Authorised Prescriber Scheme

Guidance for Medical Practitioners, Human Research Ethics Committees, Specialist Colleges and Sponsors

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3 July 2017

Information for Sponsors

Releasing unapproved goods to medical practitioners

You must obtain a copy of the TGA approval letter from the medical practitioner before the release of the unapproved good.

Reporting of supply to TGA

You must report to us ever six months the quantity of the unapproved good that you have supplied during that six-month period under the Authorised Prescriber scheme. It is preferred that this information be provided to us via email.

Reporting adverse events and product defects

We encourage sponsors to report all adverse events and product defects to us. This helps us to monitor the safety of all therapeutic goods.

Sponsors are encouraged to report:

  • fatal or life-threatening outcomes to us early (ideally within seven calendar days of becoming aware of them) and then follow up with a more complete report (ideally within the next eight calendar days)
  • other serious and unexpected adverse within 15 calendar days (advise TGA if you think any of these may have already been reported to us)

Advise TGA as soon as possible of any information that could affect the risk-benefit assessment of the product or situations in which the product should be used.

There are various ways to report adverse events and product defects, which can be found on our website at Reporting problems.

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