GDP certification and MHRA licensing for pharmaceutical storage
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Any business in the UK that stores and supplies human medicines to other businesses needs a wholesale dealer's license from the Medicines and Healthcare products Regulatory Agency (MHRA), known as a WDA(H). To get one, it has to pass an MHRA inspection against Good Distribution Practice (GDP), the standard for how medicines are stored, handled, and transported. A successful inspection leads to a GDP certificate.
For ecommerce brands selling medicines, from over-the-counter painkillers to licensed herbal remedies, this matters as soon as stock moves into a warehouse. A general Third-Party Logistics (3PL) provider needs a license and an MHRA inspection before it can hold medicines for you, which rules out most general ecommerce warehouses.
This guide covers what GDP requires, which MHRA license applies to your business, what a GDP certificate does and doesn't prove, how the licensing process works, what compliant storage looks like inside a 3PL warehouse, and the questions to ask before you hand over your stock.
What is Good Distribution Practice?
Good Distribution Practice is the set of standards that makes sure medicines keep their quality and integrity between the manufacturer and the pharmacy, hospital, or customer. In the UK, the MHRA inspects against the GDP guidelines for medicinal products for human use, first published by the European Commission in 2013 and applied in the UK alongside the MHRA's own guidance.
GDP covers every part of a distribution operation:
Quality management: a documented quality system covering every activity, including anything outsourced.
Personnel: a named Responsible Person (RP) and trained staff.
Premises and equipment: secure, clean storage that holds the temperatures stated on the packaging, backed by temperature mapping and calibrated monitoring.
Documentation: written procedures and records for every activity.
Operations: checks on suppliers and customers, goods-in, storage, picking, and dispatch.
Complaints, returns, suspected falsified medicines, and recalls: defined processes for each.
Outsourced activities: written contracts and audits for any third party, including 3PLs and carriers.
Self-inspection: regular internal audits to check the system works.
Transport: keeping medicines within their labeled storage conditions throughout delivery.
One principle runs through all of it: you can outsource activities, but you can't outsource regulatory responsibility. If a 3PL stores your medicines, your quality system has to cover what it does, and you're expected to audit it.
Which MHRA license do you need?
The license depends on what you do with the medicines, and the key distinction is between selling to the public and supplying other businesses.
A wholesale dealer's license, formally a Wholesale Distribution Authorisation (Human) or WDA(H), covers procuring, holding, supplying, or exporting human medicines to other businesses. It's tied to named sites and approved activities, and every license names an RP who oversees GDP compliance.
Selling to the public is retail, which works differently. Registered pharmacies can sell General Sales List (GSL) medicines, sell Pharmacy (P) medicines, and supply Prescription Only Medicines (POMs) they've dispensed against a prescription. Every other retailer can only sell GSL products.
What you do | What you need |
Sell GSL medicines to the public online | Be legally entitled to sell them, and source them from licensed manufacturers, importers, or distributors |
Sell P medicines or supply POMs | A pharmacy registered with the General Pharmaceutical Council (GPhC) |
Supply medicines to other businesses, such as retailers or pharmacies | A WDA(H) |
Manufacture, assemble, or import medicines | A manufacturer's license, sometimes alongside a WDA(H) |
Handle controlled drugs | A Home Office license, in addition to the above |
Wholesale veterinary medicines only | An authorization from the Veterinary Medicines Directorate (VMD) |
Some brands do both retail and wholesale, for example selling direct to customers while also supplying independent pharmacies. If any part of your business supplies other businesses, you'll need a WDA(H) for that activity or a licensed partner to carry it out.
Northern Ireland has its own requirement for online sellers. Since 1 January 2021, sellers based in Great Britain haven't needed to display the Distance Selling Logo, but anyone in Northern Ireland selling medicines to the public online must still register with the MHRA and display it on every page offering medicines.
Not every health product is a medicine. Most vitamins and supplements are regulated as food, and medical devices follow their own rules, covered in our guide to medical device regulations and UKCA marking. If you're unsure how a product is classified, check with a regulatory adviser before you list it.
What GDP certification means
"GDP certification" is used loosely, so it's worth being precise about what you're asking for.
An MHRA GDP certificate: when the MHRA inspects a licensed site, it can issue a GDP certificate confirming that the site complies with GDP. This is the certificate that matters. It's linked to a specific company and site, and it follows a regulatory inspection.
