Regulatory Focus™ > News Articles > German Court Upholds BfArM Rules for Use of 'Acute' in Labeling

German Court Upholds BfArM Rules for Use of 'Acute' in Labeling

Posted 31 July 2013 | By

In a final judgment rendered earlier this week, the Cologne Administrative Court affirmed the view held by Germany's Federal Institute for Drugs and Medical Devices (BfArM) that the additional designation "acute" may only be used for drugs that act fast or at least faster than other drugs. (Ref. 7 K 6757/10 - Cologne).

The case involved a pharmacy drug containing omeprazole, which is approved for the "treatment of heartburn and acid reflux." After drug was released with an active ingredient content of 20 mg, the plaintiff company wanted to add the term "acute" to the labeling.

The Cologne Administrative Court determined that the use of "acute" would be misleading because the drug does not act particularly quickly. Consumers would associate the term "acute" in the drug label with a rapid effect and not with the treatment of "acute progressive forms" of the disease. A purely linguistic interpretation is not appropriate to assess the consumer expectation, the court said.

BfArM President Prof. Walter Schwerdtfeger welcomed the ruling as an important contribution to consumer protection: "Patients must be able to rely particularly on the importance of additional terms for non-prescription medicines. Your safety should not be compromised by misconceptions about the drug and its effect. "

CAC Judgment

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Tags: Germany

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