Should the MAH send ICSRs to the Norwegian Medicines Agency (NoMA)?
No, from November 2017 the MAH sends all serious and non-serious ADRs only to EudraVigilance and not to NOMA.
Does NoMA accept submission of ICSRs on paper/fax?
No, electronic reporting is required as from the 20th of November 2005 and as of 22 November 2017 all reports should be sent directly to EudraVigilance, and not to NoMA.
How do MAHs receive ICSRs from the Norwegian Medicines Agency?
NoMA sends all ICSRs received from healthcare professionals and patients in Norway to EudraVigilance. The reports will then be made available for downloading by the MAH in EudraVigilance.
Why has there, in some cases, been made causality assessments on medicinal products that are coded as “concomitant”?
According to the ICH E2B-guidelines, the drug role (suspect/interacting/concomitant) should be based solely on the role denoted by the reporting health care professional. This implies that we always code the drug role given by the reporting health care professional, regardless of our assessment. However, in cases where we suspect another medicinal product (in addition or alone) to be a suspect/interacting drug, we would code a causality assessment for this drug without changing the drug role. In accordance with the ICH E2B guideline, it is not considered good coding practice to change the information given by the reporting health care professional.
Does NoMA accept MedDRA-terms given as text?
No. Only MedDRA-terms given as codes are accepted in MedDRA-fields, as described in the EU Individual Case Safety Report (ICSR) Implementation Guide.
Why is the information in the “Case narrative” section in Norwegian?
Please note that the information given in Norwegian (in ) is not a case narrative. In all reports from NoMA this field will contain the feedback that is given from our regional pharmacovigilance centres to the reporting health care professional. This text is not meant to replace a case narrative, but is considered for internal use and thus not relevant for MAHs. However, as it would have to be filtered out when transmitting to MAHs, we decided to let this information remain in the reports transmitted to the MAHs. Our regional pharmacovigilance centres are instructed to write a case narrative in English (in ) for serious cases and non-serious cases where all the relevant information cannot be coded structurally or when the chronology or description of the case as such is not describes adequately by the structured information. Translating the Norwegian feedback to English will not be an option as it is not considered relevant for the case and thereby the MAHs.
What about SUSARs (i.e. reports of adverse events arising from clinical trials)?
Please do not send SUSARs to NOMAADVRE.
SUSARs should be sent to NOMACT (only Norwegian cases) and EVCT.
What should MAH do in case of system system failure?
Procedures in case of system failure are described on EMAs website - EudraVigilance: electronic reporting - What to do in case of system failure
How has the Pharmacovigilance legislation (from July 2012) been implemented in Norway?
Please refer to the information in Questions and answers – new Pharmacovigilance legislation.
Does NoMA have a list of journals to be reviewed by the MAHs?
No. It is the MAHs responsibility to search through journals applicable for their products. As a minimum, journals indexed in PubMed should be monitored. In addition, national journals considered relevant for a specific product should be monitored.
Request for obtaining follow-up information:
All available and relevant information is coded in the ICSRs sent by the NoMA. This implies that NoMA/the Regional Pharmacovigilance Center does not possess additional information. Please note that additional information which is received later on automatically will be updated in the report and sent to the MAH (as a follow-up report).
Due to limited resources, NoMA can only handle requests for follow-up information in cases where there is a commitment for this in the Risk Management Plan (RMP).
Where can we find information on Medical Litterature Monitoring Service?
Please see information on EMAs website.
This is a dynamic document that will be updated continuously if necessary.