4.—(1) No person shall, in the course of a business carried on by him, incorporate in an animal feeding stuff a medicinal product of any description, except a veterinary drug which is exempted under article 3 (exemptions from licences and certificates in respect of medicinal tests on animals) of the Medicines (Exemptions from Licences and Animal Test Certificates) Order 1986(1), unless—
(a)there is a valid product licence or animal test certificate relating to the incorporation of that medicinal product (whether held by him or another person) and, subject to paragraph (2) below—
(i)where the medicinal product is incorporated at a rate below 2 kilograms per tonne, his name is entered in Part A of the Register in respect of the premises where the medicinal product is incorporated, or
(ii)in any other case, his name is entered in Part A or Part B of the Register in respect of the premises where the medicinal product is incorporated,
and the medicinal product is incorporated either in accordance with provisions relating to its incorporation contained in a product licence or animal test certificate (whether held by him or another person) or, in the case of medicinal products to which a product licence relates, in accordance with a veterinary written direction; or
(b)his name is entered in Part A or Part B of the Register and he intends to export the animal feeding stuff in accordance with a written export order and he stores such animal feeding stuff in a part of a building separate from the storage of any other animal feeding stuff.
(2) The requirement for his name to be entered in the Register, specified in paragraph (1)(a)(i) or (ii) above, shall not apply—
(a)to a fish farmer;
(b)to a person incorporating a medicinal product in accordance with a veterinary direction where—
(i)a veterinary surgeon or veterinary practitioner has reason to believe it necessary to authorise a derogation from that paragraph on grounds of immediate danger to the health of animals under his care and the veterinary written direction authorises such derogation on those grounds, and
(ii)the person incorporating the medicinal product sends a copy of the veterinary written direction to the Society (if he is carrying on a business elsewhere than in Northern Ireland) or to the Department (if he is carrying on a business in Northern Ireland) within 28 days of incorporation; or
(c)to a person operating mobile mixing equipment if—
(i)his name is entered in the Register in respect of the premises where his mobile equipment is normally kept, and
(ii)in a case where his name is entered in Part B of the Register, the medicinal product is incorporated in the animal feeding stuff at a rate of at least 2 kilograms per tonne.
(3) Any person who exports medicinal animal feeding stuffs, shall keep, for a period of at least 2 years from the date of export, a record of—
(a)the name and address of the person to whom the animal feeding stuff was exported;
(b)the written export order; and
(c)the name, identification and quantity of the animal feeding stuff.
(4) No person shall, in the course of a business carried on by him, incorporate in an animal feeding stuff a combination of prescription only medicinal products except in accordance with a veterinary written direction and then only where in the opinion of a veterinary surgeon there is no effective licensed medicinal product for the disease to be treated or for the species concerned.
(5) A person who, in the course of a business carried on by him, incorporates in an animal feeding stuff any medicinal product in accordance with a veterinary written direction, shall ensure that—
(a)the daily dose of medicinal product is contained in a quantity of final feeding stuff corresponding to at least half the daily feed ration of the animals treated or, in the case of ruminants, corresponding to at least half the daily requirement of non-mineral complementary or supplementary feedings stuffs;
(b)the feeding stuff to be used for producing the medicated feeding stuff does not contain the same antibiotic nor the same coccidiostat as those used as an active substance in the medicinal product.