S.L. 437.73 Art. 3Medicated feedingstuffs to be manufacturedfrom authorised medicated pre- mixes.

(1) The Veterinary Services shall prescribe that, as regards the medicinal component, medicated feedingstuffs may be manufactured from authorized medicated pre-mixes only.

(2) By way of derogation from sub-rule (1), the Veterinary

Services may, provided they comply with the requirements of Article 6 of European Union Directive 2001/82/EC:

(a) subject to any specific conditions laid down in authorizations to place authorized medicated pre-mixes on the market, authorize intermediate products which are prepared from such medicated pre-mixes authorized in accordance with Article 6, 7, 8, 9, 10, and 11 of European Union Directive 2001/82/EC and from one or more feedingstuffs and which are intended for the subsequent manufacture of medicated feedingstuffs ready for use;

(b) the Veterinary Services shall take all necessary steps to ensure that intermediate products are manufactured only by establishments authorized in accordance with rule 4 and that they are the subject of a declaration to the Veterinary Services, authorize the veterinarian to have manufactured under the conditions laid down in Article 4(3) of Directive 81/851/EEC, and under his responsibility and on prescription, medicated feedingstuffs from several authorized medicated pre-mixes, provided that there is no specific authorized therapeutic agent in pre-mix form for the disease to be treated or for the species concerned;

(c) until the date on which the Veterinary Services has to comply with the new rules laid down in Article 9 of European Union Directive 2001/82/EC, national rules governing the above conditions shall remain applicable, with due regard to the general provisions of the Treaty.

(3) Products authorized pursuant to sub-rule (1) shall be subject to the rules laid down in Articles 44 to 63 of European Union Directive 2001/82/EC. OF MEDICATED FEEDINGSTUFFS [