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What is a WDA(V)?

A Wholesale Distribution Authorisation for veterinary medicines (WDA(V)) is the licence required to enable the procurement, sale, storage and distribution of medicines for veterinary purposes.

In this blog we will explain who will require a WDA(V) and what the application process involves.

 

Who Needs a WDA(V)?

A WDA(V) applies to any business that supplies only veterinary medicines on a wholesale basis to anyone other than the final user (for example, a vet, pharmacist, or pet owner). If your business sells or supplies veterinary medicines to anyone other than the end user, then obtaining a WDA(V) is not optional, it’s a legal requirement under the Veterinary Medicines Regulations (VMR).

The Role of the Wholesale Dealer Qualified Person (WQP)

One of the key differences between a WDA(H) and an WDA(V) is in regard to personnel.
Whilst at WDA(H) requires a Responsible Person to be listed on the licence, a WDA(V) requires a Wholesale Dealer Qualified Person (WQP), the veterinary equivalent of the Responsible Person (RP) in human medicine.

When submitting your application, you’ll need to nominate a Wholesale Qualified Person (WQP). Your WQP is responsible for ensuring that your business complies with all conditions of your WDA(V). They’ll oversee the quality system, conduct self-inspections, and ensure staff follow GDP requirements amongst other duties and responsibilities. Full obligations of the WQP can be found in Chapter 3, Personnel Requirements, of the Good Distribution Practice for Veterinary Medicinal Products in Great Britain guidelines.

A suitable WQP can be:

    • A pharmacist, veterinary surgeon, or Suitably Qualified Person (SQP); or
    • Someone with at least one year’s experience handling or distributing medicines, plus a further year managing wholesale operations.

The WQP does not necessarily need to be an employee; a contractor may be enlisted as your WQP. Regardless as to whether your WQP is an employee or a contractor, they must be continuously contactable to fulfil their responsibilities.

If your WQP hasn’t held the role before, the VMD may wish to assess their suitability before granting your application.

WDA (V) Application Process

The process of applying for a WDA(V) differs from that of Wholesale Distribution Authorisation for Human medicines (WDA(H)) as the Veterinary Medicines Directorate (VMD) oversees all WDA(V) applications in the UK, not the Medicines and Healthcare products Regulatory Agency (MHRA).  However, if your organisation handles both human and veterinary medicines the MHRA has an agreement with the Veterinary Medicines Directorate to inspect and approve manufacturing/distribution licences only where the company undertakes both human and veterinary activities. If you handle both human and veterinary medicines, please see our “Applying for your WDA” blog for more information.

Unlike MHRA WDA applications, the process for applying for a WDA(V) via the VMD is a little more traditional. To apply, you will need to complete a WDA(V) application form, which you can download here, and email it to inspections@vmd.gov.uk.

If you already hold a WDA(V) via the VMD and need to make changes to your site, staff, or operations, you’ll instead complete a variation application form.

Once received, the VMD will review your application to make sure it’s complete. When it’s validated, the VMD will arrange an onsite inspection of your premises and Quality Management System (QMS).

GB and NI: Understanding the Differences

The application process for WDA(V) differs slightly depending on whether your business is based in Great Britain (GB) or Northern Ireland (NI).

 

The table below highlights the differences: 

Aspect Great Britain (GB) Northern Ireland (NI)
Regulator Veterinary Medicines Directorate (VMD) under UK law VMD acting under EU-aligned NI Protocol
Applicable Legislation Great Britain Veterinary Medicines Regulations EU Veterinary Medicines Regulation (2019/6)
Fees GB-specific WDA(V) fee schedule NI-specific WDA(V) fees
Product Authorisations GB marketing authorisations EU marketing authorisations recognised
GDP Standards GB GDP guidance EU GDP guidance
Trade Flow GB supply chain only (or with export licence) Can distribute within NI and EU

In essence, businesses in Northern Ireland operate under EU veterinary medicine rules as part of the Windsor Framework, while those in Great Britain follow UK-specific regulations.

Please note: If you distribute across both regions, you may need separate authorisations.

What to Expect from the Inspection

Before your application is approved, a VMD inspector will visit your premises, usually within 90 days, to assess whether your facilities, processes, and staff meet the standards of Good Distribution Practice (GDP).

This inspection is comprehensive and typically covers:

    • Storage conditions and temperature control
    • Stock management and rotation
    • Documentation and record keeping
    • Staff training and competence
    • Quality management systems
    • Emergency recall procedures

 If deficiencies are found, you will receive a post-inspection response letter detailing the findings and you’ll be given time to correct them before final approval is granted.

Once authorised, your site and operations will be subject regular risk-based inspections, usually every two to four years, although highly compliant or low-risk sites may be inspected less frequently.

It’s important to note that you cannot begin wholesale operations until you’ve received written confirmation from the VMD that your authorisation has been granted, even if you’ve already had your inspection.

In rare cases, the VMD may issue a conditional authorisation to allow operations to begin before inspection, but again, you must have written confirmation first.

Final Thoughts

The Wholesale Dealer’s Authorisation (Veterinary) application process may seem daunting at first, but with preparation and a solid understanding of the VMD’s expectations, it’s entirely manageable.

Make sure your Quality Management System (QMS), documentation and facilities are inspection-ready before you apply, and ensure your WQP is confident in their GDP responsibilities.

Once approved, your WDA(V) demonstrates that your business meets the highest standards of animal medicine safety and quality, a vital step for any company supplying veterinary medicines in the UK.

Help and Support

The application process isn’t a hugely time-consuming activity; however prior proper planning can certainly speed it up and save you time and money.

    • Do you need assistance applying for your WDA(V)?
    • Would you like a review of your QMS and site prior to submitting your application?
    • Could you benefit from a mock VMD inspection?
    • Does your Licence Holder or WQP require formal GDP training?

Paradigm Shift Consulting can help! 

We have been asked to step in to assist many organisations who have spent significant amounts of time, sometimes over 6 months, trying to get WDA applications through the system and approved by the VMD or MHRA (sites that handle both human and veterinary medicines).
With our intervention these organisations were up to speed, all QMS procedures, processes and training in place and had their operations inspected and WDA approved within six weeks.

Our consultants have many years of experience assisting companies of all sizes, including those with simple or more complex business models, preparing, and submitting WDA(V) applications.

Contact us using our GDP Wholesale Questionnaire for our list of requirements for your WDA application, and a no obligation chat about your needs, and we can help you move ahead.

Welcome to a new Paradigm!