Complaints, product recall and emergency unblinding
Article 14
1. The manufacturer shall, in cooperation with the sponsor, implement a system for recording and reviewing complaints together with an effective system for recalling investigational medicinal products which have already entered the distribution network promptly and at any time. The manufacturer shall record and investigate any complaint concerning a defect and shall inform the sponsor and the competent authority of the Member States concerned of any defect that could result in a recall or abnormal restriction on supply. All trial sites shall be identified and, in so far as possible, the countries of destination shall be indicated. In the case of an authorised investigational medicinal product, the manufacturer shall, in cooperation with the sponsor, inform the marketing authorisation holder of any defect that could be related to that product. 2. Where blinding of investigational medicinal products is required by the protocol of a clinical trial, the manufacturer in conjunction with the sponsor shall implement a procedure for the rapid unblinding of blinded products, where this is necessary for a prompt recall as referred to in paragraph 1. The manufacturer shall ensure that the procedure discloses the identity of the blinded product only in so far as it is necessary.