Decision Due Next Month On Job-Creating EU SPC Manufacturing Waiver
A decision is due to be taken next month on whether to go ahead with a proposal for an EU supplementary protection certificate manufacturing waiver that could create thousands of new manufacturing jobs in the generics and biosimilars industry and increase competition on the European market.
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A European Commission legislative proposal to change the EU’s rules on supplementary protection certificates and allow for the production of versions of patent-protected medicines for sale outside the EU has been welcomed by the generics and biosimilars industry – albeit with caveats – but criticized by the originator industry as an attack on intellectual property that could hit investment in Europe.
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Ukraine has established a system for issuing emergency use authorizations for COVID-19 vaccines that recognizes authorizations granted by other world regulators.
The Russian backers of the vaccine’s development say that if it receives a marketing authorization in the EU, distribution could begin in June this year.