New EudraVigilance -system

Frequently asked questions

Is it mandatory to notify Fimea of the post-authorization safety studies (i.e. PASS studies)?
How to submit a Swedish summary of product characteristics to Fimea?
What should be attached to the application for addition?
Is it possible to submit a Swedish summary of product characteristics for a product family in one application?
In connection with submitting a Swedish summary of product characteristics, is it possible to make changes also to the package leaflet?
In connection with submitting a Swedish summary of product characteristics, it possible to make other changes to the SPC?
Transferring marketing authorisation
How does the need for Swedish summary of product characteristics affect the centralised medicines?
Does the submission of the summary of product characteristics in Swedish apply also for veterinary medicinal products?
When should a summary of product characteristics in Swedish be submitted?
How should the summary of product characteristics in Swedish be submitted for new Marketing Authorisation applications, which are currently under assessment?
Can the submission of the summary of product characteristics in Swedish be combined with some other kind of variation application?
How should the summary of product characteristics in Swedish be submitted for already granted Marketing Authorisations?
In which format should the summary of product characteristics in Swedish be submitted?
Brexit
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?
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?
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?

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