Header graphic for print
Focus on Regulation

Tag Archives: E.U. proposal

European Commission proposes SPC waiver for EU biosimilars or generics manufactured solely for export from the EU

On 28 May 2018, the European Commission has published a draft regulation amending Regulation 469/2009 concerning the supplementary protection certificate for medicinal products[1]. This proposal is intended to modify the EU rules on Supplementary Protection Certificate (SPC) and allow EU generic and biosimilar companies to manufacture versions of medicinal products still protected by a SPC,

Changes in E.U. merger rules could be huge

The European Commission recently published a consultation paper that invites comments on a proposal to allow review of the acquisition of non-controlling minority shareholdings. The proposed reform is the most significant in the last 10 years and could have a huge impact on many corporate transactions. Under the current E.U. Merger Regulation, the commission only