Local view for "http://purl.org/linkedpolitics/eu/plenary/2012-09-11-Speech-2-373-000"

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	"es"^^xsd:language2
lpv:document identification number	"en.20120911.32.2-373-000"2
lpv:hasSubsequent	lp_eu:2012-09-11-Speech-2-374-0002
lpv:speaker	lp:Raül Romeva i Rueda2
lpv:spokenAs	substitute; Delegation to the Parliamentary Assembly of the Union for the Mediterranean (2012-02-13--2014-06-30)3 unknown; Iniciativa per Catalunya Verds (2009-07-14--2014-06-30)3 substitute; Delegation to the EU-Turkey Joint Parliamentary Committee (2009-09-16--2014-06-30)3 substitute; LIBE (2012-01-19--2014-06-30)3 substitute; Delegation for relations with the countries of Southeast Asia and the Association of Southeast Asian Nations (ASEAN) (2009-09-16--2013-04-17)3 member; PECH (2012-01-19--2014-06-30)3 member; Delegation for relations with the countries of Central America (2009-09-16--2014-06-30)3 vice-chair; G/EFA (2012-02-01--2013-03-20)3 member; Delegation to the Euro-Latin American Parliamentary Assembly (2009-09-16--2014-06-30)3 member; FEMM (2012-01-19--2014-06-30)3
lpv:translated text	"In favour. In December 2010, Parliament and the Council agreed on a revision of the rules governing pharmacovigilance at EU level by adopting Directive 2010/84/EU and Regulation No 1235/2010. This new legislation is due to come into force in July 2012. The rapporteur believes that the range of measures adopted in this new legislation will lead to improved safety of medicines at EU level by strengthening the role of the European Medicines Agency (EMA) in collecting and acting on signal detection and increasing cooperation between Member States. However, the emergence of a major medicine safety enquiry in France, the ‘Mediator’ case in 2011 (see below), prompted calls for an urgent review of pharmacovigilance systems in the EU. The Commission responded by carrying out a ‘stress test’ on the December 2010 legislation in order to identify any additional lessons which needed to be learned in the light of the Mediator case. The result 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 Commission is therefore proposing some further changes to Directive 2010/84/EU and Regulation No 1235/2010 to address these concerns."@en1
lpv:unclassifiedMetadata	"Raül Romeva i Rueda (Verts/ALE ),"1 "in writing."1

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