Cover letter
The cover letter must contain information regarding previous and/or ongoing clinical trials with the medicinal product in question. If there has been, or is ongoing, clinical trials in Norway please refer to the respective EudraCT-numbers, as well as NoMA reference numbers.
Information on application for Marketing Authorisation (MA)
If an application for MA has been submitted, NoMA must be notified. If so, the application must include the reference number for the MA application and the date of submission. This information can be provided in the cover letter.
Justification
The need of a CUP must be justified, reasoning why the patients cannot be satisfactorily treated with approved medicinal products. In addition, it must be justified why the patients cannot be included in an ongoing clinical trial.
Safety monitoring
The application must contain a description on how adverse reactions will be registered and reported.
Protocol (project plan)
There are no formal requirements on the content of a CUP protocol. For guidance, chapter 6 in ICH GCP and chapter 4 (page 10 and 11) in the Guidance on the Norwegian Regulation on Clinical Trials may be used.
Informing the patients
There are no formal requirements on the content of the patient information. For guidance, the template published by Regional Ethics Committee on clinical trials may be used.
Labelling
A label suggestion must be submitted with the application.
Benefit/risk assessment
Unless described in the protocol, a benefit/risk assessment has to be submitted with the application. The assessment must address the risks of using the medicinal product with respect to the potential benefits for the intended patient population. The benefit/risk assessment must contain a summary of the results from clinical trials where patients with the indication in question have been included.
Documentation of the medicinal products
If the application involves the use of a new active substance, or a new formulation of an already authorized substance, pharmaceutical documentation must be submitted. The investigator’s brochure must be submitted.
A list of all previous and/or ongoing clinical trials must be submitted. A reference to the corresponding EudraCT-number(s) should be made, if available, as well as the NoMA reference numbers if any trials has been performed in Norway.
Contact information
The name and contact details for the person who can be contacted regarding the CUP must be provided in the application. This information will be publicly available on NoMAs website, please see Overview of CUPs.
List of included patients
The responsible physician must have a list of all patients in the program. The list must be continuously updated while patients are included in the program. The applicant must once a year submit an update to NoMA regarding the number of patients included in the program.