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Re: Slave1 post# 776435

Thursday, 07/17/2025 10:42:54 AM

Thursday, July 17, 2025 10:42:54 AM

Post# of 822893

Why? Because NICE cannot appraise a product until the company submits either a draft or final SmPC along with its evidence package. This is a published requirement in NICE’s STA process guide.


See the word "draft"? The MAA included that, no need for approval.

And again, is easy to find examples of evidence submissions well before MAA decision.
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