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Re: MayoMobile post# 508131

Friday, 11/14/2025 2:22:27 PM

Friday, November 14, 2025 2:22:27 PM

Post# of 517473
https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/procedural-advice-re-examination-chmp-opinions_en.pdf

The applicant/MAH shall forward to the Agency the detailed grounds for the request for reexamination of the opinion. As stated in Article 62.1 paragraph 4 of Regulation 726/2004 and Article 32.4 paragraph 3 of Directive 2001/83/EC, as amended, “the re-examination procedure may deal only with the points of the opinion initially identified by the applicant/MAH and may be based only on the scientific data available when the Committee adopted the initial opinion.”

The above seems pretty definitive about whether new info can be brought to bear or not. How do you read this?
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