S.L. 437.47 Art. 71Procedureuponthe result of the evaluation.

(1) Where, as a result of the evaluation of veterinary pharmacovigilance data, the Veterinary Services considers that a marketing authorisation should be suspended, withdrawn or varied to restrict the indications or availability, amend the posology, add a contra-indication or add a new precautionary measure, it shall forthwith inform the Agency, the Member States and the marketing authorisation holder.

(2) If urgent action is necessary for protecting human or animal health, Malta may suspend the marketing authorisation of a veterinary medicinal product, provided that the Agency, the Commission and the other Member States are informed on the following working day at the latest.