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Tag Archives: manufacturing waiver

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

EU: New developments in the SPC manufacturing waiver legislative process

Following the European Commission’s draft proposal for implementing the so-called SPC manufacturing waiver the Committee on Legal Affairs of the European Parliament published a draft report on presenting its suggested amendments to the Commission’s proposal. The Committee in essence supports the plan to introduce the manufacturing waiver but is asking for some clarifying amendments as