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A Journey Through EU Pharmaceutical Terminology

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Joshua Baldacchino

on 10 September 2013

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Transcript of A Journey Through EU Pharmaceutical Terminology

A Journey Through EU Pharmaceutical Terminology
In essence:
products presented to the public as not being medicinal will not fall under the first category of medicinal product if that product can also prove it has no medical function either, it is irrelevant in part, that it may have negative effects to individuals health.
What Are We Talking About?

Bios Naturprodukt GmhB v Saarland: C-27/08

Medicinal Product
Case Breakdown
Involved Parties:
Bios Naturprodukt GmbH

The Product
Weihrauch H 15-Tabletten
H 15 incense tablets
What Went Wrong?
BNG has allegedly been selling a

Pharmaceutical Product - P 2(1) of the Law on medicinal products (AMG)

Medicinal Product - Article 1(2) of Directive 2001/83
Medicinal Product
Under EU law, a medicinal product is defined as any substance or combination of substances
for treating or preventing diseases in human beings...


Any substance...which may be administered...with a view to making medical diagnosis or to restoring, correcting or
modifying physiological
functions in human beings
What Happens Next?
After several failed appeals by BNG, the case finally appears before the ECJ (fifth chamber)

The court is essentially asked to answer the following question:

"Whether Article 1(2) of Directive 2001/83 is to be interpreted as meaning that a product which includes in its composition a substance which has a physiological effect when it is used in a particular dosage is a medicinal product by function since, regard being had 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"
The ECJ used a number of cases and submission in coming to a distinct conclusion:
The Netherlands
United Kingdom
Commission of European Communities
C‑140/07 Hecht‑Pharma [2009]
C‑319/05 Commission v Germany [2007]
C‑150/00 Commission v Austria [2004]
So...Is This A Medicinal Product Or Not?
Although the product may in fact have physiological effects at higher dosages and even negative consequences on human health it is not a medicinal product by function
Full transcript