The WQP: Duties and Responsibilities

The critical role of the WQP in Veterinary Wholesaling

At first glance, ‘WQP’ might sound like just another regulatory role, but if you are a wholesale or distributor operating under a Wholesale Distribution Authorisation – Veterinary (WDA(V)), the Wholesale Qualified Person (WQP) plays a critical role in your operation and for your licence retention.

In this blog we take a closer look at what a Wholesale Qualified Person actually does, why the role exists, and what can happen if you enlist the wrong person. We will also explore how veterinary guidelines differ from the GDP guidelines for human medicines in relation to this important role, in comparison with those for the Responsible Person (RP).

Why does a WDA(V) holder require a WQP?

The Veterinary Medicines Regulations (VMR) (as amended) and the Veterinary Medicines Directorate’s (VMD) Good Distribution Practice (GDP) for Veterinary Medicinal Products lay out how veterinary medicinal products must be stored, transported, and supplied in Great Britain.

Every wholesaler that handles veterinary medicines must hold a WDA(V) licence from the VMD and to hold that licence, you must have at least one named WQP on your authorisation.

The WQP’s purpose is simple but vital: to make sure your wholesale activities comply with National law and the principles of GDP. They ensure medicines are handled safely, customers are authorised to procure and handle such medicines, and that no corners are cut that could affect product quality or animal welfare.

What the WQP Does

The VMD sets out a surprisingly wide list of responsibilities for the Wholesale Qualified Person, they go far beyond just signing off paperwork!

The WQP carries heavy responsibility in the wholesale chain.  Under the VMS’s “Personnel Requirements” section of the GDP for Veterinary Medicinal Products guidelines, they must perform a number of duties, many personally.

The documented duties and responsibilities of the WQP are as follows:

(i) implementing and maintaining the quality management system

(ii) managing authorised activities and ensuring the quality and accuracy of the data recorded

(iii) developing, implementing and recording a continuous training programme for all staff involved in the wholesale of veterinary medicinal products

(iv) co-ordinating and performing any recall operations for veterinary medicinal products in the required time frames

(v) ensuring that relevant customer complaints are dealt with effectively

(vi) ensuring that validations regularly occur on suppliers and customers to ensure that they are authorised

(vii) approve and manage any subcontracted activities which may impact on the wholesale supply of veterinary medicinal products

(viii) perform self-inspections at appropriate regular intervals

(ix) keep appropriate records of any delegated tasks

(x) decide on the final disposition of returned, rejected, recalled or falsified veterinary medicinal products

(xi) approve any returns to saleable stock

(xii) ensure that the requirements of the Veterinary Medicines Regulations 2013 (as amended) and the associated Good Distribution Practice document are adhered to

(xiii) monitor and document deviations against the quality system, conduct CAPAs to correct deviations and avoid their reoccurrence, and monitor the effectiveness of the actions put in place.

Because the WQP’s functions are legally mandated, the person designated must perform them personally.
While some duties may be delegated, they remain ultimately responsible and accountable and must ensure proper controls and oversight of those delegations.

The WQP must be continuously available. If for any reason they are not available, a suitably qualified and trained person must be appointed to maintain continuity; you cannot let the WDA(V) operate without a qualified WQP.

Where a WDA(V) holder appoints more than one Wholesale Qualified Person, each must personally carry out an annual self-inspection and bear the responsibility for their portion of oversight.

Should the WQP leave the organisation, they must inform the VMD, and the licence holder must promptly vary the WDA(V) to appoint a replacement or cease wholesaling until a new WQP is appointed.

Finally, failure by the WQP to carry out the mandated duties can lead to regulatory action. The VMD or MHRA (for dual WDA(H) and WDA(V) licence holders) may suspend or revoke the WDA or remove acceptance of the Wholesale Qualified Person.

Who can be a WQP?

The VMR do not provide formal qualification or years of experience for a WQP, however Good Distribution Practice (GDP) for Veterinary Medicinal Products stipulates “desirable” qualifications and experience:

“The WQP may be a pharmacist, vet or suitably qualified person (SQP), but if they’re not one of these, they must have at least a year’s experience in either handling, storing and distributing medicines, or in the supplying or obtaining of medicines. They must also have at least a year’s experience in managing the wholesale distribution of medicines on a similar scale with a similar product scope.”

When nominating or varying a Wholesale Qualified Person on a WDA(V), you will be required to submit their CV, references and evidence of professional membership or supporting documents relating to experience.

