Managed Access Programs

Managed Access
Programs UK
for Supply of UK-Licensed Medicines

Euro Biom is an MHRA WDA-licensed UK wholesaler that can supply UK-licensed medicines into Managed Access Programs (MAPs) held by the buyer or sponsor in destination markets, including compassionate use, expanded access and early access programmes. Euro Biom trades exclusively in UK-licensed medicines.

MHRA WDA Licence No. WDA(H) 59239

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What is a Managed Access Program

Patient access
where a medicine is
not yet registered.

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 sponsors, a MAP gives a structured route to manage clinician demand in markets where the product is not yet registered. Euro Biom can supply only where the product holds a UK marketing authorisation.

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

"We supply into a managed access programme only where the product is UK-licensed. The programme, the patients and the local approvals stay with the sponsor or buyer."

Programme Types

Four MAP Frameworks
We Can Supply Into

The right MAP framework depends on the regulatory stage of the medicine, the patient population and the sponsor's strategic objective. We can supply into all four where the product is UK-licensed.

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 access to medicines not yet launched in that country. We can supply only where the product is UK-licensed.

Type 03

Post-Trial Access Programme

Supply of a UK-licensed medicine to a sponsor-held post-trial programme in a destination market, where the product holds a UK marketing authorisation.

Type 04

Named Patient Access under MAP

Single-patient access within a sponsor-led MAP umbrella programme. The sponsor runs the programme, and each patient is imported under the destination country's named-patient route.

Why Sponsors Run MAPs

Access, Ethics
and Demand Management

A well-designed MAP gives structure to access in markets where a medicine is not yet registered.

Real-World Data

The sponsor may collect data on dosing and tolerability in routine clinical use. This sits with the sponsor, not with the wholesaler.

Ethical Patient Access

For serious unmet need indications, access ahead of local registration is often expected by clinicians and patient groups.

Demand Management

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

The Euro Biom MAP Service

UK logistics, distribution
and consignment documentation.

MAPs are operationally complex. Euro Biom supplies UK-licensed product and wholesaler-side supply records into programmes held by the buyer or sponsor. Our service is designed for sponsors who need a UK partner that already has the regulatory authorisation in place.

UK Receipt and GDP Storage

UK-licensed product is sourced through the UK licensed supply chain and held at a GDP-compliant contract storage site. 2-8°C storage for refrigerated formulations at the contract storage site, receipt documentation, and quarantine controls where required by the sponsor's quality system.

2-8°C storage at the contract site

Distribution to the Programme Holder

Dispatch of UK-licensed product to the programme holder's nominated licensed recipient, with chain-of-custody documentation. International shipment under our WDA export authorisation; the importer handles destination-country import.

UK and 40+ international destinations

Consignment-Level Documentation

Dispatches are documented at consignment level; patient-level records are held by the programme holder.

Consignment-level audit trail

Supply Records and Reporting

For compassionate use, early access and named-patient import programmes, we maintain wholesaler-side supply records that the sponsor can use in its own reporting.

Supply records | Sponsor documentation

How It Works

From Enquiry
to Supply Records

A typical Managed Access Program runs over months or years. Our process is designed for long-running supply.

Step 01

Enquiry and Scope Discussion

Discuss programme type, indication, expected patient volume, country scope and timeline. Agreement of the logistics workflow and documentation requirements.

Step 02

Patient Registration and Site Set-Up

The sponsor or buyer sets up sites and patient registration. Euro Biom agrees dispatch documentation with them before first supply.

Step 03

Drug Supply and Distribution

Product is held at the contract storage site and dispatched to the programme holder's licensed recipient. A data logger for 2-8°C lines and chain-of-custody documentation accompany export shipments. Customs clearance is handled by the importer of record.

Step 04

Supply Records

Supply records for volumes dispatched are available to the programme holder on request.

Where MAP Demand Concentrates

Therapeutic Areas We Support

MAPs are most common in indications where unmet need is high and patients cannot wait for local registration.

Rare Disease

UK-licensed, non-biologic medicines for rare conditions, where a sponsor-led MAP is the access route in the destination market.

Oncology

Access to UK-licensed oral targeted therapies and cytotoxics in markets where they are not yet registered.

‍

Paediatric

Compassionate use and early access programmes for paediatric indications, including paediatric oncology and neurology, for UK-licensed medicines.

Metabolic Conditions

UK-licensed, non-biologic medicines for inherited metabolic conditions.

Neurology

Programmes for rare epilepsy syndromes and neurodegenerative conditions where a UK-licensed, non-biologic product is needed in markets without registration.

Cardiovascular Rare

Pulmonary arterial hypertension and other rare cardiovascular conditions, where a UK-licensed, non-biologic product is needed.

Immunology and Inflammation

Supply of UK-licensed small-molecule medicines for severe autoimmune, dermatologic and rheumatologic conditions into buyer-held programmes.

Other Indications

If your programme involves another UK-licensed medicine within our licence scope, send us the details.

Ready to Discuss Your MAP?

Tell us the indication, programme type, expected volume and country scope. We respond the same working day. Confidentiality assured.

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Frequently Asked Questions

Managed Access Programs, Explained

Common questions from specialty pharma sponsors planning a MAP in a destination market.

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 medicine before it is registered locally, under the early access rules of the destination country.

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, dispatch to the programme holder's nominated licensed recipient in the UK or for export, chain-of-custody documentation, and 2-8°C shipping arranged with specialist carriers.

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 supply UK export documents, pass on Certificates of Pharmaceutical Product where available, and share information with sponsor regulatory teams, who handle import requirements at the destination.

What documentation comes with each MAP supply?

Each supply comes with batch number and expiry confirmation, GDP chain-of-custody and supply records, an invoice and packing list, with a manufacturer Certificate of Analysis confirmed at quotation stage where the manufacturer makes one available.

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 quotation covering logistics, documents and pricing to follow. 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