Local view for "http://purl.org/linkedpolitics/eu/plenary/2002-11-20-Speech-3-329"
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"en.20021120.10.3-329"2
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". – Mr President, allow me to comment briefly on some of the speeches and amendments. A full listing of the Commission's position on each of the amendments is provided in writing to Parliament.
Firstly, on the extension of the scope of the simplified procedure. Let me underline that I am grateful for your support to limit, in principle, the new simplified procedure to traditional herbal medicines. It is crucial that we gain sound experience with this new procedure before we can plan any possible extension.
At the same time, I understand the request from the Committee on the Environment, Public Health and Consumer Policy to slightly extend the scope of the procedure to those herbal medicines, which contain additional non-herbal ingredients. In principle, the Commission could support such additives as vitamins and minerals. However, we have to be prudent and exclude certain substances such as biological ingredients, which involve particular risks. For such substances we must insist on getting the standard scientific data.
Many speakers have mentioned the minimum time of use. As a general rule, 30 years of traditional use in total and 15 years within the Community are the minimum to ensure safety and efficacy of the products. However, there will be exceptions. It may be that a product has been used outside the EU for thousands of years, but has been available within the Community for only 10 years or less.
The Committee on the Environment proposed to shorten the minimum usage time within the Community from 15 to 10 years. The Commission is ready to lay down specific rules for such exceptions. From a European perspective, however, it is preferable to provide a European solution.
Where a product does not fulfil the general criteria of 30 and 15 years, we could empower the new committee to look into this product and to assess if the available information is sufficient. This way of establishing flexibility would have the advantage of meeting the double objectives to ensure the protection of public health while at the same time facilitating the free movement of these medicines within the EU.
The Commission’s proposal already gives the new committee considerable powers. The Committee on the Environment wants to go even further and replace the committee which generally deals with medicines for human use (CPMP) with the new 'herbal committee'.
In principle, the Commission could support part of the proposed extension. We agree that the 'herbal committee' should deal with deciding mutually recognised procedures where divergent national decisions on herbal medicines are involved."@en1
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