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

7 July 2009

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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