Entering The UK Pharmaceutical Market
What international companies need to understand prior to selecting a partner.
Entering the UK pharmaceutical market is an appealing but unfamiliar territory. This article is designed for international business development teams seeking a practical overview of the UK process, including MHRA approval, National Health Service (NHS) procurement, and pharmaceutical distribution. It also highlights key considerations for choosing a UK in-licensing partner before making a commitment.
In this article you will learn:
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Why the UK is commercially worth the effort, and which product types make the strongest propositions.
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How the NHS buys medicines, and why it looks nothing like any other system.
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What to look for in a UK in-licensing partner, and the five questions to ask before you commit.
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What the process looks like in practice, from overseas licence to NHS dispensing shelf.
The NHS serves a population of 67 million individuals through a singular national system. While this may appear straightforward, it is, in fact, complex. Factors such as formulary committees, Integrated Care Board structures, MHRA regulatory requirements, national tender frameworks, and dispensing system configurations add layers of complexity.
The process of bringing a licensed product from Australia, the United States, or Europe onto an NHS dispensing shelf is not transparent to external observers. Most international pharmaceutical companies that attempt to navigate this process independently encounter multiple delays before identifying the appropriate entry point.
Those who achieve success in a timely manner typically share one characteristic: they have engaged a partner already familiar with the landscape.
Why the UK is worth the effort
​The NHS operates as a single-payer healthcare system.[1] For pharmaceutical companies accustomed to fragmented private insurance, diverse state regulations, or multi-payer models, this represents a significant difference. Securing MHRA approval and inclusion in the NHS formulary enables a product to be distributed nationwide to patients via a single commercial channel and distribution network.
The MHRA now functions independently from the European Medicines Agency, yet its standards are globally recognised, and its procedures are well established.[2] An MHRA-approved dossier contains the necessary information for subsequent European authorisation. Companies planning to enter the UK are not duplicating efforts if they also intend to expand into Europe.
There is also a specific commercial opportunity worth noting. Many NHS patients cannot take medicines in standard tablet or capsule form. These include children needing weight-adjusted dosing, older adults with swallowing difficulties, and patients on enteral feeding in intensive care. These patients are often served by unlicensed compounded products sourced through a special’s supplier.[3] Such products are more expensive, carry greater clinical risk, and expose hospitals to audit.
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A company with a licensed, stable alternative has a commercially and clinically convincing proposition for the NHS.
How the NHS buys medicines (for non-UK companies)
Many international pharmaceutical companies lack a clear understanding of NHS procurement processes. This deficiency is merely a result of the NHS's unique nature, distinguishing it from any other system globally. Comprehending its structure is the initial step towards effectively navigating it.
For companies used to the US system, it’s natural to look for a UK equivalent to GPO contracts, PBM negotiations, or state Medicaid formularies. There isn’t one. The NHS is a single national system. The complexity shows up in various areas, including formularies, ICBs, tender frameworks, and dispensing system configurations. The upside is also different: one commercial route to national reach, not fifty separate market-access battles.
Worth knowing
Most NHS Trusts already hold an active account with the major pharmaceutical wholesalers and 3PL operators. A product distributed through an established 3PL means NHS Trusts can order without setting up a new supplier account, removing the single most common administrative friction point in NHS market activation.
Which product types work best for UK in-licensing?
The qualifying criterion for a UK in-licensing opportunity is not the product format. It is the patient at the end of it. Tablets, liquid formulations, vials — any of these can represent a compelling proposition if there is a patient population with an unmet clinical need that the mainstream market has not adequately served.​
The commericial logic
​A licensed product typically replaces an unlicensed one already used and funded by the NHS.[3] When a hospital sources an unlicensed compounded product for patients who cannot take standard tablets, it confirms the clinical need. A licensed alternative does not need to create demand — it redirects existing NHS spending toward a product with stronger clinical credentials, longer shelf life, and lower risk. This is a faster commercial process than launching a product for which the NHS does not already have alternatives.
CLINICAL AND COMMERCIAL COMPARISON
Where licensed alternatives to unlicensed specials win
Criterion
Stability and shelf life
Product integrity over time
Patient safety profile
Clinical risk
Audit exposure
Prescribing justification burden
Cost predicability
NHS procurement planning
Where this dynamic is strongest
Patient populations where the unlicensed-to-licensed opportunity is most active:
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Neonates and paediatric patients requiring weight-adjusted doses
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Older adults with dysphagia associated with Parkinson’s disease, dementia, or stroke
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Patients receiving enteral nutrition in intensive care or rehabilitation settings
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Adults managing conditions where the available licensed tablet formulation is not clinically appropriate
Why this matters for in-licensing
These are not niche populations. Dysphagia is common in older adults and in people with conditions such as stroke, Parkinson’s disease, and dementia, and is associated with increased healthcare use and costs.[8,9] Historically, many medicines used in children have lacked age-appropriate licensed formulations, which is one reason paediatric regulation now requires dedicated investigation plans.[10] Local prescribing guidance across NHS ICBs consistently encourages switching from unlicensed specials to licensed alternatives where clinically appropriate.[11]
What to look for in a UK commercialisation partner
Choosing a UK partner is the most consequential step in market entry. The partner handles regulatory submission, NHS strategy, supply chain, and ongoing distribution and compliance. Five criteria determine a strong partnership.
