Complaints
1. Complaints, whether received orally or in writing, shall be recorded and investigated according to a procedure.
In the event of a complaint about the quality of an active substance used as a starting material in veterinary medicinal products, the persons referred to in Article 1(2) shall review the complaint with the original active substance manufacturer, as applicable, in order to determine whether any further action shall be initiated either with other customers who may have received that active substance, or with the competent authority, or both. The investigation into the cause for the complaint shall be conducted and documented by the appropriate party.
2. Complaint records shall include the following:
(a)
name or company name and permanent address or registered place of business of complainant;
(b)
name, title, where appropriate, and contact details of the person submitting the complaint;
(c)
nature of the complaint, including name and batch number of the active substance used as a starting material in veterinary medicinal products which is the subject of that complaint;
(d)
date the complaint is received;
(e)
action initially taken, including dates and identity of the person taking that action;
(f)
any follow-up action taken;
(g)
response provided to the originator of the complaint, including the date of the response;
(h)
final decision on the active substance batch concerned.
3. Records of complaints shall be retained in order to evaluate trends, product related frequencies, and severity, with a view to taking additional, and if appropriate, immediate corrective action. Those records shall be made available to the competent authorities during inspections.
4. Where a complaint is referred to the original active substance manufacturer, the record maintained by the person referred to in Article 1(2) shall include any response received from the original active substance manufacturer, including the date and information provided.
5. In the event of a serious or potentially life-threatening situation, the persons referred to in Article 1(2) shall inform, seek advice from and follow the instructions of local, national or international authorities, as appropriate.
Returns
1. Returned active substances used as starting materials in veterinary medicinal products shall be identified as such and segregated physically or, if an equivalent electronic system is available, electronically, pending the outcome of an investigation into those returned active substances.
2. Active substances used as starting materials in 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 active substance used as a starting material in veterinary medicinal products is in its original unopened containers with all original security seals present and is in good condition;
(b)
it is demonstrated by written information provided by the customer that the active substance used as a starting material in veterinary medicinal products has been stored and handled under proper conditions;
(c)
the remaining shelf life is acceptable;
(d)
the active substance used as a starting material in veterinary medicinal products has been examined and assessed by a person trained and authorised to do so;
(e)
no loss of information or traceability has occurred.
3. The assessment under paragraph (2) shall take into account the nature of the active substance used as a starting material in veterinary medicinal products, any special storage conditions it requires and the time elapsed since it was supplied. As necessary and if there is any doubt about the quality of the returned active substance used as a starting material in veterinary medicinal products, advice shall be sought from the original active substance manufacturer.
4. Records of returned active substances used as starting materials in veterinary medicinal products shall be maintained. For each return, documentation shall include the following:
(a)
name or company name and permanent address or registered place of business of the consignee returning the active substance used as starting materials in veterinary medicinal products;
(b)
name or designation of the active substance used as a starting material in veterinary medicinal products;
(c)
batch number of the active substance used as a starting material in veterinary medicinal products;
(d)
quantity of active substance used as a starting material in veterinary medicinal products returned;
(e)
reason for return;
(f)
use or disposal of the returned active substance used as a starting material in veterinary medicinal products and records of the assessment performed.
5. Only appropriately trained and authorised personnel shall release active substances used as starting materials in veterinary medicinal products for return to saleable stock.
6. Active substances used as starting materials in veterinary medicinal products returned to saleable stock shall be placed so that the stock rotation system operates effectively.
Recalls
1. There shall be a procedure in place that defines the circumstances under which a recall of an active substance used as a starting material in veterinary medicinal products shall be considered.
2. The recall procedure shall specify:
(a)
who shall be involved in evaluating the information;
(b)
how a recall shall be initiated;
(c)
who shall be informed about the recall;
(d)
how the recalled material shall be treated.
3. The person responsible for the quality system shall be involved in recalls.
