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EU SPC Waiver: Originators May Need To Act Soon

 
• By Ian Schofield

A new EU regulation relaxing the rules on generic and biosimilar manufacturing during a product’s supplementary protection certificate period will take effect on 1 July. Originator companies wanting to benefit from a three-year transition period should consider taking action now.

Changes ahead
Changes to the EU SPC regime take effect in July • Source: Shutterstock

On 1 July, new legislation allowing generics and biosimilars firms in the EU to manufacture and stockpile medicines before the supplementary protection certificate on the originator drug expires will come into effect. All SPCs that have not yet been granted will be affected by the waiver, but the inclusion of a transition period means originator companies may be able to avoid its effects for three years if they file their SPC applications before 30 June.

Regulation (EU) 2019/933, which was adopted by the Council of the EU in May and published in the Official Journal on 11 June, provides an exemption to SPC rights by...

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