Special Access Scheme
The Special Access Scheme allows for the importation and supply of an unregistered drug for an individual patient under the supervision of a medical practitioner on a case-by-case basis. This is the most common scheme used by medical practitioners and healthcare professionals.
Circumstances, when a patient can access an unregistered drug may include:
- Experimental or investigational products for terminally ill patients;
- A medication administered to a patient in a clinical trial but has not yet received TGA approval; or
- Drugs available overseas but not marketed in Australia (including when similar registered products are in short supply in Australia).
What does ‘unapproved’ mean
Therapeutic goods that are not included in the Australian Register of Therapeutic Goods (and are not otherwise exempt from being in the ARTG) are described by us as ‘unapproved’.
‘Unapproved’ doesn’t mean the Therapeutic Good isn’t safe or effective. It means for some reason the medicine might not be registered in Australia. It could be new therapy and is yet to be evaluated by the TGA. Or the manufacturer has decided not to market the product within a particular country. ‘Unapproved’ drugs are typically registered and widely used overseas.
Special Access Scheme Medicines
Download our Special Access Scheme Medicines flyer and learn how Medsurge can assist you and your patient to source ‘unapproved’ therapeutic goods globally.
