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Import Unlicensed Medicines, Clinical Supplies & Laboratory Equipment

Accelerating Access Through Regulatory Precision
Challenge:
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 Are Unlicensed Medicines?

Unlicensed medicines are pharmaceutical products that do not hold marketing authorisation in the country where they are needed.

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.

Unlicensed medicines are typically supplied under regulated access pathways such as:

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

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

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

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

Research-Only Reagents & Samples

Imported with proper declaration and documentation.

Handled in accordance with regulatory and transport requirements.

Importation of Record (IoR) Services

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

Regulatory Advice & Licensing

Country-specific guidance for import authorisations and customs approvals.

We support permit applications and local regulatory coordination.

What We Import — Pharmaceutical & Clinical Products

Medicines

Medicines

  • investigational products
  • comparator drugs
  • unlicensed medicines
Diagnostic Devices

Diagnostic Devices

  • sample kits
  • point-of-care tools
  • test systems
Laboratory Equipment

Laboratory Equipment

  • centrifuges
  • freezers
  • analytical devices
  • cryo equipment
Reagents & Biologicals

Reagents & Biologicals

  • DNA and RNA samples
  • cell cultures
Clinical Trial Ancillaries

Clinical Trial Ancillaries

  • kits
  • packaging
  • infusion materials
  • PPE (personal protective equipment)

What is an Importer of Record (IoR) in Pharmaceutical Imports?

An Importer of Record (IoR) is the legal entity responsible for ensuring imported goods comply with local regulations, managing customs clearance, and assuming legal liability.

COREX can act as your Importer of Record (IoR) and offers the following benefits:

  • Import products without establishing a local entity
  • Manage compliance without setting up a local presence
  • Support imports of unlicensed medicines, clinical trial supplies, and medical devices
  • Minimise the risk of delays or shipment rejection
What is an Importer of Record (IoR) in Pharmaceutical Imports?
COREX Global Network

COREX Global Network

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

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.
Importing Unlicensed & Special-Use Products

Localised Regulatory Knowledge

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

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.
Seamless Integration with Logistics

Frequently Asked Questions

Is it legal to import unlicensed medicines?

Yes, unlicensed medicines can be imported under specific regulatory pathways when no approved alternatives are available. These include Named Patient, Compassionate Use, and Managed Access programmes. COREX ensures compliance with local regulations and import requirements.

How do you import pharmaceutical products for clinical trials?

Importing clinical trial supplies involves regulatory approvals, import permits, customs clearance, and controlled logistics. COREX manages the full process — from documentation and licensing to delivery to clinical sites.

Do I need a local entity to import pharmaceutical products?

In many countries, importing pharmaceutical products requires a locally registered entity. COREX can support importation without the need to establish a local presence.

What is the difference between an Importer of Record and a customs broker?

An Importer of Record (IoR) takes full responsibility for ensuring that imported goods meet local regulatory requirements, including permits and licensing.

A customs broker supports the import process by preparing documentation, coordinating with customs authorities, and handling clearance procedures.

COREX provides both IoR and brokerage services to ensure compliant and efficient importation. Learn more about our brokerage services.

Which countries does COREX support for pharmaceutical importation?

COREX supports pharmaceutical importation across 45+ countries, including regions with complex regulatory requirements and multi-country supply chains.

Our network enables compliant importation and local support where required. Explore our global network for full coverage.