Managed Access
Programs UK
for Pre-Launch & Post-Trial Supply
Euro Biom is an MHRA WDA-licensed UK logistics partner for Managed Access Programs (MAPs), including compassionate use, expanded access, EAMS early access and post-trial supply for biotech and specialty pharma sponsors.
⚡ Same-day response to every enquiry · Mon-Fri 09:00-18:00 · WhatsApp us
before market
authorisation.
A Managed Access Program is a pharmaceutical-sponsored programme that enables patients to access an investigational, unlicensed or pre-launch medicine ahead of full marketing authorisation. MAPs typically respond to serious or life-threatening conditions where no licensed alternative is suitable.
In the UK the framework includes compassionate use under Regulation 167 of the Human Medicines Regulations 2012, the MHRA Early Access to Medicines Scheme (EAMS) for promising pre-licensing products, post-trial access for clinical trial participants, and named patient supply within MAP umbrella programmes.
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.
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.
Ethics, and Demand Management
A well-designed MAP delivers strategic, ethical and operational value during the pre-licensing or pre-launch window.
UK logistics, distribution
and patient-level documentation.
MAPs are operationally complex. Investigational 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 investigational or pre-launch 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.
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.
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.
Regulatory Liaison and Reporting
For EAMS, compassionate use and named patient 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.
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.
MAPs are most common in indications where unmet need is high and the patient population cannot wait for full licensing and reimbursement.
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.
Common questions from biotech and specialty pharma sponsors planning a UK MAP.
Further reading for biotech and specialty pharma sponsors.