S.L. 437.108 ст. 13Complaints and product recall.

(1) The manufacturer shall implement a system for recording and reviewing complaints together with an effective system for recalling promptly and at any time the veterinary medicinal products in the distribution network.

(2) Any complaint concerning a quality defect shall be recorded and investigated by the manufacturer.

(3) The competent authority shall be informed by the manufacturer of any quality defect that could result in a recall or abnormal restriction on the supply. In so far as possible, the countries of destination shall also be indicated.

(4) Any recall shall be made in accordance with the requirements referred to in Article 91 of Directive 2001/82/EC.