A WDA(H): the license itself, listing the sites, activities, and products it covers, and naming the RP.
Commercial GDP certificates: some consultancies and training providers issue their own "GDP certificates" for courses or private audits. These can show that a team has been trained, but they don't replace an MHRA license or inspection.
MHRA inspections are risk-based. Sites with a strong compliance record are inspected less often, and sites with weaker self-inspection or a poor inspection history are classed as higher risk and inspected more often. A recent clean inspection is a good sign, while a long gap combined with a vague answer about the outcome is worth probing.
When you speak to a pharmaceutical 3PL, ask for its WDA(H) number, the sites and activities it covers, and the date and outcome of its most recent MHRA inspection. Then check that the site your stock would sit in is actually named on the license.
How to get an MHRA wholesale dealer's license
If your business needs its own WDA(H), the MHRA will only grant it once it's satisfied, following an inspection of your site, that you meet the license conditions and GDP. The process usually looks like this:
Appoint a Responsible Person: the RP needs enough knowledge, authority, and time to oversee every GDP activity, including anything delegated or outsourced. Some businesses use a contract RP from a specialist consultancy. The MHRA assesses the RP at inspection.
Build your quality system: written procedures covering suppliers, customers, goods-in, storage, temperature control, dispatch, returns, complaints, recalls, suspected falsified medicines, and self-inspection.
Prepare your premises: secure, appropriately sized storage, with temperature mapping completed before stock goes in and calibrated monitoring in place. If you'll use a 3PL for storage or transport, you'll need written contracts and audits for those arrangements.
Apply through the MHRA portal: the application needs to name your sites, activities, and RP, and the fee is payable when you apply.
Pass the inspection: an MHRA GDP inspector visits the site, reviews your systems, and interviews the RP. Any deficiencies need to be addressed before the license is granted.
Stay compliant: after the license is granted, you'll pay periodic fees, keep your quality system running, and be inspected again on a risk-based schedule.
On cost, the MHRA's current fee schedule sets the inspection fee for a new WDA(H) application at £4,136, on top of the application fee. Reduced fees apply in some cases. A reduced application with a reduced inspection for GSL-only wholesaling comes to £3,060 in total. If you withdraw before the inspection, 90% of the application fee is refunded.
For most ecommerce brands, the bigger cost is the ongoing one: an RP, a working quality system, and inspection-ready premises. A 3PL that already holds a WDA(H) can carry much of the operational load. A business that buys and supplies medicines can still need its own license even if it never handles the stock, so get regulatory advice on how to structure your wholesale activity.
What GDP-compliant storage looks like in a 3PL warehouse
A GDP-compliant 3PL looks like a standard warehouse from the outside. The difference is in the controls around the stock.
Storage conditions: medicines have to be stored as stated on their outer packaging. Many need controlled ambient storage, and refrigerated medicines need 2 to 8°C. Our guide to cold chain logistics covers temperature-controlled storage in detail.
Temperature mapping and monitoring: storage areas should be mapped under representative conditions before stock goes in, with mapping repeated to reflect seasonal changes. The MHRA expects monitoring equipment for cold stores, fridges, and controlled temperature areas to be calibrated to an accuracy of ±0.5°C.
Segregation: returned, rejected, recalled, and suspected falsified medicines need to be kept physically separate from sellable stock, with access controlled.
Security: medicines are a target for theft and diversion, so access to storage areas should be restricted and monitored. Controlled drugs need additional secure storage under Home Office rules.
Stock rotation and traceability: batch numbers and expiration dates need to be recorded, and stock should be picked on a First Expired, First Out (FEFO) basis. That depends on a Warehouse Management System (WMS) that captures batch data at goods-in and dispatch.
Contracts and audits: GDP requires a written contract setting out each party's duties for any outsourced activity, and an audit of the 3PL before the work starts. The 3PL can't pass your work to a subcontractor without your prior approval.
Qualified transport: carriers moving medicines need to keep them within their labeled storage conditions, and the contract with them needs to meet the same GDP requirements as storage.
Where pharmaceutical storage goes wrong in fulfillment
Most compliance problems with outsourced medicines storage start with assumptions. The brand assumes the 3PL is covered, the 3PL assumes the brand has the paperwork, and nobody checks until an inspector or a customer complaint does.
