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EU SPC Manufacturing Waiver now in force

The SPC Manufacturing Waiver (the “Waiver“) is now in force, effective from 1 July 2019 (Regulation 2019/933 amending the SPC Regulation 2009/469). The Waiver has been introduced with the stated aim of putting EU generic and biosimilar manufacturers on a level playing field with their competitors in third countries. The Waiver carves out of SPC