The Veterinary Medicines (Amendment etc.) Regulations 2024
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Change 1
As published
57 Amendment to paragraph 38
In paragraph 38 (suspension of marketing authorisation: grounds)—
(a) for sub-paragraph (1) substitute—
(1) If the Secretary of State is satisfied at any time that the benefit-risk balance of a veterinary medicinal product is not positive or is insufficient to ensure food safety, the Secretary of State may—
(a) suspend the marketing authorisation;
(b) require the holder of the marketing authorisation to submit an application for its variation;
(c) revoke the marketing authorisation.
;
(b) for sub-paragraph (3) substitute—
(3) The Secretary of State may take the steps set out in sub-paragraph (1)(a), (b) and (c) on being satisfied at any time that—
(a) information given in the application documents is incorrect;
(b) any control tests required have not been carried out;
(c) changes have been made to the manufacturing process without the authority of the Secretary of State;
(d) any information required to be supplied to the Secretary of State has not been so supplied;
(e) the holder of the marketing authorisation has failed to comply with the requirements of these Regulations;
(f) the pharmacovigilance system in relation to a veterinary medicinal product is inadequate;
(g) in the case of a generic authorisation, the reference product is updated to show a reduction in antimicrobial resistance;
(h) the qualified person (pharmacovigilance) has failed to comply with the requirements of these Regulations
;
(c) in the heading, after “suspension” insert “, revocation, etc”.
Your change, as a redline
57 Amendment to paragraph 38
In paragraph 38 (suspension of marketing authorisation: grounds)—
(a) for sub-paragraph (1) substitute—
(1) If the Secretary of State is satisfied at any time that the benefit-risk balance of a veterinary medicinal product is not positive or is insufficient to ensure food safety, the Secretary of State may—
(a) suspend the marketing authorisation;
(b) require the holder of the marketing authorisation to submit an application for its variation;
(c) revoke the marketing authorisation.
;
(b) for sub-paragraph (3) substitute—
(3) The Secretary of State may take the steps set out in sub-paragraph (1)(a), (b) and (c) on being satisfied at any time that—
(a) information given in the application documents is incorrect;
(b) any control tests required have not been carried out;
(c) changes have been made to the manufacturing process without the authority of the Secretary of State;
(d) any information required to be supplied to the Secretary of State has not been so supplied;
(e) the holder of the marketing authorisation has failed to comply with the requirements of these Regulations;
(f) the pharmacovigilance system in relation to a veterinary medicinal product is inadequate;
(g) in the case of a generic authorisation, the reference product is updated to show a reduction in antimicrobial resistance;
(h) the qualified person (pharmacovigilance) has failed to comply with the requirements of these Regulations
;
(c) in the heading, after “suspension” insert “, revocation, etc”.
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