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Prescription medicines registration process

3 August 2020

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Phase 5: Second round assessment

5.5.1 Objective

a diagram showing the steps of the second round assessment phase

During the second round assessment phase, evaluators will consider the response provided by the applicant to the section 31 request (if applicable) and complete the evaluation of the data.

5.5.2 Milestone 5

All second round assessment reports are completed.

5.5.3 Key dates

The second round assessment phase will commence on completion of the consolidated section 31 request response phase, whether or not a response is received from the applicant.

The TGA will complete the second round assessment reports:

  • within two months for applications for new generic medicines
  • within one month for all other applications.

TGA will issue the second round assessment reports:

  • at the completion of the second round assessment phase for applications not referred to the Advisory Committee on Medicines (see Section 5.7.4.1).
  • with the delegate's Request for ACM advice for applications referred to the Advisory Committee on Medicines (see Section 5.6.4.2).

5.5.4 Assessment of response

During the second round assessment phase evaluators consider the applicant's section 31 response to questions raised in relation to issues identified in the first round assessment. Where the section 31 response is inadequate or raises further issues, evaluators may liaise directly with applicants for clarification, but no additional time will be added and no additional section 31 requests will be formally sent. Any outstanding issues will be highlighted in the evaluation reports. These may be significant enough to warrant a recommendation to reject the application or they may be minor, possibly leading to the imposition of conditions of registration for applicant compliance.

The final reports are independent assessments of the data that include advice for consideration by the decision delegate.

The TGA has no way of anticipating at the pre-submission phase whether a consolidated section 31 request will be needed or how many questions or requests for documents might be contained in such a request. Unless the TGA contacts the applicant, applicants should expect that the milestone dates identified in the Planning letter will be retained even if there is no section 31 request.

5.5.5 Opportunity to review evaluation reports

Applicants will be given a period of 14 calendar days after the TGA issues the final evaluation report(s) in which to review and advise the TGA of any perceived errors of fact or major omissions outside the Pre-ACM response.

Applicants should also use this period to revise the draft PI based on recommendations in the evaluation reports.

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