What is the maximum number of patients that can realistically be treated under a hospital exemption in the Netherlands? Specifically, how does the interpretation of ‘non-routine use’ apply to hospital exemption?
It is essential that the use of hospital exemption remains “non-routine”. What this means in practice can vary per country. In the Netherlands, it generally implies a maximum of 10 treatments per year. However, in exceptional cases, this limit can be raised, as seen with TIL therapy, where the maximum was increased to 50.
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Also check the Hospital Exemption Q&A page from IGJ for the answer to your question: Vragen en antwoorden over de hospital exemption voor ATMP’s | Inspectie Gezondheidszorg en Jeugd
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