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The Veterinary Medicines Regulations 2013
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There are currently no known outstanding effects for the The Veterinary Medicines Regulations 2013, Paragraph 25.
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Publication following the grant [F1, refusal, suspension, variation or revocation] of a marketing authorisationU.K.
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25.—(1) On granting a marketing authorisation the Secretary of State must publish—
(a)the notice granting the marketing authorisation;
(b)the summary of the product characteristics;
(c)the assessment report that has already been prepared but with any commercially confidential or personal information deleted.
(2) The Secretary of State must update the assessment report whenever new information that is of importance and relates to the quality, safety or efficacy of the veterinary medicinal product becomes available.
(3) The Secretary of State must send a copy of the assessment report, and any update, to the holder of the marketing authorisation before publication to enable the holder to make representations concerning any confidential or personal information that may be in it, and may specify a date by which representations must be made.
[F2(4) Where the Secretary of State refuses to grant a marketing authorisation or suspends or revokes an authorisation the Secretary of State must publish that fact.
(5) Where the Secretary of State varies a marketing authorisation in relation to the summary of product characteristics the Secretary of State must publish the terms of the variation.]
Textual Amendments
F1Words in Sch. 1 para. 25 heading inserted (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 46(b)
F2Sch. 1 para. 25(4)(5) inserted (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 46(a)
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