Entering the UK medicines market: what you need to know.

The regulator

Medicines in the UK are regulated by the Medicines and Healthcare products Regulatory Agency (MHRA). It grants marketing authorisations, licenses manufacturers and wholesalers, inspects for Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP), and runs the UK's safety monitoring.

Since 1 January 2025, under the Windsor Framework, the MHRA has granted UK-wide marketing authorisations that cover both Great Britain and Northern Ireland. A single UK licence now gives access to the whole UK market.

Routes to a marketing authorisation

The right route depends on whether your product already has an approval from a regulator the MHRA recognises.

• National assessment. A full MHRA assessment of your dossier. The statutory timetable allows up to 210 days, plus clock stops while you answer questions.
• International Recognition Procedure (IRP). The MHRA can rely on an approval from a reference regulator: Australia, Canada, the EU, Japan, Switzerland, Singapore or the United States.
  • Route A runs to a 60-day timetable, for approvals granted within the last two years.
  • Route B runs to a 110-day timetable, for more complex cases or older approvals.

Licences you will need

The marketing authorisation covers the product. Separate licences cover the activities around it.

• Wholesale dealer's authorisation, WDA(H). Needed to buy, hold and supply medicines. The holder must name an eligible Responsible Person (RP) and operate to GDP, and is inspected by the MHRA.
• Manufacturer's licence, MIA. Needed to import from outside the UK and to release batches. A Qualified Person (QP) certifies each batch before it can be sold.

For the filing stage, an overseas company can arrange access to these licences through agreements with third-party licence holders. To launch commercially, the UK entity will normally need its own licences and warehouse. These should be planned so they are ready when the marketing authorisation is granted.

Imports and batch release

Products made outside the UK must be certified by a Qualified Person at a UK MIA holder before release. Depending on where the product is manufactured and tested, UK batch testing may also be needed, because the UK accepts certain overseas certification and testing only from countries on its approved list. This affects cost per batch and lead times, so we build it into the plan early.

Your manufacturing sites will need current GMP evidence that the MHRA can rely on. The MHRA may also inspect sites outside the UK.

Pharmacovigilance

• The marketing authorisation holder must have a Qualified Person for Pharmacovigilance (QPPV) who lives and works in the UK or the EU. If the QPPV is based in the EU, a UK national contact person for pharmacovigilance is also needed.
• The pharmacovigilance system master file (PSMF) must be accessible from the UK.
• Suspected adverse reactions are reported to the MHRA. Periodic safety reports and risk management plans follow MHRA requirements.

Packaging and labelling

• Packs and leaflets must be in English and match the approved product information.
• Packs for the UK carry "UK Only" labelling under the Windsor Framework arrangements.
• The EU Falsified Medicines Directive safety features (unique identifier and verification) no longer apply in the UK. Tamper-evident packaging is still good practice.
• Patient information leaflets need user testing (readability testing) or a bridging justification.

Planning timelines

For a generic product on the national route, we advise clients to plan for around 18 months from programme start to grant. That allows for company set-up, licence-holder arrangements, dossier preparation, validation and assessment. A strong IRP case can be much faster. Statutory MHRA fees are payable on application and are separate from service fees.

Talk to us before you commit to a route. The best route depends on your dossier, your existing approvals and your launch plans.

This briefing is general information, not legal or regulatory advice for a specific product. Primary sources: MHRA on GOV.UK, MHRA International Recognition Procedure guidance, MHRA GMP and GDP guidance.