UK Wholesale Dealer’s Licence: What the MHRA Expects Before You Apply
There is a common misreading of the UK wholesale dealer’s licence application. The business treats it as the start of the work. The MHRA treats it as the point at which the work should be finished.
Guidance Note 6, the MHRA’s notes for applicants and licence holders, is direct on this. New applicants are expected to be inspection ready at the point of application. The licence is only issued once the licensing authority is satisfied, following an inspection of the site, that the application is accurate and the legal requirements are met.
That changes the order of events. The quality system, the premises, the people and the supply chain checks all need to exist before the form is submitted. This article sets out what that means in practice.
Who needs a wholesale dealer’s licence
The MHRA’s position is broad. A business that sells or supplies human medicines to anyone other than the patient using them needs a wholesale dealer’s licence, also written as WDA(H) or wholesale distribution authorisation.
That captures more activity than many new entrants expect. Companies that export, or that supply other wholesalers, pharmacies or hospitals, are in scope. Pharmacies that supply anyone other than the public also need to consider the requirement, subject to limited exceptions set out in separate MHRA guidance.
Scope should be settled first, because it drives everything else. The categories of product, whether cold chain is involved, whether imports or unlicensed medicines are planned and whether storage or transport is outsourced all determine what the quality system has to cover and what the inspector will look at. Businesses that arrange sales between other parties without buying or holding product should check whether broker registration applies instead. It is a separate regime with its own requirements.
What must be in place before a wholesale dealer’s licence application
The application is made through the MHRA’s process licensing portal, and the fee must be paid before it is processed. The harder part is what the application describes.
Start with the quality system. The Human Medicines Regulations 2012 require licence holders to maintain a quality system setting out responsibilities, processes and risk management measures, and to comply with Good Distribution Practice, or GDP. Guidance Note 6 expects an approved quality management system at application, including a quality manual, policies, standard operating procedures and forms. The procedures need to describe the actual business. A generic set that has not been adapted to the operation will not stand up to questions.
Premises and equipment come next. Applicants provide details of premises and equipment, including ambient and cold chain storage, transport arrangements, computerised systems and business contingency plans. Temperature mapping of the storage areas, with a documented method, is expected. A warehouse that has been leased but not yet mapped, monitored or secured is not ready.
Supply chain controls are a legal obligation. Licence holders may obtain medicines only from authorised manufacturers or wholesale dealers and may supply only to those entitled to receive them. In practice that means documented supplier and customer qualification, with licence checks, before the first transaction. Records must be kept for at least five years, and an emergency recall plan must exist.
Outsourced activities need the same attention. Where storage or transport is contracted out, the applicant remains responsible. Written agreements and evidence that each contractor has been assessed should be available on the day.
THE EXPECTATION
The MHRA expects new applicants to be inspection ready at the point of application. The form describes a business that should already be able to operate.
The Responsible Person
Regulation 45 of the Human Medicines Regulations 2012 requires the licence holder to have at least one Responsible Person, or RP, available at all times. The RP’s legal function is to ensure that the conditions of the licence are complied with and that the quality of the medicines handled is maintained.
The regulation requires knowledge and experience that are adequate in the opinion of the licensing authority. Guidance Note 6 sets out what the MHRA expects that to look like. It includes at least a year’s practical experience in the licensed activities, at least a year maintaining a relevant quality system, GDP training and a working knowledge of the regulations and licence conditions. The RP must be continuously contactable and resident in the UK.
The RP does not have to be an employee. A contract RP is acceptable where a written contract sets out the responsibilities. What matters at inspection is whether the individual knows the operation: its products, its procedures, its suppliers and its risks. An RP appointed a fortnight earlier who has never visited the site will find that difficult to demonstrate. Our guide to the RP role covers the position in more detail.
Businesses importing licensed medicines into Great Britain from countries on the approved list need to consider a further role, the Responsible Person (import), who has additional duties to confirm that imported batches have been appropriately certified. Whether this applies should be established at the scoping stage.
