Sonderzulassung (Germany): how it works and where it is recognized
A cross-border regulatory framework for supplying an unregistered or off-label medicine to a specific patient, on the order of a treating physician, under a defined permit issued by the destination-country medicines regulator.
Last reviewed 2026-05-16 by Reserve Meds clinical and regulatory team.
What Sonderzulassung is
Origin and authorising body. Germany, under Sections 73 and 79 of the Arzneimittelgesetz (AMG). The authorising body for each individual case is the Bundesinstitut fur Arzneimittel und Medizinprodukte (BfArM) for chemical drugs, Paul-Ehrlich-Institut (PEI) for biologics and advanced therapy medicinal products, acting under that jurisdiction's pharmacy or medicines legislation.
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Legal basis. Section 73 paragraph 3 AMG permits the import of unregistered medicines for individual named patients (Einzelimport) at the request of a pharmacy on the order of a treating physician. Section 79 AMG provides a Sonderzulassung framework for special authorisation in emergency situations (pandemics, public-health emergencies). Section 21 paragraph 2 AMG provides a hospital exemption (Klinikexzeption) for advanced therapy medicinal products prepared on a non-routine basis for individual patients.
Germany operates several distinct frameworks for accessing unregistered medicines. Sonderzulassung (Section 79) is the emergency special-authorisation framework used during public-health crises. Einzelimport (Section 73 paragraph 3) is the routine individual-patient import framework operationally similar to a Named-Patient Program in other jurisdictions. Klinikexzeption (Section 21 paragraph 2) is the hospital exemption for advanced therapy medicinal products prepared in-house. In practice, most cross-border individual patient supply into Germany operates through Einzelimport.
Einzelimport is a pharmacy-led process: the treating physician issues a prescription, the dispensing pharmacy files the import request with BfArM (or with PEI for biologics), and BfArM reviews the request. The framework does not require the patient or physician to file directly with BfArM. Many German specialty pharmacies have established workflows for routine Einzelimport requests and can complete the process within 2 to 4 weeks. The framework is well used in German academic medicine, with major centres at Charite Berlin, Universitatsklinikum Heidelberg, Universitatsklinikum Munchen, Universitatsklinikum Hamburg-Eppendorf, and Universitatsklinikum Koln.
This page consolidates Reserve Meds's operational view of the Sonderzulassung (Germany) framework across the ten destination countries where we currently coordinate cross-border supply. Earlier in our content build we maintained separate per-country sub-pages for each Sonderzulassung (Germany)-in-country combination; those sub-pages remain available for archival reference but are no longer separately indexed, and the operational intelligence they carried has been folded into the country-compatibility table below.
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Who can use Sonderzulassung
Einzelimport is used by German-licensed physicians prescribing for individual patients in Germany. The dispensing pharmacy carries the operational responsibility for the import application. Cross-border patients from outside Germany cannot directly use Einzelimport. Sonderzulassung is reserved for emergency situations and is granted at the BfArM's discretion during defined public-health events such as pandemics or critical drug shortages.
In practical terms, a Reserve Meds case opens when the treating physician has identified the clinical need, has reached a decision to prescribe a specific medicine, and has determined that the locally available route is unsuitable or unavailable. We then layer the regulatory and supply-chain coordination on top of that clinical decision; we do not originate the prescribing question and we do not advise on the clinical choice. The decision sits with the physician throughout.
Drug categories typically covered under Sonderzulassung
Specialty oncology agents, rare-disease biologics, advanced therapy medicinal products (under Klinikexzeption where prepared in-house, or under Einzelimport where commercially manufactured abroad), and post-approval indications not yet through European registration.
The medicine itself must be source-country approved or in active regulatory development under a recognised reference authority (typically the US FDA, the European Medicines Agency, the UK MHRA, the Japan PMDA, or Health Canada). Most destination regulators will not authorise a Sonderzulassung (Germany) import for a medicine that lacks a recognised reference authorisation anywhere in the world, because the regulator's risk assessment leans on the source-country review as a substitute for its own.
