61.—(1) Where, as a result of the evaluation of veterinary pharmacovigilance data, the Secretary of State considers that a marketing authorisation 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; or
(v)add a new precautionary measure,
the Secretary of State must forthwith inform the Agency, all other Member States (irrespective of whether the product is authorised in another member State) 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, but must inform the Agency, the Commission and the other Member States within one working day.
(3) If, following the opinion of the Agency, the Commission requests the Secretary of State to suspend, withdraw or vary the marketing authorisation, the Secretary of State must comply with that request immediately on a temporary basis.
(4) The Secretary of State must take final measures in accordance with the Decision of the Commission.