
Strength
Instruction for use
If brand substitution is allowed

The prescription must be signed and dated by the prescriber forward or back-dating is not permitted.

If you would like more information please visit the Writing the PBS Prescription section.

Top of page

What if my prescription is urgent?

In urgent cases, your doctor can communicate with your pharmacist by telephone to get your prescription to you quickly. The prescription must be forwarded to your pharmacist within seven days.

If you would like more information, please visit the Urgent Cases section.

Can my dentist prescribe general PBS items?

Dentists are not able to prescribe you general PBS medicines; however they have a separate Dental formulary from which they can prescribe your medications.

If you would like to view the PBS Dental Schedule please see the Dental Items section of the website. Dental items can also be found throughout the main Schedule of Pharmaceutical Benefits PDF available on the Publications page

Can my optometrist prescribe general PBS items?

Optometrists can only prescribe certain medications. The Optometrical PBS Schedule details which medicines they can prescribe.

If you would like more information about the Optometrical Schedule please visit the Optometrical Items section.

Who can dispense my PBS medicine?

All suppliers of PBS medicines must be approved by the Department of Health and Aged Care. These will be pharmacists, doctors in certain remote and rural areas, Friendly Society pharmacies, or hospital authorities.

If you would like more information please go to the Eligible Suppliers section on the PBS website, and the PBS Approved Suppliers section on the Department of Health and Aged Care website.

How are pharmacists subsidised by the PBS?

Pharmacists are paid by the Australian Government for dispensing PBS items. To claim their subsidy, pharmacists lodge claims with Services Australia detailing PBS prescriptions dispensed. For prescriptions issued under the RPBS, claims are submitted to the Department of Veterans' Affairs.

If you would like more information please visit How Pharmacists Claim Reimbursements: Information Required and Documents to be Submitted sections.

Top of page

What happens if there is a change to the PBS and I still have a current PBS prescription to be filled?

Your PBS prescription is valid for 12 months from the date it was written. If there is a change to the PBS before you have had the prescription, one or more of the following will apply:

If an item is deleted from the schedule: even if your medicine is listed on the PBS when you received the prescription, it cannot be supplied at the discounted PBS price.
If an item is in Supply Only on the schedule: PBS Prescriptions written prior to the Supply Only period are able to be dispensed using either the Supply Only product where available, or an equivalent product as specified on the PBS schedule.
If an item is added to the schedule: even if the item has been added the schedule, the prescription dating back to before the item was added will not entitle you to the subsidised price. You will need to get a new prescription to receive the PBS price.
If the maximum quantity has changed: You will be dispensed the original amount as specified on your prescription, even though this may be different to what is listed under the schedule.
If the restrictions have changed: If your unrestricted medicine has been made a restricted medicine, you may still get your prescription as per your original prescription.
If the number of repeats has changed: You will still receive the same amount of repeats as per your original prescription.
If the form of drug has changed: You will need to get a new prescription to receive the PBS price.

If you would like more information please go to the What to do if the Schedule changes section.

What are Improved Monitoring of Entitlements (IME)?

Improved Monitoring of Entitlements (IME) ensure that only you and other eligible Australian Residents receive PBS subsidised medicines.

If you would like more information please visit IME section of the Services Australia website.

Fees, Charges, Allowances, & Tax

How much am I required to pay for my PBS prescriptions?

If the cost of a PBS medicine falls below the general co-payment amount (under co-payment prescription), the method used to calculate the maximum general patient charge for the medicine includes an Additional Fee, an Additional Patient Charge, and any applicable price premiums.

However, the inclusion of the Additional Fee and the Additional Patient Charge are capped so that the addition of these charges, in full or in part, must not result in the total charge for the medicine being more than the general patient co-payment amount of $31.60. The maximum general patient charge for each under co-payment medicine is shown on the PBS website.

The Additional Fee is sometimes referred to as the Safety Net recording fee. This Fee forms part of the Eighth Community Pharmacy Agreement and is applied for recording prescriptions priced below the maximum general patient co-payment on the PBS Safety Net record (for example, on your Prescription Record Form). The Additional Fee is up to $1.45 for ready prepared items and $1.87 for extemporaneously-prepared items. The amounts are indexed annually on 1 July.

A pharmacist may choose to charge all, part, or none of the Additional Fee component of the maximum charge for an under co-payment prescription. Only one Additional Fee is included in the maximum charge for a dispensed item, even if multiple quantities are required to make up the prescribed amount.

The amount charged as the Additional Fee, in full or in part, counts towards your PBS Safety Net.

The Additional Fee does not apply to general patient prescriptions where the total cost is greater than the general patient co-payment amount of $31.60 as the co-payment price (with or without the $1.00 reduction) already applies for these prescriptions.

How much am I required to pay for under co-payment PBS prescriptions?

The PBS website includes information on the general patient charge for medicines listed on the PBS. Where the cost of a medicine exceeds the general patient co-payment amount, the amount shown on the website is the general patient co-payment (plus any applicable price premium).

Where the cost of a medicine is less than or equal to the general patient co-payment, the amount shown on the website is the maximum general patient charge. These are known as under co-payment medicines.

The amount shown on the website as the general patient charge for a brand of an under co-payment medicine is the maximum amount a pharmacist may charge when supplying the medicine under the PBS, including all fees, mark-ups and any applicable price premium. A pharmacist may charge any amount up to the general patient charge for an under co-payment medicine supplied under the PBS.

If a pharmacist charges more than the maximum general patient charge for a PBS prescription, that supply would be considered non-PBS (that is, the supply would be as a private prescription) and none of the amount paid would count towards your PBS Safety Net.

What is the Additional Fee or Safety Net recording fee and am I required to pay it?

