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General

Statutory Health Insurance Authorization

Authorization for a pharmaceutical to be reimbursed by statutory health insurance – prerequisite for participation in GKV tenders.

What is Statutory Health Insurance Authorization?

Kassenzulassung refers to the eligibility of a pharmaceutical for GKV reimbursement – a mandatory prerequisite for discount agreements and GKV tenders.

Prerequisites

Valid drug authorization, no exclusion under § 34 SGB V, AMNOG assessment for new substances, CE marking for medical devices.

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