The Netherlands

Requests for the withdrawal of marketing authorizations and parallel import licenses for human medicines effective 31 December 2025 — the so-called “end-of-year withdrawals”must be received by the Medicines Evaluation Board (CBG) no later than 1 November 2025. Requests submitted by this date will be processed in time to avoid the annual fee for 2026.

Requests received on or after 2 November 2025 will only be processed after 1 January 2026, meaning the authorization will remain active at year-end, and the annual fee for 2026 will apply.

Withdrawals involving combined package leaflets must be submitted per medicinal product group in a separate CESP submission. Submissions containing multiple product groups in a single CESP file cannot be accepted. Withdrawals without leaflet changes may still be submitted together in one CESP submission.

Source: Eindejaarsintrekkingen geneesmiddelen voor mensen | Nieuwsbericht | College ter Beoordeling van Geneesmiddelen

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