S.L. 437.73 Art. 8Medicated feedingstuff prescriptions.

(1) The Veterinary Services shall ensure that medicated feedingstuffs are not supplied to stockfarmers or holders of animals except on presentation of a prescription from a registered veterinarian on the following terms:

(a) the veterinarian’s prescription shall be made out on a form shown on the specimen in Schedule I; the original form shall be for the manufacturer or, where appropriate, a distributor approved by the competent authority of the Member State of destination of the medicated feedingstuffs;

(b) the veterinarian shall fill Part A of the following prescription and copies of prescription shown in Schedule I:

(i) manufacturer’s or authorised distributors original, which shall be retained by the manufacturer or authorised distributor for a period which is not less than three years from date when the prescription was filled by the veterinarian. The veterinarian shall omit the details of the disease for which the treatment is prescribed in Part A of this original. The manufacturer or authorised distributor shall fill Part B of this original. This prescription shall be made available at all times to the Veterinary Services during official inspections;

(ii) Food and Veterinary Regulation Division copy which shall be sent by the manufacturer or authorised distributor to the Veterinary Services within five days of the presentation of the prescription. The veterinarian shall omit the disease for which the treatment is prescribed in Part A of this copy. The manufacturer or authorised distributor shall fill Part B of this copy;

(iii) the veterinarian’s copy which shall be retained by the veterinarian for a period of not less than three years from the date the prescription was made by him. The disease to be treated shall only be indicated in Part A of this copy. This prescription copy shall be made available at all times to the Veterinary Services during official inspections;

(c) medicated feedingstuffs may not be used for more than one treatment under the same prescription;

(d) the veterinary prescription shall be valid only for a OF MEDICATED FEEDINGSTUFFS

period determined by the Veterinary Services which shall not exceed three months from the date on which the prescription is made by the veterinarian;

(e) the veterinarian’s prescription may be used only for animals treated by him. The veterinarian must first satisfy himself that:

(i) the use of this medication is justified for the species concerned on veterinary grounds;

(ii) administration of the medicinal product is not incompatible with a previous treatment or use and that there is no contra-indication or interaction where several pre-mixes are used;

(f) the veterinarian must:

(i) prescribe the medicated feedingstuffs only in such quantities as, within the maximum limits laid down by the national authorization for placing medicated pre-mixes on the market, are necessary for the purpose of the treatment;

(ii) satisfy himself that the medicated feedingstuff and the feedingstuff currently used to feed treated animals do not contain the same antibiotic or the same coccidiostat as active substances.

(2) However, in the case of anthelmintic medicinal products (vermifuges), the Veterinary Services may, pending the review to be carried out under European Union Directive 2001/82/EC of the risks associated with the use of these groups of substances, derogate for five years after the adoption of these rules from the obligation laid down in sub-rule (1) not to supply medicated feedingstuffs obtained from authorized medicated pre-mixes except on presentation of a veterinary prescription, provided that:

(a) the medicated pre-mixes used do not contain active substances which belong to the chemical groups used, in the territory of Malta, on medical prescription for human medicine,

(b) the medicated feedingstuffs accorded such authorization are used in their territory only prophylactically and in the dosages necessary for the purpose in question.

(3) The Veterinary Services shall inform the European Union Commission and the other Member States within the Standing Veterinary Committee of the application of such a derogation, specifying in particular the nature of the medicinal products and animal species that it covers.

(4) Where medicated feedingstuffs are administered to animals whose meat, flesh, offal or products are intended for human consumption, the stockfarmer or holder of the animals concerned must ensure that treated animals are not slaughtered in order to be offered for consumption before the end of the withdrawal period OF MEDICATED FEEDINGSTUFFS [

and that products obtained from a treated animal before the end of such a withdrawal period are not disposed of with a view to their being offered for human consumption.