In May 2024 the Veterinary Medicines Directorate (VMD) published and regarding the Veterinary Medicines Regulations 2013 (VMR). The Veterinary Medicines (Amendment etc.) Regulations 2024 are not effective but what does this mean for UK wholesalers?
I was lucky to attend the VMDs Introduction to Veterinary Wholesale Qualified Person (WQP) in October 2024 to discuss with the inspectors the impact.
Routine Inspections
An important point to note is for licence holders of both human and veterinary medicines, you can now expect joint inspections by both the MHRA and VMD and will be issued a GDP compliance certificate from both agencies. Where a joint inspection is not possible, then wholesalers will be expected to host both regulatory inspections separately. Any WDA(V) GDP certificates issued by the MHRA will remain valid.
2023 Inspection Findings
The VMD performed 43 GDP audits in 2023, and the main observations were around self-inspection, import documents, temperature control, WQP duties, GDP training and customer verification. The October 2024 focused on all of these areas and their importance.
Updated Regulations
The main driving force for the update in 2024 is to provide clarity for wholesalers in both Northern Ireland and Great Britain where there are differences. The VMD have published guidelines to help companies navigate aspects of the VMR and these can be found here: https://www.gov.uk/government/collections/veterinary-medicines-guidance-notes-vmgns
Good Distribution Practice for Veterinary Medicinal Products in Great Britain
For wholesalers, it was hugely beneficial to review the updates for Good Distribution Practice (GDP) and the role of the Wholesale Qualified Person (WQP).
The new guidelines are closely aligned to the Good Distribution Practice of medicinal products for human use (2013/C 343/01) but there are some subtle differences which may catch our Responsible Persons (RPs) who act as both RP on their WDA(H) and WQP on their WDA(V).
These include:
- The requirement for each WQP on the license to perform a self-inspection that covers the entirely of the WDA(V). Where more than one WQP is named, each WQP must demonstrate they have performed this self-inspection at least annually.
- The WQP can nominate a deputy to delegate duties but not responsibilities.
- There is no fixed timeline for management of non-defective returns. WQPs must use a risk-based approach to ensure medicines are managed appropriately.
- Customers have the right to request to see evidence of adequate storage and transportation to ensure that medicines with special storage conditions have not experienced any temperature deviations.
So how can you best prepare for your next VMD inspection?
- Ensure your WQPs are trained in and understand The Veterinary Medicines (Amendment etc.) Regulations 2024.
- Review your self-inspection process to ensure this is robust and your WQP are comfortable performing audits. Many companies can offer support with this. Our next RP Forum on 12th November 2024 will be focusing on the importance of audits: https://pharmacyconsulting.co.uk/events/event/rp-forum-auditing-and-self-inspections/
- Ensure you are managing importation of veterinary medicines appropriately. Detailed guidance is available here: https://www.gov.uk/guidance/apply-for-a-certificate-to-import-a-veterinary-medicine-into-the-uk