The Norwegian Medicines Agency's Notice 9/99: "Requirement for marketing authorisation holders to report adverse drug reactions in connection with medicinal products for human use, as a result of Norway's participation in an extended EEA agreement", describes reporting of adverse drug reactions (ADRs) to the national authorities. According to Notice 9/99 all suspected, serious adverse reactions occurring in Norway and all suspected, serious and unexpected adverse reactions occurring outside the EEA should be reported to the Norwegian Medicines Agency (NMA) immediately or at the latest 15 days after the receipt of the information. Further, Notice 9/99 states that marketing authorisations holders (MAHs) are requested to use internationally accepted reporting forms and that NMA until further notice requires hard-copy reports.
From June 1st 2001 NMA also accepts ADR reports from MAHs (CIOMS-I reports) sent electronically as e-mail. Until further notice, NMA can only accept reports in word-, pdf- or similar formats.
Guidelines for reporting of ADRs by e-mail
To simplify classification and filing of the incoming ADRreports, and to make the information searchable, the Norwegian Medicines Agency requests that the following guidelines be followed:
- The name of the sender (MAH) should be stated in the "subject"-line of the e-mail.
- Norwegian reports and reports from countries outside the EEA should be sent in separate e-mails. The origin of the reports (Norwegian or non-EEA) should appear in the "subject"-line of the e-mail.
- The ADR reports should be attachments to the e-mail.
- The e-mail body must include the name of the (suspected) medicinal product(s) in the attached reports, and state if the reports are Norwegian or from countries outside the EEA.
E-mail-address: CIOMS-I@legemiddelverket.no
In order to avoid misunderstandings: CIOMS-I is written with Roman number one (corresponding to a capital letter i) at the end.
Example
To: CIOMS-I@legemiddelverket.no
Subject: <MA-holder> – Norwegian CIOMS-I reports
Or: <MA-holder> – non-EEA CIOMS-I reports
Body:
Please find attached Norwegian CIOMS-I reports for the following medicinal products:
– <Medicinal product A> 2 reports
– <Medicinal product B> 1 report
– <Medicinal product C> 3 reports
Attachments:
CIOMS-I /ADR-reports, word- or pdf-format.
The Norwegian Medicines Agency asks MAHs to inform their respective foreign drug-safetyunits responsible for reporting ADRs to the Norwegian authorities about the possibility to send reports by e-mail.
Reporting of adverse drug reactions and serious adverse events in clinical trials
Reports of ADRs and serious adverse events during clinical trial (SAE-reports) may be sent to clinical.trials@legemiddelverket.no. The e-mails should fulfil the requirements described above.
NORWEGIAN MEDICINES AGENCY
Ivar Vollset
Head of Department
Pernille Harg
Scientific Officer