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Re: AllSheWrote post# 795624

Thursday, 10/30/2025 3:33:09 PM

Thursday, October 30, 2025 3:33:09 PM

Post# of 822255
Why is that hard to understand? Mostly because it is wrong.

Innovative Medicines (new active substances, biologics, etc.):
First RFI: After the MHRA's initial assessment, you will receive a first RFI by Day 90. You must respond to all questions within six months to avoid a proposed refusal of your application. Extensions may be granted in exceptional cases.
Second RFI: If only minor issues remain after the first response, a second RFI may be issued by Day 150. You must submit your complete response within three months.
Third RFI: A third RFI may be issued to resolve any final minor issues. You must submit your complete response within three months.



Here are the relevant regulations. https://www.gov.uk/guidance/national-assessment-procedure-for-medicines#:~:text=If%20you%20do%20not%20submit,150%20(see%20section%202.5).

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