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).
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 prescriptionrequired
Official approval
Individual patient care
Legal framework
Focus
Risk fordoctor/pharmacy
Named patientpathway (§ 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.
DELIVERED TO AND SOURCED FROM
DELIVERED TO
SOURCED FROM
OVER THE PAST 24 MONTHS
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.