United Kingdom Pharmaceutical Licensing

This record covers only retail pharmacies, wholesale distribution and manufacture/import of medicines for human use in the United Kingdom. MHRA official guidance expressly treats manufacture, assembly, import and wholesale as different licensed activities, while pharmacy premises registration falls under different regulators in Great Britain and Northern Ireland.

Company formation is not a medicines licence. Companies House deals only with company registration; the sources reviewed do not prescribe a particular company form, minimum capital, specific floor area or foreign ownership percentage for a medicines licence.

— Great Britain: pharmacy premises in England, Scotland and Wales are handled by the GPhC.

— Northern Ireland: pharmacy premises are handled by the PSNI; domestic controlled drug licensing also has separate departmental arrangements.

— Veterinary medicines are outside the scope of this guide. For those engaged solely in the manufacture or wholesale of veterinary medicines, MHRA guidance requires separate consultation with the Veterinary Medicines Directorate.

The MHRA regulates medicines in the United Kingdom and is responsible for the MIA, WDA(H), GMP/GDP inspections and marketing authorisations for medicines for human use covered in this record. The MHRA states that manufacturers and wholesalers are inspected on application and subsequently at regular risk-based intervals.

Retail pharmacies are not handled through a single UK-wide register. The legislation states that registration is with the GPhC in Great Britain and the PSNI in Northern Ireland. Great Britain’s procedures must not be applied to Northern Ireland pharmacy premises registration or Northern Ireland’s domestic controlled drug regime.

— MHRA: manufacture/import, WDA(H), GMP/GDP and product marketing authorisations.

— GPhC: pharmacy premises and pharmacy professional registration in Great Britain.

— PSNI: pharmacy premises and relevant professional registration in Northern Ireland.

— Home Office/Northern Ireland DoH: additional controlled drug licensing.

The GPhC states that an organisation or business in Great Britain intending to sell P medicines from physical premises, or supply P medicines/POM to specific patients on prescription, must register those premises as a pharmacy and meet the standards for registered pharmacies in a safe and effective manner. Registration must be renewed annually.

In Northern Ireland, the PSNI handles applications for new premises, plans and inspections by the Medicines Regulatory Group; this is a Northern Ireland rule, not a uniform UK-wide rule on floor area or plans.

— First confirm whether the retail medicines are GSL, P or POM, and whether prescription dispensing, remote/online services, veterinary prescriptions or controlled medicines are involved.

— Great Britain: register the premises with the GPhC and renew annually.

— Northern Ireland: register the premises with the PSNI; nomination of the superintendent pharmacist for a corporate pharmacy is handled separately.

The MHRA states that selling or supplying medicines for human use to persons other than the patients who will use them requires a wholesale distribution licence/authorisation. Applications are made through the MHRA Process Licensing Portal. Before granting it, the competent authority inspects the sites to verify that the application information is accurate and compliant.

The core requirement for a WDA(H) is GDP: medicines must be sourced through a licensed supply chain and properly stored, transported and handled in accordance with the product authorisation or specifications. The premises should be ready for inspection when the application is submitted.

— Description of the business model, products and flow of funds.

— Information on sites, ambient and cold-chain storage, transport, computer systems and business continuity.

— Quality Management System (QMS), SOPs, risk assessments, training and job descriptions.

— Lists of qualified suppliers and customers, temperature mapping, transport validation, self-inspection and management review records.

Manufacturing, assembling or importing human medicines requires a manufacturer’s licence. Ordinary MIAs, unlicensed medicines, clinical trial medicines and certain exempt activities have different categories and applicable boundaries.

An MIA application must demonstrate GMP compliance and pass an inspection; the Site Master File should describe the proposed manufacturing and/or control activities.

— Manufacture, assembly or import of licensed medicines: assess the need for an MIA.

— Manufacture or import from overseas of unlicensed ‘specials’: assess the need for a Manufacturer’s ‘specials’ licence.

— Investigational medicinal products: assess the need for an MIA(IMP); do not confuse it with licensing for routine commercial products.

— Businesses applying for product marketing authorisations generally need the corresponding manufacturing licence first, but product marketing authorisations still require separate applications.

Every registered pharmacy that is open for business must have a Superintendent Pharmacist appointed by its owner; that person must be a registered pharmacist. To practise pharmacy in Great Britain, a pharmacist must be registered with the GPhC.

An MIA must have at least one named QP; a WDA(H) must have at least one RP with the necessary competence, experience, and GDP knowledge and training. The RP is responsible for the quality system, recalls, supplier/customer approval, and related GDP controls.

— Responsible pharmacist: responsible for the safe and effective operation of the pharmacy, procedures and records; absence arrangements are subject to legislation.

— QP: the statutory designated person for an MIA, responsible for ensuring that batches comply with legislation and applicable product authorisation requirements.

— RP: the statutory designated person for a WDA(H); whether an RPi is required depends on specific circumstances, such as importing licensed medicines into Great Britain from approved countries for import.

