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SPC manu­facturing waiver and SPC with 'unitary effect' under its way

On 28 May 2018, the European Commission finally revealed the highly-anticipated legislative proposal for an SPC "manufacturing waiver".

The SPC "manufacturing waiver" will allow generic manufacturers based in the EU to produce copies of medicines covered by the SPC, for exporting purposes outside the EU, where SPC protection has already expired or has never existed. 

According to the Commission, the purpose of the proposed waiver is "to help Europe's pharmaceutical companies tap into fast-growing global markets and foster jobs, growth and investments in the EU."

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