EudraVigilance

The Danish Medicines Agency is participating in the EudraVigilance project, which is a common European IT project. The vision of the project is that all adverse reaction reports between health authorities and pharmaceutical companies within the EU must be submitted electronically by means of the common information standard e2b.

The European Medicines Agency (EMEA) is in charge of the EudraVigilance project. EudraVigilance is a common European database containing information on adverse reactions in humans, animals and in clinical trials. The system has been running since December 2001. For further information about the EudraVigilance system, please go to www.eudravigilance.org.

During the summer of 2002, the Danish Medicines Agencies began transferring adverse reaction reports electronically to the EudraVigilance system. Thereby, the Danish Medicines Agency was among the first institutions that were fully e2b compatible.

Electronic transmission replaces paper on 20 November 2005

In the communication between health authorities and pharmaceutical companies, electronic adverse reaction reports will replace adverse reaction reports on paper for marketed medicinal products on 20 November 2005 .

This is laid down in executive order no. 262 of 19 April 2004 “Executive order on requirements for presentation of adverse reaction reports and periodic safety update reports etc.” (”Bekendtgørelse om krav til udformning af bivirkningsindberetninger og periodiske sikkerhedsopdateringer m.v.”) and executive order no. 1247 of 13 December 2004 “Executive order amending the executive order on requirements for presentation of adverse reaction reports and periodic safety update reports etc.” (” Bekendtgørelse om ændring af bekendtgørelse om krav til udformning af bivirkningsindberetninger og periodiske sikkerhedsopdateringer m.v.”).

In order to transfer adverse reaction reports electronically to and from the Danish Medicines Agency, pharmaceutical companies must carry out the test procedure available via the fact box to the right. The test must be initiated early on, so that it can be completed before 20 November 2005 .