S.L. 437.47 Art. 17Homeopathic veterinary medicinal products which may be authorised.

(1) Without prejudice to the provisions of European

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 Malta;

(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.

(2) The criteria and rules of procedure provided for in Chapter 3, with the exception of regulation 25, shall apply by analogy to the special, simplified registration procedure for homeopathic veterinary medicinal products referred to in subregulation (1), with the exception of the proof of therapeutic effect.