S.L. 437.47 Art. 57Labelling of homeopathic veterinary medicinal product.

(1) Without prejudice to subregulation (2), homeopathic veterinary medicinal products shall be labelled in accordance with the provisions of this title and identified by the inclusion on their labels, in clearly legible form, of the words "homeopathic medicinal product for veterinary use".

(2) In addition to the clear mention of the words "homeopathic veterinary medicinal product without approved therapeutic indications", the labelling and, where appropriate, package leaflet for the homeopathic veterinary medicinal products referred to in regulation 17(1) shall bear the following information and no other information:

(a) the scientific name of the stock or stocks followed by the degree of dilution, using the symbols of the Pharmacopoeia used in accordance with regulation 2(8). If the homeopathic veterinary medicinal product is composed of more than one stock, the labelling may mention an invented name in addition to the scientific names of the stocks,

(b) name and address of the marketing authorisation holder and, where appropriate, of the manufacturer,

(c) method of administration and, if necessary, route,

(d) expiry date, in clear terms (month, year),

(e) pharmaceutical form,

(f) contents of the sales presentation,

(g) special storage precautions, if any,

(h) target species,

(i) a special warning if necessary for the medicinal product,

(j) manufacturer’s batch number,

(k) registration number.