Local view for "http://purl.org/linkedpolitics/eu/plenary/2012-09-11-Speech-2-384-000"

Predicate	Value (sorted: default)
rdf:type	lpv_eu:Speech2
dcterms:Date	"2012-09-11"^^xsd:date2
dcterms:Is Part Of	lp_eu:Explanations of vote2
dcterms:Language	"sk"^^xsd:language2
lpv:document identification number	"en.20120911.32.2-384-000"2
lpv:hasSubsequent	lp_eu:2012-09-11-Speech-2-384-2502
lpv:speaker	lp:Monika Beňová2
lpv:spokenAs	unknown; SMER-Sociálna demokracia (2009-07-14--2014-06-30)3 member; Delegation for relations with Israel (2009-09-16--2014-06-30)3 member; S&D (2012-01-19--2014-06-30)3 substitute; AFET (2012-01-19--2014-06-30)3 member; CRIM (2012-03-28--2013-10-23)3 member; LIBE (2012-01-19--2014-06-30)3
lpv:translated text	"The case of the medicine Mediator, the safety of which is under investigation, occurred in France in 2011. The case drew attention to the need for an urgent review of the pharmacovigilance system in the EU. The European Commission responded by carrying out a stress test on the legislation from December 2010 in order to identify any additional lessons that needed to be learned in the light of the Mediator case. The results of the stress tests showed that while the new legislation did strengthen pharmacovigilance at EU level, there are some potential weaknesses in the EU system that need to be addressed. The stress tests suggest that, though there is much improvement under the new system, further changes are needed to close any potential loopholes. In the interests of public health, a consensus must be reached as soon as possible. I agree with the Commission’s approach in these proposals, which aim to further strengthen the pharmacovigilance system at EU level."@en1

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