The Additional Patient Charge forms part of the Seventh Community Pharmacy Agreement between the Commonwealth of Australia and the Pharmacy Guild of Australia.

The Additional Patient Charge is currently an amount up to $3.45.

If the cost of the medicine is less than $31.60, the Additional Fee of $1.45 or $1.87 is added first; if the cost is still less than $31.60, then a maximum of $3.45 is added as the Additional Patient Charge so that the total charge is not more than $31.60.

A pharmacist may choose to charge all, part or none of the Additional Patient Charge component of the maximum charge for an under co‑payment prescription. Only one Additional Patient Charge is included in the maximum charge for a dispensed item, even if multiple quantities are required to make up the prescribed amount.

The amount charged as the Additional Patient Charge, in full or in part, does not count towards your PBS Safety Net.

The Additional Fee does not apply to general patient prescriptions where the total cost is greater than the general patient co‑payment amount of $31.60 as the co-payment price already applies for these prescriptions.

The Additional Fee and the Additional Patient Charge are discretionary fees. Pharmacists are free to discount these fees for PBS items where the cost is below the general patient co-payment.

Top of page

What is the brand premium policy?

When there are two or more brands of the same medicine listed under the PBS, the Commonwealth subsidises each brand up to the same amount. The Government and a pharmaceutical company can agree to list a brand at a higher price than other brands. This can only occur if at least one other brand of the same medicine is listed on the PBS at the base price and is available in sufficient quantities for patients to purchase if they do not wish to pay the premium. If you choose the more expensive brand, the price difference is paid by you as a brand premium.

A brand premium, which reflects the higher price that is paid to the pharmaceutical company, is paid in addition to the patient co-payment amount.

Brand premium charges

Where a brand premium applies for a PBS prescription, a community pharmacist is required to charge that additional amount. The co-payment may still be reduced by the allowable $1.00 discount, but if a brand premium applies, it must be added to the charge to the consumer. This is to ensure that the same pricing method applies for all subsidised PBS medicines across all approved PBS community pharmacies. However, it is not mandatory for hospitals to charge brand premiums for PBS prescriptions; for hospital pharmacies, adding a brand premium is optional.

Since 1 January 2023, pharmacists may offer an increased discount for pharmaceutical items, excluding any price premiums (such as brand premiums), at their discretion. This is not a mandatory discount and patients are encouraged to compare pharmacy prices for their medicines.

At your request, your pharmacist can substitute a less expensive brand, provided your prescriber has not written ‘brand substitution not permitted’ on your prescription.

Brand premium amounts do not count towards the Safety Net threshold.

PBS medicines are listed as substitutable if the manufacturer has proven that the brands are bioequivalent or therapeutically equivalent, or if the supporting evidence has already been provided and accepted by the Department of Health and Aged Care.

On the PBS website, substitutable brands are listed with either an ‘a’ or ‘b’ flag to indicate their interchangeability.

If you would like more information please see the Special Patient Contributions, Brand Premiums and Therapeutic Group Premiums section.

What is the Special Patient Contribution (SPC)?

The Special Patient Contribution (SPC) is a surcharge attached to certain PBS medicines. It is the difference between what the manufacturer is charging and what the Government is willing to cover.

This cost is in addition to the patient co-payment and may take the cost above the patient co-payment threshold. This premium does not count towards the Safety Net threshold.

For some SPCs, if you have medical or other reasons to prevent you from taking the lower priced medicine, your doctor may apply through the Authority Line for an exemption from paying the SPC. Your prescription will then be marked with ‘SPX’.

If you are a Department of Veterans' Affairs patient you do not have to pay the SPC.

If you would like more information please visit the Special Patient Contribution and the Special Patient Contributions, Brand Premiums and Therapeutic Group Premiums sections.

How much am I charged for non-PBS items?

If your medicine is not listed under the PBS Schedule, you will have to pay full price as a private prescription; it is not subsidised by the Commonwealth.

Pharmacies may charge differently for these non-PBS medicines, so you may want to shop around to find the best price.

Please note that the cost of private prescriptions cannot count towards the Safety Net threshold.

Can a PBS medicine be discounted?

Where the total cost of a PBS medicine is above the patient co-payment, pharmacists are permitted to reduce the patient co‑payment by applying an allowable discount up to a maximum of $1.00 for each supply. This is not mandatory and is applied at the discretion of the pharmacist. If a reduced co‑payment is paid, the reduced amount (not the full co‑payment amount), counts towards the PBS Safety Net.

Since 1 January 2023, a pharmacist also has the additional option to provide a discretionary increased discount to general patients. This is not mandatory and it is the pharmacist’s choice to provide a discount.

To be eligible for the increased discount the prescription must:

be an ordinary prescription for a general patient
have a Commonwealth price that is higher than the general co-payment amount of $31.60, but less than the upper threshold of $48.10. Both of these amounts are indexed annually on 1 January.

The amount counting toward the Safety Net for these prescriptions is calculated in the same way as for non-discounted under co-payment prescriptions.

As PBS medicines can vary in price depending on the pharmacy from which they are purchased, it may be beneficial for patients to compare pharmacy prices for the dispensed price of medicines.

Where the total cost of a PBS medicine is below the patient co-payment amount, a pharmacist may, at their discretion, charge less than the maximum patient charge. If a pharmacist charges more than the maximum patient charge (apart from after hours or delivery fees, if applicable), the supply would not be a PBS supply and the amount paid would not count towards the PBS Safety Net.

What is the Pharmaceutical Allowance?

The pharmaceutical allowance is a sum of money paid by Centrelink to help you afford the cost of your medicines.

For more information please visit the Pharmaceutical Allowance section on the Centrelink website.

