What does Euro Biom do for a Managed Access Program?

Euro Biom acts as the UK MHRA-licensed wholesale partner. Our role typically covers receipt of UK-licensed product from the sponsor or manufacturer, GDP-compliant storage at our contract warehouse, patient-level or site-level distribution within the UK or for export, full chain-of-custody documentation, temperature monitoring, and regulatory liaison with the MHRA where required.

What therapeutic areas does Euro Biom support for MAPs?

MAP demand is most concentrated in rare disease, oncology, paediatric and ultra-rare metabolic conditions, but the framework applies across all therapeutic categories. We support sponsors and biotech launching in any indication where managed access is the right pre-licensing or post-licensing pathway.

Managed Access Programs

Managed Access
Programs UK
for Pre-Launch & Post-Trial Supply

Euro Biom is an MHRA WDA-licensed UK wholesale partner for Managed Access Programs (MAPs) in destination markets, including compassionate use, expanded access, early access and post-trial supply for biotech and specialty pharma sponsors. Euro Biom trades exclusively in UK-licensed medicines.

MHRA WDA Licence No. WDA(H) 59239

Discuss Your Programme How It Works

⚡ Same-day response to every enquiry · Mon-Fri 09:00-18:00 · WhatsApp us

What is a Managed Access Program

Patient access
before market
authorisation.

A Managed Access Program is a pharmaceutical-sponsored programme that enables patients to access a medicine that is not yet registered in their own country. MAPs typically respond to serious or life-threatening conditions where no licensed alternative is suitable.

Destination-country frameworks include compassionate use programmes, early access schemes for pre-launch products, post-trial access for clinical trial participants, and named-patient import supply within MAP umbrella programmes. Euro Biom supplies the UK-licensed medicine into these routes.

For pharma sponsors, MAPs deliver pre-launch evidence, ethical patient access ahead of authorisation, and a structured route to manage demand from clinicians and patient advocacy groups during the regulatory review window. The execution requires an MHRA-authorised logistics partner.

Compassionate Use Early Access Supply Post-Trial Supply Named-Patient Import under MAP

"A Managed Access Program is the bridge between clinical trial closure and market launch. The patients who depend on it cannot wait, and the sponsor cannot afford a logistics partner that does not understand MHRA expectations."

Programme Types

Four MAP Frameworks
We Support

The right MAP framework depends on the regulatory stage of the medicine, the patient population and the sponsor's strategic objective. We support all four.

Type 01

🩸

Compassionate Use Programme

Supply of a medicine not yet registered in the patient's country to identified patients with a serious unmet medical need, under the destination country's compassionate use rules. Suitable for UK-licensed products not yet approved in the destination jurisdiction. Patient-named, prescriber-led, sponsor-funded.

Type 02

⚡

Early Access Programme

Early access schemes run by destination-country regulators allow structured pre-launch access to promising medicines. Suitable for new therapies addressing serious unmet need where the sponsor wants structured access for cohorts of patients across multiple sites, supplied as UK-licensed product.

Type 03

🧪

Post-Trial Access Programme

Continued supply of a medicine to clinical trial participants after trial closure, until commercial launch or alternative access. An ethical commitment increasingly written into trial protocols and consent documents, requiring a logistics partner who understands trial-to-MAP transition handover.

Type 04

🩺

Named Patient Access under MAP

Single-patient access within a sponsor-led MAP umbrella programme. Combines the patient-level individuality of named-patient import supply with the sponsor governance, pricing structure and pharmacovigilance reporting of a formal Managed Access Program. Ideal for ultra-rare conditions with sporadic demand.

Why Pharma Sponsors Run MAPs

Pre-Launch Evidence,
Ethics, and Demand Management

A well-designed MAP delivers strategic, ethical and operational value during the pre-licensing or pre-launch window.

📊

Pre-Launch Real-World Evidence

MAP supply generates real-world data on dosing, tolerability and outcomes in routine clinical use, supporting payer dossier preparation, NICE submissions and post-launch HTA work.

💍

Ethical Patient Access

For serious unmet need indications, compassionate access ahead of authorisation is increasingly an ethical and reputational expectation from clinicians, regulators and patient advocacy groups.

🎯

Demand Management Pre-Launch

A structured MAP gives the sponsor a controlled framework for responding to clinician requests during the regulatory review window, avoiding ad-hoc import pressure on local distributors.

The Euro Biom MAP Service

UK logistics, distribution
and patient-level documentation.

MAPs are operationally complex. Specialist product handling, patient-level traceability, sponsor reporting and MHRA liaison must all run in parallel. Our service is designed for sponsors who need a UK partner that already has the regulatory authorisation in place.

UK Receipt and GDP Storage

Receive UK-licensed product from the sponsor or contract manufacturer at our GDP-audited UK warehouse. Cold chain handling for refrigerated and frozen formulations, full receipt documentation, and quarantine controls where required by the sponsor's quality system.

+2 to +8 cold chain | GDP-audited site

Patient-Named Distribution

Patient-level dispatch to UK hospitals, specialist centres and homecare providers, with full chain-of-custody from receipt through to clinical site. International shipment under our WDA export authorisation, with destination-country import liaison.

