# The Veterinary Medicines Regulations 2013, Paragraph 61: Action taken on account of pharmacovigilance

Extent: E+W+S

(1) Where, as a result of the evaluation of veterinary pharmacovigilance data, the Secretary of State considers that a marketing authorisation , or a group of marketing authorisations containing the same active substance, should be—
(a) suspended;
(b) revoked; or
(c) varied so as to—
(i) restrict the indications;
(ii) change the distribution category;
(iii) amend the dose;
(iv) add a contraindication; ...
(v) add a new precautionary measure, or
(vi) implement a risk management plan,
the Secretary of State must forthwith inform ... and the marketing authorisation holder.
(2) If urgent action is necessary for protecting human or animal health, the Secretary of State may suspend the marketing authorisation of a veterinary medicinal product....
(3) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
(4) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

---
Source: https://www.legislation.gov.uk/uksi/2013/2033/schedule/1/paragraph/61 (the official version)
Page: https://openlegislation.uk/veterinary-medicines-regulations-2013/schedule-1/paragraph-61
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.