When the MHRA requests an RFI from a company that submitted a MAA to the MHRA, does the MHRA return the entire MAA to the company
until it receives a comprehensive response that addresses all the questions raised by the RFI?
AI Overview.
" No, when the MHRA sends a Request for Information (RFI) to a company that submitted a Marketing Authorisation Application (MAA), the MHRA does not return the entire MAA to the company.
Instead, the MHRA sends a letter detailing the specific information or clarifications needed to continue with the assessment. This RFI will be a consolidated list of questions covering all relevant sections of the dossier.
The company is expected to provide a comprehensive response addressing all the questions raised in the RFI, including any necessary updated documentation. This response should be submitted as an eCTD sequence using the MHRA's RFI response template. The response document should be provided in both PDF and Word (.docx) formats.
The RFI process essentially pauses the clock for the assessment timeline, allowing the company time to gather and submit the required information. Once the complete response to the RFI is received, the clock restarts, and the MHRA continues its assessment.
In summary: The MAA remains with the MHRA, and the company provides a targeted response to the RFI, addressing the specific areas needing further information or clarification"
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