Local view for "http://purl.org/linkedpolitics/eu/plenary/2003-12-16-Speech-2-292"
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"en.20031216.7.2-292"2
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".
In January 2002 the Commission proposed its directive amending, as regards traditional herbal products, the Community code relating to medicinal products for human use. Now we have the possibility to adopt the legislation successfully in the second reading. I would like to thank the rapporteur, Mr. Nisticò, for his consistent effort in this.
What were the concerns that we wanted to address through the adoption of this legislative initiative? The proposal aimed at guaranteeing a high level of health protection for European patients using traditional herbal products. It was also intended to ensure a single market for herbal medicines by introducing harmonised rules and procedures. To that end, the proposal provided for a simplified registration system for traditional herbal products. The quality requirements to be met are the same as those for all medicinal products. But to avoid unnecessary testing and burdens on firms, the legislation foresees that new pre-clinical and clinical trials will not be necessary when sufficient knowledge already exists about a particular product.
The Council common position is consistent with these objectives and main principles. Moreover, it retains the substance of around two-thirds of the amendments proposed by the EP during its first reading.
On 27 November the parliamentary committee adopted two amendments. The Council has already acknowledged that it finds these amendments acceptable. The first aims at clarifying that foodstuffs (including herbal products) will continue to fall within the scope of food law. The second aims at specifying the purpose of the list of herbal substances to be drawn up by the future committee on herbal medicinal products. The Commission supports these two clarifications.
I would like to take this opportunity to thank you all for your efforts concerning the adoption of this directive, and in particular for the discussions over the past weeks leading to the possibility of successfully concluding the dossier during this second reading at the European Parliament."@en1
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