Council Directive of 26 March 1990 laying down the conditions governing the preparation, placing on the market and use of medicated feedingstuffs in the Community (90/167/EEC)

Article 8

1. Member States 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 which contains the headings shown on the specimen in Annex A; 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 competent national authorities shall determine the number of copies of the prescription form, the persons who are to receive a copy and the period for which the original and the copies must be kept;

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

The veterinary prescription shall be valid only for a period determined by the competent national authority which may not exceed three months;

(d) the veterinarian's prescription may be used only for animals treated by him. He 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;

(e) 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), Member States may, pending the review to be carried out under Directive 81/851/EEC of the risks associated with the use of these groups of substances, derogate for five years after the adoption of this Directive from the obligation laid down in paragraph 1 not to supply medicated feedingstuffs obtained from authorized medicated pre-mixes except on presentation of a veterinary prescription, provided that:

• the medicated pre-mixes used do not contain active substances which belong to the chemical groups used, in their territory, on medical prescription for human medicine,

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

Member States applying such a derogation shall inform the Commission and the other Member States thereof within the Standing Veterinary Committee, before the date provided for in the first indent of the first subparagraph of Article 15, specifying in particular the nature of the medicinal products and animal species that it covers.

Not more than six months before the expiry of the five-year period laid down in the first subparagraph the Commission shall report to the Council on the risks associated with the use of these groups of substances and may include proposals on which the Council will decide by a qualified majority.

3. 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 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.