The Medicines (Labelling of Medicinal Products for Incorporation in Animal Feeding Stuffs and of Medicated Animal Feeding Stuffs) Regulations 1988

Regulations 6(1) and (3) and 8

SCHEDULE 4 PARTICULARS REQUIRED IN THE LABELLING OF CONTAINERS AND PACKAGES OF MEDICINAL PRODUCTS OR MEDICATED FEEDING STUFFS FOR MEDICINAL TESTS ON ANIMALS

1.  Such designation as will sufficiently identify the animal test.

2.—(a) Where more than one medicinal product or excepted medicated feeding stuff is supplied in the course of the animal test, such designation on the container of each medicinal product or excepted medicated feeding stuff as will sufficiently identify each such medicinal product or excepted medicated feeding stuff.

(b) Where more than one medicinal product or excepted medicated feeding stuff has been incorporated in the medicated feeding stuff which is supplied in the course of the animal test, such designation on the container of the medicated feeding stuff as will sufficiently identify each such medicinal product or excepted medicated feeding stuff.

3.  The quantity of the medicinal product or of each active ingredient contained in the medicated feeding stuff expressed in terms of weight, volume or capacity or number of dosage units.

4.  The purposes for which the medicinal product or medicated feeding stuff is to be used, the species, and categories within species, of animals to which it is to be administered and the directions for use including dosage and any warning statements.

5.  In the case of a medicinal product or intermediate medicated feeding stuff, the directions for incorporation of that medicinal product or intermediate medicated feeding stuff in any animal feeding stuff, and a statement that such incorporation must be in accordance with the terms of a product licence or animal test certificate.

6.  Any special requirements for the handling and storage of the medicinal product or medicated feeding stuff.

7.—(a) In the case of a medicinal product or excepted medicated feeding stuff, the expiry date.

(b) In the case of a medicated feeding stuff (not being an excepted medicated feeding stuff) where the period during which any active ingredient in that feeding stuff remains effective is shorter than the period during which the medicated feeding stuff is recommended by the manufacturer as suitable for use as food for animals—

(i) a statement of the date (in terms of month and year) by which that feeding stuff should be consumed if the active ingredient is to be effective, or

(ii) a statement of the date (in terms of month and year) of manufacture of that feeding stuff and the period during which that feeding stuff should be consumed if the active ingredient is to be effective.

8.  Any other statement or particulars required to be stated on the label of any container or package of the medicinal product or medicated feeding stuff, or to be contained in any leaflet supplied with the medicinal product or medicated feeding stuff, by the provisions of an animal test certificate or product licence.

9.  In any case where particulars from this Schedule are omitted from a label in accordance with the provisions as to small-sized labels contained in regulation 6(3), a statement that a leaflet of instructions is supplied with the medicinal product or medicated feeding stuff.