Local view for "http://purl.org/linkedpolitics/eu/plenary/2010-09-22-Speech-3-198"
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"en.20100922.20.3-198"2
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"Pharmacovigilance is the process and science of monitoring the safety of drugs, which includes gathering and managing drug safety data, evaluating the relevant data to detect a safety-related problem, the actions taken to rectify the problem, which also means providing information about the nature of the problem and evaluating the procedures used and results obtained. Under current EU legislation, medicines can be authorised in two ways: a) through a central procedure where an application is made by a pharmaceutical company to the EMEA (European Medicines Agency), as stipulated in Regulation (EC) No 726/2004, or b) through a system of mutual recognition where one country leads on the assessment of the new drug and coordinates with other Member States through mutual recognition. I support the report because consumers and healthcare professionals should also have full access to the central European Eudravigilance database in order to prevent the repetition of adverse drug reactions which could have been avoided by making validated information easily available. This is an effective way to tackle inequalities in information about adverse drug reactions among Member States. Public access to Eudravigilance is needed to restore citizens’ trust in health authorities’ ability to protect public health."@en1
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