Regulation 36 Amendment to paragraph 12

omit sub-paragraph (1);

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.”;

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

omit sub-paragraph (4).