13/14 December 2022
With Regulation (EU) 2019/6 on veterinary medicinal products, which applies since 28 January 2022, the European Union has revised the veterinary medicinal products legislation. In August 2021, the new Commission Implementing Regulation (EU) 2021/1248 on measures on good distribution practice for veterinary medicinal products entered into force.
The European Medicines Agency (EMA) provides answers to frequently asked questions on Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) on its website, which have been compiled and agreed by the GMP/GDP Inspectors Working Group. In October 2022, the list was updated.
The newly inserted section revolves around the requirement relating to the nature of check at the reception of veterinary medicinal products before being transferred to saleable stock.
In accordance with Article 23 of regulation 2021/1248, during receipt of veterinary medicinal products, the responsible persons shall ensure that the arriving consignment is correct, that the veterinary medicinal products originate from approved suppliers and that they have not been damaged during transport.
Art. 23 (3) states: "Batches of veterinary medicinal products intended for the Union market shall not be transferred to saleable stock before assurance has been obtained in accordance with procedures, that they are authorised for sale. For batches coming from another Member State, prior to their transfer to saleable stock, the control report referred to in Article 97(6) and (9) of Regulation (EU) 2019/6, the results of necessary tests, as applicable, referred to in Article 97(7) of that Regulation or another proof of release to the market in question based on an equivalent system, shall be carefully checked by appropriately trained personnel."
The newly added explanations refer to the following question: "What kind of proof of release to the market could be requested and controlled by the staff of WDA holder for ensuring that received veterinary medicinal products coming from another Member State be transferred to saleable stock?"
The answer is that "in this context, wholesalers shall check that batches of veterinary medicinal products coming from another member state are be accompanied by evidence that the manufacturer’s qualified person has certified the finished product batch. This check could be done by different means: paper based check (copy of controls reports), electronically check or other equivalent system as agreed with the supplier (manufacturer or wholesaler)."