Local view for "http://purl.org/linkedpolitics/eu/plenary/2012-09-11-Speech-2-376-500"

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	"ro"^^xsd:language2
lpv:document identification number	"en.20120911.32.2-376-500"2
lpv:hasSubsequent	lp_eu:2012-09-11-Speech-2-376-6252
lpv:speaker	lp:Minodora Cliveti2
lpv:spokenAs	substitute; Delegation to the Euronest Parliamentary Assembly (2012-05-21--2014-06-30)3 member; EMPL (2012-05-23--2014-06-30)3 member; S&D (2012-05-18--2014-06-30)3 substitute; Delegation to the EU-Armenia, EU-Azerbaijan and EU-Georgia Parliamentary Cooperation Committees (2012-05-21--2014-06-30)3 substitute; ENVI (2012-05-21--2014-06-30)3 unknown; Partidul Social Democrat (2012-05-18--2014-06-30)3 member; Delegation to the EU-Moldova Parliamentary Cooperation Committee (2012-05-23--2014-06-30)3 substitute; Delegation for relations with Canada (2012-06-20--2014-06-30)3 substitute; FEMM (2012-05-21--2014-06-30)3
lpv:translated text	"Parliament and the Council have agreed to review the rules regulating pharmacovigilance at EU level by adopting Regulation (EU) No 1235/2010. It has been observed that a range of measures need to be taken following the stress test carried out by the Commission on this legislative act, specifically: an automatic urgent procedure – for example, when Member States want to withdraw a medicine, with some room for discretion on this, while the Commission is proposing to make the urgent procedure automatic; a new trigger for the urgent procedure – if companies decide not to apply to renew a marketing licence due to safety reasons, this should trigger the urgent procedure; in the case of medicines featuring in the list of medicines subject to additional monitoring, the summary of product characteristics and the leaflet which comes with the packaging must include the statement ‘This medicine is subject to additional monitoring’. This statement must be preceded by a black symbol selected by the Commission on the recommendation of the Pharmacovigilance Risk Assessment Committee by 2 July 2013, and must be followed by an appropriate standard explanatory note."@en1

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