For physicians and dentists
Published:
Changes
When compassionate use, named patient may be granted, requirements for medical justification, procedures for submitting applications.
Page contents
Medical product for an individual patient, practice or for use in the hospital department?
Compassionate use, named patient may be granted for:
- a specific medicinal product for an individual patient
- a specific medicinal product to be used at the prescriber’s practice (including institutions such as nursing homes)
- a specific medicinal product to be used in hospitals. For use in hospitals, the application must be signed by the responsible senior medical consultant of the department
If a patient is discharged from the hospital and needs to continue with a medicinal product that requires compassionate use, named patient, a new application must be submitted for each patient via e-prescription.
Compassionate use, named patient is granted for a specific quantity or for a limited period, up to a maximum of one year.
Information about the medicinal product
The prescriber must have the necessary information regarding the safety and efficacy of the product. Wholesalers/pharmacies can provide information about the manufacturer, package sizes, and similar details. NOMA does not have this information.
Requirements for medical justification
The application must include a medical justification for the need for a product that is not marketed in Norway. When using medicinal products without a marketing authorisation, the practitioner has a special responsibility to ensure that the use is justifiable according to the Medicinal Products Regulation § 2-5.
The justification must be included in every application. NOMA is not permitted to store personal data, and therefore the prescriber cannot refer to information provided in previous applications.
A medical justification may include:
- the patient requires a different formulation than what is marketed in Norway
- there is no marketed product that meets the medical need
It is not necessary to apply for compassionate use, named patient for medicinal products marketed in Norway, even if the intended use is off-label.
About electronic applications via e-prescription
Most medicinal products are dispensed directly at pharmacies (notification). However, some medicinal products must be pre-approved by the Norwegian Medical Products Agency (NOMA) before dispensing. The patient can visit a pharmacy to get information about this.
Applications for medicinal products that require approval from NOMA are typically processed within three working days. The patient can check the status of their application on Helsenorge. Once the application is approved, the patient can visit a pharmacy to obtain the medicinal product.
If the application is rejected, NOMA provides a reason for the rejection. If the reason is not found in your medical record system, you must contact the record provider for guidance.
Electronic applications can currently only be used for applications for compassionate use, named patient for individual patients. Applications for use in practice or hospital departments must be submitted using paper forms. For procedures regarding applications for use in hospital departments, see a separate page.
If the patient is discharged from a hospital/institution and needs to continue with a medicinal product that requires compassionate use, named patient, a new application must be submitted for each patient (via e-prescription).
About paper applications
Applications for individual patients should no longer be submitted using paper forms. Exceptionally, paper forms can be used for individual patients if the prescriber does not have access to a system that allows for electronic prescriptions.
You must contact your record provider for guidance if you have difficulties writing an e-prescription.
We recommend that the prescriber submits paper applications to the pharmacy. The pharmacy will determine whether the medicinal product can be dispensed directly or if NOMA must approve the application before dispensing.
Paper forms must still be used for applications concerning the use of medicinal products in practice (including institutions such as nursing homes). Applications for compassionate use, named patient for use in practice do not contain patient information and can be sent to the pharmacy via email as a signed PDF.
Application forms
Go to the page for application forms, submission, and processing time.
NOMA offers a simplified procedure for hospitals.
Reimbursement for medicinal products under compassionate use, named patient
Reimbursement under the Blue Prescription Scheme generally only applies to medicinal products approved in Norway. However, HELFO may, upon application from the prescribing doctor, grant individual support for expenses related to medicinal products under compassionate use, named patient. Contact HELFO for questions about reimbursement.