On How to Assess a Medicinal Product by Function
1 European Journal of Risk Regulation, 2010, 90-92, January 2010
3 Pages Posted: 12 Sep 2012 Last revised: 14 Oct 2012
Date Written: 2010
Abstract
Case Note on ECJ, C-27/08 BIOS Naturprodukte GmbH v. Saarland: Article 1(2) of Directive 2001/83 on the Community code relating to medicinal products for human use, as amended by Directive 2004/27 must, apart from the case of substances or combinations of substances intended for the purpose of making a medical diagnosis, 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 (…)
Keywords: Medicinal Product, ECJ. Article 1(2) of Directive 2001/83
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