A comparison of OTC status of medicines across Europe

Regulation of over-the-counter (OTC) medicines varies significantly across European Union (EU) member states due to diverse healthcare policies, cultural attitudes towards self-medication, and regulatory frameworks. Understanding these differences is crucial for stakeholders in the pharmaceutical industry for market access and strategic planning.

A recent analysis of 250 Active Pharmaceutical Ingredients (APIs) across 30 European countries, using data from Cortellis Regulatory Intelligence™ and Competent Authorities’ databases, shows that countries like the United Kingdom, Germany, and Italy have the highest number of available OTC medicines.

This suggests a regulatory environment that supports self-care and greater patient autonomy in managing health conditions, as also shown by the Rx-to-OTC switch process. In contrast, countries such as Cyprus, Denmark, Slovenia, and Croatia have fewer OTC options, reflecting a more conservative approach to OTC accessibility.

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