On this page: Obtaining the 'unapproved' goods | Prescribing and using the 'unapproved' good | Six monthly reporting | Reporting adverse events and product defects | Revoking authorisation | If a suitable alternative good is available in the ARTG | Review of medicines with an established history of use
Obtaining the 'unapproved' goods
As an Authorised Prescriber, you are responsible for obtaining the 'unapproved' good. You can do this by contacting the sponsor of the good to arrange supply; however, the sponsor is not legally obligated to supply the good. You can also ask a pharmacy or supplier to arrange supply of the 'unapproved' good.
You must give the sponsor a copy of your TGA approval letter. This authorises them to legally supply the good for use.
You must also consider whether the good is controlled under the Customs (Prohibited Import) Regulations 1956 and the Customs (Prohibited Export) Regulations 1958, and, if the good is controlled, obtain a permit to import it from the Office of Drug Control.
Access to medicinal cannabis may have additional requirements. For further information, refer to the TGA web page discussing Access to medicinal cannabis products: steps to using access scheme.
If you are supplying the goods in a hospital, you might need any hospital drugs and therapeutics committees to approve the use and funding of these goods within the institution.
Unapproved therapeutic goods are not subsidised under the Pharmaceutical Benefits Scheme (PBS), so you should consider the cost that will be incurred.
Prescribing and using the 'unapproved' good
In prescribing the 'unapproved' good for a patient, you are responsible for considering the benefits and risks that apply for the patient. As 'unapproved' goods have not been evaluated by the TGA, you should remain informed of changes to the benefits and risks as they arise.
You should also prescribe the goods in accordance with the legislative requirements relevant to your State or Territory.
Six monthly reporting
You will receive a six monthly report template with your letter of approval. You must report every 6 months (for the periods 1 January to 30 June and 1 July to 31 December) how many patients you treated with the 'unapproved' good during that six-month period. You must send your six monthly report to us within one month after the reporting period. There are two categories to report:
AND
- patients who have newly commenced use of the 'unapproved' product in the 6 month period for reporting
- patients who have continued on the treatment (those who have received supply of the product in a previous reporting period and required further supply in the current reporting period).
If no patients were treated during that time, you must also report this.
Reporting adverse events and product defects
'Unapproved' therapeutic goods generally have not been evaluated for safety, quality and efficacy and could pose unknown risks. Authorised Prescribers are responsible for reporting adverse events or defects arising from the use of 'unapproved' therapeutic goods accessed under the Authorised Prescriber scheme.
If you become an Authorised Prescriber, you must report any suspected adverse events or product defects related to the 'unapproved' good to us within 15 calendar days of learning of it.
You are also required to report any fatal or life threatening adverse drug reactions to the TGA within 7 calendar days after becoming aware of the information and follow up with a complete report if necessary within 8 additional calendar days.
The HREC, specialist college and the good's sponsor may also require you to provide them with adverse event reports.
There are various ways to report adverse events and product defects, which can be found on our website at Reporting adverse events.
Revoking authorisation
TGA can revoke your Authorised Prescriber status if:
- the HREC or specialist college withdraws their approval or endorsement of your status
- you do not meet the conditions we apply to your approval
- a suitable alternative good becomes available and is entered on the ARTG
- we become aware of any significant concerns about a good's safety
If a suitable alternative good is available in the ARTG
If a suitable alternative good becomes available in the ARTG, you should stop using the 'unapproved' good.
If you want to continue using the 'unapproved' good you must submit a new Authorised Prescriber application to the TGA.
If applicable, you will need to submit a clinical justification to your evaluating HREC or specialist college to explain why you want to use the 'unapproved' good instead of the now approved good. The HREC or specialist college will consider this and decide whether continued approval or endorsement is appropriate in light of any available approved good (that has been thoroughly evaluated for safety, quality and efficacy). You must then resubmit this approval or endorsement to the TGA in a new application to become an Authorised Prescriber.
Review of medicines with an established history of use
The TGA will periodically review the 'unapproved' therapeutic goods included in subregulation 12B(1B) of the Therapeutic Goods Regulations 1990 to determine if additional therapeutic goods or indications need to be added.
We will also remove certain therapeutic goods or indications from the list where necessary, for example, this may be where the products become registered in Australia or if a safety concern arises. These may be administrative or clinical decisions based on the ongoing monitoring of the scheme.
Sponsors and health practitioners cannot apply to the TGA to have goods included or removed from the list. At this time, only medicines have been included in the list.