Consequences of Employing the Wrong Person for the Role

Because the WDA is a legal requirement for a valid WDA(V) the consequences of nominating an incompetent WQP carries serious risk to your licence and reputation:

1. 1. Suspended or revoked licence: Operating without an appropriately qualified and competent WQP can lead to the VMD or MHRA (for dual licence holders) suspending or revoking your WDA(V).
   2. Reputational damage and operational disruption: Suspension or revocation of your licence interrupts the ability to procure, store and distribute veterinary medicines. This could lead to supply shortages and jeopardise customer relationships.
   3. Regulatory sanctions, fines or prosecutions: Wholesalers found in violation of the VMR or GDP for Veterinary Medicines can face civil penalties, criminal sanctions or other enforcement outcomes.
   4. Liability for incorrect decisions: If a Wholesale Qualified Person allows the introduction of counterfeit or falsified veterinary medicines into the supply chain, or fails to act appropriately on deviations or recalls, the wholesaler risks liability for animal health harm, financial losses and / or regulatory penalties.
   5. Mis-managing a QMS: Can lead to critical deficiencies triggering costly remediation actions, regulatory sanctions or higher frequency of inspections.

In short, the Wholesale Qualified Person is not a minor role, it is critical to regulatory compliance and licence retention.  The integrity of a wholesaler’s operations depends heavily on the competence and ability of the person in this role.

How the GDP for veterinary medicines WQP role differs from that of the RP for GDP for human medicines

Many wholesalers dealing in both human and veterinary medicines will be familiar with Regulation 45 of the Human Medicines Regulations 2012 and the concept of a Responsible Person (RP) for GDP.

However, although the veterinary WQP role mirrors many aspects of the RP’s roles and responsibilities, there are important differences.  Understanding these critical differences is critical for veterinary distributors or those transitioning into veterinary wholesaling.

Similarities:

1. Both vary legal accountability for distribution compliance with National law and GDP guidelines
2. Both must ensure a QMS is in place and maintained
3. Both roles are key in regulatory inspections and must be continuously available
4. Both may delegate duties but not responsibilities

Key Differences:

1. Separate GDP guidelines and regulatory bodies (unless holding both WDA(H) and WDA(V).
2. Annual self-inspection requirement for each named WQP. They must conduct an annual self-inspection covering the full scope of the WDA.  This is less explicit in the GDP guidelines for human medicines.
3. Broader disposition authority relating to returned and recalled products. The WQP powers to approve reintroduction to saleable stock, disposition or rejects and recall decisions are clearly documented within the veterinary medicinal products guidance.  Whilst RPs also have medicinal product final disposition. responsibilities under GDP, the specifics within the guidelines are not as detailed as those within the veterinary GDP guidelines.
4. Handling unauthorised imports and certificates obligations are clearly set out in the VMR amendments 2024, requiring that imported veterinary medicinal products comply with GMP or equivalent or hold valid certificates, this is not the case for human medicinal products.

These differences mean that a person doubling as a Wholesale Qualified Person and an RP must appreciate the nuances of both sets of guidelines and regulations, simply being qualified in one does not automatically guarantee suitability for the other.

Practical Tips for WDA(V) Holders

If you are preparing for a new WDA(V) or are reviewing your current compliance status:

1. Choose your WQP carefully/review their competence regularly. Make sure their knowledge and experience aligns with the relevant guidelines and legislation, your product range and business model.
2. Invest in training. Even experienced WQPs need to stay current with updates to GDP guidelines and the Veterinary Medicine Regulations.
3. Plan for continuity. If your WQP resigns or takes extended leave (e.g. maternity leave) have deputy arrangements in place and inform the VMD / MHRA immediately.
4. Empower the role. The Wholesale Qualified Person needs real authority and independence within your organisation to do their job.

Paradigm Shift Consulting Perspective

At Paradigm Shift we see the WQP role as integral to the longevity of an organisation.

A well-supported WQP helps companies move from a reactive compliance mindset to one with a proactive quality culture, where the goal isn’t to find the grey areas but to be compliant and inspection ready at all times.

If your organisation is thinking of applying for a WDA(V), are reviewing your QMS, or preparing for a VMD inspection, out team can help you understand exactly what is expected of your WQP, how to embed their role into your wider operations and prepare for your next regulatory inspection.

In a world where every vial, tablet or bottle matters, your Wholesale Qualified Person is not just a regulatory necessity. They are your best defence against disruption and enforcement action and your biggest ally in keeping animal health products safe, effective and available when needed most.

Contact us today for a free 5-minute consultation.