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EU introduces new SPC manufacturing waiver

Cristina Biggi of Bugnion examines the introduction of the new SPC manufacturing waiver, including the process that led to its creation and the amendments it makes to the SPC regulation

What is a supplementary protection certificate? Supplementary protection for patented medicinal products was created in the European Union (EU) in 1992 with Council Regulation No. 1768/92 of June 18 1992 – repealed by Regulation (EC) No. 469/2009 of May 6 2009...

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