16Under Article 14(1) of Directive 2001/83, read in conjunction with Article 1(5), a homeopathic medicinal product, that is to say a medicinal product prepared from products, substances or combinations called homeopathic stocks in accordance with a homeopathic manufacturing procedure described by the European Pharmacopoeia or, in absence thereof, by the pharmacopoeias currently used officially in the Member States, may be subject to the special simplified registration procedure only in so far as it is administered orally or externally, no specific therapeutic indication appears on the labelling of the medicinal product or in any information relating thereto and, finally, there is a sufficient degree of dilution to guarantee its safety.
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