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Australian Public Assessment Report (AusPAR) guidance document

Version 1.5, March 2015

11 March 2015

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5. Sponsor consultation

5.1 Scope

Once an AusPAR for a product is drafted by the TGA, the sponsor is given the opportunity to review the document prior to it being published so that any information that may be commercially confidential information (CCI) or personal information can be identified. Although permitted to be released under subsections 61(5C) and 61(5D) of the Act, the TGA may decide not to include this information in the document to be published. See Appendix 2 of this Guidance document for further clarification of the management of CCI and personal information.

A sponsor must justify any assertion that information is CCI or personal information which it seeks to be excluded from the AusPAR. Sponsors are required to carefully consider the definitions of CCI and personal information in crafting their justification.

It is not possible however, for the comments of evaluators, the Delegate or the advisory committee to be edited because they are an integral part of the evaluation and decision process.

Completion of an AusPAR is independent from other regulatory processes - the Delegate's decision, marketing approval, and related regulatory processes are not dependent on finalisation of an AusPAR.

5.2 Outcome of review of draft AusPAR

Following a sponsor's review of a draft AusPAR, the TGA will review any proposed changes relating to the removal of CCI by a sponsor. Should there be disagreement about the proposed removal of CCI content, an internal review process will be applied by the TGA. The sponsor will be asked to provide a request/justification in writing for the removal of the content which will be referred for advice (as needed) prior to a final decision being made.

The internal review process is undertaken with the aim of publishing the completed AusPAR within 12 weeks from the date the product is included on the ARTG. More details about publishing timeframes for an AusPAR, based on whether the AusPAR is approved, not approved or the submission is withdrawn are in the Section 4.2 - AusPARs for approved, rejected and withdrawn submissions and Section 6 - AusPAR publishing.

5.3 Review period

The TGA provides a sponsor with 14 calendar days to undertake a review of the draft AusPAR and identify any information that it believes is CCI that it does not want published in an AusPAR. If the review identifies significant issues which require resolution, the TGA will respond and provide the sponsor with an additional 3-7 calendar days to review the TGA response.

5.4 Failure to respond within AusPAR review period

If there is no response from a sponsor to a TGA request to review a draft AusPAR, the TGA reserves the right to publish the finalised AusPAR without further reference to the sponsor.

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