Phase 4: Consolidated section 31 request response
5.4.1 Objective
The consolidated section 31 request response phase allows applicants time to consider the TGA's consolidated section 31 request for information or documents, prepare a response and send the response to the TGA.
5.4.2 Milestone 4
Applicants will send TGA a response to:
- any consolidated section 31 request for information or documents
- the first round assessment reports prepared by the quality, nonclinical and clinical evaluators, if required.
5.4.3 Key dates
The consolidated section 31 request response phase commences on completion of the first round assessment phase when the TGA sends the consolidated section 31 request for information or documents to the applicant.
The consolidated section 31 request response phase ends on the date by which the applicant is required to respond to the section 31 as identified in the section 31 request letter. The section 31 response time will be either 30 or 60 days as nominated by applicant in the PPF and confirmed by the TGA in the Planning letter.
Note: The consolidated section 31 request response period does not count towards the statutory 255 working day period for evaluation (Regulation 16A(2)).
5.4.4 Response to section 31 request
Responses to a section 31 request for information or documents must be provided in CTD format. Applicants need to send both hard copy and electronic copy formats of the response to the TGA. Information on providing a section 31 response is contained in CTD Module 1: Administrative information and prescribing information for Australia.
Applicants should pay close attention to the questions raised in the s31 letter, as well as any requests in the letter for other information or documents, as this may be the sole opportunity that an applicant has to provide this information.
5.4.5 Response to first round assessment reports
Applicants should review the first round assessment reports and advise the TGA of any perceived errors of fact or major omissions. Each identified error of fact or omission must be referenced to information previously submitted (Study number and location, for example, Module 3.2.P.4.3 Method validation, p.23). It is not appropriate to submit new data to negate a perceived error of fact or omission (see Section 2.5 Information). Although there is no limit to the size of an applicant's response, it is expected that the response to any one report should be no more than six single sided A4 pages and in a font no smaller than 12 point.
Responses to the assessment reports must be included in Module 1.0.2. and should be submitted with, but as separate file(s) to, the response to the section 31 request. For those applications where there is no section 31 request, applicants must respond by the date specified in the Milestone 3 letter. At least 14 calendar days of TGA issuing the first round assessment reports will be provided.
5.4.6 What happens if an applicant misses a key date?
The consolidated section 31 request response phase will end on the due date specified in the section 31 letter irrespective of whether an applicant's response to the request is received by the TGA.
Should the applicant not reply in the nominated time period, the second round assessment phase will be concluded based on the information available to the TGA.