Local view for "http://purl.org/linkedpolitics/eu/plenary/2008-10-22-Speech-3-019"

Predicate	Value (sorted: default)
rdf:type	lpv_eu:Speech2
dcterms:Date	"2008-10-22"^^xsd:date2
dcterms:Is Part Of	lp_eu:Variations to the terms of marketing authorisations for medicinal products - Counterfeiting of medicinal products (debate)2
dcterms:Language	"sk"^^xsd:language2
lpv:document identification number	"en.20081022.2.3-019"2
lpv:hasSubsequent	lp_eu:2008-10-22-Speech-3-0202
lpv:speaker	lp:Irena Belohorská2
lpv:spokenAs	member; Conference of Presidents (2007-01-15--2009-07-13)3 member; Delegation for relations with the countries of Central America (2007-03-14--2009-07-13)3 substitute; AFET (2007-11-06--2009-07-13)3 member; DROI (2007-01-31--2009-07-13)3 vice-chair; Delegation to the Euro-Latin American Parliamentary Assembly (2007-10-24--2009-07-13)3 member; ENVI (2007-01-31--2009-07-13)3 unknown; Hnutie za demokratické Slovensko (2004-07-20--2009-07-13)3 member; NA (2004-07-20--2009-07-13)3
lpv:translated text	"In most Member States, there has been no harmonisation with community law in the area of marketing authorisations for medicinal products, and therefore varying practices have emerged in these states. The aim of the proposal is that all medicinal products, regardless of the procedure under which they were authorised for release onto the market, should be subject to the same assessment criteria in respect of the administrative process for approving changes. I welcome initiatives of this kind, aimed at simplifying the framework, without abandoning the criteria necessary for protecting the health of humans and animals. Harmonisation is necessary mainly because of the risk to public health which arises through Member States applying varying sets of scientific criteria when evaluating changes to medicinal products. Without this legal amendment, such a state of affairs constitutes a barrier to the free movement of medicinal products, which is to the detriment of patients. The consultations relating to the drafting of the amendment to the directive themselves showed that many Member States support harmonisation in this area. The administrative burden and logistical complications are, however, a shared issue which we must resolve. We must therefore emphasise that the improvements to the system will, apart from anything else, be beneficial for patients in the long term, since better use will be made of drugs and better use will also be made of the resources employed by the relevant authorities for protecting public health. Despite this, I recommend caution in view of the hidden costs which will arise for the Member States. Care must also be taken to ensure a reasonable timetable for practical implementation. Member States cannot be called on to change their internal laws in order to fulfil this provision, but must rather be assisted in order to ensure that excessively short implementation periods do not impose a major expense on them."@en1
lpv:videoURI	<go to Events_and_structure europarl>2

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