Local view for "http://purl.org/linkedpolitics/eu/plenary/2012-09-10-Speech-1-230-000"

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	"bg"^^xsd:language2
lpv:document identification number	"en.20120910.29.1-230-000"2
lpv:hasSubsequent	lp_eu:2012-09-10-Speech-1-231-0002
lpv:speaker	lp:Antonyia Parvanova2
lpv:spokenAs	vice-chair; ALDE (2012-01-27--2014-06-30)3 member; Delegation to the Parliamentary Assembly of the Union for the Mediterranean (2009-09-16--2014-06-30)3 member; FEMM (2012-01-19--2014-06-30)3 substitute; Delegation for relations with Iran (2009-09-16--2014-06-30)3 unknown; National Movement for Stability and Progress (2009-07-14--2014-06-30)3 member; ENVI (2012-01-19--2014-06-30)3 substitute; IMCO (2012-01-19--2014-06-30)3 member; Delegation for relations with Canada (2009-09-16--2014-06-30)3 substitute; Delegation for relations with the Mashreq countries (2009-09-16--2014-06-30)3
lpv:translated text	"Madam President, let me start by congratulating Linda McAvan on a successful leadership on this dossier and by praising the work accomplished by the Danish Presidency, the Commission and all political groups in making possible a prompt and necessary agreement on such a crucial issue. Less than two years after the case in France, we shall review the remaining gaps and loopholes in our European pharmacovigilance framework. All the European institutions and stakeholders are demonstrating today that when patient safety is at stake, actions can be taken swiftly and effectively. The ALDE Group welcomes the agreement, which will be put to the vote tomorrow, upgrading our new framework adopted in 2010 with a clear focus on transparency, efficiency, follow-up mechanisms and the reinforcement of the monitoring of drugs placed on the market but subject to post-authorisation studies. I particularly welcome two key elements of the future provisions to be implemented: the obligation for companies to communicate the reasons for withdrawing a product from the market and the automatic trigger of the emergency procedure when this decision is taken due to safety concerns. We must indeed keep in mind that, in addition to guaranteeing the highest level of patient safety, the good functioning of our pharmacovigilance system is also a tool to reinforce European citizens’ confidence and understanding of the medicines they are taking. As decision makers, we have a public health responsibility, which we are taking today in ensuring the efficiency of our system and adapting it when necessary. To conclude, I would like to mention the need to provide sufficient resources for the European Medicines Agency to assume effectively its new missions. I understood that the Commission is already working on this issue and I hope it will come up with the relevant proposal without undue delay."@en1
lpv:unclassifiedMetadata	"Antonyia Parvanova,"1 "on behalf of the ALDE Group."1
lpv:videoURI	<go to Events_and_structure europarl>2

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