Information on compassionate use, named patient for pharmacies
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Procedures for pharmacies when dispensing electronic applications
Before dispensing, the pharmacy checks:
- whether the requested product is on the negative list or can be directly dispensed at the pharmacy (notifiable).
- that the active substances, quantity, and time period are specified.
- that a medical justification is provided, including why a marketed alternative cannot be used. This is required by regulations and must be included with each application.
NOMA does not have access to patient information from previous applications.
Specifics for notifiable applications
After verifying the information on the application, the medicinal product is dispensed according to standard procedures. Pharmacies should ensure that they do not mistakenly notify a medicinal product that requires assessment by NOMA before dispensing. Seek advice if uncertain. Information can be found by checking the wholesaler link or contacting the wholesaler directly.
Specifics for applications for products on the Negative List
If NOMA approves the application, the approved application can be found in the Prescription Intermediary. The pharmacy orders and dispenses the product in accordance with current requisition and dispensing regulations. The application is valid until it is dispensed or outdated.
For most products listed on the negative list, the application will be sent for approval directly from the doctor's prescribing module to NOMA.
Therefore, pharmacies will find that these products are already processed when they are downloaded from the prescription intermediary. Applications requiring pre-approval from NOMA will typically be processed within three working days. If the doctor's systems are not updated, there may be instances where the pharmacy must press "send application to NOMA".
Missing a response to an electronic application?
If NOMA rejects the application, the requisitioner will receive an electronic notification. The application will then be marked as "Under review by NOMA" or "Withdrawn" in the Prescription Intermediary. Pharmacy staff can find information about the application using the "Extended prescription search" in FarmaPro.
The most common reason for NOMA to reject an application is incomplete information. Often, the doctor's justification for why a marketed medicine cannot be used is missing. The doctor must justify the choice of unregistered medicine in each application since NOMA does not have access to patient information from previous applications.
Procedures for pharmacies when dispensing paper applications
Before dispensing, the pharmacy checks that the correct box is ticked regarding whether the requested product is on the negative list or can be directly dispensed at the pharmacy (notifiable). Additionally, the pharmacy verifies that:
- the application is signed by the requisitioner and includes an ID number.
- the requisitioner's name is clearly indicated with a stamp or block letters.
- the active substances, quantity, and time period are specified.
- a medical justification is provided, including why a marketed alternative cannot be used. This is required by regulations and must be included with each application.
Specifics for notifiable applications
- After controlling the information on the application, the original application is stamped, dated and signed by the pharmacy and the box for processed is checked.
- The medicine is dispensed according to normal procedures and the application is kept by the pharmacy. If the application is repeated, the pharmacy may apply additional processing.
Before 15th of January of the following year, all processed and outdated applications are sent together to the DMP. The envelope is marked "compassionate use, named patient - human" and sent to:
Directorate for Medical Products, (compassionate use, named patient - human), P.O. Box 240 Skøyen, 0213 Oslo.
Specifics for applications for products on the Negative List
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After controlling the information on the application, it is signed and stamped in the section for detalins with the pharmacy's contact information.
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The original application and a copy are sent to DMP together with an addressed return envelope. The pharmacy retains a copy of the application.
Response to application
If the DMP grants the application, a copy of the granted application will be sent to the pharmacy. The pharmacy orders and dispatches the goods in accordance with the applicable requisition and dispensing regulations. The original application is retained by the DMP. If the application is reiterated, any further dispatches are recorded on the pharmacy's copy. The application is valid until it is dispatched or out of date. In the event of missing information, refusal or where the preparation is notifiable, the DMP returns the original application to the pharmacy with an explanation. The pharmacy contacts the requester in the event of refusal or missing information.
NB: If it is not clear which pharmacy has submitted the application, the DMP sends processed applications back to the requester. The requester (possibly the patient) delivers/sends the granted application to the pharmacy for ordering and dispatch in the usual way. We recommend that all applications are submitted via the pharmacy for correct and efficient processing.
Applications for compassionate use, named patient to practice
Applications for compassionate use, named patient marked "for practice" can be sent via email from the physicians office, clinic, institution, etc., as a signed PDF to the pharmacy, provided the pharmacy has procedures to verify the requisitioner's identity. If pre-approval by NOMA is required, the pharmacy can forward the application via email to NOMA. The approved application from NOMA is printed at the pharmacy and processed as a standard paper application. It is not necessary to send these applications to NOMA afterward. For notifications, the pharmacy can print the received PDF and handle it as a standard paper application, i.e., sign and check off for dispensed under the notification scheme and then send it to NOMA no later than January 15th of the following year.
Applications by email must go through the pharmacy, as it is the pharmacy's responsibility to verify the requisitioner's identity. The pharmacy must have procedures to verify who orders and collects the medicines.
Application form
Visit the page about the application form, submission, and processing time.
Negative list
The list shows product groups and products that cannot be dispensed before NOMA has assessed the application for compassionate use, named patient.
Dispensing list (formerly called the positive list)
Unregistered medicines used in pharmacy production
When the pharmacy uses unregistered medicines in production, no application for compassionate use, named patient is required. In such cases, the unregistered medicine is considered a raw material in the manufacture. The physician must requisition the pharmacy-made product. If the pharmacy dispenses an unregistered medicine and only prepares the medicine according to the product description, the physician must apply for compassionate use, named patient.