Health practitioners are encouraged at all times to use therapeutic goods that have been entered on the Australian Register of Therapeutic Goods (ARTG) as these have been evaluated for quality, safety and effectiveness (or performance).
However, we recognise there are times where it may be necessary to use a therapeutic good that is not on the ARTG.
There are a number of pathways available to access unapproved therapeutic goods, including the Special Access Scheme (SAS) and Authorised Prescriber (AP) Scheme.
To help health practitioners determine which of these pathways, if any, is appropriate to be used in any given circumstance, we have developed a tool to guide you down the appropriate access pathway.
In conjunction with this tool, you are encouraged to familiarise yourself with the Special Access Scheme Guidance for Health Practitioners and Sponsors and Authorised Prescriber Scheme Guidance for Medical Practitioners, Human Research Ethics Committees and Specialist Colleges.
Medical device - Individual patient - Special Access Scheme Category B
You may be able to access the unapproved medical device by submitting a separate SAS Category B application for each individual patient through the SAS Category B pathway.
Useful links:
Medical device - Authorised Prescriber (AP) pathway
You may be able to access the unapproved medical device for your patient through the Authorised Prescriber (AP) pathway.
Useful links:
Biological - Individual patient - Special Access Scheme Category B
You may be able to access the unapproved biological by submitting a separate SAS Category B application for each individual patient through the SAS Category B pathway.
Useful links:
Biological - Authorised Prescriber (AP) pathway
You may be able to access the unapproved biological for your patient through the Authorised Prescriber (AP) pathway.
Useful links:
HREC? - medical practitioner - medical device
A medical practitioner seeking to become an Authorised Prescriber of a medical device should first seek approval from a Human Research Ethics Committee (HREC).
In circumstances where the medical practitioner seeking to become an Authorised Prescriber of an unapproved medical device does not have access to an ethics committee, the medical practitioner may obtain endorsement from a specialist college that has expertise relevant to the treatment of the medical condition for which authority is sought.
Under the Therapeutic Goods Act 1989, an ethics committee must be constituted and operate in accordance with the National Health and Medical Research Council guidelines and have notified its existence to the Australian Health Ethics Committee.
Medicine - Individual patient - Special Access Scheme Category B
You may be able to access the unapproved medicine by submitting a separate SAS Category B application for each individual patient through the SAS Category B pathway.
Useful links:
Medicine - Authorised Prescriber (AP) pathway
You may be able to access the unapproved medicine for your patient through the Authorised Prescriber (AP) pathway.
Useful links:
HREC? - medical practitioner - biological
A medical practitioner seeking to become an Authorised Prescriber of a biological should first seek approval from a Human Research Ethics Committee (HREC).
In circumstances where the medical practitioner seeking to become an Authorised Prescriber of unapproved biologicals does not have access to an ethics committee, the medical practitioner may obtain endorsement from a specialist college that has expertise relevant to the treatment of the medical condition for which authority is sought.
Under the Therapeutic Goods Act 1989, an ethics committee must be constituted and operate in accordance with the National Health and Medical Research Council guidelines and have notified its existence to the Australian Health Ethics Committee.
HREC? - medical practitioner - medicine
To become an Authorised Prescriber of products that are not included in subregulation 12B(1B) of the Therapeutic Goods Regulations 1990, a medical practitioner should first seek approval from a Human Research Ethics Committee (HREC).
In circumstances where the medical practitioner seeking to become an Authorised Prescriber of unapproved medicines does not have access to an ethics committee, the medical practitioner may obtain endorsement from a specialist college that has expertise relevant to the treatment of the medical condition for which authority is sought.
Under the Therapeutic Goods Act 1989, an ethics committee must be constituted and operate in accordance with the National Health and Medical Research Council guidelines and have notified its existence to the Australian Health Ethics Committee.
Intended patient? - medical practitioner - biological - not critically ill
Different pathways might be available depending on whether you intend to supply the unapproved therapeutic good to an individual patient or a class of patients.
Do you want to access the unapproved biological for an individual patient or for a class of patients?
Intended patient? - medical practitioner - medical device - not critically ill
Different pathways might be available depending on whether you intend to supply the unapproved therapeutic good to an individual patient or a class of patients.
