Product recalls
Article 45
1. Procedures for the recall of products shall be established, which shall include how a recall is to be initiated, who is to be informed in the event of a recall (including relevant authorities) and how the recalled material is to be treated. The respective role and tasks of the manufacturer and marketing authorisation holder regarding the initiation and organisation of recalls shall be clearly established. 2. It shall be ensured that recall operations can be initiated promptly and at any time. In certain cases, and with a view to protect the health of consumers or animals, it may be necessary to recall products prior to establishing the root cause or the full extent of the quality defect. 3. The effectiveness of the procedure for recalls shall be periodically evaluated, including during office hours and out-of-office hours. The possibility of performing mock-recall actions shall be considered and the outcome of this evaluation shall be documented. 4. Recalled products shall be identified and stored separately in a secure area while awaiting a decision on their fate. The progress of the recall shall be recorded until the recall procedure is closed and a final report is issued, including a reconciliation between the delivered and recovered quantities of the concerned products or batches. 5. All competent authorities concerned shall be informed prior to the initiation of a recall unless urgent action is required to protect the health of consumers or animals. The competent authorities shall also be informed in situations in which no recall action is being proposed for a defective batch because the batch has expired. 6. In addition to recalls, there are other risk-reducing actions that may be considered to manage the risks presented by quality defects, such as the transmission of appropriate information to healthcare professionals. Such course of action shall be discussed with and agreed by the competent authorities.