Local view for "http://purl.org/linkedpolitics/eu/plenary/2008-10-22-Speech-3-228"

Predicate	Value (sorted: default)
rdf:type	lpv_eu:Speech2
dcterms:Date	"2008-10-22"^^xsd:date2
dcterms:Is Part Of	lp_eu:Explanations of vote2
dcterms:Language	"pt"^^xsd:language2
lpv:document identification number	"en.20081022.17.3-228"2
lpv:hasSubsequent	lp_eu:2008-10-22-Speech-3-2292
lpv:speaker	lp:Carlos Coelho2
lpv:spokenAs	unknown; Partido Social Democrata (2007-11-23--2009-07-13)3 member; Delegation to the ACP-EU Joint Parliamentary Assembly (2004-10-13--2009-07-13)3 member_of_the_bureau; EPP-ED (2004-11-14--2009-07-13)3 member; LIBE (2007-01-31--2009-07-13)3
lpv:translated text	". The current way of managing variations is proving increasingly inefficient and is no longer satisfactory either for the authorities or for the pharmaceutical industry as a whole. Any one change to products authorised under purely national procedures in different Member States is treated in a number of different ways in terms of the dossier to be submitted and the evaluation procedure. This situation causes problems in various areas: public health, the internal market, legal and practical applications. The report proposes certain improvements. For reasons of harmonisation and simplification, it is important that changes to marketing authorisations should be governed by the same regulatory requirements, whatever licensing procedure was initially used. This will bring benefits for all concerned: patients, authorities and pharmaceutical companies. I agree with the amendments proposed in the compromise position as they emphasise the need to simplify and reconcile administrative procedures, allow the possibility of submitting a single application for one or more identical changes and highlight the need to apply the subsidiarity principle."@en1

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