Named patient pathways in accordance with § 73.3 AMG – secure, fast and compliant

As an expert in drug imports, we enable doctors, pharmacies and clinics to legally access unlicensed drugs – reliably, transparently and in accordance with § 73.3 of the German Medicines Act (AMG).

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Why named patient pathways under § 73.3 AMG are so important

Innovative therapies, shortages, rare diseases or expired drug approvals – they all often have one thing in common: they require named patient access.

73.3 of the German Medicines Act (AMG) provides the legal basis for this and enables doctors, pharmacies and clinics to continue to provide patients with fast and safe care.

Hope for patients: access to modern, adequate and often life-saving therapy

Self-determination & care: patients receive treatment options that they did not have before

Our mission: Patient first! Fast access can save lives

Legal basis for named patient pathways

In order for named patient pathways under Section § 73.3 (AMG) to be lawful, three conditions must be met:

Medical prescription for a specific patient

We review each request individually and assist doctors and pharmacies in ensuring correct processing.

The medicine is not available in the Germany (not approved or not available)

Thanks to our international network, we source medicines worldwide – quickly, safely and transparently.

The order is placed via a pharmacy or clinic

We support public pharmacies, hospital pharmacies and clinics alike – including documentation and billing (DRG/NUB in the clinic sector).

Your safety

We combine the legal requirements with clear processes, international sourcing and GDP-compliant logistics. This ensures that every named patient pathway is 100% compliant and reliably implemented.

Named patient pathway vs. parallel import vs. re-import – the differences

There are various forms of import in the pharmaceutical trade – but they differ significantly in purpose and significance:

Named patient pathway
(§ 73.3 AMG):

Individual patient care with medicines that are not approved or currently unavailable in Germany. Medically prescribed, strictly regulated and always patient-oriented.

Parallel import

Trade model for medicines already approved in the EU. The focus is on price and competitive advantages, not on individual care.

Re-import

Re-import of medicines approved in Germany that are brought back from abroad at a lower price. Also economically oriented.

While parallel and re-imports serve trade and price advantages, named patient pathways focus on medical necessity and patient care.

Feature

Approval in Germany

Purpose

Medical prescription required

Official approval

Individual patient care

Legal framework

Focus

Risk for doctor/pharmacy

Named patient pathway (§ 73.3 AMG)

Not approved, only possible under § 73.3 AMG

Patient care in cases of medical emergency

Mandatory

Individual approval required

Always individualised for each patient

§ 73.3 AMG

Patient care / medical necessity

Legally compliant if handled correctly

Parallel import

Already approved EU medicine

Economic trade (price advantages)

Not necessary

No individual approval

No

EU internal market regulations

Trade / pricing

Low

Re-import

Already approved in Germany

Price advantages through re-import to the country of origin

Not necessary

No individual approval

No

EU internal market regulations

Trade / pricing

Low

Our process – step by step

To enable you to treat your patients safely and quickly, we support you in researching and sourcing named patient pathways.

Your advantage:

One contact person, one consistent process, full transparency.

Drug Request

Extensive research

Regulatory review under § 73.3 AMG

Global product sourcing

Customs & documentation

Quality & compliance management

GDP-compliant delivery within Germany

Our experience & expertise

Over 60 years of experience in international pharmaceutical imports

Supplying pharmacies, clinics, and wholesalers throughout the DACH region

Own WDA-licensed and GDP-compliant warehouse network

International supply chains in over 50 countries

Specialized team for customs, national regulations and documentation

We combine global reach with local compliance.

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contact

Have you got a specific patient request or would you like to learn more about named patient pathways under § 73.3 AMG?

Contact us now for a fast, secure and legally compliant solution.