What is the medical expenses tax offset?

The net medical expenses tax offset is being phased out. If you would like more information please visit the Medical Expenses section on the Australian Tax Office (ATO) website.

The Safety Net

What is the PBS Safety Net?

The Safety Net is a scheme designed to protect you and your family from the high total cost of large numbers of PBS, RPBS and non-PBS public outpatient medicines. Once you or your family’s applicable total out-of-pocket expenses for PBS and eligible non-PBS medicines have reached a threshold amount during a calendar year, the costs of your PBS medicines are generally reduced for the remainder of that year.

Once you have reached your Safety Net threshold and you are a general patient, you will usually receive your PBS medicines at the concessional rate for the remainder of that year; if you are a concessional patient you will usually receive your PBS medicines free of charge.

If you would like more information please visit the PBS Safety Net Scheme section.

Top of page

What are Safety Net thresholds?

Once you or your family’s applicable total out-of-pocket expenses for PBS, RPBS and non-PBS public outpatient medicines have reached a threshold amount, you are eligible for the PBS Safety Net. Your pharmacist can then give you a Safety Net Concession card (CN Card) that entitles you to a reduced price for PBS medicines.

If you and your family are general patients, you are usually entitled to your PBS medicines at a concessional price once you have reached the general patient Safety Net threshold. The threshold amount is adjusted each year in line with the Consumer Price Index. You will be entitled to this concessional price for the remainder of the calendar year. You will still be required to pay any special patient contributions or brand premiums, if applicable.

If you or someone in your family is a concessional patient, you may be entitled to your PBS medicines for free once you have reached the concessional Safety Net threshold. Your pharmacist can then issue you or your family with a Safety Net entitlement card (SN Card) which is then valid for the remainder of the calendar year. You will still be required to pay any special patient contributions or brand premiums, if applicable.

Both Safety Net threshold amounts are indexed on 1 January each year in line with the Consumer Price Index.

If you would like more information please visit The Safety Net Scheme section in the PBS website.

What medicines count towards reaching the Safety Net threshold?

The total of your patient out-of-pocket expenses, less any allowable discounts, special patient contributions or brand premiums, from all of your PBS/RPBS listed medicines and non-PBS public outpatient medicines count towards the Safety Net threshold.

If the cost of one of your prescriptions takes you exactly to the threshold amount, the particular prescription will not be reduced. Only when you have exceeded the threshold will you receive the reduced Safety Net price.

Each of your dispensed PBS prescriptions will be added to the threshold amount one at a time, so that the remainder of the repeats can be dispensed at a reduced cost if you exceed the threshold amount.

What are cross-over arrangements?

If you change between being a general patient and a concessional patient within a calendar year, cross-over arrangements apply to you.

If you change from being a general to a concessional patient you will then have your threshold lowered to the concessional patient Safety Net threshold. Any prior prescriptions filled while you were still a general patient count towards the threshold. Each prescription you had filled will be counted as a concessional prescription and the full concessional co-payment value will be attributed to the concessional Safety Net threshold. If you reach the Safety Net threshold, you can then be issued a SN Card.

If you change from being a concessional to a general patient, you will then have to work towards the higher general Safety Net threshold. Each prior prescription you had filled will count towards the prescriptions required for the Safety Net threshold but only to the value of the concessional co-payment amount, less any allowable discount. If you reach the Safety Net threshold, you can then be issued a CN Card.

If you would like more information please visit the Safety Net Cross-Over Arrangements section on the PBS website.

Who is covered under Safety Net within my family?

You and family members can be covered by the Safety Net, and can all work together towards the same Safety Net threshold.

Your family includes your partner; children under the age of 16 and in your care; and dependent full-time students under the age of 25.

There are some different options available to your family:

If all of your family members are general patients: then you will all work towards the general Safety Net threshold, and will be eligible for the CN Card.
If all of your family members are concessional patients: then you will all work towards the concessional Safety Net threshold, and will be eligible for the SN Card.
If one parent in your family is a concessional patient and all other members are general patients: then your family can work towards either threshold. Your family will then be eligible for the relevant Safety Net Card.
If both parents in your family are general patients and one child is a concessional patient: then the child can work towards their own concessional threshold, or your whole family can work towards the general threshold.
If both parents in your family are general patients and two of the children are concessional patients: then your family can work towards the general threshold together, or both children can work towards separate concessional thresholds.
If you are a same sex couple: you may work towards the same Safety Net threshold. This is effective from 1 January 2010 with amendments made to the National Health Act 1953.
If you are a couple separated due to ill health: for example, one partner is living in a nursing home, you can still work towards the same Safety Net threshold.

If you would like more information please visit the Safety Net Cross-Over Arrangements section on the PBS website.

Who is responsible for recording the amount spent on PBS medicines?

It is your (the patient’s) responsibility to keep a record of the amount spent on PBS medicines. This includes keeping track of your dependants’ spending. You can do this by using a Prescription Record Form (PRF), which may be available at community pharmacies. The form can be downloaded and printed by patients or pharmacies by going to PBS/RPBS Safety Net prescription record form and application for a Safety Net card form (PB240) - Services Australia.

Your medicine purchase is usually recorded using computer generated stickers given to you by your pharmacist. You can record them by hand, but your record must include:

The date of supply
The PBS/RPBS item code (for community pharmacies only)
The Safety Net value of the medicine (for community pharmacies only)
The pharmacist’s approval number (for community pharmacies only)
The item identification — medicine code, name of medicine or abbreviation (for public hospitals only)
The hospital Safety Net number (for public hospitals only)
The hospital charge (for public hospitals only)
The signature of the authorised person making the entry on your PRF

At your pharmacist’s discretion, you may be supplied with a print-out of your total PBS spending which can be used as an alternative to the PRF. It is also possible to keep your PRF stored at the pharmacy.

