Local view for "http://purl.org/linkedpolitics/eu/plenary/2002-11-20-Speech-3-325"
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"en.20021120.10.3-325"2
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"Mr President, Commissioner, ladies and gentlemen, herbal medicinal products have been used throughout the world for many centuries. In Europe, too, consumers' interest has extended far beyond the household remedies which are customarily used in individual regions. Many people swear by these natural products, whether they are Chinese ginseng root or Indian tea tree oil. In the European Union, however, herbal medicinal products are not yet regulated on a uniform basis. In some Member States, they have to be authorised, whereas in others, facilitated evidence of efficacy is sufficient. Mr Nisticò has presented a very good report which creates broadly uniform provisions governing the manufacture, marketing and labelling of herbal medicinal products and sets high quality and safety standards.
In this context, the following points are especially important. First of all, there is the issue of quality and safety. The manufacturers of herbal medicinal products must provide evidence of their safety in the same way as is required for chemical medicinal products. In the simplified authorisation procedure, the efficacy and harmlessness of a product are proven through its long, that is, traditional, use.
We also need a new committee on herbal medicinal products within the European Agency for the Evaluation of Medicinal Products. This committee should take over responsibility for the full range of tasks relating to herbal medicinal products. It will establish herbal monographs relevant for the precise but speedy evaluation of the applications for authorisation. The proposal before us not only enables us to achieve broadly uniform authorisation criteria in Europe; it also allows us to facilitate the marketing of herbal medicinal products in all Member States while maintaining subsidiarity.
European consumers can continue to choose from a broad range of products which have been submitted by the manufacturer in accordance with the legal provisions and have been carefully scrutinised and authorised by the authorities. This guarantees product quality and protects human health to the greatest possible extent."@en1
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