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Re: flipper44 post# 692089

Friday, 05/17/2024 3:55:39 AM

Friday, May 17, 2024 3:55:39 AM

Post# of 724147
Flipper its 2 .

The initiation of the 150-day evaluation for an MHRA Marketing application is triggered by:

2. Being informed MAA passed validation.

Here's why:

Option 1 (receipt of MAA) doesn't guarantee a valid application. The MHRA needs to first assess the application for completeness and compliance.
Option 3 (MAA validation confirmed) might be redundant. "Passed validation" is the usual term used after a successful assessment.
[color=red]The MHRA specifically outlines in their guidance that the 150-day clock starts ticking after a valid application is submitted [2]. A valid application is one that has passed the initial validation stage.[/color]
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