It is possible for you as an individual or your family to have more than one PRF.

Once you or your family have reached the Safety Net threshold, and you can provide evidence of PBS spending, then you will be able to go to any community pharmacy and obtain the Safety Net Card to which you are entitled.

If you would like more information please visit the Recording PBS Prescriptions section on the PBS website. Alternatively, please visit the Safety Net section.

Top of page

What is the Joint Safety Net?

The Joint Safety Net allows your non-PBS prescriptions dispensed at outpatient pharmacies at public hospitals to count towards your total spending for the PBS Safety Net.

Although these medicines are not dispensed through the PBS, they can still count towards your total spending for the PBS Safety Net.

Expenses for non-PBS public outpatient medicines can be recorded on the PRF.

Can I get a supplementary Safety Net Card?

Your pharmacist can give you a supplementary card for your dependant only when your original SN or CS Card is issued. If you would like to get a supplementary card at a later stage, you must contact Services Australia.

If you would like more information, please refer to the Issuing Supplementary Cards section.

What happens if I lose my card?

If your SN or CN Card has been lost, damaged, stolen, or destroyed, your pharmacist will not be able to issue you a new one. You or your spouse must contact Services Australia to request a new card.

For more information please refer to the Lost Safety Net Entitlement/Concession Cards section.

Repeat Prescriptions

What are repeat intervals for PBS prescriptions?

PBS entitlements are subject to certain limits on the frequency of repeat prescriptions obtained under the PBS. There are minimum required intervals between supplies. However, in some circumstances a prescription can be supplied by a pharmacist as ‘immediate supply necessary’ before the minimum interval period has elapsed.

A prescription cannot usually be obtained as a pharmaceutical benefit if the same or an equivalent pharmaceutical benefit (any brand) has already been supplied to the patient within the legally specified period for early supply purposes

– or,

if there is no specified period,

on the same day or within the previous 20 days, if it is a pharmaceutical benefit (other than an eye preparation) that has five or more repeats allowed in the PBS Schedule, (e.g. an interval of 20 days means for a pharmaceutical benefit supplied on Tuesday 4 June not being supplied again for that patient until Tuesday 25 June of the same year);

or otherwise, for all other items,

on the same day or within the previous four days (e.g. an interval of four days means for a pharmaceutical benefit supplied on a Monday not being supplied again for that patient until the next Saturday).

However, if your PBS medicine has been lost, stolen or destroyed, or if you require your medicine without delay for treatment, then your pharmacist, if they believe the conditions are met, can dispense a prescription as an early repeat supply. The prescription must be marked as ‘immediate supply necessary’ and signed by the pharmacist.

These rules are in place to keep the PBS fair for all Australians.

If you would like more information please visit the Repeat Authorisations section.

What is the Safety Net early supply rule (SNESR)?

Under the Safety Net early supply rule (SNESR), for some PBS medicines, an early repeat supply obtained within less than a specified period is not eligible for Safety Net benefits.

If you obtain a repeat supply for a specified medicine early (within less than the specified interval period), none of the amount charged for the medicine will count towards your Safety Net threshold. If you have already reached the Safety Net threshold, and an early supply of a specified medicine is required, the prescription will be supplied at your non-Safety Net payment or co-payment amount, and not at the reduced Safety Net rate.

If you would like more information, including about the medicines involved and the interval periods which apply, please visit the Patient Contributions for Early Supply of Some PBS Medicines section.

Top of page

What is a Regulation 49 prescription?

Regulation 49 (previously Regulation 24) provides that, in certain circumstances, a PBS prescription can be written so that the quantities for the original and repeats are supplied at the same time.

A PBS Prescriber can write a prescription in this way if:

the single maximum quantity in the PBS listing is not sufficient for treatment of the condition;

and

you are using the medicine for treatment of a chronic illness or live in an area remote from the nearest pharmacy;

and

it would cause great hardship if you collected repeat supplies on separate occasions.

PBS prescriptions of this type must be endorsed with the words ‘one supply’ or ‘1 supply’ (the words ‘Regulation 49’, ‘Reg 49’, ‘Section 49’, ‘Regulation 24’ or ‘Reg 24’ are also valid for this purpose). Similarly, RPBS prescriptions must be endorsed with the words 'hardship conditions apply'.

The patient charge that applies is a combined total equivalent to the patient payment or co‑payment amount that would otherwise apply for the original and each repeat making up the total supply. There may also be brand or therapeutic premiums charged for each quantity making up the total. The total patient payment or co‑payment amount eligible for Safety Net purposes (e.g. excluding premiums) can be recorded on your prescription record form (PRF) in the usual way.

Safety Net benefits for Regulation 49 prescriptions apply for the quantity as a whole. For medicines subject to early supply rules, Safety Net benefits apply for the total quantity if the interval between the Regulation 49 supply and the previous supply is greater than the specified period for the medicine. Safety Net benefits do not apply for the original, or any repeats making up the total, if a Regulation 49 supply is an early supply (within the specified period).

It is not necessary to have all repeats on a Regulation 49 prescription dispensed. However, any repeats not used when the prescription is supplied are forfeited.

For more information please visit the Regulation 49 sections under Prescribing Medicines, Supplying Medicines, and Patient Charges; and the Patient Contributions for Early supply of Some PBS Medicines section under Patient Charges.

PBS Refunds

What happens if I forget to present my Medicare or Concession Card when I am getting my prescription?

