Commission Implementing Regulation (EU) 2025/2091 CHAPTER X — QUALITY DEFECTS AND RECALL OF PRODUCTS

Article 44–Article 45 · 2 articles

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Quality defects

Article 44

1. A system shall be put in place to ensure that all quality-related complaints, whether received orally or in writing, are recorded and thoroughly investigated and that appropriate actions are implemented, including the recall of veterinary medicinal products where appropriate. 2. Personnel responsible for managing quality-related complaints and quality defect investigations shall be independent from marketing and sales departments unless otherwise justified. If the qualified person involved in the certification of the concerned batches does not participate in the investigation, it shall be informed in a timely manner. 3. Operating procedures shall be developed describing the actions to be taken upon the receipt of a quality-related complaint. Those operating procedures shall address at least the following: (a) the determination of the extent of quality defect; (b) the assessment of the risks posed by the quality defect; (c) the identification of the potential root causes of the quality defect or, where such route cause cannot be ascertained, the most probable reason; (d) the need for appropriate risk minimisation measures; (e) the need for corrective or preventive measures; (f) the assessment of the impact that any recall action may have on the availability of the veterinary medicinal product; (g) the internal and external communications to be made. 4. If the handling of quality-related complaints and suspected quality defects is managed centrally within an organisation, the relative roles and responsibilities of the parties concerned shall be documented. 5. If the veterinary medicinal product is manufactured by an entity that is not the marketing authorisation holder, the role and responsibilities of the manufacturer, the marketing authorisation holder and any other relevant third party shall be laid down in writing. 6. When a quality defect is discovered or suspected in a batch, consideration shall be given whether it is necessary to check other batches or, as appropriate, other products to determine if they are also affected. Batches that may contain portions of the defective batch or components shall be investigated. 7. Quality defect investigations shall include a review of previous quality defect reports or any other relevant information that is indicative of specific or recurring problems. 8. The priority during an investigation shall be to ensure that appropriate risk-minimisations measures are taken. All decisions and measures adopted shall reflect the level of risk and shall be documented. The effectiveness of the corrective and preventive measures implemented shall be monitored. 9. Quality defects shall be reported in a timely manner to the marketing authorisation holder. Competent authorities shall also be informed in the case of a confirmed quality defect that may result in the recall of the product or an abnormal restriction in the supply. Unplanned deviations as described in Article 42 need not be notified. 10. Measures to address quality defects shall be proportionate to the risks and the priority shall be the protection of treated animals and user safety. Wherever possible, the actions to be taken shall be discussed with the competent authorities concerned in advance.

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.

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