Global Guide to Named-Patient Import Programs (2026 Edition)

Named-Patient Import Programs: A Global Guide for Hospitals & Procurement Teams (2026)

Around the world, a large number of patients require medicine that is unapproved or unavailable for use and in some cases has been withdrawn by its manufacturer from their country. Therefore, they are not able to obtain a medicine from a local market. In these situations, many hospitals and clinicians utilize Named Patient Import Programs.

The Named Patient Import Program allows healthcare professionals to apply for a medicine for one specific patient for medical necessity when no alternative is available to them.

This guide explains — in simple language:

• What Named-Patient Import Is
• Differences between various Named Patient Import Programs in each country
• When hospitals should consider using Named Patient Import Program
• What supporting documents, approval process, and the expected timeline to receive the imported medicine will look like
• Risks associated with using Named Patient Import Programs, the regulatory compliance requirements to use Named Patient Import Programs and best practices
• Using digital sourcing platform to expedite getting access to unapproved/imported medicine
   

What Is a Named-Patient Import Program?

The Named Patient Import Program allows healthcare professionals to import unapproved medications from a foreign country, on behalf of a specific patient being treated. This would typically be the case when:

Typically it is used in circumstances where:

• The drug is not approved or not marketed in the country
• There is no effective alternative treatment available
• The patient's condition is serious or life-threatening
• The prescribing physician submits adequate clinical rationale/evidence for the medication's use
• The drug has already been approved in another regulatory market

The Named Patient Import Program is intended for non-commercial, individual patient use only, and may not be used to import or resell large quantities of a medication.
 

When Hospitals Use Named-Patient Import Programs

Hospitals/clinicians can use this type of program if they have:

1. Rare or Orphan Disease Treatments

Some medications are only available in very limited locations.

2. Oncology and Advanced Biologic Medicines

A number of new and advanced drugs in the treatment of cancer/autoimmune disease will be made available later than others in some regions.

3. Products that are nolonger Available or are Discontinued

Some older drugs that treat serious illness will be removed from the local marketplace.

4. Public Health Emergencies or Urgent Situations

Used in the case where immediate access may save the patient's life.

5. Pre-Approval Access in Certain Countries

These are typically referred to as early access programs or compassionate use programs.

How the Process of Named Patient Import Works - A Basic Overview

Although some countries may have slightly different details, the overall flow is generally the same.

Step 1: The Treating Physician Determines If there is a Need

The physician will confirm the medical necessity of therapy and document it in a justification.

Step 2: The Hospital gathers the Necessary Documents

The most common documents included for this purpose are:

• A prescription and summary of the medical case
• Diagnostic reports
• The Patient's consent
• Product information and safety data

Step 3: Submit Application for Import to the Regulating Authority

Approval of the application may be issued by the National Health Authority or a Special Access Office.

Step 4: Permission to Import Medicine is Obtained

Each patient-specific import of medication requires individual patient-specific permission and expiration date for the dosage quantity.

Step 5: Sourcing, Transporting and Cold Chain Management

The medication will be delivered through approved and compliant channels.

Step 6: Dispensing to the Patient and Patient Monitoring

After the medication has been dispensed, hospitals are required to keep records of any usage and report any adverse events associated.

Common documentation requirements

Most countries have very similar requirements for supporting documentations.

• Letter from treating physician
• Clinical justification and/or case history
• Prescription with dosage information
• Patient consent form
• Product information brochure or SmPC
• Certificate of Analysis (where applicable)
• Request for import permit/special access form
• Proof of regulatory approval in country of origin exporting the product
• Cold Chain Plan for biologics and injectables

Strong documentation allows for rapid approval.
 

Regional Approaches to Named-Patient Access (Global Overview)

There are different requirements by region, but the purpose of named-patient access is the same; to provide individual patients with access to needed medical treatments.

European Union & UK

Usually process handled using the specialities pathway, compassionate-use or product supply.

India & South Asia

Hospitals in India and South Asia submit applications for named-patient access through national regulatory agencies.

Middle East & GCC

Requests are generally sent to hospital authorities to obtain Ministry of Health (MOH) approval.

Latin America

Most countries will offer named-patient access for humanitarian or exceptional circumstances.

Africa & Emerging Markets

Used to fill availability voids for critical therapies.

Each market has different timelines, forms and processes for named-patient access; always verify that all local market rules have been fulfilled.

Compliance Obligations and Risks

Hospitals have significant compliance responsibilities with Named-Patient access.

Key compliance issues associated with Named-Patient access

• Reporting of all pharmacovigilance incidents
• Safe storage and dispensing of products
• Use only for the named patient
• Prohibition of commercial sales
• Clear and detailed audit trail and record keeping
• Ethical communication with patients and/or families
• Strong privacy and data security measures

Noncompliance with the requirements for named-patient access will create liability.
 

Common Challenges Faced by Hospitals

1. Incomplete Documentation

A small mistake can cause a lot of time being wasted.

2. Limited Manufacturer Supply

Sometimes manufacturers do not allow patients to receive the drugs without undergoing a long process.

3. Cold-Chain or Transit Risks

Biologics have to be transported in controlled temperature and the temperature must be logged.

4. Customs Delays

Wrong documents lead to problems in clearing the shipment.

5. High Cost of Therapy

The cost of the drug is often borne by the patients or families through self-funding schemes.
 

Best Practices for Safe & Efficient Named-Patient Imports

The success of the named-patient import pathway for most hospitals is achieved by consistently following:

• Starting the documentation process early
• Sourcing from verified and authorized suppliers
• Checking the regulatory forms thoroughly for errors
• Keeping batch-level traceability for the products
• Arranging logistics and control of temperature well in advance
• Communicating clearly with patient families
• Monitoring and documenting adverse reactions
• Storing drugs only under the conditions mentioned on their labels

Additionally, hospitals must track and report any adverse events related to the use of these medications and store them according to the labeling instructions. By maintaining a standardized process, hospitals can provide patients with safe and compliant access to these imports.

How Digital B2B Platforms Support Named-Patient Access

Hospitals are supported by modern sourcing platforms (such as PharmaTradz) and service partners with:

• Verified global sourcing networks
• Support with regulatory documentation
• Templates for getting patient consent and forms
• Monitoring of the cold-chain and shipment
• Help with customs and import
• Assurance of authenticity and batch traceability
• Faster coordination between stakeholders

This allows hospitals to spend less time on administrative work and more time getting medications to patients who need them urgently.

Conclusion

Named-Patient Import Programs allow hospitals to save lives when there are no other treatment options available locally. With accurate documentation, verified sources, and strong compliance practices, patients are able to have safe and timely access to vital medications from outside of their origin country. This method remains a very important connection between getting medicine, new ideas, and caring support in 2026.

Frequently Asked Questions(FAQs)

Is Named-Patient import legal?

Yes — when approved by the relevant national authority.

Can patients apply directly?

Most programs require a request from the hospital or clinician that is utilizing the imported medication.

Is this the same as commercial import?

No — it is patient-specific and non-commercial.

Are biologics allowed?

Yes, but they require strict handling and cold-chain controls.

Is approval guaranteed?

No — approval depends on clinical and regulatory review.