Local view for "http://purl.org/linkedpolitics/eu/plenary/2011-02-15-Speech-2-601-000"
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"en.20110215.30.2-601-000"2
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"In effect, the procedures that were in force at the time of the historic events that I recounted in my answer were as I stated: there was a clear separation between Member States and the European authority – a separation that is still, in fact, in force and jealously guarded by Member States. In effect, that is why, over time, we feel that we should be strengthening our pharmacovigilance processes and procedures.
I must say that, in 2004, a step forward was taken on revising the pharmacovigilance procedures and processes that we already have, and also in the last pharmacovigilance agreement. We now have a lot of ‘stoppers’ and it is now also possible for other action to be taken at European level, too, to ensure that anything that is withdrawn from any market is notified and action can be taken upon it. This was not the case before.
So this is the situation today. I have instructed my services to conduct a stress test now, including on the new pharmacovigilance processes and procedures put in place after our last agreement. They are taking Médiator as a case study to see whether something like Médiator could still happen with the latest pharmacovigilance processes. We will make sure that if we do find any vacuums, bottlenecks or spaces where action will not be taken in these cases, we will come back to you and try to correct the situation."@en1
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