Local view for "http://purl.org/linkedpolitics/eu/plenary/2010-09-22-Speech-3-192"
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"en.20100922.20.3-192"2
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"The EU’s pharmacovigilance system has changed over recent years in the sense that the work of the Member States is better coordinated. Nevertheless, there are still gaps in the legislation in force, and so the Commission has proposed changes designed to strengthen pharmacovigilance in the EU and to rationalise procedures.
This report not only endorses the Commission’s proposed changes but also enhances them in some areas, including: strengthening the role of the Pharmacovigilance Risk Assessment Advisory Committee, which must have the power to recommend action to the Committee for Medicinal Products for Human Use; strengthening the role of healthcare professionals in the sense of voluntarily reporting adverse drug reactions; strengthening the role of patients in directly reporting adverse reactions; requiring that all adverse drug reactions (and not just serious ones) are reported to the Eudravigilance database by competent authorities and companies, which means that information on all adverse drug reactions will, for the first time, be centralised in one place in the EU; and requiring patient information leaflets that give a clearer indication of the main features of the drugs.
For all the above reasons, I voted in favour of this report. There can be no doubt that pharmacovigilance is a priority for European public health policy."@en1
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