What is an importer of record and why is it required?

An Importer of Record (IoR) is the legal entity responsible for ensuring that imported goods comply with the destination country's regulations, customs procedures, and tax obligations. An IoR is required whenever the foreign sender does not have a registered legal presence in the destination country, or when the products being imported (such as unlicensed medicines, clinical trial supplies, or medical devices) are subject to specialised regulatory control.

Who can act as importer of record?

Any locally registered legal entity can technically act as an IoR — including the sponsor's own subsidiary, a CRO with local presence, or a specialised third-party provider. However, for pharmaceutical and clinical trial shipments, an IoR with regulatory and GxP expertise is strongly recommended to handle the complex documentation and compliance requirements.

Can a customs broker or freight forwarder be the importer of record?

Generally, no. Customs brokers and freight forwarders act as agents that facilitate clearance procedures, but they do not assume legal liability for the shipment, nor do they take responsibility for regulatory compliance. The IoR, by contrast, is legally and financially accountable for the import. In most countries, this is a separate role that requires a registered local entity with appropriate licences.

Do you provide IoR services for clinical trials and medical devices?

Yes, COREX supports clinical trials, unlicensed medicines, and medical devices.

Importer of Record (IoR) Services

Q: When do you need an importer of record?

You need an importer of record when importing into a country without a local legal presence, or when handling unlicensed medicines, clinical trial supplies, and other regulated shipments.

Challenge

Lack of local registration can block access to critical treatments in global trials.

Solution

As an Importer of Record, COREX assumes legal responsibility to import investigational and unlicensed products into multiple countries in full regulatory compliance.

What We Offer:

COREX provides complete IoR support for companies without a legal presence in the import destination country:

Legal Representation for Imports

Acting as your authorised Importer of Record in key regions.

Regulatory & Tax Compliance

Managing local requirements for licensing, documentation, VAT, and customs duties.

Customs Clearance Coordination

Liaising with authorities and brokers to ensure seamless import processing.

GxP-Compliant Receiving & Distribution

Once cleared, products are stored or shipped under validated conditions.

Applicable to a Wide Range of Products

Including unregistered drugs, trial supplies, diagnostic equipment, and ancillaries.

Contact Our Regulatory Team

When Do You Need an Importer of Record?

Importing into a country where your organisation has no legal or tax presence

Handling unregistered or investigational products

Working with time-critical or temperature-controlled shipments

Avoiding delays due to incomplete or inaccurate documentation

Why IoR is Critical for Pharma & Clinical Trials

Pharmaceutical imports involve some of the strictest regulatory controls in international trade. Investigational drugs, biologics, and medical devices cannot simply be shipped, declared, and released — they must be cleared through processes that consider GMP compliance, local marketing authorisation status, temperature integrity, and patient safety.

Without a qualified IoR, sponsors and CROs face the real risk of customs delays, shipment rejection, regulatory fines, and even the loss of investigational batches that took months to manufacture. In time-sensitive clinical trials, a single border delay can mean missing a patient dosing window or jeopardising study endpoints.