If you do not present your Medicare Card or Concession Card when having your prescription filled you may pay more than the co-payment amount at the time of purchase. You may be eligible for a refund of money if:

You are a general patient unable to present your Medicare Card and pay the full private prescription amount
You are a concessional patient unable to present your Concession Card (including SN or CN Cards) and pay the general patient amount
You are a concessional patient unable to present your Concession Card and Medicare Card and pay the private prescription amount

To claim a refund of the overpaid amount at any Medicare Service Centre you must take with you:

Your proof of eligibility to receive PBS medicines (your Medicare card)
Any relevant Concession Card
A PBS refund receipt (requested from your pharmacist)
A PBS patient claim for refund from (available from a Medicare Service Centre)

You will receive the difference between the amount that you paid when filling your prescription and the amount that you were entitled to pay at time of payment.

The price you were entitled to at payment is determined by adding the applicable co-payment amount with any applicable premiums.

The price you paid when filling your prescription is the dispensed price for maximum quantity price listed in the schedule.

If the difference calculated is a negative number, you will not receive a refund. This could be because the Australian Government does not subsidise your particular medicine, if you are a general patient.

Brand premiums, therapeutic group premiums, special patient contributions, the Allowable Extra fee, and the Additional fee are not refunded.

If you have exceeded the Safety Net threshold and require a refund, you can claim the overspent amount by applying in writing to Services Australia. You need to include photocopies of your PRF, Medicare card, and Concession Card if you have one.

Please send to:

Services Australia
GPO Box 9826
[In your State Capital]
[Your State & applicable postcode]

If you would like more information please visit the Retrospective Entitlement and Patient Refunds section.

Can someone else collect my PBS refund for me?

Yes, you will need to get a nominated agent to do this for you. You can get a patient/claimant form to authorise this from a Medicare Service Centre. The agent will need to take the PBS refund receipt from your pharmacist and a completed PBS Patient Claim for refund form.

If you would like more information please visit the Claiming and Collecting PBS for Someone Else section on the Services Australia website. Alternatively, please visit the Receipts section.

Top of page

Other Information

What is Supply Only?

When a product is deleted from the PBS, that product may be available for Supply Only where appropriate. Products that are in a Supply Only state will be available for dispensing, but not for prescribing, usually for a period of up to 12 months from the deletion date.

Supply only provides benefits to individuals and dispensing pharmacies by allowing eligible existing prescriptions to be filled for a time after a product has been deleted from the PBS, thus reducing the requirement of a doctor’s visit to get a new script, and reducing wastage in pharmacies.

Can a clinical trial investigator (i.e. health professional/medical practitioner) prescribe a PBS medicine to a participant patient in a clinical trial?

Through the PBS, the Australian Government subsidises medicines that are necessary to maintain the health of the community in a way that is cost effective. A clinical trial investigator is not precluded from prescribing a PBS listed medicine. However, a participating patient would need to be eligible for PBS benefits (as evidenced by a Medicare card) and the patient’s condition would need to meet any conditions or restrictions which apply when the medicine is supplied through the PBS. Information about the medicines listed on the PBS and the applicable restrictions can be found in the PBS Schedule (this can be accessed online at www.pbs.gov.au). Information for medical professionals about how to prescribe PBS medicines is available on the PBS website at www.pbs.gov.au/info/healthpro/explanatory-notes/section1/Section_1_2_Explanatory_Notes

What happens if I take my PBS medicines overseas?

It is illegal to take your PBS medicines overseas unless it is for personal use, or for the use of the person travelling with you.
For more information please call the Taking or Sending PBS Medicines Overseas inquiry line on 1800 500 147. Please also see Travelling Overseas with PBS Medicines on the Services Australia website or Travelling with medicines and medical devices on the TGA website.

What are Emergency Treatment (doctor’s bag) supplies?

Certain medicines are provided free of charge to your doctor, so in time of emergency they can be provided to you with out charge.

If you would like more information, please call Services Australia on 132 290. Please also see the Emergency Drug (Doctor’s Bag) Supplies section.

What is an extemporaneously prepared medicine?

An extemporaneously prepared medicine is prepared by your pharmacist with several different ingredients. Only if each ingredient is listed on the PBS Schedule, can you receive it at a reduced PBS price.

For more information please visit Pricing Extemporaneously Prepare Items section.

What are Section 100 items?

Section 100 of the National Health Act 1953 gives the Minister for Health the power to arrange an alternative method of supply of medicines to patients when supply through a community pharmacy is not appropriate or efficient for the patient. Section 100 items, are medicines that are specialised and generally cannot be obtained through your community pharmacy.

Section 100 programs include:

Highly Specialised Drugs Program
Efficient Funding of Chemotherapy
Botulinum Toxin Program
Human Growth Hormone Program
IVF Program
Opiate Dependence Treatment
Special Authority Program

If you are receiving benefits through a Section 100 program you are generally required to pay a contribution for each supply at the PBS co-payment amount.

If you would like more information please visit the Section 100 section.

What is the Special Access Scheme?

You can access medicines not available in Australia for personal use through the Special Access Scheme (SAS). Your doctor must apply to the Therapeutic Goods Administration (TGA) for approval to import these medicines. This is done by calling 02 6232 8111.

All costs of SAS medicines are at your expense. Prescriptions supplied under the SAS are considered to be private prescriptions and cannot count towards your Safety Net threshold.

For more information please visit the Special Access Scheme section on the TGA website.

What is a section 19A medicine, and how is it listed on the PBS?

Generally, prescription and over-the-counter medicines must be included in the Australian Register of Therapeutic Goods (ARTG) before those medicines can be marketed in Australia.

Occasionally, the availability of a registered medicine is affected by a medicine shortage or unavailability. In these circumstances, there is provision under section 19A of the Therapeutic Goods Act 1989 to approve the import or supply of a medicine that is not included in the ARTG.

