As a marketing authorisation holder, you are legally obliged to submit reports of adverse reactions to the medicines authorities. There are detailed instructions on what to submit and how this should be done.
ADR obligations based on pharmacovigilance legislation
Individual Case Safety Reports (ICSRs) from the Netherlands must be sent directly to the EMA EudraVigilance database (Organisation Identifier: EVHUMAN).
- Serious ICSRs must be sent within 15 days after the report has become known to you.
- Non-serious ICSRs must be sent within 90 days after the report has come to your attention.
The electronic submission should be delivered to EudraVigilance in an ICH E2B(R2) message or in an ICH E2B(R3) message. Your report is automatically forwarded from EudraVigilance to the relevant national competent authorities.
As a marketing authorisation holder, you must comply with the obligations for recording and reporting reports of suspected adverse reactions (ADRs; Adverse Drug Reactions) as described in the Guideline on good pharmacovigilance practices Module VI – Collection, management and submission of reports of suspected adverse reactions to medicinal products (Rev 2). In addition:
- Dutch reports may be made prepared either in Dutch or in English.
- If submission to EudraVigilance is temporarily impossible due to technical problems, please follow the instructions from the EMA. It is not necessary to inform the MEB separately about this.
Reporting obligations for reporting suspected adverse reactions can be found in Regulation (EC) no. 726/2004 and Directive 2001/83/EC.
The Netherlands Pharmacovigilance Centre Lareb manages the national spontaneous reporting system on behalf of the MEB and forwards the reports to EudraVigilance. As a marketing authorisation holder, you can obtain the Lareb reports (both serious and non-serious) via EudraVigilance in an ICH E2B(R3) message. In order to obtain the correct access rights, you must ensure that your ‘EudraVigilance User Registration’ is in order. Moreover, it is essential that your data in the Art. 57 database are complete and up-to-date. Please consult the EudraVigilance section on the EMA website for more information.
Lareb reports are ‘regulatory reports’; therefore, you do not have to resubmit them to the EudraVigilance database.