Medicinal products can only be marketed if a marketing authorisation has been granted. In cases of compassionate use, medicinal products for which no marketing authorisation has yet been granted may be made available to a group of patients suffering from a serious disease for which there is no authorised medicinal product.
To this end, manufacturers of medicinal products can submit an application to the Medicines Evaluation Board for approval of a Compassionate Use Programme (CUP).
An alternative to make medicinal products without a marketing authorisation available to individual patients is on a named patient basis. For supplying on a named patient basis an application can be submitted to the Health and Youth Care Inspectorate (IGJ). For more information, please consult the website of IGJ.
Criteria
For a medicinal product to be eligible for a CUP, three criteria apply.
- The medicinal product must be intended for treatment of a group of patients (cohort) suffering from a chronic disease, a disease that is detrimental to their health or a life-threatening disease.
- This disease cannot be treated satisfactorily using an authorised medicinal product.
- An application for a marketing authorisation for the medicinal product has been submitted, or clinical tests to support such an application are still ongoing.
Request for compassionate use programme
An application for a Compassionate Use Program can be submitted to the MEB via CESP. The application consists of a cover letter, a completed application form and attachments.
You can complete the application form via <this link>. Once you have completed the form, it will be emailed to you, after which you can submit the documentation via CESP accompanied by the filled out form.