— Corporate pharmacies in Northern Ireland: PSNI states that a superintendent pharmacist registered in Northern Ireland must be nominated.

A retail pharmacy must operate safely and effectively at its registered premises. Pharmacy procedures should cover ordering, storage, supply, personnel, complaints, incidents, and handovers, and should be recorded and reviewed regularly.

An MIA and a WDA(H) are premises-based authorisations. A manufacturing authorisation covers only the named approved premises; a wholesale application must demonstrate arrangements for storage, the cold chain, transport, systems, and emergencies.

— Pharmacy: registered premises, implementable procedures, records and appropriate pharmaceutical supervision.

— Wholesale: temperature control, storage and transport validation, returns and segregation, quality systems and inspection readiness.

— Manufacturing: Site Master File, appropriate facilities and equipment, independent quality control, batch documentation and recall systems.

The MIA application form and supporting documents are submitted to the MHRA; a WDA(H) application is submitted through the Process Licensing Portal. The MHRA may verify the designated personnel and company information and will make a decision after inspection.

In Great Britain, a pharmacy applies to the GPhC. In Northern Ireland, new premises are handled through the PSNI, plans, and an inspection; product authorisations, controlled drugs, imports, and personnel matters should be addressed separately in parallel.

— Define the scope of activities and the licence type.

— Confirm each actual site, designated personnel and quality system.

— Prepare application forms, premises/quality information and applicable supporting documents for products or imports.

— Undergo inspection, respond to deficiencies or requests for corrections, and await a decision.

— Once licensed, operate within the authorised scope and establish change control.

MHRA guidance states that manufacturing/wholesale applications usually take 90 working days and standard variations usually take 30 working days; where an inspection is required, this may extend to 90 working days. These are not guaranteed timeframes.

The MHRA charges annual service fees to manufacturing and wholesale authorisation holders and publishes fees for matters including new applications, holding periods, variations, and inspections; the current fee schedule and invoice apply.

— MHRA: new applications, variations, inspections, changes of ownership and annual service charges may be charged separately.

— GPhC: pharmacy premises registration must be renewed annually.

— PSNI: its public page includes historical tables of premises registration, ownership change and retention fees; these have not been used to infer current amounts for 2026 across the UK or in Northern Ireland.

MIA holders must continue to comply with GMP, and WDA(H) holders must continue to comply with GDP. The MHRA inspects on a risk basis or where non-compliance is suspected; serious non-compliance may lead to restrictions, suspension, or revocation.

GPhC pharmacy premises registration must be renewed annually; the Superintendent Pharmacist's procedures and records must be kept on the premises and reviewed regularly. In Northern Ireland, requirements under PSNI/DoH rules must be maintained.

— Retain quality, batch, storage and transport, training, complaint, recall and self-inspection records appropriate to the licensed scope.

— Maintain arrangements for QPs, RPs, responsible pharmacists and, where necessary, Northern Ireland superintendent pharmacists.

— Cooperate with risk-based inspections, sampling, document reviews and remediation as required by the regulator.

— Address MHRA annual charges and annual pharmacy premises renewals before the deadlines.

Changes to information in a manufacturing/wholesale authorisation application must be reported as variations, including changes to business processes, named personnel, premises, or administrative information; the MHRA decides whether an inspection is required.

A licence does not automatically transfer as a result of a share transaction. For a change of ownership of a WDA(H), the new company must apply, and the previous authorisation ends once the matter is processed; an MIA must be varied as directed by the MHRA. Changes to a pharmacy's owner, Superintendent Pharmacist, or services must also remain lawful.

— Before proposed changes to premises, structure, cessation of use of a site, quality processes or named personnel, first determine whether notification or an application to MHRA is required.

— Before acquisition, verify the licence holder, designated personnel, scope, outstanding inspection deficiencies, product authorisations and controlled medicines licences; do not assume that transaction documents can themselves transfer a licence.

— When adjusting retail pharmacy ownership or services, also check GPhC/PSNI premises registration requirements.

A product marketing authorisation (MA) is separate from a business or premises authorisation. An MA application is submitted through the MHRA portal in accordance with requirements such as eCTD; from 2025, the MHRA is responsible for approvals for the UK market, and a UK-wide Product Licence can usually be used.

Imports cannot be assessed solely by looking at the product authorisation. Requirements for an MIA, ‘specials’, a WDA(H), and designated personnel depend on the product, source, and subsequent activities; the specific route should be confirmed with the MHRA.

Controlled drugs are subject to an additional regime. In England, Wales, and Scotland, a domestic licence is usually obtained from the Home Office; in Northern Ireland, it is handled by the DoH. Imports and exports usually require a separate licence for each consignment and are not automatically covered by an MIA, WDA(H), or pharmacy registration.

— First verify each product’s MA/registration/traditional herbal registration or applicable exemption.

— Check MIA, WDA(H), QP/RPi and customs requirements according to the product, origin, place of import, batch release, distribution and destination.

— For controlled medicines, separately check domestic licensing, import/export licensing, security, records, reporting and location requirements.