Spontaneous reporting - Electronic reporting

For human medicinal products:

According to regulation EG/726/2004 the Marketing Authorisation Holder (MAH) shall send all spontaneous reports electronically to the EudraVigilance Human Post-Authorisation Module (EVPM).

Swedish Medical product Agency forward received spontaneous reports from consumers and healthcare professionals originating in Sweden, to EVPM.

For further guidance, please see European Medicines Agencies; Guideline on good pharmacovigilance pratices, Module VI – Collection, management and submission of report of suspected adverse reactions to medical products (Rev 2).

For veterinary medicinal products:

To all Marketing Authorisation Holders (MAHs) for veterinary medicinal products marketed in Sweden.

The Swedish Medical Products Agency (MPA) requests that all serious adverse events, deriving from a MAH, should be sent electronically to the MPA (ID: SEMPAV) and NOT directly to the EudraVigilance Veterinary database (EVVet). The MPA will then forward the adverse event reports to EVVet. The MAHs are welcome to apply the above mentioned scenario on their non-serious cases also.

The Swedish legislation requests the veterinarians to send their adverse event reports directly to the MPA. The MPA then forward the reports electronically to the MAH and to EVVet. 

 



 

 
 
   
 

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