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EU drug legislation

This article was originally published in The Tan Sheet

Executive Summary

European Parliament adopts legislation allowing for an additional year of data exclusivity for OTC switch drugs April 30. Member states have until Oct. 30, 2005 to implement provisions of the new pharmaceutical legislation package. An additional year of data exclusivity for a new indication of a well-established substance also is enacted in the legislation, "provided that significant pre-clinical or clinical studies were carried out in relation to the new indication." The legislation initially allowed for three years of additional data exclusivity but was amended before its adoption (1"The Tan Sheet" Jan. 5, 2004, p. 9)...

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