Do you want to access the unapproved medical device for an individual patient or for a class of patients?
Intended patient? - medical practitioner - medicine - not critically ill
Different pathways might be available depending on whether you intend to supply the unapproved therapeutic good to an individual patient or a class of patients.
Do you want to access the unapproved medicine for an individual patient or a class of patients?
Medicine - Special Access Scheme Category A
You may be able to access the medicine for your patient through SAS Category A pathway.
Useful links:
Intended patient? - medical practitioner - medicine - critically ill
Different pathways might be available depending on whether you intend to supply the unapproved therapeutic good to an individual patient or a class of patients.
Do you want to access the unapproved medicine for an individual patient or a class of patients?
Biological - Special Access Scheme Category B
You may be able to access the unapproved biological for your patient through the SAS Category B pathway.
Useful links:
Biological - Special Access Scheme Category C
Health practitioners may be able to access the unapproved medical device for a single patient through the SAS Category C pathway if the type of health practitioner, biological, route of administration and indication match an entry in the Therapeutic Goods Rules. The Category C pathway is a notification pathway that does not require you to wait for approval from the TGA.
Useful links:
Medical device - Special Access Scheme Category B
You may be able to access the unapproved medical device for your patient through the SAS Category B pathway.
Useful links:
Medical device - Special Access Scheme Category C
Health practitioners may be able to access the unapproved medical device for a single patient through the SAS Category C pathway if the type of health practitioner, kind of medical device and intended purpose match an entry in the Therapeutic Goods Rules. The Category C pathway is a notification pathway that does not require you to wait for approval from the TGA.
Useful links:
Medicine - Special Access Scheme Category B
You may be able to access the unapproved medicine for your patient through the SAS Category B pathway.
Useful links:
Medicine - Special Access Scheme Category C
Health practitioners may be able to access the unapproved medicine for a single patient through the SAS Category C pathway if the type of health practitioner, medicine, dosage form, route of administration and indication match an entry in the Therapeutic Goods Rules. The Category C pathway is a notification pathway that does not require you to wait for approval from the TGA.
OR
Medical practitioners may also be able to access the unapproved medicine through the Authorised Prescriber scheme for a class of patients if the type of health practitioner, medicine, dosage form, route of administration and indication match an entry in subregulation 12B(1B) of the Therapeutic Goods Regulations 1990. Human Research Ethics Committee (HREC) approval or Specialist College endorsement is not required to be submitted to the TGA for medicines in this list.
Useful links:
Established history of use? - medical practitioner - biological - not critically ill
The pathway to access the unapproved biological may depend on whether it is considered to have an established history of use.
About the Therapeutic Goods Rules
The Therapeutic Goods Rules list certain goods with an established history of use. You should check to see if the health practitioner type, biological, route of administration and indication match an entry in the Rules.
Biological - Special Access Scheme Category A
You may be able to access the biological for your patient through SAS Category A pathway.
Useful links:
Established history of use? - medical practitioner - medical device - not critically ill
The pathway to access the unapproved medical device may depend on whether it is considered to have an established history of use.
About products with an established history of use
The Therapeutic Goods Rules list certain goods with an established history of use. You should check to see if the health practitioner type, kind of medical device and intended purpose match an entry in the Rules.
Medical Device - Special Access Scheme Category A
You may be able to access the medical device for your patient through SAS Category A pathway.
Useful links:
Established history of use? - medical practitioner - medicine - not critically ill
The pathway to access the unapproved medicine may depend on whether it is considered to have an established history of use.
About products with an established history of use
There are two separate lists of medicines with an established history of use available in:
- Therapeutic Goods Rules; and
- Subregulation 12B(1B) of the Therapeutic Goods Regulations 1990.
You should check to see if the medicine, dosage form, route of administration and indication match an entry in the lists above.
Poisons standard? - medical practitioner - medicine - critically ill
The Poisons Standard consists of decisions regarding the classification of medicines and poisons into Schedules for inclusion in the relevant legislation of the States and Territories.
Established history of use? - other health practitioner - biological
The pathway to access the unapproved biological may depend on whether it is considered to have an established history of use.