The license doesn't cover the site: a 3PL may hold a WDA(H) for one warehouse and offer to store your stock in another. The license is tied to named sites, so check that yours is on it.
The RP is a name on paper: an RP who's responsible for several businesses, or rarely on site, may not have real oversight of your stock. Ask how much of their time covers the site you'd use.
No contract, or a generic one: a standard 3PL service agreement rarely covers GDP duties. You need a written agreement that sets out who's responsible for storage conditions, returns, recalls, complaints, and subcontracting.
Returns going straight back to stock: a returned medicine can only go back into sellable stock once checks confirm it's been stored and handled correctly and the packaging is intact. A 3PL that restocks returns by default needs a separate process for your medicines.
Temperature excursions without follow-up: an alarm that's acknowledged and forgotten leaves stock in an unknown state. Every excursion needs investigating, with affected stock quarantined until a decision is made.
Mixed product ranges: brands selling medicines alongside supplements, cosmetics, or medical devices sometimes store everything together under the same processes. Medicines need GDP controls even when the products around them don't.
Recalls that take too long: when a recall is issued, you need to know which customers received which batch. That depends on batch numbers being recorded at dispatch, which plenty of general ecommerce warehouses don't do as standard.
Questions to ask a pharmaceutical 3PL
These questions separate 3PLs that are licensed and inspected for medicines from those that simply have space. Use them alongside our questions for a 3PL site visit, and check the answers in person.
License: what's your WDA(H) number, and which sites, activities, and product categories does it cover? Is the site my stock would sit in named on it?
Inspection history: when was your last MHRA GDP inspection, and what was the outcome? Were any deficiencies raised, and how were they closed?
Responsible Person: who's your RP, how much time do they spend on the site I'd use, and who covers when they're away?
Storage conditions: which temperature ranges can you hold, when were your storage areas last mapped, and can you share monitoring records?
Excursions: what happens when a temperature goes out of range, and how quickly would I be told?
Traceability: do you record batch numbers and expiration dates at goods-in and dispatch, and pick on a FEFO basis?
Returns and recalls: what's your process for assessing returned medicines, and how quickly can you identify every order containing a recalled batch?
Contracts: will you sign a GDP agreement that sets out each party's responsibilities, and will you allow us to audit you?
Subcontractors: which carriers do you use for medicines, how are they qualified, and do you subcontract anything else?
Experience: which pharmaceutical brands do you already work with? Similar product types and order volumes are a good sign. Ask for a reference you can call.
GDP and MHRA licensing FAQs
What is GDP certification?
It usually refers to the GDP certificate the MHRA can issue after inspecting a licensed site, confirming that the site complies with Good Distribution Practice. Commercial certificates from training providers or consultancies don't replace it.
What is an MHRA license for medicines storage?
The main one is a wholesale dealer's license, or WDA(H). It covers procuring, holding, supplying, or exporting human medicines to other businesses from named sites, with a named Responsible Person.
How much does a WDA(H) cost?
Under the MHRA's current fee schedule, a new application includes a £4,136 inspection fee on top of the application fee. A GSL-only application with reduced fees comes to £3,060 in total. Periodic fees apply once the license is granted.
Do I need a WDA(H) to sell medicines online?
Not for selling to the public, which is retail. General retailers can sell GSL medicines, and P and POM medicines can only be sold or supplied through a registered pharmacy. You'll need a WDA(H) if you supply medicines to other businesses.
Does my 3PL need a WDA(H)?
It depends on how the arrangement is structured. In practice, a 3PL storing medicines for distribution should hold a WDA(H) covering the site your stock will sit in, and work to GDP under a written agreement with you.
What does a Responsible Person do?
The RP is named on the WDA(H) and is responsible for making sure the license holder complies with GDP. That includes approving suppliers and customers, overseeing storage and returns, managing recalls, and approving any subcontracted activities.
Does GDP apply to supplements or medical devices?
The GDP guidelines cover medicinal products. Most supplements are regulated as food, and medical devices have their own regulations, though GDP-style controls are still a good sign in any 3PL handling them.
Find a GDP-compliant 3PL
Storing medicines with a 3PL comes down to a license that covers the right site, a Responsible Person with real oversight, GDP-compliant storage, and a clear written agreement. Compare medical and pharmaceutical 3PLs on Fulfilment.com and get quotes from providers that already hold the licenses your products need.
