Spring Intro 2023
16/02/2023
National review and approval timelines: 30 – 60 days
Member State
Reg approval**
EC approval**
Latvia
45 days (reduced for Phase 1)
30 days
Lithuania
60 days (average 45) reduced for Phase 1
60 days
Luxemburg
60 days
60 days
Malta
60 days
60 days
Netherlands
14 days – limited check only - relies on EC approval
60 days
Poland
60 days - +30d for biotech?
60 days
Portugal
60 days + 5 day validation
60 days
Romania
60 days
60 days
Slovakia
60 days if questions (phase 1, 14 – 21 days)
60 days
Slovenia
60 days if questions (phase 1, 14 – 21 days)
60 days
Spain
60 days + 10 day validation
Up to 75 days
Sweden
Up to 60 days if questions
Up to 60 days if questions
UK
Up to 60 days if questions
60 days
**In all cases submissions can run in parallel except Bulgaria. Unless otherwise stated timelines assume no questions
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