You are here

Australian Public Assessment Report (AusPAR) guidance document

Version 1.5, March 2015

11 March 2015

Book pagination

6. AusPAR publishing

The timeframe for the publication of an AusPAR for a prescription medicine by the TGA depends on whether the submission is approved or not approved by the Delegate under section 25 of the Act or whether and when the submission is withdrawn by the sponsor prior to a decision by the Delegate. The circumstances for publishing an AusPAR and applicable timeframes are provided in the relevant sections.

6.1 TGA website location and search functionality

AusPARs published by the TGA are located at Australian Public Assessment Reports for prescription medicines (AusPARs).

They can be searched by the following fields:

  • active ingredient
  • product name
  • sponsor.

6.2 Product Information

To ensure the AusPAR can be read in conjunction with the relevant approved Product Information (PI), a copy of the approved PI is included in the AusPAR document when it is published by the TGA. This version of the PI will remain static (similar to the AusPAR) and will be 'watermarked' to ensure that this is clear to the reader that any later version of the approved PI is available via the TGA PI/CMI publishing facility at TGA eBusiness Services.

Publishing the approved PI with the AusPAR does not replace the requirement for the sponsor to load their PI, and Consumer Medicine Information (CMI) documents onto the TGA eBusiness Services system.

6.3 Release of AusPAR to NPS MedicineWise

The Secretary can, by reason of the Therapeutic Goods Information (Sharing of Information about Prescription Medicines) Specification 2015 provide information set out in an AusPAR to NPS MedicineWise prior to the publication of the AusPAR on the TGA website for the purpose of assisting in the preparation of comments on newly registered medicines for publication in the Australian Prescriber.

The information will only be provided after the consultation process with the sponsor has been completed and extracts from the AusPAR will not be published in Australian Prescriber before the AusPAR is published on the TGA website. Sponsors will be informed that the AusPAR will be provided to NPS MedicineWise following its finalisation.

The Specification can be found at Therapeutic goods information specifications.

Book pagination