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

See all articles by Kai P. Purnhagen

Kai P. Purnhagen

University of Bayreuth; Erasmus University of Rotterdam - Rotterdam Institute of Law and Economics

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

Suggested Citation

Purnhagen, Kai Peter, On How to Assess a Medicinal Product by Function (2010). 1 European Journal of Risk Regulation, 2010, 90-92, January 2010, Available at SSRN: https://ssrn.com/abstract=2144828

Kai Peter Purnhagen (Contact Author)

University of Bayreuth ( email )

Universitatsstr 30
Bayreuth, D-95447
Germany

Erasmus University of Rotterdam - Rotterdam Institute of Law and Economics ( email )

Burgemeester Oudlaan 50
PO box 1738
Rotterdam, 3000 DR
Netherlands

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