Local view for "http://purl.org/linkedpolitics/eu/plenary/2012-09-11-Speech-2-376-171"

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	"lt"^^xsd:language2
lpv:document identification number	"en.20120911.32.2-376-171"2
lpv:hasSubsequent	lp_eu:2012-09-11-Speech-2-376-1872
lpv:speaker	lp:Vilija Blinkevičiūtė2
lpv:spokenAs	substitute; FEMM (2012-01-19--2014-06-30)3 member; S&D (2009-07-14--2014-06-30)3 vice-chair; Delegation to the EU-Ukraine Parliamentary Cooperation Committee (2009-09-29--2014-06-30)3 member; EMPL (2012-01-19--2014-06-30)3 member; Delegation to the Euronest Parliamentary Assembly (2009-10-07--2014-06-30)3 substitute; LIBE (2012-01-19--2014-06-30)3 unknown; Lietuvos socialdemokratų partija (2009-07-14--2014-06-30)3 substitute; Delegation to the EU-Kazakhstan, EU-Kyrgyzstan and EU-Uzbekistan Parliamentary Cooperation Committees, and for relations with Tajikistan, Turkmenistan and Mongolia (2009-09-16--2014-06-30)3
lpv:translated text	"I voted in favour of this report because it is very important to ensure improved safety of medicines at EU level. Therefore, we have to strengthen the role of the European Medicines Agency in collecting and immediately acting on signal detection and enhance cooperation between Member States. The additional amendments are needed to ensure that the Pharmacovigilance Risk Assessment Committee can manage its workload and to ensure that patients and health care professionals are fully involved in improving the pharmacovigilance system. Firstly, if drugs are subject to a post-authorisation safety study, or other conditions or requirements, they should be included in the list of ‘black symbol’ drugs subject to additional monitoring. Secondly, the Pharmacovigilance Risk Assessment Committee will not be constituted until July 2012, and so the 12-month deadline to choose a black symbol should start from then. Thirdly, the urgent procedure should be triggered automatically. Fourthly, the urgent procedure should be triggered if, for safety reasons, companies decide not to apply to renew a marketing licence. Fifthly, in order to ensure full implementation of the new provisions related to pharmacovigilance, the European Medicines Agency should be empowered to charge fees to marketing authorisation holders for the fulfilment of the pharmacovigilance tasks."@en1

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