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Regulatory Focus™ > News Articles > Countries Responsible for EU-wide Safety Monitoring Announced

Countries Responsible for EU-wide Safety Monitoring Announced

Posted 08 October 2012 | By Ansis Helmanis

The European Medicines Agency (EMA) published on 5 October 2012 the first list of EU member states responsible for monitoring the safety of specific active substances across the EU. 

In effect, each listed country will be responsible for monitoring specific medicinal products that have been approved for marketing in more than one EU member state through either the national, mutual recognition or decentralized procedures. 

The monitoring data that each country will rely on will be the European pharmacovigilance system (EudraVigilance) established in 2010 by Regulation 1235/2010.  According to EMA, the list will be updated "on a regular basis" to add further substances, countries not as yet included, and possibly "co-leader" countries if needed to ensure that drug products are adequately monitored.


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