CRED NPM

05/11/2024

Case study 1: Switch Strategies and Challenges on the Example of Triptans in Germany

Berit Frei

Regulatory Affairs Director, Haleon Germany (former GSK Consumer Healthcare)

The Organisation for Professionals in Regulatory Affairs The Organisation for

Professionals i Regulatory Affairs

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Agenda

• Naratriptan switch Germany – A major milestone in the history of Rx to OTC switches • Switch strategy – Hurdles to overcome & product profile

• Switch criteria – risk assessment & minimization measures

• Switching process in Germany – as an example for substance-based switches

The Organisation for Professionals in Regulatory Affairs

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