FAQ – Electronic reporting of ADR:s to the MPA

What regulations apply for safety surveillance in Sweden?

In Sweden reference is made to LVFS 2012-15. Current guideline is Volume 9B.

To other Nordic countries you do not have to send serious, unexpected reports originating outside the EU. Do you have to send these to the MPA?

No.

Is it acceptable to send all serious spontaneous reports occurring outside the EU, i.e. also expected cases?

Follow EMA/EVVets guidelines.

Do you have to attach the article if you send reports from the literature?

No, a reference is sufficient.

What are the time limits?

A serious report must be sent within 15 days after the receipt by the company.

What is the MPA address in the Eudravigilance Veterinary system?

All adverse reactions, occuring in Sweden, should be reported directly to the MPA (Id = SEMPAV) via the gateway.

 
 
 
 

Swedish Medical Products Agency, P.O. Box 26, SE-751 03 Uppsala, SWEDEN | +46 18 17 46 00 | registrator@lakemedelsverket.se | Contact information