About products with an established history of use
The Therapeutic Goods Rules list certain goods with an established history of use. You should check to see if the health practitioner type, biological, route of administration and indication match an entry in the Rules.
Established history of use? - other health practitioner - medical device
The pathway to access the unapproved medical device may depend on whether it is considered to have an established history of use.
About products with an established history of use
The Therapeutic Goods Rules list certain goods with an established history of use. You should check to see if the health practitioner type, kind of medical device and intended purpose match an entry in the Rules.
Established history of use? - other health practitioner - medicine
The pathway to access the unapproved medicine may depend on whether it is considered to have an established history of use.
About products with an established history of use
The Therapeutic Goods Rules list certain goods with an established history of use. You should check to see if the health practitioner type, medicine, dosage form, route of administration and indication match an entry in the Rules.
Critically ill patient? - medical practitioner - biological
Patient is seriously ill with a condition from which death is reasonably likely to occur within a matter of months, or from which premature death is reasonably likely to occur in the absence of early treatment.
Critically ill patient? - medical practitioner - medical device
Patient is seriously ill with a condition that is reasonable likely to lead to the person's death within a year, or without early treatment, to the person's premature death.
Critically ill patient? -medical practitioner - medicine
Patient is seriously ill with a condition from which death is reasonably likely to occur within a matter of months, or from which premature death is reasonably likely to occur in the absence of early treatment.
Type of product? - other health practitioner
Medicines can be any good used to treat or prevent disease, condition or injury. These products can range from pain-killers and sunscreens to herbals, vitamins, biological medicines (monoclonal antibodies) and blood components - some of which may require a medical prescription.
Medical devices include a range of goods such as bandages, pacemakers, x-ray equipment, and in vitro diagnostic medical devices. Goods containing non-viable animal products may also be considered devices.
Biologicals generally comprise, contain or are derived from human cells or human tissues and are represented for a therapeutic use.
Do you want to access an unapproved medicine, medical device or biological?
Type of product? - medical practitioner
Medicines can be any good used to treat or prevent disease, condition or injury. These products can range from pain-killers and sunscreens to herbals, vitamins, biological medicines (monoclonal antibodies) and blood components - some of which may require a medical prescription.
Medical devices include a range of goods such as bandages, pacemakers, x-ray equipment, and in vitro diagnostic medical devices. Goods containing non-viable animal products may also be considered devices.
Biologicals generally comprise, contain or are derived from human cells or human tissues and are represented for a therapeutic use.
Do you want to access an unapproved medicine, medical device or biological?
Not a health practitioner
You need to be a health practitioner (and more specifically, for some pathways, a medical practitioner) to access unapproved therapeutic goods through the Special Access Scheme (SAS) or Authorised Prescriber (AP) Scheme. If you are a patient, you may be able to access the unapproved therapeutic good through the Personal Importation Scheme.
Are you a medical practitioner?
Certain unapproved therapeutic goods access pathways can only be accessed by persons who are registered as a medical practitioner in a State or internal Territory of Australia.
Are you a health practitioner?
A health practitioner is taken to be any of the following persons:
- Aboriginal and Torres Strait Islander Health Practitioner
- Dentist
- Medical Practitioner
- Radiographer
- Nurse
- Midwife
- Occupational Therapist
- Optometrist
- Pharmacist
- Physiotherapist
- Podiatrist
- Psychologist
Failure to accept terms of the disclaimer
You are unable to continue using this tool unless you agree to the terms of the disclaimer.
Go back and try again or contact us.
This is an approved therapeutic good
The product has already been approved by the TGA and has been authorised for supply in Australia. Please contact a pharmacy to see if they can source the good, or the sponsor of the goods listed on the ARTG entry.
Accessing unapproved therapeutic goods
Therapeutic goods entered in the Australian Register of Therapeutic Goods (ARTG) have been approved for lawful supply in Australia.
Note: goods entered in the ARTG are approved for specific uses (indications), dosage forms (e.g. injection), routes of administration (e.g. IV) and presentations (e.g. glass vial).
Disclaimer
The Department of Health has taken due care in preparing these materials but we do not guarantee, and assume no legal liability or responsibility for, the accuracy, currency or completeness of the information contained in these materials. It should be noted that this is general information only.