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On How to Assess a Medicinal Product By Function

Published online by Cambridge University Press:  20 January 2017

Kai Purnhagen*
European University Institute, Florence, Italy, Justus-Liebig-University, Giessen, Germany


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 (…) (official headnote).

Case Notes
Copyright © Cambridge University Press 2010

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1 Judgment of 30 April 2009.

** Editorial Hint: Article 1 No. 2 of Directive 2001/83/EC on the Community Code Relating to Medicinal Products for Human Use, last amended by Directive 2004/27/EC, OJ L – 311, of 28 November 2004, pp. 67 – 128.

2 Case-C-319/05, Commission v. Germany [2007| ECR I-09811.

3 Case C-140/07, Hecht-Pharma GmbH v. Staatliches Gewerbeaufsichtsamt Lüneburg, [2009] ECR (judgment of 15 January 2009), see also the commentary of Müller, Rolf-Georg, “Grundfragen des Arzneimittelbegriffs und der Zweifelsregelung”, Neue Zeitschrift für Verwaltungsrecht (2009), pp. 425 et sqq.

4 See Purnhagen, Kai, “Systematisation in European Risk Regulation” (forthcoming PhD thesis, on file at the European University Institute in Florence from 2011 on).

5 Para. 19 “cannot automatically be classified as medicinal products by function unless the competent administration has made an assessment”. This is clearer in the German version, where instead of ‘automatically’ the term as ‘systematisch’ is used.