Concept of medicinal product by function: “BIOS Naturprodukte” ruling dated April 30, 2009, case C-27/08

7 July 2009

In this case the European Court of Justice responded to a petition for a preliminary ruling on the interpretation of Article 1.2 of Directive 2001/83/EC. Said petition was filed in the framework of the litigation between BIOS Naturprodukte GmbH and Saarland (Germany) regarding the classification of a product called “Weihrauch H 15-Tabletten” (H 15 incense tablets) for the purposes of is marketing in German territory.

Said product is manufactured in India based on an incense extract and exported to Austria where it can be found on the market as a dietary supplement: “In addition to various excipients, each tablet contains 400 mg of Indian incense extract.” The ECJ concluded that the health risk cannot convert a dietary supplement in a medicine.

The questioned referred by Bundesverwaltungsgericht (Germany) for a preliminary ruling was the following:

Should the concept of foodstuff referred to in Article 1, point 2 of Directive 2001/83/EC, as amended by Directive 2004/27/EC, be interpreted to mean that a product meant for human consumption and designed as a dietary supplement is a medicinal product by function if it contains substances which, when administered as recommended in the package instructions and in the small dosage amount contained in the product constitute a health risk and cannot provide therapeutic effects, and which in higher dosages does have therapeutic effects?

The ECJ (Fifth Chamber) ruled as follows:

“Article 1(2) of Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use, as amended by Directive 2004/27/EC of the European Parliament and of the Council of 31 March 2004, must be interpreted as meaning that a product which includes in its composition a substance which has a physiological effect when used in a particular dosage is not a medicinal product by function where, having regard to its content in active substances and under normal conditions of use, it constitutes a risk to health without, however, being capable of restoring, correcting or modifying physiological functions in human beings.”

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