Country compatibility
The table below summarises how the Sonderzulassung (Germany) framework is recognised across the ten destination countries where Reserve Meds currently coordinates cross-border supply. The "Accepts Sonderzulassung (Germany) dossiers" column reflects whether the destination regulator typically reviews and grants permits on the strength of a Sonderzulassung (Germany) clinical justification packet, or whether the patient must use a different parallel framework on the receiving side. Timelines reflect routine cases with a complete documentation set; first-import scenarios, paediatric weight-banded presentations, advanced therapy medicinal products, and large multi-cycle quantities can extend the regulator review by several weeks.
| Country | Local pathway equivalent | Accepts Sonderzulassung (Germany) dossiers? | Typical timeline | Local regulator |
|---|---|---|---|---|
| Bahrain | NHRA Compassionate / Special Import Permit | Indirect (reference precedent only) | Varies by case | NHRA |
| Egypt | EDA Single-Patient Import (Decree 425) | Indirect (reference precedent only) | Varies by case | EDA |
| India | Rule 36 personal-use import (D&C Rules 1945) | Indirect (reference precedent only) | Varies by case | CDSCO |
| Jordan | JFDA Compassionate / Special Use Import | Indirect (reference precedent only) | Varies by case | JFDA |
| Kuwait | MoH Unregistered Medicine Import Permit | Indirect (reference precedent only) | Varies by case | KDFC (MoH) |
| Lebanon | MoPH Special Import for Named Patient | Indirect (reference precedent only) | Varies by case | MoPH |
| Oman | MoH Compassionate / Named-Patient Import | Indirect (reference precedent only) | Varies by case | MoH-DGPADC |
| Qatar | MoPH Single-Patient Unregistered Drug Import | Indirect (reference precedent only) | Varies by case | MoPH-DPA |
| Saudi Arabia | SFDA Personal Importation Permit | Indirect (reference precedent only) | Varies by case | SFDA |
| United Arab Emirates | EDE Unregistered Medicine Import Permit | Indirect (reference precedent only) | Varies by case | EDE |
Notes. "Indirect" means the destination regulator does not directly accept Sonderzulassung (Germany) authorisation as the legal basis for import but does recognise a Sonderzulassung (Germany) authorisation as supporting precedent within its own named-patient or compassionate-use review. "Not applicable" means the framework is not a patient-access pathway in the cross-border sense and is shown here for completeness. Regulator names: NHRA (Bahrain), EDA (Egypt), CDSCO (India), JFDA (Jordan), KDFC (Kuwait), MoPH (Lebanon), MoH-DGPADC (Oman), MoPH-DPA (Qatar), SFDA (Saudi Arabia), and EDE (United Arab Emirates, federal from 29 December 2025).
Documentation required
A Sonderzulassung application is typically assembled in coordination with the treating physician, the dispensing facility, and the cross-border supply partner. The documentation set below covers the routine case; specific destination countries may require additional items (most frequently a hospital ethics committee notification for paediatric or complex cases, and an insurer pre-authorisation letter where the patient intends to seek reimbursement).
- Treating physician's prescription with clinical justification.
- Patient clinical history.
- Dispensing pharmacy's BfArM or PEI import application.
- Informed consent for unregistered-medicine use.
- Chain-of-custody documentation.
- For biologics: PEI-specific submission requirements.
Typical timeline
BfArM routine Einzelimport: 2 to 4 weeks from a complete pharmacy submission. PEI biologic Einzelimport: 3 to 5 weeks. Sonderzulassung is granted on emergency timelines (days) during defined public-health situations. We give you a written timeline estimate for your case before you commit.
Costs and reimbursement
German statutory health insurance (Gesetzliche Krankenversicherung) may cover Einzelimport medicines depending on indication and insurer policy; private health insurers (Private Krankenversicherung) may have different rules. Cross-border patients pay the relevant per-country acquisition cost plus logistics, customs, dispensing, and coordinator fees.
Where Reserve Meds fits in
Reserve Meds is a US-based digital health company that coordinates cross-border access to specialty medicine. For Sonderzulassung (Germany) cases, we coordinate supply through a US-licensed pharmaceutical wholesale partner, prepare the documentation packet your physician submits, coordinate validated cold-chain logistics with continuous temperature logging into the destination country, and give you one point of contact through the case. We do not replace your treating physician, we do not replace the destination-country regulator, and we do not replace your dispensing pharmacy. We coordinate the supply side so the physician can focus on patient care.
For each of the ten destination countries above, we publish a country-specific page documenting the operational realities (which dispensing facilities handle named-patient cases, how the cold chain is verified at the local airport, how the dispensing pharmacy releases the medicine, and what the typical insurer interaction looks like). Those country pages, combined with this pathway page and the specific drug pages, give the prescribing physician and the patient a coherent picture of what to expect before any commitment is made.
Our coordination fee is itemised separately on every firm quote alongside the drug acquisition cost, international logistics, customs, and dispensing pharmacy handling. The patient sees the full breakdown before deciding to proceed; we do not bundle costs and we do not charge an intake deposit. If the case cannot proceed for regulatory or supply reasons, we say so before any payment is taken.
Next step
If your treating physician has identified a clinical need that fits the Sonderzulassung (Germany) framework and you are weighing the cross-border route, the next step is a short intake. We reply within one business day, then send a documentation checklist to your doctor.
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