German Supreme Court Confirms D-Mannose Pharmacological Effect
Germany's Federal Court of Justice (BGH) has ruled that D-mannose is to be classified as a medicinal product, aligning with EU court rulings on its pharmacological action.
Germany's Federal Court of Justice (BGH) ruled on October 9, 2025, that D-mannose must be classified as a medicinal product. This decision aligns with the case law established by the European Court of Justice (ECJ) regarding the substance's pharmacological effects.
The ruling clarifies the regulatory status of D-mannose in Germany, confirming its classification based on its medicinal properties. Previously, the ECJ had determined that D-mannose exhibits a pharmacological action, necessitating this reclassification.
Pharma Deutschland e.V., an industry association, highlighted the significance of this decision for the market. The BGH's judgment applies the ECJ's precedent, underscoring the legal framework for substances with established medicinal properties.
This legal precedent reinforces the importance of accurate classification for products with therapeutic effects. Companies marketing D-mannose or similar substances in Germany must now adhere to the regulations for medicinal products.