The Veterinary Medicines (Amendment etc.) Regulations 2024

Amendment to paragraph 12

36.  In paragraph 12 (extension of time limits)—

(a) omit sub-paragraph (1);

(b) for sub-paragraph (2) substitute—

“(2) Subject to sub-paragraph (2B), if a person submits an application for a marketing authorisation or for a variation to a marketing authorisation for a product, and within five years of the original marketing authorisation being granted, the marketing authorisation is extended to include an additional major species or a new antimicrobial product, the relevant protection period is extended by one year for each additional major species added to the marketing authorisation.

(2A) Subject to sub-paragraph (2B), if a person submits an application for a marketing authorisation mentioned in sub-paragraph (2) and the marketing authorisation is extended to include an additional minor species, the relevant protection period is extended by four years.

(2B) Sub-paragraphs (2) and (2A) do not apply where the application to extend the marketing authorisation is made fewer than three years before the expiration of the protection period.”;

(c) in sub-paragraph (3) for “13” substitute “18”;

(d) omit sub-paragraph (4).