Local view for "http://purl.org/linkedpolitics/eu/plenary/2012-09-10-Speech-1-228-000"

Predicate	Value (sorted: default)
rdf:type	lpv_eu:Speech2
dcterms:Date	"2012-09-10"^^xsd:date2
dcterms:Is Part Of	lp_eu:Pharmacovigilance (amendment of Directive 2001/83/EC) - Pharmacovigilance (amendment of Regulation (EC) No 726/2004) (debate)2
dcterms:Language	"es"^^xsd:language2
lpv:document identification number	"en.20120910.29.1-228-000"2
lpv:hasSubsequent	lp_eu:2012-09-10-Speech-1-229-0002
lpv:speaker	lp:Pilar Ayuso2
lpv:spokenAs	unknown; Partido Popular (2009-07-14--2014-06-30)3 vice-chair; Delegation to the EU-Chile Joint Parliamentary Committee (2012-03-11--2014-06-30)3 member; EPP (2009-07-14--2014-06-30)3 substitute; Delegation for relations with the countries of Central America (2009-09-16--2014-06-30)3 substitute; AGRI (2012-01-19--2014-06-30)3 member; ENVI (2012-01-19--2014-06-30)3 member; Delegation to the Euro-Latin American Parliamentary Assembly (2009-09-16--2014-06-30)3
lpv:translated text	"Madam President, Commissioner, first of all, I would like to draw attention to the excellent work done by Ms McAvan, the rapporteur, and also the other shadow rapporteurs, in order to reach this agreement at first reading. This was very important because the regulation we adopted in 2010 was coming into force and it needed to be amended. It was not amended because it was a flawed piece of legislation – quite the contrary. Rather, it was amended because, as has been said, recent events took place, of which we are all aware, showing that there was a loophole that needed to be closed in order for it not to occur again. It was also necessary to strengthen certain specific points concerning pharmacovigilance and the safety of medicines once placed on the market. As we have already heard, from now on, marketing authorisation holders who do not renew a marketing authorisation or who withdraw or request the withdrawal or suspension of an authorisation will be obliged to inform the competent authorities of the real reasons and motives for withdrawing or suspending it. This is a major success for transparency and it will prevent the market authorisation holder from trying to conceal the real reasons behind its decision. Moreover, in the event that any of these actions is carried out in a third country, all the Member States in which that medicine is marketed must be informed. All this will improve transparency and safety, without the European Medicines Agency and national agencies being overly burdened as a result. The second important amendment we have achieved is that all authorised products that are subject to some kind of post-authorisation safety study (PASS) will be systematically included on the list of products subject to such monitoring. Lastly, we cannot forget that pharmacovigilance plays a fundamental role, and Parliament should therefore adopt this proposal."@en1
lpv:videoURI	<go to Events_and_structure europarl>2

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