The Veterinary Medicines (Amendment etc.) Regulations 2024
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Change 1
As published
69 Amendment to paragraph 57
In paragraph 57 (adverse reactions to product administered in UK)—
(a) in sub-paragraph (1)—
(i) in paragraph (a) for “serious adverse reaction” substitute “adverse event in respect of an animal”;
(ii) in paragraph (b)—
(aa) for “adverse reaction” substitute “adverse event”;
(bb) omit “or”;
(iii) after paragraph (c) (and immediately before the words “following the administration”) insert—
(d) occurrence of an adverse environmental event, or
(e) lack of efficacy,
;
(iv) omit “in the United Kingdom”;
(b) after sub-paragraph (1) insert—
(1A) A marketing authorisation holder must also act in accordance with this paragraph where—
(a) after the end of the withdrawal period a product of animal origin is found to include a pharmacologically active substance or marker residue exceeding the maximum residue limit established in accordance with Regulation (EC) No 470/2009 of the European Parliament and of the Council; or
(b) there is evidence in published scientific literature of an adverse event in connection with the product.
;
(c) in sub-paragraph (3) for “15” substitute “30”;
(d) in sub-paragraph (4) for “reaction” substitute “event”;
(e) after sub-paragraph (4) insert—
(4A) The Secretary of State may require the marketing authorisation holder—
(a) to collect specific pharmacovigilance data (in addition to the data mentioned in sub-paragraph (4)) and submit those data to the Secretary of State; and
(b) to carry out specific post-marketing surveillance studies.
(4B) Where the Secretary of State exercises the power mentioned in sub-paragraph (4A), the Secretary of State must—
(a) state the reason for the requirement; and
(b) state the time by which, or the period during which, the requirement must be complied with.
;
(f) omit sub-paragraph (5);
(g) for the heading substitute—
Adverse events following administration of a veterinary medicinal product
.
Your change, as a redline
69 Amendment to paragraph 57
In paragraph 57 (adverse reactions to product administered in UK)—
(a) in sub-paragraph (1)—
(i) in paragraph (a) for “serious adverse reaction” substitute “adverse event in respect of an animal”;
(ii) in paragraph (b)—
(aa) for “adverse reaction” substitute “adverse event”;
(bb) omit “or”;
(iii) after paragraph (c) (and immediately before the words “following the administration”) insert—
(d) occurrence of an adverse environmental event, or
(e) lack of efficacy,
;
(iv) omit “in the United Kingdom”;
(b) after sub-paragraph (1) insert—
(1A) A marketing authorisation holder must also act in accordance with this paragraph where—
(a) after the end of the withdrawal period a product of animal origin is found to include a pharmacologically active substance or marker residue exceeding the maximum residue limit established in accordance with Regulation (EC) No 470/2009 of the European Parliament and of the Council; or
(b) there is evidence in published scientific literature of an adverse event in connection with the product.
;
(c) in sub-paragraph (3) for “15” substitute “30”;
(d) in sub-paragraph (4) for “reaction” substitute “event”;
(e) after sub-paragraph (4) insert—
(4A) The Secretary of State may require the marketing authorisation holder—
(a) to collect specific pharmacovigilance data (in addition to the data mentioned in sub-paragraph (4)) and submit those data to the Secretary of State; and
(b) to carry out specific post-marketing surveillance studies.
(4B) Where the Secretary of State exercises the power mentioned in sub-paragraph (4A), the Secretary of State must—
(a) state the reason for the requirement; and
(b) state the time by which, or the period during which, the requirement must be complied with.
;
(f) omit sub-paragraph (5);
(g) for the heading substitute—
Adverse events following administration of a veterinary medicinal product
.
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