The Veterinary Medicines (Amendment etc.) Regulations 2024
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Change 1
As published
36 Amendment to paragraph 12
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).
Your change, as a redline
36 Amendment to paragraph 12
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).
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