HOW TDP SUPPORTS THIS
TDP’s Built for You service establishes licensed, operational life sciences entities on behalf of clients, covering entity formation, quality management build-out and regulatory licensing.
Built for You: Entity and Licence Build →
The timeline, realistically
MHRA guidance states that an application should take 90 working days to process. That is a processing time for the application. It should not be read as a launch date.
The sequence runs like this. The application is submitted. The MHRA may check the identities of the RP and other named staff and confirm company details with Companies House. An inspection is arranged. Shortly afterwards the applicant receives a report setting out any issues. The licence, and a GDP certificate for each inspected site, follows once the inspector is satisfied those issues have been addressed.
Two things extend the timeline in practice. One is the preparation that comes before submission, which for a business building a quality system from nothing takes considerably longer than completing the form. The other is the time taken to close inspection findings. Both are in the applicant’s hands.
Costs follow the same logic. The fee depends on the type of application and the number of sites, and an annual charge falls due each April. A withdrawn application is only partly refunded: 90 per cent of the application fee before inspection and 50 per cent after. The inspection fee itself is payable in full unless the application is withdrawn at least 15 days before the inspection date. Submitting early to secure a place in the queue is an expensive way to find out the business was not ready.
What the inspector will look at
Guidance Note 6 describes a predictable format. An opening meeting covers the business and its arrangements. The inspector then goes through the operation, including goods inward, ambient and refrigerated storage and returns areas. Key personnel are interviewed. Stock movement records and quality system documents are reviewed, including the arrangements for recalls.
A new applicant has little or no trading history, so there are few records of past activity to examine. The questions turn to whether staff understand the procedures they will be working to. Can the RP explain how a new supplier would be approved? What happens when a temperature alarm sounds at night? How would a suspected falsified product be handled? Who decides whether a return goes back into saleable stock?
Deficiencies are graded as critical, major or other. For GDP, the number and type of deficiencies feed into the site’s risk score along with the activities carried out, and that score indicates when the next inspection is likely.
An independent audit before submission, carried out by someone who was not involved in the build, is a reliable way to find gaps while there is still time to close them.
HOW TDP SUPPORTS THIS
TDP’s Global GxP Auditing as a Service provides experienced, risk-based audit capability, with scope and deliverables aligned to your quality system.
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After the licence is granted
Grant is the start of ongoing obligations. The licence holder must tell the licensing authority about any change to the RP and about proposed structural alterations to, or discontinued use of, licensed premises. Changes to the business process, the named persons or the site address are standard variations. A variation should take 30 working days to process, extended to 90 if an inspection is required.
Growth plans should take that into account. A second site, a move into cold chain or a new category of product is a variation with a lead time, and it belongs in the project plan from the outset.
Routine inspections then follow on a risk basis. The quality system that satisfied the first inspector has to keep working when volumes rise and the founding team is no longer doing everything personally. Our article on Good Distribution Practice looks at staying inspection ready once a licence is in use.
Build it yourself or bring in support
Some applicants have experienced quality staff and need little more than a second opinion. Others are entering the sector from logistics, technology or overseas markets and are building a regulated function for the first time. For the second group, the choice is between learning through the inspection process or using people who have built and operated licensed entities before.
Whichever route is taken, the applicant’s own team needs to understand and own the system. An inspector assesses the business in front of them, and the licence holder carries the obligations afterwards. Our article on choosing the right licensed entity model looks at how that decision shapes the build.
How TDP can help
TDP’s Built for You service establishes fully licensed and commercially operational life sciences entities on behalf of organisations in the UK and internationally. The work covers entity formation, quality management build-out, regulatory licensing and registration, with the aim of a new entity that is inspection ready and aligned with the GDP and GMP requirements that apply to it. Where an existing licence holder has gaps to close, our Compliance and Remediation service provides structured support.
If you are planning a wholesale dealer’s licence application, or have one under way and want an independent view of readiness, request a call back to discuss your plans.