ANNEX II U.K. REQUIREMENTS REFERRED TO IN POINT (B) OF ARTICLE 8(1) (1)

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.

(1)

This Annex will be amended by the Commission in accordance with Articles 146 and 153. All references to Articles or to ‘this Directive’ in this Annex, unless otherwise specified, are to be understood as references to Directive 2001/82/EC.