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Special Access Scheme: Guidance for health practitioners and sponsors
Version 1.1, September 2017
Information for sponsors
Information for sponsors
Suppliers are under no obligation to supply an unapproved product regardless of whether the TGA has approved or authorised the use of the product or received a notification under the SAS.
Responsibilities of sponsors
Under the Therapeutic Goods Regulations 1990 (The Regulations) (regulation 47B), the sponsor is required to provide us with six-monthly reports detailing each kind of therapeutic good supplied, the number of times supplied to a health practitioner and the quantity supplied by the sponsor during the period to which the report relates.
If you, as the sponsor, anticipate a need for long-term supply of the product, you should consider submitting a registration application.
Reporting adverse events and defects
You are responsible for continually monitoring the use of the therapeutic good you supply under the SAS, reporting the types of adverse reactions and effects described below and any defects, and recording the balance of its benefit and risk. Ideally, the use of an unapproved medicine, biological or medical device should be the subject of treatment protocols that are issued by yourself, with clear requirements for the treating health practitioner to report any adverse outcomes to yourself.
Sponsors of products supplied under the SAS are also required to rapidly advise TGA of any information that has bearing on the benefit-risk assessment of the product—particularly any information that change how the product is used under the SAS.
As part of the evaluation dossier and overall development of a medicine, biological or medical device, sponsors should continually monitor and record the product's safety and assess the risk-benefit of its use.
We expect sponsors to report all suspected unexpected serious adverse reactions (for medicines and biologicals), unanticipated serious adverse device effects (for medical devices) and any defects that affect unapproved therapeutic goods supplied in Australia to TGA. This helps us to monitor the safety of all therapeutic goods.
Suspected unexpected serious adverse reactions are defined as an adverse reaction that is both serious and unexpected.
An unanticipated serious adverse device effect is defined as a serious adverse device effect which by its nature, incidence, severity or outcome is both serious and unanticipated.
These should be reported in accordance with the following timelines:
- For fatal or life-threatening outcomes, these should be reported to us within seven calendar days of first knowledge (initial report) and then follow up with a more complete report within eight additional calendar days
- All other serious and unexpected/unanticipated adverse reactions/effects and any defects should be reported within 15 calendar days
There are multiple ways in which adverse events and defects can be reported to the TGA (see Reporting mechanisms).
Supply of products
SAS Category A
A completed notification form from the prescribing medical practitioner or a health practitioner on behalf of the prescribing medical practitioner is required to be submitted to the sponsor before the sponsor can legally supply the product.
SAS Category B
An approval letter from TGA is required to be submitted to the sponsor before the sponsor can legally supply the product.
SAS Category C
The inclusion of a product in the following legislative instruments acts as the authorisation for these products to be supplied:
- Medicines: Therapeutic Goods (Authorised Supply of Specified Medicines) Rules September 2017
- Medical Devices: Therapeutic Goods (Authorised Supply of Specified Medical Devices) Rules September 2017
- Biologicals: Therapeutic Goods (Authorised Supply of Specified Biologicals) Rules September 2017
The sponsor is not legally required to be in receipt of the notification form from an authorised health practitioner before they can supply an unapproved therapeutic good that is included in lists of products that are deemed to have an established history of use. The health practitioner needs to submit the notification form only to TGA, and can do so after the goods have been supplied to the patient.
It is the responsibility of the health practitioner to ensure that the therapeutic goods are supplied to patients in accordance with the 'rules' of the instrument. This means that the goods must only be supplied for the indications and by the health practitioner(s) who have been authorised to supply these goods.
The legislative instruments are publically available so that sponsors can check to see if any of their products are affected.
Unapproved therapeutic goods that are not included on any of the legislative instruments; or are included but need to be accessed for an indication or by a health practitioner that is not on the instrument may potentially still be supplied to health practitioners provided that supply occurs lawfully through one or more of the existing unapproved therapeutic goods schemes, including: SAS Category A, SAS Category B application or Authorised Prescriber.
Sponsors cannot apply to the TGA to have goods included or removed from the legislative instruments. The TGA will regularly review unapproved therapeutic goods and make changes to add or remove products as appropriate. Sponsors may wish to subscriber to the email subscriber list which will be utilised by TGA to notify of any changes to the current SAS processes including changes to the goods that can be notified via SAS Category C.