SCHEDULE 1Marketing authorisations

PART 3Grant of a marketing authorisation

Marketing authorisations for food-producing animals

23.—(1) The Secretary of State shall not grant a marketing authorisation for a veterinary medicinal product for food-producing species unless all its pharmacologically active substances appear in Annex I, II or III to Council Regulation (EEC) No. 2377/90.

(2) This shall not apply in the case of a marketing authorisation for a veterinary medicinal product for administration to a horse that has been declared as not intended for slaughter for human consumption in accordance with—

(a)the Horse Passports (England) Regulations 2004(1);

(b)the Horse Passports Regulations (Northern Ireland) 2004(2);

(c)the Horse Passports (Scotland) Regulations 2005(3);

(d)the Horse Passports (Wales) Regulations 2005(4),

but the product shall neither include active substances that appear in Annex IV to Council Regulation (EEC) No. 2377/90 nor be intended for use in the treatment of conditions, as detailed in the authorised Summary of Product Characteristics, for which a veterinary medicinal product is authorised for horses.

(3) In this paragraph “horse” includes any member of the equidae family.