Frequently asked questions (FAQ) – Electronic transmission of individual case safety reports (ICSRs)
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This information is meant as guidance on specific topics, and reflects frequently asked questions from the Marketing authorisation holders (MAHs).
In general, the reporting of Adverse Drug Reactions (ADRs) occurring in Norway should be in line with the requirements of EU directive 2001/83 and Regulation 726/2004 and the guidelines for Good Pharmacovigilance Practices (GVP) module VI.
The MAH shall report all serious and non-serious ADRs occurring in Norway to EudraVigilance. ADRs occurring in other EU/EEA-countries and outside the EEA should also be reported to EudraVigilance, in line with the requirements in the legislation/GVP VI.
Norwegian ADRs reported by marketing authorisation holders, will be rerouted from EudraVigilance to NOMA.
All reports submitted directly to NOMA by healthcare professionals and consumers in Norway will be submitted to EudraVigilance. EudraVigilance will make these available to the MAHs for downloading.
Does NoMA have national pharmacovigilance requirements?
No, there is no additional national requirements. Handling of Adverse Drug Reactions (ADRs) occurring in Norway should be in line with the requirements of EU directive 2001/83 and Regulation 726/2004 and the guidelines for Good Pharmacovigilance Practices (GVP) module VI.
Does the national legislation for Norwegian Adverse Drug Reaction Registry add additional reporting obligations for MAHs?
No, the legislation for the Norwegian Adverse Drug Reaction Registry (Bivirkningsregisterforskriften) does not affect reporting obligations for MAHs. The legislation requires Health Care Professionals (HCPs) to report certain ADRs to NoMA. This requirement applies only to HCPs providing health care to patients. MAH’s obligation to collect information on ADRs remains unchanged.
Why should MAHs communicate that Health Care Professionals and consumers should report ADRs directly to Norwegian Adverse Drug Reaction Registry (NoMA)?
NoMA has the legal right to collect personal identifiers (national personal identification number) in the Norwegian Adverse Drug Reaction Registry (NorADRR). This information is important for the data quality in NorADDR. The national personal identification number is used for follow-up and for linking data from ICSRs to other national health registries on patient level. This makes it possible to analyse data across national health registries and thus do better signal detection and signal analysis.
ICSRs received from MAHs will not include the patients’ national personal identification number. NoMA therefore ask that MAH refer to NoMAs electronic reporting forms whenever promoting ADR reporting to HCPs and consumers.
Note that this does not affect the MAHs obligations to report outlined in Good Vigilance Practice module VI.
Will ICSRs received from MAH be part of the Norwegian Adverse Drug Reaction Registry?
Yes, ICSRs received from MAHs will be included in Norwegian Adverse Drug Reaction Registry (NorADDR). These cases will not include the patients’ social security number and it not be possible to link data from ICSRs received via MAH to other national health registries on patient level.
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.
Why is some of the information in “Case narrative” or Senders comments in Norwegian?
Please note that the information given in Norwegian is not a case narrative. All Health Care Professionals (HCPs) reports from NoMA will contain the feedback given from our regional pharmacovigilance centres to the reporting HCP. This text is not a case narrative, but is considered for internal use and thus not relevant for MAHs. A case narrative is provided in English 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. The Norwegian feedback will not be translated to English.
How should SUSARs be handled(i.e. reports of adverse events arising from clinical trials)?
What are the requirements for handling ADRs of parallel imported medicinal products?
Requirements regarding pharmacovigilance for parallel imported medicines is not detailed in regulations or guidelines. Parallel import is not a regular Marketing Authorization (MA). Parallel import is a permission to import a medicinal product that the originator has documented and are responsible for quality, effect and safety for. Therefore, a parallel importer is not required to set up a Pharmacovigilance-system and not required to forward ICSRs to the originator. NoMA strongly encourage that the parallel importer follow the reporting requirements outlined in GVP module VI, as this is of importance to public health. Since the MAH of the originator is responsible for the safety of their product, NoMA also encourage that the originator is informed. The parallel importer should also inform the originator of the ICSRs world-wide unique identification number to avoid the creation of duplicates.
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).
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.
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
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.
What does NoMA do with reports with «no adverse reaction» or lack of therapeutic efficacy?
Reports of lack of therapeutic efficacy are followed-up if incomplete, but normally they are not submitted as ICSRs and nullfied if there is no associated suspected adverse reaction. In these instances, a feedback is given to a reporter that they can report this to the MAH.
In certain circumstances, reports of lack of therapeutic efficacy with no suspected adverse reactions may be submitted and considered as valid by NoMA. Medicinal products used in critical conditions or for the treatment of life-threatening diseases, vaccines, contraceptives are examples of such cases.