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ARTICLE · 16 OCTOBER 2023

SPC Shake-Up? Proposals For New And Revised EU Regulations Raise Concerns

The EU Commission published four proposals for amending the current regime for Supplementary Protection Certificates (SPCs) to enable a centralised...

European UnionIntellectual Property

The EU Commission published four proposals for amending the current regime for Supplementary Protection Certificates (SPCs) to enable a centralised examination of national and unitary SPCs. We summarise the proposals and some aspects of concern.

The current framework for obtaining SPCs in the European Union (EU) is set out in Regulation (EC) No 469/2009 for human and veterinary medicinal products and Regulation (EC) No 1610/96 for plant protection products. At present, SPCs can only be examined and granted on a national level, requiring action in each EU country separately. This can be costly for applicants with multiple sets of legal and official fees, and the potential for inconsistencies arising between Member States.

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