TITLE IIIMARKETING
CHAPTER 2Particular provisions applicable to homeopathic veterinary medicinal products
Article 17
F11.
Without prejudice to the provisions of Regulation (EEC) No 2377/90 on the establishment of maximum residue limits of pharmacologically active substances intended for food-producing animals, only homeopathic veterinary medicinal products which satisfy all of the following conditions may be subject to a special, simplified registration procedure:
(a)
they are administered by a route described in the European Pharmacopoeia or, in the absence thereof, by the pharmacopoeias currently used officially in Member States;
(b)
no specific therapeutic indication appears on the labelling of the veterinary medicinal product or in any information relating thereto;
(c)
there is a sufficient degree of dilution to guarantee the safety of the medicinal product. In particular, the medicinal product shall not contain more than one part per 10 000 of the mother tincture.
F2If it appears justified in the light of new scientific evidence, the Commission may adapt points (b) and (c) of the first subparagraph. Those measures, designed to amend non-essential elements of this Directive, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 89(2a).
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 Chapter 3, with the exception of Article 25, shall apply by analogy to the special, simplified registration procedure for homeopathic veterinary medicinal products referred to in paragraph 1, with the exception of the proof of therapeutic effect.
F33.
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