Local view for "http://purl.org/linkedpolitics/eu/plenary/2012-09-11-Speech-2-374-875"
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"en.20120911.32.2-374-875"2
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"I voted for the resolution on the proposal for amending Directive 2001/83/EC as regards pharmacovigilance because recent events relating to pharmacovigilance in the EU have highlighted the need for an automatic procedure at EU level in the specific cases of safety issues, in order to ensure that the problem is assessed and dealt with in all the Member States where the medicine is authorised.
The normal procedure should be triggered for the quality, safety and effectiveness of medicines when the EU’s interests are at stake. The urgent EU-level procedure should be triggered when a quick assessment needs to be carried out of the concerns which have arisen following the assessment of the data produced by pharmacovigilance activities. Irrespective of whether the urgent or normal procedure is applied at EU level or of the procedure, centralised or not, used to authorise the medicine, the Pharmacovigilance Risk Assessment Committee should always submit a recommendation if the reason for taking action is based on pharmacovigilance data. The measures adopted reinforce substantially the legal framework for monitoring medicines through provisions consolidating the coordinating role of the European Medicines Agency, through the options for signal detection and through the application of harmonised procedures at EU level."@en1
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