If the brand, drug, form, manner of administration and responsible person of the section 19A medicine are all the same as the PBS Listing in short supply, then the section 19A medicine is a ‘pharmaceutical benefit’ as defined in the National Health Act 1953, and may be subsidised under the existing PBS Listing. The responsible person of a section 19A medicine must be the sponsor for whom the TGA approval is granted.

Where the brand, drug, form, manner of administration and responsible person of the section 19A medicine are not all the same as the PBS Listing in short supply, sponsors need to submit an application to list the item on the PBS. The section 19A sponsor is required to complete the following documents and submit them to PBSpricing@health.gov.au and PBAC@health.gov.au.

Part C of the Application Form for Submission Services
PB11 – Application to list
PB11a – Request for Approved Ex-manufacturer Price
PB11b – Cost of goods information
Notification of Responsible Person Form
Copy of TGA section 19A approval
Copy of Product Information sheet

Copies of the PBS forms mentioned are available at PBS forms.

There are no cost recovery fees associated with the temporary listing of a section 19A item.

Top of page

Is the full cost of the medicines listed on the medicine labels?

Yes, since 1 August 2003 the full cost (dispensed price for maximum quantity as in the PBS schedule) of your medicine is required to be listed on the labelling of your medication packaging. The purpose of this is to show you the true cost of the medicine.

What is considered fraud in relation to the PBS?

It is considered fraud when someone:

Is using someone else’s Medicare Card
Is using an invalid Concession Card
Forges prescriptions for PBS medicines
Makes PBS claims for pharmaceutical benefits that were not provided
Swaps PBS prescription medications for other pharmacy medications or goods

If you suspect a case of PBS fraud or require more information, please call Services Australia on 131 524 or visit the Report Fraud section on their website.

What is the Eighth Community Pharmacy Agreement (8CPA)?

The Eighth Community Pharmacy Agreement (8CPA) is an agreement between the Commonwealth of Australia, and the Pharmacy Guild of Australia. It supports consumer access to PBS subsidised medicines through community pharmacies across Australia.

How do I report an adverse drug reaction?

If you are taking medication and believe you have experienced an adverse drug reaction, then you can report it to the Consumer Adverse Medication Events line on 1300 134 237.

If you are a health professional and you are a registered user of the Therapeutic Goods Administration (TGA) Australian Adverse Drug Reaction Reporting System then you may report such reactions online, there is also a reporting card that can be obtained from the TGA.

You can send completed cards to:

Office of Product Review, TGA
Reply Paid 100
Woden ACT 2602

***If you think you may be suffering an adverse drug reaction please seek immediate medical attention***

If you would like more information please visit the Report a Problem with a medicine or medical device section on the TGA website.

What is the prescription shopping information service?

The prescription shopping information service provides information to doctors regarding the types and quantities of medicines that their patient is getting from a pharmacist. The doctor may use this service if they suspect their patient is seeking to obtain medicine in excess of their medical need. The doctor will need to be registered with Services Australia to access this service.

If a patient has been identified as meeting the prescription shopping project criteria, the doctor may find out the number of PBS items supplied to the patient and the number of doctors who prescribed those medications. A more in-depth report can be issued detailing the types and quantities of medicines supplied.

If you would like more information please view the Prescription Shopping Program section on the Services Australia website. Doctors can also contact a 24 hour phone line on 1800 631 181 to access the service.

Continuation Rules for PBS-listed Drugs

When a drug is listed on the Pharmaceutical Benefits Scheme (PBS), certain restrictions or conditions may apply to ensure that the product is subsidised in situations where treatment has been proved to be both medically effective and cost-effective. This is especially the case with high-cost drugs which may only be effective in specific patient groups.

Access to PBS-subsidised drugs falls into three broad categories:

unrestricted benefits – where the doctor can prescribe through the PBS without restrictions on therapeutic use;
restricted benefits – where the doctor can prescribe through the PBS when satisfied that the patient’s clinical condition matches the approved therapeutic uses, as determined by the Pharmaceutical Benefits Advisory Committee (PBAC); and
authority-required benefits – where the doctor can prescribe through the PBS when satisfied that the patient’s clinical condition matches the approved therapeutic restrictions, as determined by the PBAC and prior approval from Medicare Australia has been obtained.

For some authority-required drugs available on the PBS, patients must meet continuation criteria in order to continue treatment with the subsidised drug. These restrictions are a way of ensuring that PBS drugs are used in a way that represents good value for taxpayers’ money.

Top of page

Industry Questions

New brand, Delete brand or List management service request submission are now lodged through the Health Products Portal (HPP). For instructions on how to get started, please visit the HPP website.

What do I need to do when I want to change the Responsible Person (RP) for a PBS product?

A Responsible Person (RP) is the supplier of a particular brand of a PBS item. The RP may be an individual or an Australian corporation and must have an Australian Business Number (ABN).

Responsibilities of the new RP

To change the RP for a PBS product, you should email a request to PBS Listings. Your request should include a Responsible Person declaration for the new PBS supplier. The Responsible Person form must detail all the products which are transferring to the new RP.

A new PB11a form is required for the purpose of a new price agreement where the RP changes for a PBS product. For information concerning requirements and submission of the form contact the Pricing Section at PBS Pricing.

Responsibilities of the relinquishing RP

You should email PBS Listings authorising the change of Responsible Person. Alternatively, the Public ARTG summary should be updated to reflect the new Responsible Person details.

Transfer of Responsible Person will take effect in line with normal listing timelines once all information is received. For more information on these timelines, please see the Summary of Deadlines.

What do I need to do if I want to change and/or add an Authorised Representative (AR) for a Responsible Person (RP)?

