Local view for "http://purl.org/linkedpolitics/eu/plenary/2012-09-11-Speech-2-381-000"

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.20120911.32.2-381-000"2
lpv:hasSubsequent	lp_eu:2012-09-11-Speech-2-381-0032
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. The Commission’s stress tests suggest that though much improves under the new system, further changes are needed to close any potential loopholes. An automatic urgent procedure (Article 107i, directive): the 2010 legislation already specifies a list of triggers which would activate the urgency procedure (e.g. if a Member State withdraws a drug), but Member States have some discretion over this. The Commission is now proposing to make the urgent procedure purely automatic. · A new trigger for the urgent procedure (Article 107i, directive): if companies decide not to apply to renew a marketing licence (as was the case for Mediator), and if this is due to safety reasons, then this should trigger the urgent procedure. · Clarification of transparency obligations on companies (Article 123(2), directive): when companies voluntarily withdraw a drug or do not reapply for a marketing licence, they must specifically declare if this is due to a safety concern. (When Servier did not reapply for authorisation for Mediator in Italy and Spain, they claimed it was for commercial reasons.)"@en1
lpv:unclassifiedMetadata	"Raül Romeva i Rueda (Verts/ALE ),"1 "in writing."1

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