Complaints, Returns, Suspected Counterfeits and Recalls
Source: gov.uk (2025-06-20)

Requirements for handling complaints, returns, suspected counterfeits and recalls.

7.1 Complaints
- Complaints must be recorded with all the original details. A distinction must be made between complaints related to the quality of a medicinal product and those related to wholesale distribution.
- In the event of a complaint about the quality of a medicinal product and a potential product defect, the manufacturer and/or marketing authorisation holder (MAH) must be informed without delay. Any product distribution complaint must be thoroughly investigated to identify the origin of or reason for the complaint.
- If necessary, appropriate follow-up actions (CAPA) must be taken after investigation and evaluation of the complaint, including where required notification to the competent authorities.
7.2 Returns of Non-Defective Veterinary medicinal products
- Returned products must be handled according to a written, risk-based process taking into account the product concerned, any specific storage requirements and the time elapsed since the medicinal product was originally dispatched.
- The WQP is responsible for assessing any returned medicines to check if they’ve been stored, including during transport, in accordance with the relevant SPC and product label.
- Veterinary medicinal products must only be returned to saleable stock if the following conditions are met:
- (i) the products are in their unopened and undamaged secondary packaging and are in good condition
- (ii) the veterinary medicinal products have not expired and have not been recalled
- (iii) the product has been returned within an acceptable time period
- (iv) there is evidence that the product was supplied to the customer returning the products and they have not been dispensed or supplied to an animal owner
- (v) there is documented evidence that the product has been handled, stored and transported in compliance with the authorised storage conditions
- (vi) there are checks made to ensure that the product is not counterfeit
- (vii) the products have been examined and assessed by appropriately trained personnel, and any return to stock has individually been authorised by the WQP.
-4. Where the returned product has not been stored (including during transport) in accordance with the SPC, or where it has not been possible for the WQP to determine whether it has, the product may not be returned to saleable stock. For veterinary medicinal products requiring specific temperature storage conditions such as low temperature, returns to saleable stock must only be made if there is documented evidence that the product has been stored under the authorised storage conditions. These medicines must be segregated from saleable stock before being destroyed.

-5. Veterinary medicinal products which have been stolen and subsequently returned must not be entered into saleable stock.

-6. Records of returns must be kept including any formal release to stock by the WQP.

7.3 Suspected Counterfeit Products
- Wholesale dealers must immediately stop the distribution of any veterinary medicinal product they suspect to be counterfeit and inform both the competent authority (VMD) and the MAH. The wholesale dealer must have a procedure in place to this effect and document the incident and any subsequent investigations.
- Any counterfeit veterinary medicinal products found in the supply chain must be physically segregated immediately and stored in a dedicated area away from all other veterinary medicinal products. All relevant activities in relation to such products must be documented and records retained.
- Any product defect found by the wholesaler or notified to the wholesaler by a customer must be reported to the MAH/manufacturer immediately.
7.4 Product Recalls
- There must be an emergency plan for urgent and non-urgent recalls, and this must be described in a procedure. A person must be designated as responsible for execution and co-ordination of recalls.
- The distributor must follow the instructions of a recall message, which must be approved, if required, by the competent authorities or the marketing authorisation holder (MAH).
- In the event of a veterinary medicinal product recall, the person designated as responsible for the recall must inform, with the appropriate degree of urgency and clear actionable instructions, all affected customers to whom the product has been distributed.
- If the recall has been instigated by the wholesale dealer premises, then the person designated as responsible for the recall must also inform the VMD of the recall.
- If the recall includes veterinary medicinal products which were exported, then the person designated as responsible for the recall must also inform the competent authorities in the countries where the products were exported.
- Any recall messages must be approved by the MAH and/or VMD. The recall message must indicate to what level the recall must occur. The message must request that the recalled products be removed immediately from the saleable stock and stored separately in a secure area until they are sent back according to the instructions of the MAH.
- The effectiveness of the arrangements for product recall must be evaluated regularly (at least annually). Recall operations must be capable of being initiated promptly and at any time.
- Any recall operation must be recorded at the time it is carried out. A final report including a reconciliation between the delivered and recovered quantities of the recalled veterinary medicinal product must be produced.
- To ensure that the recall procedure is effective at least one recall must be conducted annually. If no recall has occurred, then then a test recall must be conducted, and this must be fully documented. Records must be made readily available to the competent authorities.