Complaints and product recall
Article 13
1. The Member States shall ensure that manufacturers 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. Any complaint concerning a defect shall be recorded and investigated by the manufacturer. The manufacturer shall be required to inform the competent authority and, if applicable, the marketing authorisation holder of any defect that could result in a recall or an abnormal restriction on supply and, in so far as possible, indicate the countries of destination. 2. Any recall shall be made in accordance with the requirements referred to in Article 123 of Directive 2001/83/EC.