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An Expert’s Guide To Switching In Germany, Part 1: Navigating The Reclassification Process

 
• By David Ridley

Elmar Kroth, scientific director of the German Medicines Manufacturers´ Association, the BAH, talks exclusively to HBW Insight about prescription-to-OTC switching in Germany and the association’s efforts to improve this process.

German flag
The German federal parliament • Source: Shutterstock

Prescription-to-OTC switching can be an extremely risky and expensive endeavour for consumer healthcare companies. Firms must present extensive clinical and post-authorisation data on the safety and efficacy of potential switches, and there is no guarantee that after making such an investment, switches will be approved by regulators. Despite efforts by OTC industry stakeholders to harmonise switching procedures within the European Union (EU) single market, local reclassification practices remain frustratingly idiosyncratic.

In the first part of a two-part interview, Elmar Kroth, scientific director of the German industry association, the BAH, explains how the switching process works in Germany, and what the...

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