Article 14
1. Only homeopathic medicinal products which satisfy all of the following conditions may be subject to a special, simplified registration procedure: - they are administered orally or externally, - no specific therapeutic indication appears on the labelling of the medicinal product or in any information relating thereto, - there is a sufficient degree of dilution to guarantee the safety of the medicinal product; in particular, the medicinal product may not contain either more than one part per 10000 of the mother tincture or more than 1/100th of the smallest dose used in allopathy with regard to active substances whose presence in an allopathic medicinal product results in the obligation to submit a doctor's prescription. At the time of registration, Member States shall determine the classification for the dispensing of the medicinal product. 2. The criteria and rules of procedure provided for in Article 4(4), Article 17(1) and Articles 22 to 26, 112, 116 and 125 shall apply by analogy to the special, simplified registration procedure for homeopathic medicinal products, with the exception of the proof of therapeutic efficacy. 3. The proof of therapeutic efficacy shall not be required for homeopathic medicinal products registered in accordance with paragraph 1 of this Article, or, where appropriate, admitted in accordance with Article 13(2).