In-licensing process:
From overseas licence to NHS dispensing shelf
The journey from a product licensed in another market to commercial supply into the NHS follows a defined sequence. Timelines vary depending on the product, its existing dossier, and the regulatory pathway selected, but the stages are consistent.
Click in-licensing tabs below to view each process
Current Phase
Launch and grow
STEP 6 of 6
Ongoing support and European expansion
Post-launch support covers supply management, pharmacovigilance obligations, and NHS account management. For companies with wider ambitions, the MHRA dossier provides a foundation for European expansion without starting from scratch.
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The process does not end at launch if the partnership is built well.
How Green Park Pharma approaches in-licensing
“Entering the UK NHS market successfully is rarely about the product alone. It is about finding a partner who has navigated the system before and can move without losing time at every decision point.”
Green Park Pharma is a UK speciality pharmaceutical company focused on licensed medicines for patients with unmet clinical needs. The team holds a long-duration NHS national supply agreement and has taken products through the MHRA licensing process. We distribute through Alloga Healthcare, one of the UK’s leading pharmaceutical 3PLs, serving both NHS and private hospital channels.
In practice, the companies that lose the most time entering the UK market are not the ones with the wrong product. They are the ones who secure MHRA authorisation, only to discover that the NHS dispensing system has never heard of them. Getting a product onto a formulary and getting it to appear on a hospital pharmacist's screen are two entirely separate tasks. We have navigated both across multiple products and multiple NHS Trusts.
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We work with products across formats such as tablets, liquids, and vials that address unmet clinical needs for patients. If you have a product addressing a patient group the UK market has not adequately served, we would like to hear about it.
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To find out more about how Green Park Pharma works with partners, visit our in-licensing page.
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Sources & References
​​​1. NHS England. About us. NHS England; accessed 2026.
https://www.england.nhs.uk/about/
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2. Medicines and Healthcare products Regulatory Agency. Apply for a licence to market a medicine in the UK. GOV.UK; updated 2024.
https://www.gov.uk/guidance/apply-for-a-licence-to-market-a-medicine-in-the-uk
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3. NHS Specialist Pharmacy Service. Unlicensed medicines: the use of unlicensed medicines in NHS practice. SPS; 2023.
https://www.sps.nhs.uk/articles/understanding-unlicensed-medicines/
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4. NHS England. Regional arrangements for medicines optimisation in the NHS in England. NHS England; 2024.
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5. NHS England. Integrated care systems. NHS England; 2023.
https://www.england.nhs.uk/integratedcare/
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6. NHS Specialist Pharmacy Service. Medicines Procurement and Supply Chain (MPSC) frameworks. SPS; updated 2026.
https://www.sps.nhs.uk/articles/medicines-procurement-and-supply-chain-mpsc-frameworks/
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7. NHS England. Secondary care electronic prescribing and medicines administration (ePMA) directions 2024. NHS England; 2024.
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8. Baijens LWJ et al. European Society for Swallowing Disorders — European Union Geriatric Medicine Society white paper: oropharyngeal dysphagia as a geriatric syndrome. Clinical Interventions in Aging; 2016.
https://pmc.ncbi.nlm.nih.gov/articles/PMC5674114/
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9. Attrill S, White S, Murray J, Hammond S, Doeltgen S. Impact of oropharyngeal dysphagia on healthcare cost and length of stay in hospital: a systematic review. BMC Health Services Research; 2018.
https://pmc.ncbi.nlm.nih.gov/articles/PMC6090960/
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10. Medicines and Healthcare products Regulatory Agency. Legal requirements for children's medicines. GOV.UK; 2026.
https://www.gov.uk/government/publications/legal-requirements-for-childrens-medicines
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11. North East London Integrated Care Board. Resources for the prescribing of unlicensed ‘specials’. NHS North East London; 2018.
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12. The statue pictured is the Mary Seacole Memorial Statue, located at the entrance to St Thomas' Hospital, London. Unveiled in 2016, it is the UK's first public monument dedicated to a named Black woman. Mary Seacole (1805–1881) was a Jamaican-born nurse who overcame significant barriers to deliver care where it was needed most — travelling at her own expense to the frontlines of the Crimean War to provide medical care and comfort to sick and wounded British soldiers. The statue was commissioned by the Mary Seacole Trust. Learn more at maryseacoletrust.org.uk
This article is intended for pharmaceutical industry and business development professionals only. It does not constitute medical or clinical guidance.