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Re: Steady_T post# 450982

Tuesday, 02/06/2024 1:13:11 PM

Tuesday, February 06, 2024 1:13:11 PM

Post# of 464537
I posted some time ago that a document on the NIH website describes a Letter of Intent as "triggering" a Centralised Procedure request. Here is the link, which is all about the EMA process:

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3149704/

"The process of the centralized procedure is triggered when the applicant sends the letter announcing the intent to submit a MAA (letter of intent), which is usually done at least seven months prior to the targeted submission date."
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