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NTIOL Application Cycle Our process for reviewing applications to establish new classes of NTIOLs is as follows: Applicants submit their NTIOL requests for review to CMS by the annual deadline which is announced in the annual OPPS/ASC final rule with comment period

MHRA Borderline Guidance MHRA guidance updated on 2 July 2026 explains that classification can consider pharmacological properties, explicit and implied claims, intended purpose, packaging, websites, social-media content and customer reviews

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