EU device definition
This article was originally published in The Gray Sheet
Executive Summary
European Parliament votes Oct. 2 to define pharmaceuticals as substances that may be "used in" human beings instead of "administered to," as proposed in original pharmaceutical directive review legislation. The words "by exerting a pharmacological action" have been added, however, and Eucomed will lobby to insert "as primary mode of action" into the text. European industry reps have been wary of the definition since summer, when concerns first surfaced that combination products would automatically be legislated as drugs (1"The Gray Sheet" June 24, 2002, p. 12)...