Global Access to Unlicensed Medicine

– Ethical & Compliant Solutions Worldwide

Access to life-saving treatment should not be limited by geography, regulatory timelines, or local availability. Global access to unlicensed medicine plays a critical role in ensuring patients receive essential therapies when approved alternatives are unavailable or delayed in their country.

Through legally compliant pathways such as Named Patient Supply, Early Access Programs, and Compassionate Use, unlicensed medicines can be supplied ethically and responsibly to meet urgent medical needs worldwide.

What Is Global Access to Unlicensed Medicine?

Unlicensed medicines are pharmaceutical products that are not approved or not yet registered in a specific country but may be approved elsewhere or still under clinical development. Global access programs allow these medicines to be supplied legally under strict medical and regulatory oversight.

This access is typically enabled through:

• Named Patient Programs (NPP)
• Early Access / Expanded Access Programs
• Compassionate Use Programs

These mechanisms ensure patients are not deprived of treatment due to regulatory delays.

Why Global Access to Unlicensed Medicine Is Essential

In many regions, patients face limited treatment options due to:

• Delayed drug approvals
• Rare or orphan diseases
• Shortages of approved medicines
• Lack of local availability

Global access to unlicensed medicine bridges this gap by allowing healthcare professionals to source necessary treatments ethically and legally.

This is especially critical in:

• Oncology
• Rare diseases
• Neurology
• Autoimmune disorders
• Infectious diseases

Named Patient Supply – A Key Access Pathway

One of the most common routes for accessing unlicensed medicines is the Named Patient Supply (NPS) pathway.

Under this framework:

• A licensed physician requests a medicine for a specific patient
• The medicine is supplied on a non-commercial basis
• Full documentation and regulatory compliance are maintained

This approach ensures patient-specific access while respecting national laws.

Early Access & Compassionate Use Programs

Early Access Programs

These programs allow patients to access medicines that are:

• In late-stage clinical development
• Approved in other markets
• Not yet commercially available locally

Compassionate Use

Compassionate use applies when:

• Patients have serious or life-threatening conditions
• No approved alternatives exist
• Clinical trial participation is not possible

Both pathways are governed by strict ethical and regulatory frameworks.

Ethical & Compliant Supply of Unlicensed Medicines

Compliance is the foundation of any unlicensed medicine supply. Ethical access requires:

• Physician authorization
• Patient consent
• Regulatory documentation
• Transparent sourcing

We support global access to unlicensed medicine while adhering to:

• WHO guidelines
• Local import regulations
• GDP (Good Distribution Practices)
• Ethical supply principles

Patient safety and regulatory integrity are always the priority.

Global Coverage – Access Without Borders

Unlicensed medicines can be supplied globally through compliant pathways to:

• Hospitals
• Clinics
• Government institutions
• NGOs
• Authorized healthcare providers

We support access across:

• Africa
• Middle East
• Asia-Pacific
• Europe
• Latin America

Each country’s regulatory framework is respected, ensuring lawful and smooth access.

Therapeutic Areas Commonly Supplied

Global access programs frequently support medicines in:

• Oncology & Hematology
• Rare & Orphan Diseases
• Neurology & CNS Disorders
• Autoimmune & Inflammatory Conditions
• Infectious Diseases

These therapies are often critical and time-sensitive.

Regulatory & Documentation Support

Accessing unlicensed medicines requires precise documentation. Support typically includes:

• Physician request letters
• Patient consent forms
• Product documentation
• Import permits
• Temperature-controlled logistics

End-to-end regulatory coordination ensures timely and compliant delivery.

Cold Chain & Secure Global Logistics

Many unlicensed medicines require strict handling conditions. Global access solutions include:

• Cold chain shipping
• GDP-compliant storage
• Real-time tracking
• Secure international transport

This ensures product integrity from source to patient.

Who Benefits from Global Access to Unlicensed Medicine?

This access model supports:

• Patients with unmet medical needs
• Physicians seeking alternative therapies
• Hospitals managing complex cases
• Governments addressing shortages
• NGOs supporting humanitarian care

It enables healthcare systems to act quickly and responsibly.

Commitment to Patient-Centric Access

Global access to unlicensed medicine is not about commercialization — it is about ethical patient care. Every request is evaluated with medical justification, regulatory compliance, and patient welfare at its core.

Global Access to Unlicensed Medicine – A Responsible Path Forward

When time is critical and options are limited, global access programs provide a lifeline. By enabling compliant access to unlicensed medicines, healthcare providers can deliver timely treatment while respecting international regulations.

If you are seeking ethical, compliant global access to unlicensed medicine, the right framework, documentation, and logistics make all the difference.

Contact for Global Access Solutions

For enquiries related to:

• Named patient supply
• Early access programs
• Compassionate use medicines
• Regulatory guidance

📩 Reach out to discuss compliant global access to unlicensed medicine.