S.L. 458.42 Art. 14Complaints, and product recall. Cap. 458.

(1) The manufacturer shall:

(a) implement a system for recording and reviewing complaints together with an effective system for recalling, promptly and at any time, medicinal products in the distribution network;

(b) record and investigate any complaint concerning a defect;

(c) inform the competent authority and, if applicable, the marketing authorization holder of any defect that could result in a recall or abnormal restriction on supply and, in so far as is possible, indicate the countries of destination. Any recall shall be made in accordance with the requirements referred to in the Medicines Act.