S.L. 437.47 Art. 35Necessity for variation of the terms of a marketing authorisation.

(1) Where the Director considers that the variation of the terms of a marketing authorisation which has been granted in accordance with the provisions of this Chapter or its suspension or withdrawal is necessary for the protection of human or animal health or the environment, it shall forthwith refer the matter to the Agency for the application of the procedure laid down in articles 36, 37 and 38 of European Union Council Directive 2001/82.

(2) Without prejudice to the provisions of regulation 34(1), in exceptional cases, where urgent action is essential to protect human or animal health or the environment, until a definitive decision is adopted, the Director may suspend the marketing and the use of the veterinary medicinal product concerned on its territory. It shall inform the European Commission and the other Member States no later than the following working day of the reasons for its action.