An Authorised Representative (AR) is an individual who has legal authority to act on behalf of a Responsible Person (RP) in matters pertaining to the PBS.

Any individual with AR status for an organisation will be able to fill the functions of an AR for all PBS listed products for that organisation. Care should be taken that those assigned the AR role are appropriate for PBS authority decisions, and the contact details are accurate for those users.

To add or change the AR for an RP you should update member permissions, via the Organisation profile in the Health Products Portal (HPP).

For more information, you can find relevant support articles by searching ‘Update details’ on Health Products Portal (HPP).

The removal of an Authorised Representative from Departmental systems will take effect in line with normal listing timelines. For more information on these timelines, please see the Summary of Deadlines.

What do I need to do if I want to change contact details (e.g. address, telephone number, email address) for a Responsible Person (RP) or Authorised Representative (AR)?

To update the contact details of an AR, the AR should use the HPP to update their personal profile in the Health Products Portal (HPP). Please note, a personal email address for an AR will not be accepted by the Department (please ensure the email address includes a company domain).

To update RP details, you should update the Organisation profile in the Health Products Portal (HPP). Please ensure the ‘Company details’ section is completed with your organisation’s customer service contact number and email address. These details are displayed on the PBS website for Manufacturer/Supplier contact details.

For more information, you can find relevant support articles by searching ‘Update details’ on Health Products Portal (HPP).

How do I list a new brand of an existing PBS item on the PBS?

Listing requirements for a new brand can be found in the Procedure guidance for listing medicines on the Pharmaceutical Benefits Scheme. The deadlines which apply can be found on the PBS Calendar page. Listing of new brands which cause a price change can only occur 6 times a year (February, April, June, August, October and December) and it should be noted that different deadlines apply to these products. New brands that are equivalent to existing brands must be marked as equivalent and interchangeable in the Schedule of Pharmaceutical Benefits. If there is no evidence of equivalence to a brand that can be prescribed, an application to list the new brand should be made to the Pharmaceutical Benefits Advisory Committee.

Please note that the Repatriation Pharmaceutical Benefits Scheme is managed by the Department of Veterans’ Affairs (DVA) and applications to list a new brand on the Repatriation Schedule of Pharmaceutical Benefits must be emailed to DVA (Repatriation.Pharmaceutical.Reference.Committee@dva.gov.au).

What do I need to do if the brand name of my PBS-listed product has changed?

All instances of changing a brand name require a statement from the Therapeutic Goods Administration (TGA) to the effect that the old and new brands are the same product. Whilst the Australian Register of Therapeutic Goods (ARTG) identification number (ID) will generally remain the same for the new brand, this may not be the case in all instances. It is a general condition that a Responsible Person may not supply the currently listed brand once supply of the new brand has commenced; however, there may be a period of overlap no greater than 12 months where both brands are concurrently PBS-listed, to ensure that pharmacies have an opportunity to deplete stock, and so that patients can utilise any existing brand-specific prescriptions (including repeats).

See below for managing re-branding submissions via the Health Products Portal (HPP).

Concurrent listing of new brand and previous brand

A Responsible Person may not supply a currently listed brand once PBS supply of the new brand of the same product has commenced. The Responsible Person must therefore submit an application to delist the currently listed brand contemporaneously with the new brand submission. To provide time for pharmacies to deplete existing stock of the old brand, the delist submission can allow for up to 12 months’ dual PBS-listing (noting that the Responsible Person may opt for a shorter period). To change the brand name of a PBS‑listed product, the following steps must be followed:

Use the Health Products Portal (HPP) to make a ‘New Brand’ submission. Include in the submission title the words ‘re-branding’ and a reference to the associated HPP delist submission number (see below) within the submission purpose.
Use the Health Products Portal to make a ‘Delist Brand’ submission. Include in the submission title the words ‘re-branding delisting’ and a reference to the associated HPP new brand submission number within the submission purpose.
Add a brief explanation for the proposed length of concurrent PBS-listing (if required) of the old and new brands, e.g. “we expect that all stock of the old brand will be fully exhausted in the market by that date”.
If the preferred Effective Date cannot be selected in the HPP submission template, the nearest available date should be selected, while stating your preferred delisting date within the submission purpose.

Note that after the delist request has been lodged in HPP, you can (if necessary) request an update to the Effective Date a Correspondence from within the relevant HPP Submission. In this event, please refer to the FAQ entitled How do I change the Forecast Effective Date (FED) in a PBS new listing or delist submission?

Delist/ Relist for the same Forecast Effective Date

As noted above, the Responsible Person may not supply the currently listed brand once supply of the new brand has commenced; however, rather than seek concurrent listing, the Responsible Person may instead opt for a deletion of the currently listed brand at the time the new brand lists (contiguous delist/relist). Refer to the instructions above to submit a ‘New Brand’ submission and ‘Delist Brand’ submission via HPP where the same FED applies to both submissions.

If you require any further guidance, you can contact the PBS Listing team at PBS Listing.

What do I need to do in order to delete (delist) my product from the PBS?

To delete (delist) a product from the PBS Schedule, please use the Health Products Portal to make a ‘Delete brand’ submission.

Item deletion: If the product you wish to delete is the only brand of an item listed in the Schedule of Pharmaceutical Benefits (the Schedule), your submission will generally require advice from the PBAC. In this case, you should complete your ‘Delete brand’ submission in the HPP, for that brand only, and include as much information as possible about the reason(s) for the deletion and whether the product will continue to be marketed in Australia. This will enable efficient progression of the submission to the PBAC for consideration. Please note that deletion from the Schedule cannot occur within 5 months of the date of PBAC consideration.
Brand deletion: If the product you wish to delete is one of several brands of an item listed in the Schedule, your submission will generally not require advice from the PBAC. If you are seeking the deletion of more than one brand of this kind and the effective dates for deletion are the same, please complete a single ‘Delete brand’ submission in the HPP, including all requested deletions. Where multiple deletions would have more than one effective date, you should complete a separate ‘Delete brand’ submission per effective date. The usual deadlines apply for publication in the Schedule.

