Wholesale dealer licence for UK medicines and MHRA rules
A wholesale dealer licence generally covers UK medicines supplied beyond patients. Learn how to apply to MHRA, budget for fees and check suppliers.
A wholesale dealer licence is generally needed when you sell or supply human medicines to someone other than the patient. In the UK, MHRA calls this a wholesale distribution authorisation for human medicines, or WDA(H). MHRA's application guidance explains the general requirement and application process.
For a new pharmaceutical wholesaling business, the work includes appointing a Responsible Person and preparing for good distribution practice inspection. For a buyer checking a supplier, the task is different: match the licence to the company, supplying site and permitted activities. A company-name match alone is not enough. See MHRA's licensing guidance and its WDA search service.
Who needs a wholesale dealer licence?
MHRA's general rule covers individuals and companies selling or supplying human medicines to anyone other than the patient. It includes prescription-only medicines, pharmacy medicines, general sales list (GSL) medicines and traditional herbal medicines. Supplying only non-prescription products does not, by itself, remove the licensing requirement. Source: MHRA.
Direct supply to patients falls outside that quoted wholesale rule. It does not place a retail pharmacy outside medicines regulation. Keep the distinction between wholesale distribution and patient supply clear when assessing your proposed business. Source: MHRA application guidance.
Does pharmacy wholesale distribution need authorisation?
Do not assume a pharmacy has a general exemption. MHRA's medicines shortages guidance describes a narrow exception. Pharmacists may supply small quantities to another pharmacist to meet an individual patient's needs without a wholesale dealer licence. That narrow provision does not authorise a separate wholesale business.
The former pharmacist wholesale exemption was repealed in 2012. MHRA has a publication on that repeal. Also keep licensing separate from fee reductions: the 15% wholesale-turnover criterion in the fee schedule concerns reduced fees, not a general exemption from holding a licence.
This guide concerns human medicines in the UK. It does not cover veterinary medicines or US drug-wholesaler licences.
How to apply for an MHRA WDA(H)
Submit applications through MHRA's Process Licensing Portal, known as PCL. The portal supports new applications and variations. Its WDA application overview covers applicant details, communications and invoicing addresses, financial information, sites and personnel. Use the portal's requirements rather than treating that overview as a complete document checklist.
Prepare the sites and Responsible Person
Identify the sites and personnel for your application. Arrange an appropriate Responsible Person, or RP, and give them the authority to perform the role. MHRA's inspectorate guidance explains that the licence holder must ensure an RP is available and notify the licensing authority.
The appointment needs more than a name on a form. The licence holder must enable the RP to act effectively. The RP remains responsible for good distribution practice (GDP) activities even when tasks are delegated. MHRA discusses knowledge, experience, training and familiarity with the operation. A commercial course certificate alone does not guarantee acceptance. Source: MHRA inspectorate.
GDP requires medicines to come from the licensed supply chain. They must be stored, transported and handled under suitable conditions. Prepare your operation for those duties before inspection, rather than treating GDP as paperwork submitted with the application. MHRA checks compliance through application inspections and later risk-based inspections. Source: MHRA GDP guidance.
Submit, undergo inspection and address findings
The application guidance describes this sequence:
- Submit the application and pay the applicable fee.
- Allow for MHRA's assessment, which may include checks on named personnel and Companies House information.
- Undergo GDP inspection and address the findings.
- Once MHRA is satisfied, receive the licence document and a GDP certificate for each inspected wholesale-distribution site.
Paying the fee does not authorise wholesale operations. The licence document and GDP certificate are separate outputs of the process. Keep both when reviewing what MHRA has issued. Source: MHRA application guidance.
How long does an application take?
MHRA says applications “should take 90 working days to process”. Treat this as an indicative processing time, not a guaranteed opening date. It means working days, not calendar days. The same guidance directs applicants to RegulatoryConnect to check application and existing authorisation status. PCL remains the submission route described above.
MHRA wholesale dealer's licence fees
The current MHRA fee schedule lists these amounts. Its 2025–2027 fees apply from 1 April 2025. The page's April 2026 update date is not a new effective date for these charges.
| Published category | Fee |
|---|---|
| Standard application plus inspection | £6,295 |
| Reduced application plus full inspection | £5,128 |
| Reduced application and reduced inspection, GSL only | £3,060 |
| Each additional site inspected, if required | £4,136 |
| Standard annual WDA fee | £346 |
| Reduced-rate or GSL annual fee | £206 |
The standard £6,295 combination consists of a £2,159 application fee and £4,136 inspection component. It is not an application-only charge. Nor is it a guaranteed cap: the inspection schedule describes standard GDP charging as £4,136 per day, while the combined table labels the inspection component per site. Duration, additional inspector time and further sites can affect charges. Source: MHRA fees.
Reduced-fee categories include GSL-only wholesalers, qualifying registered pharmacies and qualifying small wholesalers. The schedule refers to a 15% wholesale-turnover criterion for registered pharmacies and £35,000 in wholesale sales for small wholesalers. These figures concern fee eligibility, not permission to distribute medicines without authorisation. Check the conditions before budgeting at a reduced rate. A reduced application fee does not automatically bring a reduced inspection fee. Inspection notes include an on-site duration condition of under 3.5 hours. Source: MHRA fees.
The fee schedule uses different wording for turnover thresholds across sections. If your figures are close to a boundary, ask MHRA to confirm eligibility. Annual charges are invoiced and payable in April, according to the application guidance. Proposed April 2027 fees should not replace the current published amounts when checking today's charges. Source: current fee schedule.
How to check the MHRA wholesale dealer's licence register
Start with the register of licensed wholesale distribution sites. GOV.UK publishes the human-medicines register monthly. At 6 November 2026, the page offered the October 2026 CSV and its key. The data reflects MHRA's records on the publication date, rather than a real-time guarantee.
Match the supplier's legal entity, WDA(H) number and actual dispatch or storage site address. MHRA explains that the licence number identifies the company, while the site number identifies the site. Use the register's published key to interpret its entries. Source: MHRA register.
Then open MHRA-GMDP's WDA search. It supports searches by authorisation number, holder, site name, address and postcode. Read the authorisation document itself. Check that the relevant site and permitted scope match the supply you plan to buy. A company can have a matching name while the address you are checking belongs to a different site. Use the site details in the authorisation, rather than stopping when the search returns the expected company.
Check the GDP certificate and inspection information separately. A GDP certificate does not replace the authorisation document or establish its permitted scope. MHRA describes the licence and certificate as distinct outputs in its application guidance.
RegAffairs AI's answer on UK wholesale dealer licensing covers the application and supplier-check questions.
If a site is missing or details disagree, investigate with the supplier or MHRA before relying on the search. A failed search alone does not prove unlawful trading: the monthly register records information held on its publication date.