CRED NPM

05/11/2024

Internal

ALLERVI switch from prescription to non-prescription drug in FR

The Organisation for Professionals in Regulatory Affairs

The Organisation for Professionals i Regulatory Affairs

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Internal Evidence supporting a switch from prescription to non

prescription drug Key elements

▪ The typical required dossier content to address the EU GUIDELINE ON CHANGING THE CLASSIFICATION FOR THE SUPPLY OF A MEDICINAL PRODUCT FOR HUMAN USE (Rev Jan 2006)*

➢ Address why the medicinal product not subject to a medical prescription criteria are met

▪ Safety data of fexofenadine

▪ A comparison of the safety data of fexofenadine 120 mg vs all other antihistamines present in the FR market

▪ Overview of the benefits of reclassification

▪ Local explanation on why this switch is relevant for FR

The Organisation for Professionals in Regulatory Affairs

*https://health.ec.europa.eu/system/files/2016 11/switchguide_160106_en_0.pdf

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