Pharmacovigilance: reporting behavior of marketing authorization holders

messages in brief | 18/09/2009

As of January 1, 2008, the reporting system in Austria was converted from paper form to E2B (electronic reporting). Compliance in terms of time has now been evaluated for the first time for the period from 01.01.2009 to 30.06.2009: the legally required 15-day period was exceeded in only around five percent of cases. The compliance rate of 95 percent is therefore gratifyingly high.


In the same period, the Federal Office for Safety in Health Care (BASG)/AGES PharmMed achieved a compliance value of 99.5 percent for the transmission of case data to the European database EudraVigilance.



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Institute PharmacovigilanceDr. Bettina SchadeE-mail:


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