Regulation 35 Amendment to paragraph 11

in sub-paragraph (1) for “pharmacologically equivalent” substitute “generic veterinary medicinal”;

for sub-paragraph (3) substitute—

“(3)

The product may not be placed on the market until the end of the longest of the following periods which is relevant—

(a)

subject to sub-paragraph (3A), 10 years in the case of a veterinary medicinal product authorised for major species;

(b)

18 years in the case of a veterinary medicinal product authorised for bees; and

(c)

14 years for a veterinary medicinal product authorised for all other species.

(3A)

Where the product—

(a)

is intended for administration to a major species; and

(b)

contains an active substance which is an antimicrobial which has not been an active substance in a veterinary medicinal product previously subject to a marketing authorisation in Great Britain,

the period mentioned in sub-paragraph (3)(a) is 14 years.

(3B)

Where a patent in relation to a reference product has lapsed, the summary of product characteristics of the relevant generic product must be updated in order to include the protected information.

(3C)

Where, as a result of a variation to an existing marketing authorisation a product is accorded a new marketing authorisation number any relevant protection period applies in relation to that product.

(3D)

In this regulation “major species” means cattle, sheep (for meat production), pigs, chickens, dogs and cats.”;

in the heading for “pharmacologically equivalent” substitute “generic veterinary medicinal”.