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Two-Year Stockpiling Provision ‘Vastly Improves’ European SPC Waiver

 
• By Dave Wallace

The latest vote from the European Parliament’s legal committee has been praised by industry for allowing firms to stockpile for two years ahead of SPC expiry to prepare for a ‘day one’ launch.

EUParliament
The European Parliament's Legal Committee Has Passed A New Agreement • Source: Shutterstock

A planned waiver to allow generics and biosimilars firms to manufacture in the European Union (EU) during the term of supplementary protection certificates (SPCs) will include the possibility of stockpiling for ‘day one’ launch within the EU as well as manufacturing for export, according to a compromise agreement approved by the European Parliament’s legal committee, JURI.

European off-patent industry Medicines for Europe has warmly welcomed the move, which comes shortly after the European Council approved a mandate for negotiations

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