Medicinal Products Commission of the German Alternative Practitioners: Obligation to Approve Dietary Supplements: In response to the mail campaigns on the Food Code (LMBG) and the EU guidelines for traditional herbal medicinal products, the Medicinal Products Commission of the Association of German Alternative Practitioners takes the following position.
Approval requirement for food supplements According to German law, additives in food were subject to approval and in combination with the ban on harmful ingredients in food, this was a protection of the consumer from additives which could be problematic in dosage. This also applied to food supplements. In addition, e.g. Vitamins and minerals are approved as medicinal products or as medical devices and are therefore properly prescribed by the naturopath.
The Federal Administrative Court ruled on July 25, 2007 (BVerwG 3 C 21.06) that a certain plant extract from grape seeds should be classified as a characteristic ingredient of a food supplement consisting essentially of it and therefore not prior approval as one of the additives according to the food and Animal Feed Code. This unclear legal situation is currently to be clarified by a new version of this law. In the interest of preventive health protection, this law is intended to clarify that such substances are subject to the authorization requirement.
If the food industry or the manufacturer of the food supplements now spreads the concern that traditional and proven applications are at risk here, it must be borne in mind that it has been a judicial interpretation of the law since 2007, and therefore certainly not a longstanding tradition .
But it is the case that even after the new version of the law, all food supplements that have no health risk can be approved as additives. Vitamins, minerals or similar in medicinal products and medical devices are not affected by this legal regulation. The medicinal products commission of German alternative practitioners is involved in the examination of the law and will also take a position if it is relevant for the alternative practitioner profession.
European directive for traditional herbal medicinal products The EU guideline for traditional herbal medicinal products (THMPD 2004/24 / EG), which has been implemented in the European countries for many years and will be effective until 2011, has been implemented and effective in Germany for many years.
It should be noted that the European directive is not current, it is old. There are now German and European registrations for traditional herbal preparations and this has proven itself. All plant preparations with proof of efficacy and the right to indications must be approved. The representatives of the pharmaceutical commission in the approval committee E are also involved in the approval procedure.
The limitation in the mixture of herbal preparations, vitamins and minerals in a medicinal product certainly makes sense, because a therapeutic dose differs from the substitution of vitamins and minerals. The prescription of individual plant drugs (with a positive or zero monograph) remains unchanged and is not restricted in Germany.
The whole discussion is, by the way, an old discussion, since the guideline is from 2004 and even then the drug commission and the medical practitioners' associations were involved and had an influence on the traditional registration of the herbal preparations. Everything that is a "century-old or millennium-old" tradition has the possibility of registration, because it only needs to be 30 years of use. (Association of German Alternative Practitioners, 11/14/2010)
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