Local view for "http://purl.org/linkedpolitics/eu/plenary/2002-11-20-Speech-3-320"
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"en.20021120.10.3-320"2
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"Mr President, Commissioner, ladies and gentlemen, you are quite right. We have very considerable experience of the use of traditional herbal medicinal products. In the European Union, consumers attach ever greater importance to the use of them. This is why, in my view, it is time to establish a harmonised legal framework for traditional herbal medicinal products.
For far too long, trade in these traditional products within the Community has been hampered by differences in the national provisions. I think that in its current form, the directive will correct this imbalance, thanks not least to the excellent work carried out by the rapporteur, Mr Nisticò.
Let me touch upon two points which are, in my view, especially important. Firstly, the establishment of a new committee on herbal medicinal products within the European Agency for the Evaluation of Medicinal Products: I believe this is a necessary step, and I welcome the fact that the Commission has opted in favour of this approach. One of the committee's most important tasks will be to set up a list of herbal substances. However, I also think that the classification into various groups, as called for by the committee, is especially important. I very much hope that we can achieve this further classification. The phytopharmaceuticals with what is termed 'well-established medicinal use'
should be included in the group of rational phytopharmaceuticals. Let me briefly explain the significance of this distinction: in the case of phytopharmaceuticals with well-established use, monographs containing generally available data can be presented as evidence for an application. No extract-specific data are required in this type of evidence.
A different situation applies to rational phytopharmaceuticals. In this case, evidence is provided through the presentation of specific extract-related data which describe the precise effect of the individual extract. In order to avoid distortions of competition – and I think this is especially important – the manufacturer, who has invested substantial sums in researching the effects of rational phytopharmaceuticals, should be permitted to draw attention to his special efforts as part of the registration process, thus benefiting consumers through the provision of better product information."@en1
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