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E.U. Pharmaceutical Reform Package Comes Into Effect

Law360 (March 12, 2004, 12:00 AM EST) -- A sweeping policy reform aimed at standardizing regulatory data protection for drugs is now in effect across the European Union.

The E.U.’s Competitiveness Council adopted the pharmaceutical review package on Thursday, finalizing the co-decision process in the wake of the vote in the European Parliament in second reading on 17 December 2003.

Under the new “8+2+1” regime, new drugs will receive 10 years of protection from generic competition, including eight years of data protection, plus an additional year for new uses.

The two resolutions passed by...
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