Regulation 57 Amendment to paragraph 38

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.”;

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”;

in the heading, after “suspension” insert “, revocation, etc”.