S.L. 437.47 Art. 32Procedure by the VeterinaryServices upon grounds for supposing that the marketing authorisationofthe veterinary medicinal product concerned may present a risk to human health or animal health.

(1) If Malta cannot, within the period allowed in regulation 31(4), agree with the assessment report, summary of product characteristics, labelling and package leaflet on grounds of a potential serious risk to human or animal health or to the environment, a detailed statement of the reasons shall be provided to the reference Member State, the other Member States concerned and the applicant. The points of disagreement shall be referred without delay to the coordination group.

If a Member State to which an application has been submitted invokes the reasons referred to in regulation 64(1), it shall no longer be regarded as a Member State concerned by this Chapter.

(2) Within the co-ordination group, all Member States referred to in subregulation (1) shall use their best endeavours to reach agreement on the action to be taken. They shall provide the applicant with the opportunity to make his point of view known orally or in writing. If, within sixty days of the communication of the reasons for disagreement to the coordination group the Member States reach an agreement, the reference Member State shall record the agreement, close the procedure and inform the applicant accordingly. Regulation 31(5) shall apply in such cases.

(3) If within the period of sixty days the Member States fail to reach an agreement, the Agency shall be immediately informed with a view to application of the procedure laid down in Articles 36, 37 and 38 of European Union Council Directive 2004/28/EC. The Agency shall be provided with a detailed description of the matters on which agreement could not be reached and the reasons for the disagreement. The applicant shall be provided with a copy of such information.

(4) As soon as the applicant has been informed that the matter has been referred to the Agency, he shall forthwith forward to the Agency a copy of the information and documents referred to in the first subparagraph of regulation 31(1).

(5) In the case referred to in subregulation (3), the Member States that have approved the assessment report, summary of product characteristics, labelling and package leaflet of the reference Member State may, on request by the applicant, grant a marketing authorisation for the veterinary medicinal product without waiting for the outcome of the procedure laid down in Article 36 of European Union Council Directive 2004/28/EC. In that case, the authorisation granted shall be without prejudice to the outcome of that procedure.