5 November 2025
In Kwizda Pharma II, Court of Justice of European Union Provides Guidance on Application of Directive 2001/83/EC to Borderline Products
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The Court of Justice of the European Union issued a judgment that clarifies the application of the rule of precedence in Article 2(2) of Directive 2001/83/EC of 6 November 2001 on the Community code relating to medicinal products for human use.
The Court of Justice of the European Union issued a judgment that clarifies the application of the rule of precedence in Article 2(2) of Directive 2001/83/EC of 6 November 2001 on the Community code relating to medicinal products for human use, and sheds light on the role of competent national authorities. The judgment was delivered in response to a second preliminary reference concerning Kwizda Pharma and the regulatory classification of specific foods for special medical purposes.
Attached is a case note offering a link to the judgment.
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