Complaints
1. Complaints shall be recorded with all the original details. A distinction shall be made between complaints related to the quality of a veterinary medicinal product and those related to wholesale distribution.
In the event of a complaint about the quality of a veterinary medicinal product and a potential product defect, the manufacturer or marketing authorisation holder shall be informed without delay.
Any veterinary medicinal product distribution complaint shall be thoroughly investigated to identify the origin of or the reason for the complaint.
2. A person shall be appointed to handle complaints and sufficient personnel shall be allocated to support that person.
3. If necessary, appropriate follow-up actions (including CAPA) shall be taken after investigation and evaluation of the complaint, including, where required, notification to the national competent authorities.
Returns
1. Returned veterinary medicinal products shall be handled according to a written, risk-based process taking into account the nature of the veterinary medicinal product concerned, any special storage conditions it requires and the time elapsed since it was supplied. Returns shall be conducted in accordance with national law and contractual arrangements between the parties.
2. Veterinary medicinal products which have left the care of the persons referred to in Article 1(2) shall only be returned to saleable stock if all of the following conditions are met:
(a)
the veterinary medicinal products are in their unopened and undamaged secondary packaging and are in good condition;
(b)
the veterinary medicinal products have not expired and have not been recalled;
(c)
the veterinary medicinal products returned from a customer not holding a wholesale distribution authorisation or from pharmacies or persons authorised to supply veterinary medicinal products to the public in accordance with national law of the Member State concerned have been returned within a defined acceptable time limit determined by using quality risk management principles;
(d)
the veterinary medicinal products have not been returned by the animal owner to the pharmacy or to other persons authorised to supply veterinary medicinal products to the public in accordance with national law of the Member State concerned, unless such return is permitted under national law of that Member State;
(e)
it has been demonstrated by the customer that the veterinary medicinal products have been transported, stored and handled in compliance with their specific storage requirements;
(f)
the veterinary medicinal products have been examined and assessed by a sufficiently trained and competent person authorised to do so;
(g)
the persons referred to in Article 1(2) have reasonable evidence that the veterinary medicinal product was supplied to the customer returning the veterinary medicinal product, as evidenced by copies of the original delivery note or by referencing invoice numbers, batch numbers, expiry date etc., as required by national law, and that there is no reason to believe that the veterinary medicinal product has been falsified.
3. For veterinary medicinal products requiring specific temperature storage conditions such as low temperature, returns to saleable stock shall only be made if there is documented evidence that the product has been stored under the authorised storage conditions throughout the periods in points (a) to (f). If any deviation has occurred, a risk assessment shall be performed, which shall demonstrate the integrity of the veterinary medicinal product. The evidence shall cover all the following steps:
(a)
delivery to the customer;
(b)
examination of the veterinary medicinal product;
(c)
opening of the transport packaging;
(d)
return of the veterinary medicinal product to the packaging;
(e)
collection and return to the persons referred to in Article 1(2);
(f)
return to the wholesale distribution site refrigerator.
4. Products returned to saleable stock shall be placed so that the ‘first expiry, first out’ system operates effectively.
5. Stolen veterinary medicinal products that have been recovered shall not be returned to saleable stock nor sold to customers.
Falsified veterinary medicinal products
1. In addition to the notification referred to in Article 101(6) of Regulation (EU) 2019/6, wholesale distributors shall immediately stop the distribution of any veterinary medicinal products they identify as falsified or suspected to be falsified and act on the instructions as specified by the competent authorities. A procedure shall be in place to this effect. The incident shall be recorded with all the original details and investigated.
2. Any suspected falsified veterinary medicinal products found in the supply chain shall immediately be segregated physically or, if an equivalent electronic system is available, electronically. Any falsified veterinary medicinal products found in the supply chain shall immediately be segregated physically, stored in a dedicated area away from all other veterinary medicinal products and appropriately labelled. All relevant activities in relation to such products shall be documented and records retained.
Recalls
1. There shall be documentation and procedures in place to ensure that veterinary medicinal products received and distributed are traceable for the purposes of any product recall.
2. In the event of a veterinary medicinal product recall, the persons referred to in Article 1(2) shall inform, with the appropriate degree of urgency and clear actionable instructions, all affected customers to whom the product has been distributed.
3. The persons referred to in Article 1(2) shall inform the relevant national competent authority of all veterinary medicinal product recalls. If the veterinary medicinal product is exported, the persons referred to in Article 1(2) shall inform the third country clients or the third country competent authorities of the recall as required by national law.
4. The persons referred to in Article 1(2) shall regularly evaluate the effectiveness of the arrangements for veterinary medicinal product recall on the basis of quality risk management principles.
5. The persons referred to in Article 1(2) shall ensure that recall operations can be initiated promptly and at any time.
6. The persons referred to in Article 1(2) shall follow the instructions of a recall message, which shall be approved, if required, by the competent authorities.
7. Any recall operation shall be recorded at the time it is carried out. Records shall be made readily available to the competent authorities.
8. The distribution records shall be readily accessible to the persons responsible for the recall and shall contain sufficient information on distributors and directly supplied customers (with addresses, phone numbers and means of electronic communication inside and outside working hours, batch numbers as required by national law and quantities delivered), including those records for exported veterinary medicinal products and veterinary medicinal product samples.
9. The progress of the recall process shall be recorded in a final report including reconciliation between the delivered and recovered quantities of the recalled veterinary medicinal product.
Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.
