Delivering Excellence: Our Regulatory-Compliant Distribution Network
Safe. Secure. Seamless. Because Every Dose Matters.
In the world of rare and ultra-rare diseases, timely and reliable access to treatment is not just critical—it’s often lifesaving. At Aegerion Pharmaceuticals UK, we understand that delivering our therapies is about far more than logistics. It’s about ensuring integrity, safety, and compliance from the moment a product leaves our hands to the moment it reaches a patient.
Our regulatory-compliant distribution network is built with precision and purpose—to support the complex, high-stakes journey of orphan drugs while maintaining the highest standards of regulatory excellence.
Why Distribution in Rare Diseases Requires a Different Approach
Unlike high-volume pharmaceuticals, orphan drugs often:
Require cold chain or temperature-controlled storage
Are distributed to specialist centers or homecare settings
Must be traceable down to individual patient level
Involve special access pathways, such as Named Patient or Early Access Programs
These factors demand an infrastructure designed not just for efficiency—but for accountability and compliance.
Aegerion’s Distribution Strategy: Designed for Safety, Built for Trust
1. Full Regulatory Alignment
Our distribution model adheres to stringent standards, including:
UK Good Distribution Practice (GDP) guidelines
MHRA regulatory expectations for handling, storage, and traceability
EU Falsified Medicines Directive (FMD) compliance
Comprehensive Standard Operating Procedures (SOPs) for audits, recalls, and incident reporting
Every partner in our network is thoroughly qualified and audited, ensuring full regulatory readiness at every step of the supply chain.
2. Specialist Logistics for Orphan Therapies
We work with highly experienced specialty logistics providers to manage:
Cold chain management with temperature monitoring
Secure, tamper-evident packaging
Real-time shipment tracking and chain of custody
Contingency planning for urgent or critical delivery scenarios
Our infrastructure is capable of serving even remote or decentralized treatment centers, ensuring equitable access across the UK.
3. Integrated Pharmacovigilance and Product Safety
Our distribution model is tightly integrated with pharmacovigilance systems, allowing us to:
Track and respond to adverse events or product complaints efficiently
Ensure product integrity throughout the distribution lifecycle
Meet all post-market surveillance obligations
By linking distribution with medical and regulatory operations, we ensure that safety is monitored beyond the clinic.
4. Flexible Delivery Models for Patient Convenience
Depending on therapy and patient needs, we enable:
Homecare delivery for eligible patients, supported by nurse-administered care
Hospital pharmacy fulfillment with scheduled coordination
Named Patient and Compassionate Use deliveries, where licensed access is unavailable
Each model is designed for patient safety, privacy, and compliance with national regulations.
Cross-Functional Coordination for Seamless Supply
Our supply chain and distribution teams work closely with:
Regulatory Affairs to ensure documentation and oversight
Market Access and Commercial teams to plan for demand and payer requirements
Medical Affairs and Quality Assurance to address safety, education, and usage protocols
This alignment ensures that our therapies are not only delivered—but delivered with the right information, training, and support.
Delivering What Matters Most
At Aegerion Pharmaceuticals UK, we know that behind every shipment is a patient waiting for hope, stability, and a better quality of life. That’s why we treat our distribution network as a mission-critical function, not a back-office operation.
Through careful planning, strict regulatory adherence, and deep compassion, we ensure our therapies are available where needed, when needed, and always in the safest manner possible.
