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Product Regulation & Liability

November 02 2017
Rainer Herzig No outer packaging required?

Austria - Preslmayr Attorneys at Law

The Supreme Court recently upheld the appellate court's opinion that Section 17(1) of the Act on Medicinal Products requires the labelling of certain particulars in the case of eventual outer packaging, but does not require the outer packaging of medicinal products. This interpretation conforms with Article 54 of EU Directive 2001/83/EC, which provides that certain particulars must appear on the outer packaging of medicinal products or, where there is no outer packaging, on the immediate packaging.

Author: Rainer Herzig
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