European SPC Waiver for Export and Stockpiling of Generics and Biosimilars
On 14 February 2019, the Committee of the Permanent Representatives of the Governments of the Member States (Coreper) endorsed a draft regulation which introduces an exception to the protection granted to a medicinal product by a supplementary protection certificate (SPC) for export purposes and/or stockpiling. Next step is submission to the European Parliament and Council for adoption.
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