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The HMPC considers that propolis would not meet up with the legal definition of herbal substances or herbal preparations laid down in Directive 2001/eighty three/EC. The literature classifies propolis as a normal substance of animal origin.
Where the EU herbal monograph refers to ‘standard medicinal use’, precise herbal preparations with a specific posology is going to be said. The specific herbal preparations have been included in the monograph simply because they have been proven to fulfil the factors and also have a documented common use.
(R4) What dosages of vitamins and minerals are suitable in traditional herbal medicinal solutions eligible for simplified registration?
During this regard, the presence in the medicinal merchandise available in e.g. Liechtenstein only (due to the dimension of its populace) may very well be unlikely to suffice on its own to display extensive medicinal use for the objective of Report 10a of Directive 2001/83/EC.
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The place a monograph refers to the liquid extract a corresponding dry extract would Usually be satisfactory.
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