UK and 40+ international destinations

Patient-Level Documentation

Each dispatch is documented at patient level, supporting sponsor pharmacovigilance reporting, outcomes analysis and any obligations under the MAP protocol. Documentation is structured for easy reconciliation against sponsor systems and clinical site records.

Patient-level audit trail

Regulatory Liaison and Reporting

For compassionate use, early access and named-patient import programmes, we liaise with the MHRA on supply-related queries, maintain the wholesaler-side documentation expected for a Managed Access Program, and provide the sponsor with reporting needed for periodic regulatory updates.

MHRA liaison | Sponsor reporting

How It Works

From Programme Design
to Outcomes Documentation

A typical Managed Access Program runs over months or years. Our process is designed for the long-running operational rhythm sponsors need.

Step 01

Programme Design Support

Discuss programme type, indication, expected patient volume, country scope and timeline. Joint design of the logistics workflow, documentation requirements and regulatory touchpoints.

Step 02

Patient Registration and Site Set-Up

Set up clinical sites and patient registration workflows. Establish dispatch templates, sponsor reporting cadence and patient-level documentation standards before the first supply.

Step 03

Drug Supply and Distribution

Receive product, store under GDP, dispatch at patient or site level. Cold chain monitoring, full chain-of-custody documentation, customs clearance for international shipments.

Step 04

Outcomes and Programme Documentation

Periodic reporting to the sponsor on supply volumes, patient distribution, expiry and recall management. Full programme documentation for regulatory review, audit and post-launch transition.

Where MAP Demand Concentrates

Therapeutic Areas We Support

MAPs are most common in indications where unmet need is high and the patient population cannot wait for full licensing and reimbursement.

🩺

Rare Disease

Ultra-rare and orphan indications where the patient population is small, the unmet need is acute, and a sponsor-led MAP is the only realistic access route pre-launch.

🔬

Oncology

Pre-licensing access to targeted therapies, immunotherapies, CAR-T and novel cytotoxics for patients with limited or exhausted licensed treatment options.

🧑‍🬊

Paediatric

Compassionate use and early access programmes for paediatric indications, including paediatric oncology, neurology and metabolic conditions where adult-licensed therapies are extrapolated.

🧮

Ultra-Rare Metabolic

Inherited metabolic disorders, lysosomal storage diseases and genetic conditions requiring lifelong therapy, often with global patient registries and small national cohorts.

🧠

Neurology

Programmes for ALS, advanced MS, rare epilepsy syndromes and neurodegenerative conditions where licensed options are limited and post-trial access is ethically expected.

🧡

Cardiovascular Rare

Pulmonary arterial hypertension, hereditary amyloidosis, transthyretin disease and rare cardiomyopathies addressed through specialist centre MAPs.

🧹

Immunology and Inflammation

Pre-launch access to novel therapies for severe autoimmune, dermatologic and rheumatologic conditions, including post-trial bridging supply.

💊

Other Indications

MAP frameworks apply across all therapeutic categories. Submit your programme details for a logistics design proposal regardless of indication.

Ready to Discuss Your MAP?

Tell us the indication, programme type, expected volume and country scope. We respond the same working day with a logistics design proposal covering distribution, documentation and regulatory liaison. Confidentiality assured.

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Frequently Asked Questions

Managed Access Programs, Explained

Common questions from biotech and specialty pharma sponsors planning a UK MAP.

What is a Managed Access Program?

A pharma-sponsored programme providing patients with access to a medicine not yet registered in their own country. MAPs include compassionate use, expanded access, early access and post-trial supply, typically for serious unmet need where no licensed alternative is suitable.

What is the difference between compassionate use and early access?

Compassionate use is a destination-country pathway for supplying a medicine not yet registered there, on a named patient basis (the importing country's mechanism). Early access is a structured sponsor-led programme allowing groups of patients to access a promising medicine before licensing, typically backed by a positive MHRA scientific opinion.

What does Euro Biom do for a MAP?

We act as the UK MHRA-licensed wholesale partner. Receipt of UK-licensed product, GDP-compliant storage, patient-level or site-level distribution within the UK or for export, full chain-of-custody documentation, temperature monitoring, and MHRA regulatory liaison.

Can you support international Managed Access Programs?

Yes. Our WDA covers export, and we ship MAP product from the UK to GCC, Africa, Europe and beyond. We manage UK export documentation including Certificates of Pharmaceutical Product where required, and coordinate with sponsor regulatory teams on import requirements at the destination.

What documentation comes with each MAP supply?

Every supply includes a Certificate of Analysis, batch records, GDP transport and temperature monitoring documentation, patient-level or site-level dispatch records, and any export or import paperwork. Documentation supports sponsor pharmacovigilance, regulatory reporting and outcomes analysis.

How do I set up a MAP with Euro Biom?

Contact us with the indication, programme type, expected patient volume, country scope and timeline. We respond the same working day with a programme design proposal covering logistics, documentation, regulatory liaison and pricing. Confidentiality assured.

Related Resources

Further reading for biotech and specialty pharma sponsors.

Service

Named-Patient Import Supply for Hospitals and Institutions

View service →

Service

Reference Listed Drug Supply UK for Bioequivalence and Regulatory Work

View service →

Compliance

Our Regulatory Credentials and MHRA WDA Documentation

View compliance →

Guide