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SPC Manufacturing Waiver
The EU's manufacturing waiver for supplementary protection certificates (SPCs) permits third parties to manufacture medicinal products for export outside the EU, but divergent court interpretations have led to a 2026 CJEU referral. As national courts grapple with notification requirements and stockpiling provisions, the European Commission has announced a public consultation to evaluate whether the waiver has achieved its intended objectives.
J A Kemp LLP