ANNEX U.K.

“ANNEX I CHEMICAL, PHARMACEUTICAL AND ANALYTICAL STANDARDS, SAFETY AND RESIDUE TESTS, PRE-CLINICAL AND CLINICAL TRIALS IN RESPECT OF TESTING OF VETERINARY MEDICINAL PRODUCTS

TITLE I U.K. REQUIREMENTS FOR VETERINARY MEDICINAL PRODUCTS OTHER THAN IMMUNOLOGICAL VETERINARY MEDICINAL PRODUCTS

PART 2: U.K. PHARMACEUTICAL (PHYSICO-CHEMICAL, BIOLOGICAL OR MICROBIOLOGICAL INFORMATION (QUALITY))

G. OTHER INFORMATION U.K.

Information relating to the quality of the veterinary medicinal product not covered in the previous sections may be included in the dossier.

For medicated premixes (products intended for incorporation into medicated feedingstuffs), information shall be provided on inclusion rates, instructions for incorporation, homogeneity in-feed, compatibility/suitable feedingstuffs, stability in-feed, and the proposed in-feed shelf life. A specification for the medicated feedingstuffs, manufactured using these pre-mixes in accordance with the recommended instructions for use shall also be provided.”