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The Veterinary Medicines Regulations 2013
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Extension of time limitsE+W+S
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12.—F3(1) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
[F4(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.]
(3) The total period may not exceed [F518] years.
F6(4) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Textual Amendments
F3Sch. 1 para. 12(1) omitted (E.W.S.) (17.5.2024) by virtue of The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 36(a)
F4Sch. 1 para. 12(2)-(2B) substituted for Sch. 1 para. 12(2) (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 36(b)
F5Word in Sch. 1 para. 12(3) substituted (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 36(c)
F6Sch. 1 para. 12(4) omitted (E.W.S.) (17.5.2024) by virtue of The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 36(d)
Extension of time limitsN.I.
12.—(1) This paragraph applies in relation to veterinary medicinal products that—
(a)are intended for administration to food-producing species; and
(b)contain a new active substance that was not authorised in the Community by 30th April 2004.
(2) If a person submitted an application for a marketing authorisation for a product on or after 30th October 2005, and within 5 years of the original marketing authorisation being granted, the marketing authorisation is extended to include additional food-producing species, the ten-year protection period is extended by one year for each additional food-producing species added to the marketing authorisation.
(3) The total period may not exceed 13 years.
(4) The extension applies only if the marketing authorisation holder originally applied for determination of the maximum residue limits for the active substance.
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