New EudraVigilance -system

Frequently asked questions

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We have downloaded a report X from the EudraVigilance database to our own database, on active substance simvastatin, for which we have a MA in Finland. Shall we submit our own report to the EudraVigilance database?
A nullification for case 2017-123456 was sent to Fimea on 1 December 2017 (FINAM). The report is visible as submitted in the MAHs database but no acknowledgement has been received from Fimea. Why is that?
An ICSR reported to us includes also suspect drugs from two other MAHs. Should I send the report to those MAHs B+C as well?
We have received a report FI-FIMEA-2017XXXX at a subsidiary, but it concerned the product GoodDrug. We are not the MAH for this product in Finland, and do not have any other MAs in Finland for that active substance either. Why has the report been forwarded to us and what should we do about it?
In what language does Fimea enter the reports into the EudraVigilance database?
In what situations can the MAH ask to see the narrative/open fields of the reports (others than reports it has reported itself)?
Shall the articles (on cases fulfilling the criteria for ICSR reporting) found in the local literature review be sent to Fimea?
How to proceed if a duplicate report is suspected locally?
What is the procedure with follow-up questionnaires for some products obliged by the RMP?
What is the procedure for follow-up information requests (from the MAH) for reports reported to the EudraVigilance database by Fimea?
What information on the patient or the reporter shall be submitted to the EudraVigilance database?

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