Who needs one
A wholesale dealer’s licence is required to wholesale medicinal products for human use — broadly, supplying them to anyone other than the patient. Supplying another business, a pharmacy, a hospital or a healthcare professional is wholesale distribution; dispensing to a patient against a prescription is not.
Activities that commonly catch organisations out include supplying stock to a sister company, selling on surplus stock, and holding stock on behalf of another party. Each of these can constitute wholesale distribution even where no margin is taken.
Brokering — arranging the sale or purchase of medicines without handling or owning them — is a separate regime with its own registration requirement rather than a WDA(H).
What MHRA assesses
An application is assessed on the premises, the quality system, and the people. The named Responsible Person’s knowledge and experience are assessed directly, and the site is normally inspected before a licence is granted.
The application asks you to define the scope precisely: which categories of product, which activities, which sites. Operating outside the granted scope is a common and serious finding, so the scope requested at application should match the business you actually intend to run.
What the licence commits you to
Once granted, the licence carries standard provisions requiring compliance with GDP. In practice that means the full set of Chapter 1 to Chapter 9 obligations: a documented quality system, trained personnel, qualified premises and equipment, controlled documentation, qualified suppliers and customers, procedures for complaints, returns, falsified products and recalls, control of outsourced activities, a self-inspection programme, and controlled transportation.
Continuing obligations that are easy to overlook
- Notifying MHRA of changes to the RP, the premises, or the scope of activities.
- Maintaining the self-inspection programme even in quiet trading periods.
- Keeping supplier and customer qualification current rather than approving once at onboarding.
- Retaining records for the required period and being able to retrieve them on request.
- Paying the annual fee and responding to the periodic inspection cycle.
Timelines and preparation
Applications take time, and the largest variable is how ready the quality system is when MHRA looks at it. Sites that apply with procedures drafted but not yet operating tend to spend longer in the process, because the inspector is looking for evidence of the system working rather than the existence of documents.
A reasonable readiness test before applying: could you run a full self-inspection against the GDP chapters today and produce records for each one?
Common questions
- Do we need a WDA(H) to supply medicines to our own group companies?
- Usually yes. Supplying another legal entity is wholesale distribution even within a group, and the absence of a commercial margin does not remove the requirement.
- Is a broker registration an alternative to a licence?
- Only if you genuinely never take possession or ownership of the product. If you hold, store or supply stock, brokering registration is not sufficient.
- How long does an application take?
- MHRA publishes target timescales, but the practical duration depends on inspection scheduling and how many issues are raised. Treat the quality system readiness, not the form, as the critical path.