Frequently asked questions (FAQ) – Electronic transmission of individual case safety reports
The Norwegian Medicines Agency (NoMA) has previously published general information about electronic submission of individual case safety reports (ICSRs). Please note that NoMA would prefer not to receive reports originating outside the EEC. Such reports should be sent to the EudraVigilance database only.
This document is meant as guidance on specific topics, and reflects frequently asked questions from the marketing authorisation holders (MAHs).
- Is the Norwegian Medicines Agency (NoMA) ready for the production phase?
Yes. Electronic transmission of individual case safety reports (ICSRs) is mandatory in Norway as from the 20th of November 2005. This is according to Norwegian and EU-legislation. As from the 20th of November all MAHs (with an organisation ID in the EudraVigilance production environment) were transferred to full production in our system, irrespective of completed testing phase with NoMA. All reportable ICSRs should therefore be transmitted electronically to our production system (NOMAADVRE).
- Is a testing phase mandatory?
After the 20th of November 2005, completion of a testing phase is no longer required, but MAHs may perform testing with our test environment (NOMATEST) if considered necessary. NB: Please note that any testing would be in parallel with production transmissions and does not prevent the MAHs from entering/being in full production.
Please contact us for information about testing procedures (mailto:pernille.harg@noma.no). Please note that a pilot production phase is not necessary.
- Is submission of paper/fax copies necessary in parallel with electronic reporting?
No, please stop all parallel reporting of paper/fax copies. As from the 20th of November 2005, all MAHs were transferred to full production (meaning no parallel paper reporting).
- How do MAHs receive ICSRs from the Norwegian Medicines Agency?
As stated in Circular 5/2005, NoMA entered into full production of electronic transmissions of ICSRs with all MAHs as of 20th of November 2005. Electronic transmission is a two way communication. The MAHs are required to send all ICSRs electronically (to NOMAADVRE), as described above. Likewise, all transmissions of ICSRs from NoMA to MAHs will be sent via the same EudraVigilance-gateway. The NoMA does not have resources allocated to send additional paper copies or copies per e-mail. According to the current legislation, NoMA is required to transmit electronically all serious Norwegian reports to all relevant MAHs in an internationally agreed format (E2B via the gateway). As long as we receive a confirmation of a successfully delivered transmission (MDN), we consider our reporting responsibilities fulfilled. The ability of MAHs to upload ICSRs into their database is outside NoMA’s responsibility. The ICSRs that MAHs receive from NoMA are in exactly the same format (E2B) as the ICSRs transmitted from MAHs to NoMA. All ICSRs sent to the MAHs are also transmitted to the EMEA. We use the acknowledgment files from the EMEA to validate the correctness of the reports according to the EMEA business rules. If the report is considered valid and correct by the EMEA, we consider it to be valid also towards the MAHs.
However, if a MAH should receive reports from NoMA that are not according to the latest version of the EMEA business rules, please do inform us and we will resend the reports in a correct version. This applies only if the MAH is unable to send acknowledgement files.
- Why has there, in some cases, been made causality assessments on medicinal products that are coded as “concomitant”?
According to the 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 E2B guideline, it is not considered good coding practise to change the information given by the reporting health care professional.
- Why do some ICSRs contain different MedDRA version?
One ICSR should be coded in only one MedDRA version. There is a "bug" in our system which makes it possible to use different MedDRA versions. This occurs when a report is updated (e.g. by follow-up information) with new MedDRA-terms. Thus the new information will be coded in the latest MedDRA-version while the previous information will remain in the original MedDRA version. Currently we have to update these reports manually. We are working on a systematic approach to update/upgrade all MedDRA-terms in the ICSRs to the latest version when a new version is released. Please contact us if you are receiving ICSRs with different MedDRA-versions.
P.S: The EMEA database do not always reject or comment on this inconsistency, although it is not according to their business rules.
- Does NoMA accept MedDRA-terms given as text?
No. Only MedDRA-terms given as codes are accepted in MedDRA-fields, as described in the EMEA business rules document. The only field accepting both MedDRA-text and codes in our system is <testname>.
- Why is the information in the “Case narrative” section in Norwegian?
Please note that the information given in Norwegian (in <narrativeincludeclinical>) 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. We believe that coding information in a structured way, as E2B enables, reduces the need for a case narrative in most cases. However, our regional pharmacovigilance centres are instructed to write a case narrative in English (in <reportercomment>) for 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 information 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) and EVCT. Our post-marketing system does not reject SUSARs, but the problem arises when they are transmitted further on to the EMEA (EVHUMAN). EMEA rejects the SUSARs sent to the post-marketing system.
- Why does not NoMA’s files contain file extensions (i.e. .xml)?
Please note that both our safety and acknowledgment files do not have file extensions (e.g. "123456" and not "123456.xml"). This may cause a problem for some systems that poll for xml-files only. The lack of file extensions is a limitation of our file exchange software (Btrade). However, the files are xml files.
- Why can NoMAs acknowledgement files state another safety report version than the submitted report?
The reason why you receive an acknowledgement file with safetyreportversion=1 is because our system uses 1 as a default value in all our ICSRs. Unfortunately it uses 1 as default value also in the acknowledgement files, regardless of the value in the incoming ICSR. We are aware of this problem and will try to find a solution (report back the original value of the incoming report).
- Do MAHs receive a certificate when accepted by NoMA for production phase?
No. All MAHs approved by the EMEA are automatically accepted for full production phase with NoMA. No formal letter will be issued. However, please inform us when ready to initiate production phase.
This is a dynamic document that will be updated continuously if necessary.
Sist gjennomgått: 04.07.2006
Første gang publisert: 04.07.2006