​​​​Is the Norwegian Medicines Agency (NoMA) transmitting ICSRs electronically (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. All reportable ICSRs should therefore be transmitted electronically to our production system (NOMAADVRE).

Is a testing phase mandatory?

NoMA accepts ICSRs from all MAHs which has completed testing with EV. A “national” testing phase is not required, but MAHs may perform testing with our test environment (NOMATEST) at their own convenience. Please note that any testing would be in parallel with production transmissions and does not prevent the MAHs from entering/being in full production.

Prior to sending your first production or test ICSRs to us, the MAHs organization IDs (test and production) need to be registered in our system. Please send your request for registration via e-mail to adr@noma.no.

No new testing phase is required if a MAH move from EVWEB-reporting to reporting via gateway. If the organization ID is changed, the new organization ID must be registered at NoMA prior to sending the first report via gateway.

​Does NoMA accept submission of ICSRs on paper/fax? 

No, electronic reporting is required as from the 20th of November 2005.

How do MAHs receive ICSRs from the Norwegian Medicines Agency?

All transmissions of ICSRs from NoMA to MAHs will be sent via the 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 (ICH 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.. All ICSRs sent to the MAHs are also transmitted to the EMA. We use the acknowledgment files from the EMA to validate the correctness of the reports according to the EMA business rules. If the report is considered valid and correct by the EMA, we consider it to be valid also towards the MAHs.

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 EMA business rules document.

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. Our regional pharmacovigilance centres are instructed to write a case narrative in English (in <reportercomment>) 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.

Do MAHs receive a certificate when accepted by NoMA for production phase?

No. All MAHs approved by the EMA are automatically accepted for full production phase with NoMA. No formal letter will be issued. However, we need to register your organization ID in our system to be able to exchange reports. Please inform us by e-mail to adr@noma.no when ready to initiate production phase.

Which contact address should be used in case of system failure?

Procedures in case of system failure are described in the EMA-document e-transmission of ICSRs to the EMA: Steps to follow in case of system failure. Please note that ICSRs that have failed electronic transmission to NOMAADVRE can not be sent to NOMA by email, fax or telephone. The ICSRs must be re-transmitted v​​ia gateway/electronically, as soon as the system is available again.

 

Why has NoMA changed messageformatrelease to 2.0?

NoMA updated the ICH E2B-field “messageformatrelease” in our ADR reporting system on June 15th 2012. The standard value was changed from 1.0 to 2.0.  As 2.0 has been a valid value in this field for years, and ICH recommends using the value 2.0.

How will the new Pharmacovigilance legislation (July 2012) be implemented in Norway?

Please refer to the information in Questions and answers – new Pharmacovigilance legislation.

Which reporting requirements of Individual Case Safety Reports (ICSRs) are applicable to marketing authorisation holders during the interim period in Norway?

NoMAs requirements are outlined in Reporting requirements of Individual Case Safety Reports (ICSRs) applicable to marketing authorisation holders during the interim period published on EMAs website

​Why does the NoMA nullify company ICSRs in case of duplicate reports?

Due to technical limitations in NoMA’s database, NoMA does not have the possibility to make an ICSR inactive without nullifying it. The only way duplicate reports can be handled in the Norwegian national database is through nullification of duplicate ICSRs and the subsequent creation of master files.
All information from the MAH’s ICSR is merged into a master case so that no information is lost. MAH’s ICSRs will never be used as master files in the Norwegian database, and are therefore nullified.  The master file is either an already existing authority report that is subsequently updated or, in cases where no authority report exists, a new master file. The MAH is always notified about this nullification, and informed of the new worldwide unique case identification number (A.1.10.1) of the case.
The nullified reports are not submitted to the MAH, in order to prevent nullification of reports in the MAH’s database.

How should the MAH submit follow-up information on a case which has been nullified by NoMA?

 NoMA informs the MAH of the new, correct worldwide unique case identification number of the case when the MAH is notified of the nullification (see question above). If the MAH has new follow-up information on the case after the MAH’s ICSR has been nullified by NoMA, submission of  follow-up information is still possible by using the new  worldwide unique case identification number of the master case. The MAHs are kindly asked to populate the safety report ID-field (A.1.0.1) with their internal company reference number – and not edit the authority number (A.1.10.1) of the ICSR.  If this is not possible for the MAH, the MAH  should inform NoMA about the follow-up information via e-mail (adr@noma.com) and NoMA will do a manual update of the master ICSR. This is however not the desired option.
NoMA would also like to emphasize that addition of the MAH’s causality assessments is not considered as new medical information, even if this assessment differs from the already existing assessment(s) of the report, and the MAH should subsequently not submit the ICSR to the authorities. Only added medical information in an ICSR constitutes a reason for submission of follow-up information.

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 EMA web-page.


This is a dynamic document that will be updated continuously if necessary.

Publisert: 27.06.2016

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