Electronic reporting of Suspected Unexpected Serious Adverse Reactions (SUSARs) to the Norwegian Medicines Agency
The following information is applicable for reporting of Suspected Unexpected Serious Adverse Reactions (SUSARs) in Norway. Please check our web-site for potential updates later on at News.
Applicable reporting
According to Regulation relating to clinical trials on medicinal products for human use (FOR-2003-09-24 nr 1202, into force on 2004-05-01), the sponsor shall ensure that all suspected adverse reactions occurring in connection with a clinical trial of drugs for human beings that are fatal or life-threatening, and which are unexpected, are reported. The same is applicable for suspected adverse reactions that are serious and unexpected, see responsibilities and time frames.
Electronic Submission
The Norwegian Medicines Agency asks that these reports are submitted in an electronic E2B-compliant format starting from 20. November 2005. The requirements concerning the timeframes and contents of the reports will not be changed, but we ask that the reports are written in English since the reports will be available to all regulatory Agencies in Europe.
Requirements of notification for studies conducted in Norway
We ask that reports concerning SUSARs of Norwegian origin only are submitted both to the EMEA’s EudraVigilance Clinical Trial Module (EVCT) and to the Norwegian Medicines Agency. Identical reports should be submitted to both parties and the Norwegian Medicines Agency will not forward the reports they receive to the EVCT.
SUSARs of foreign origin
Please note that the Norwegian Medicines Agency do not wish to receive SUSARs of foreign origin even if the same study is conducted in Norway and/or if a study with the same investigational medicinal product is conducted in Norway. The requirement of notification is maintained by submitting such reports to the EVCT, where the Norwegian Medicines Agency will have access to them.
Technical information and addresses
The Norwegian Medicines Agency will use the EVWEB solution to receive SUSARs from clinical trials. The following profiles have been established: NOMACT for the production database and NOMACTTEST for the test database.
No Test phase
As the Section for Clinical Trials at the Norwegian Medicines Agency will use the EMEA system, it should not be necessary to perform a separate test phase for SUSARs to our NOMACT profile. However, we ask that everybody contacts us before they start submitting SUSAR reports. Please use the following contact information: klut@noma.no
Backlog
For studies applied after 2004-05-01, it is required to submit SUSARs retrospectively until this date (backlog). We ask that you put on hold the submission of these reports until all parties have gained some experience with the electronic system. Further guidance will be given on our web-site.
Non-commercial trials
The Norwegian Medicines Agency understands that non-commercial sponsors (i.e. studies not performed by a pharmaceutical company) might have difficulties complying with the requirements regarding electronic reporting of SUSARs. If these studies use investigational medicinal products with a marketing authorization, we would recommend that such non-commercial sponsors get in contact with the company holding the marketing authorization for potentially help with the electronic reporting. It might also be possible for the larger health institutions/hospitals to establish a core facility to aid such reporting from all the studies at that institution/hospital. The Norwegian Medicines Agency will upon request be of help in finding other solutions. If this is necessary, please contact Section for Clinical Trials.
Other information
For information regarding reporting of adverse drug reactions from post-marketing use and non-intervention studies, please contact Section for Pharmacovigilance at: CIOMS-I@noma.no.
Also see EudraVigilance web site.