Euro OTC Market Harmonization

Numerous factors in distribution of over-the-counter medicines stand inthe way of European Union market harmonization, says a new report from Datamonitor, which is available through the Marketletter.

Currently, the EU mutual recognition process is fairly impotent in terms of harmonizing the EU OTC markets, it says; while the process stipulates which products should be approved, it does not dictate their legal status within each country. So a product approved for OTC use in the sponsor country could be restricted to prescription-only use elsewhere.

This situation will continue to limit the degree to which there is homogeneity in the EU market, coupled with other factors such as OTC distribution-related issues. These include curbs on distribution, advertising and pricing of different OTC classes, and regulations regarding the establishment of chain pharmacies. These differences mean that even when the EU registration process is completely harmonized, manufacturers will have to treat individual markets as separate entities and tailor their product strategies to the circumstances of each country.