CRED NPM

06/11/2024

Key Hurdles to Overcome….

OTC Model

Regulatory Pathway

Understanding the Risk Profile

Reason to Switch

The Organisation for Professionals in Regulatory Affairs

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Regulatory Pathway – How different is different?

• EU highly polarised regulatory and pharmacy environment

• Clear divide in Health Authority opinion around the B/R profile of switching

• Needed an alternative to Centralised Procedure → Decentralised Procedure?

• BUT overarching EU policy at the time was to follow the same licensing procedure for any additional registration of the “same medicinal product” as per the original filing ie that centralised procedure must be followed

SOLUTION: Needed to demonstrate that OTC Viagra was legally NOT the same medicinal product as original Rx Viagra based on key differences in the SmPC

The Organisation for Professionals in Regulatory Affairs

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