Unlicensed Medicines & Clinical Supply Import

What are unlicensed medicines?

Unlicensed medicines are pharmaceutical products that do not hold marketing authorisation in the country where they are needed. They are typically supplied under regulated access pathways such as Named Patient Programmes (NPP), Compassionate Use, or Managed Access Programmes (MAP). Importing them requires specific regulatory approvals, import. permits, and full traceability to comply with local healthcare authorities. COREX manages the entire process — from sourcing and licensing to compliant delivery.

Problem:

Importing unlicensed medicines and clinical equipment involves complex regulatory requirements, multi-country coordination, and high compliance risks.

Delays at customs, missing permits, or lack of local legal presence can lead to shipment rejection or critical supply disruptions.

Solution

COREX navigates global import requirements with compliant access pathways for clinical and compassionate use, ensuring safe and authorised deliveries – including shipments that require Importer of Record (IoR), special permits, or local regulatory coordination.

We support companies that need to import unlicensed medicines and pharmaceutical products across 45+ countries, including complex markets in CIS, MENA, and APAC.

What We Offer:

We support the import of unlicensed medicines, clinical trial supplies, and regulated healthcare products — including pharmaceutical products requiring controlled importation — managing both regulatory approvals and operational delivery.

Our importation support covers a wide range of clinical and research-related products:

Unlicensed Medicinal Products

Including those used in Named Patient, Compassionate Use, or Managed Access Programmes.

We support sourcing, regulatory approvals, and import permits required for legal access.

Clinical Trial Supplies

Investigational drugs, comparators, kits, ancillaries, and refrigerated products.

We manage import coordination, documentation, and compliant delivery to trial sites.

Medical Devices & Lab Equipment

From diagnostic machines to freezers and specimen handling tools.

We ensure proper classification, documentation, and customs clearance.

Research-Only Reagents & Samples

Imported with proper declaration and documentation.

Handled in accordance with regulatory and transport requirements.

Importation of Record (IoR) Services

Acting as legal importer when required by local law.

We assume legal responsibility for import compliance and customs clearance.

Regulatory Advice & Licensing

Country-specific guidance for import authorisations and customs approvals.

We support permit applications and local regulatory coordination.

Contact Our Regulatory Team

What We Import — Pharmaceutical & Clinical Products

Medicines

investigational products
comparator drugs
unlicensed medicines

Diagnostic Devices

sample kits
point-of-care tools
test systems

Laboratory Equipment

centrifuges
freezers
analytical devices
cryo equipment

Reagents & Biologicals

DNA and RNA samples
cell cultures

Clinical Trial Ancillaries

kits
packaging
infusion materials
PPE (personal protective equipment)

COREX Global Network

Ensuring seamless clinical supply solutions with local expertise and global reach.

Explore our network

Why choose COREX
for Importation Solutions?

Importing Unlicensed & Special-Use Products

We support the legal movement of non-registered and off-label medications with expertise in rare diseases, early access, and emergency-use pathways.

Localised Regulatory Knowledge

Our regional teams help sponsors and manufacturers navigate local import requirements across multiple regions.

Seamless Integration with Logistics

Import processes are fully aligned with storage and distribution, ensuring faster transition from customs clearance to final delivery without additional coordination.

The Hidden Risks in Pharma Logistics-And How to Solve Them

What are unlicensed medicines?