Europe's research-based pharmaceutical industry has strongly criticized the European Parliament's vote in favour of a new regulation that would allow EU-based companies to manufacture a generic or biosimilar version of a medicine while it is still protected by a supplementary protection certificate (SPC).
The regulation includes a waiver that would allow manufacturing either for exporting the medicines to third countries where protection has expired or never existed, or for stockpiling during the final six months of an SPC to
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