Local view for "http://purl.org/linkedpolitics/eu/plenary/2010-09-21-Speech-2-484"

Predicate	Value (sorted: default)
rdf:type	lpv_eu:Speech2
dcterms:Date	"2010-09-21"^^xsd:date2
dcterms:Is Part Of	lp_eu:Pharmacovigilance of medicinal products (amendment of Regulation (EC) No 726/2004) - Pharmacovigilance (amendment of Directive 2001/83/EC) (debate)2
dcterms:Language	"es"^^xsd:language2
lpv:document identification number	"en.20100921.18.2-484"2
lpv:hasSubsequent	lp_eu:2010-09-21-Speech-2-4852
lpv:speaker	lp:Pilar Ayuso2
lpv:spokenAs	member; Delegation for relations with the Mercosur countries (2009-09-16--2012-02-12)3 substitute; AGRI (2009-07-16--2012-01-18)3 unknown; Partido Popular (2009-07-14--2014-06-30)3 member; ENVI (2009-07-16--2012-01-18)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 member; Delegation to the Euro-Latin American Parliamentary Assembly (2009-09-16--2014-06-30)3
lpv:translated text	"Mr President, Commissioner, I would first of all like to highlight the work that has been done by the rapporteur, Mrs McAvan, not only on the content of the report, but also in terms of her methods, because she has worked alongside all the shadow rapporteurs. I would also like to thank the experts from the Spanish Government for their contribution to this agreement. The purpose of this system of pharmacovigilance in the European Union is to strengthen vigilance, transparency and communication in relation to the safety of drugs once they have been put on the market, especially with regard to their risk profiles and the adverse reactions that they can cause. It is important to highlight the creation of the European Pharmacovigilance Committee, which will evaluate and issue recommendations to the European Medicines Agency on the safety issues that can arise in connection with medicines sold in the European Union. The solution that has been reached for both Member States and those responsible for marketing medicines to notify the EudraVigilance database of suspected adverse reactions is very important. EudraVigilance will be the only source of information, but the competent authority in the Member State where it is suspected that an adverse reaction has occurred will be informed at the same time, which is very important. It is also important to highlight the possibility that is being opened up of consumers being able to communicate any adverse reactions, and in this respect, the creation and management by the agency of a European medicines safety web-portal which, in turn, is linked to the portals in each of the Member States, is going to help to improve the public’s knowledge regarding the safety of the medicines that they take. Finally, we cannot forget that given that pharmacovigilance plays a fundamental role in protecting public health, the adoption of this directive and this regulation is going to make a significant contribution to that protection by improving not only the current procedures but also the coordination of actions between the different Member States."@en1
lpv:videoURI	<go to Events_and_structure europarl>2

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