FAQ – Electronic reporting of ADR:s to the MPA

What regulations apply for safety surveillance in Sweden?

In Sweden reference is made to LVFS 2012:14 (HSLF-FS 2017:70) and current guidelines from EMA; Guideline on good pharmacovigilance practices.

Does MAHs have to send serious adverse events or serious unexpected reports to MPA?

No, all adverse reactions, should be reported from MAH directly to the Eudravigilance database (EV) at EMA.

What is sent to the EV from MPA?

All spontaneous adverse event reports originating in Sweden, received by MPA.

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/EVHUMANs guidelines.

Should consumer reports be sent to EV?

Follow EMA/EVHUMANs guidelines.

What are the time limits?

Follow EMA/EVHUMANs guidelines.

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

Follow EMA/EVHUMANs guidelines.

How do you send electronically to EV?

Please, see the Eudravigilance web-site for more information.

When is the reporting obligation fulfilled?

Please, see the Eudravigilance web-site for more information.

Do you get an MDN if you are using the Webtrader?

Please, see the Eudravigilance web-site for more information.

If electronic dispatch does not work – which steps must the company take?

Please, see the Eudravigilance web-site for more information.

How can small companies cope with electronic reporting?

Small companies with very scarce reporting may contract a consultant specializing in this area to do the reporting for them.

Which e-mail address should companies use for questions to MPA?

Regarding specific electronic reporting from MPA –
bisi-system@lakemedelsverket.se

Regarding specific ADR reports –
ADR-report@lakemedelsverket.se

 
 
 
 

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