Local view for "http://purl.org/linkedpolitics/eu/plenary/2012-09-11-Speech-2-367-500"

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.20120911.32.2-367-500"2
lpv:hasSubsequent	lp_eu:2012-09-11-Speech-2-367-5622
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 Directive 2010/84/EU. A range of measures are required leading to improved safety of medicines at EU level by strengthening the role of the European Medicines Agency in collecting data and acting on signal detection, along with a series of other measures such as: clarifying companies’ obligations in terms of transparency – when companies voluntarily withdraw a medicine or do not reapply for a marketing licence, they must specifically declare if this is due to a safety concern; providing a drug fact box – a brief description of essential/necessary facts and details about the medicine, which are required by the patient to understand the usefulness as well as the possible risks of the medicine, and how to use it in a safe and proper way; publication by the agency every year of a list of the medicines for which marketing authorisations have been refused, revoked or suspended, whose supply has been banned, or which have been withdrawn from the market, including the reasons for such action."@en1

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