CRED NPM

05/11/2024

Internal Evidence supporting a direct switch from POM to GSL Key elements

▪ The typical required dossier content (POM → P and P → GSL) in the same dossier: ➢ - Address why the POM criteria are not met o - Evidence addressing the GSL criteria o - Management of risks in a GSL setting vs P setting ▪ Safety data of fexofenadine ▪ A comparison of the safety data of fexofenadine 120 mg vs all other GSL antihistamines present in the UK market ▪ Overview of the benefits of reclassification

The Organisation for Professionals in Regulatory Affairs

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Internal Considerations on regulatory application, claims and brandname

• Split UK MA from the MRP – became a national MA • Type II C .I .5 .b variation ➢ Invented name approved as part of the reclassification procedure

Challenge on brandname

Building strong product informatiom

• Labelling = first source of claims

• Rejection of the global brand Allegra (risk of confusion with another brandname available on the market) • Approval of Allevia

The Organisation for Professionals in Regulatory Affairs

10

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