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Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on veterinary medicinal products and repealing Directive 2001/82/EC (Text with EEA relevance) article 86 CELEX: 02019R0006-20220128 Registration of homeopathic veterinary medicinal products
1. A homeopathic veterinary medicinal product that meets all of the following conditions shall be subject to a registration procedure: (a) it is administered by a route described in the European Pharmacopoeia or, in the absence thereof, by the pharmacopoeias used officially in Member States; (b) it has a sufficient degree of dilution to guarantee its safety, and shall not contain more than one part per 10 000 of the mother tincture; (c) it has no therapeutic indication appearing on its labelling or in any information relating thereto. 2. Member States may lay down procedures for the registration of homeopathic veterinary medicinal products in addition to those laid down in this Chapter. |