S.L. 437.47 Art. 74Samples to be submitted.

(1) Where it considers it necessary for reasons of human or animal health, the Veterinary Services may require the marketing authorisation holder for an immunological veterinary medicinal product to submit samples of batches of the bulk product and, or veterinary medicinal product, for control by an Official Medicines Control Laboratory before the product is put into circulation.

(2) On request by the Veterinary Services, the marketing authorisation holder shall promptly supply the samples referred to in subregulation (1), together with the reports of the control referred to in regulation 73(2).

The Veterinary Services shall inform all the other Member States in which the veterinary medicinal product is authorised as well as the European Directorate for the Quality of Medicines of its intention to control batches or the batch in question.

(3) After studying the control reports referred to in regulation 73(2), the laboratory responsible for the control shall repeat, on the samples provided, all the tests carried out by the manufacturer on the finished product, in accordance with the relevant provisions shown in the dossier for marketing authorisation. The list of tests to be repeated by the laboratory responsible for the control shall be restricted to justified tests, provided that all Member States concerned, and if appropriate the European Directorate for the Quality of Medicines, agree to this. For immunological veterinary medicinal products authorized under European Regulation (EC) No 726/2004, the list of tests to be repeated by the control laboratory may be reduced only after agreement by the Agency.

(4) Malta shall recognise the results of the tests.

(5) Unless the European Commission is informed that a longer period is necessary to conduct the tests, the Veterinary Services shall ensure that this control is completed within sixty days of receipt of the samples. The Veterinary Services shall notify the other Member States concerned, the European Directorate for the Quality of Medicines, the marketing authorisation holder and, if appropriate, the manufacturer, of the results of the tests within the same period of time. If the Veterinary Services concludes that a batch of a veterinary medicinal product is not in conformity with the control report of the manufacturer or the specifications provided for in the marketing authorisation, it shall take all the necessary measures vis-a-vis the marketing authorisation holder and the manufacturer, where appropriate, and shall inform accordingly the other Member States in which the veterinary medicinal product is authorised.