Please note that item deletions and brand deletions must be requested separately via discrete ‘Delete brand’ submissions in the HPP.

In each instance it is preferred that, if possible, up to three months’ advance notice of the deletion be given in the Schedule. Some deleted products will immediately acquire Supply Only status, lasting for a period up to 12 months, to ensure prescriptions written prior to the Supply Only period can continue to be dispensed under PBS arrangements.

How do I change the Forecast Effective Date (FED) in a PBS new listing or delist submission?

To request a change to the FED in a PBS submission, use the Health Products Portal (HPP) to send a Correspondence from the relevant HPP submission. Requests for a change to an FED should be lodged at least six (6) weeks prior to the submission FED.

Note that the processes required to effect the change or withdrawal of an HPP new brand or delist submission are finalised approximately six weeks before the applicable FED; an Organisation seeking to change an FED should take this into consideration prior to making a request. This cut-off is necessary owing to the administrative complexity of the PBS listing process, and the range of stakeholders who are dependent on early receipt of PBS data to allow prescribing, dispensing, claiming and payment systems to be updated and available for use on the effective date.

New brand submissions include a supply assurance that the company will have sufficient stock available for supply on the requested effective date. If your change to FED results in a period of listing on the PBS where the product is unable to be supplied, please refer to the guidance available on the Guarantee of Supply page on this site.

What is ‘Guarantee of Supply’, and what must I do if I cannot (or believe that I will not) fulfil my Guarantee of Supply obligations?

The guarantee of supply requirements apply to newly listed brands that are bioequivalent or biosimilar to an existing listed brand and have the same drug and manner of administration. A brand subject to a guarantee of supply requirement is known as a ‘guaranteed brand’.

The Responsible Person for a guaranteed brand must be able to supply the guaranteed brand within a reasonable period after receiving a request to supply from a wholesaler or approved pharmacist. Where the responsible person wishes to advise a failure to supply a brand of an item listed on the PBS, or a belief that a failure to supply is likely to occur, the responsible person should email a completed Guarantee of Supply form to PBS Listings.

Please refer to the Guarantee of Supply page for more information.

I have a product which contains the same active moiety as an existing pharmaceutical benefit but is a different salt. My product has been demonstrated to be bioequivalent to a product which is already on the PBS although it is a different salt. Does this product have to be considered by the Pharmaceutical Benefits Advisory Committee before being able to be listed in the Schedule of Pharmaceutical Benefits?

Yes, unless the product is for oral administration. Products containing the same active moiety, but a different salt, must be recommended for listing on the PBS by the Pharmaceutical Benefits Advisory Committee (PBAC). The PBAC must also make a recommendation about whether it is appropriate to mark the new product as bioequivalent to, and interchangeable with, existing pharmaceutical benefits. The PBAC must have access to advice from the Therapeutic Goods Administration (TGA) about the bioequivalence of the new product to an existing PBS listed product.
For oral products an application to list the product should be made as a New brand submission in the Health Products Portal (HPP) – see How do I list a new brand of an existing PBS item on the PBS?

I have a product which contains the same active moiety as an existing pharmaceutical benefit but is a different dosage form. My product has been demonstrated to be bioequivalent to a product which is already listed on the PBS. Does this product have to be considered by the Pharmaceutical Benefits Advisory Committee before being able to be listed in the Schedule of Pharmaceutical Benefits?

Yes, unless the product is for oral administration. Products containing the same active moiety, but a different dosage form, must be recommended for listing on the PBS by the Pharmaceutical Benefits Advisory Committee (PBAC). The PBAC must also make a recommendation about whether it is appropriate to mark the new product as bioequivalent to, and interchangeable with, existing pharmaceutical benefits. The PBAC must have access to advice from the Therapeutic Goods Administration (TGA) about the bioequivalence of the new product to existing PBS listed products. For oral products an application to list the product should be made as a New brand submission in the Health Products Portal (HPP) – see How do I list a new brand of an existing PBS item on the PBS?

Top of page

What do I need to do if I want to supply a product on the PBS in a different container type to that for which I originally sought PBS listing, e.g. a blister pack instead of, or in addition to, a bottle?

Products packed in different container types are considered to be different products by the Therapeutic Goods Administration (TGA) and require a separate entry in the Australian Register of Therapeutic Goods. If a supplier wishes to seek authorisation to supply a product in a different, or additional, container to that for which documentation was originally provided for PBS listing, a letter should be sent via email to PBS Listings requesting this. The request should include a Responsible Person declaration detailing the “new” product and evidence of bioequivalence to the existing PBS listed product. The "new" product may not be supplied on the PBS until written communication authorising such supply is received.

What do I need to do if I want to change the ARTG number of a product on the PBS from that for which PBS listing was originally granted?

Where a Responsible Person wishes to supply a product with a different ARTG number on the PBS, as a replacement for the product for which PBS listing was originally granted, authorisation to do so must be sought and granted. This may be necessary when there is a change in manufacturer/supplier of a product, or where there is a formulation change. (If the formulation change is such that a new ARTG number is not needed, authorisation need not be sought).

The request should be sent via email to PBS Listings and should include a Responsible Person declaration and evidence of bioequivalence of the “new” product with the “old”. The "new" product may not be supplied on the PBS until authorisation is received.

Any changes to the ARTG certificate for a device should be made to the Pharmaceutical Benefits Advisory Committee (PBAC).