Paragraph 60 Action taken on account of pharmacovigilanceI1

Where, as a result of the evaluation of veterinary pharmacovigilance data, the Secretary of State considers that a marketing authorisation should be—

he shall forthwith inform the Agency, all other member States (irrespective of whether the product is authorised in another member State) and the marketing authorisation holder.

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 he must inform the Agency, the Commission and the other member States within one working day.

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 shall comply with that request immediately on a temporary basis.

The Secretary of State shall take final measures in accordance with the Decision of the Commission.