Regulation 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”.