Unlicensed medicines in Germany: which route applies, named patient or pharmacy import?

If you source unlicensed medicines across Europe, Germany will not behave like your other markets. There is no individual named patient category in German national law. Two routes exist instead, and they answer different questions. Cohort access for a defined patient group runs through hardship case programmes, the German form of compassionate use, with the national authority involved. Access for a single patient runs through a pharmacy import under § 73(3) of the German Medicines Act. Choosing the wrong route does not slow a request down, it invalidates it.

This guide is written for sourcing, market access and business development teams outside Germany. It covers regulatory routing and the evidence each route requires. It does not cover German reimbursement pricing, which is a separate topic.

What Article 5 actually delegates

Article 5 of Directive 2001/83/EC provides the legal basis for a member state to allow the supply of unauthorised medicines to individual patients. The frequent misunderstanding is to read this as a harmonised European pathway. It is not. The directive provides the basis; operationalisation remains with each member state and follows local regulatory requirements.

The practical consequence is that a process which works in Ireland or the United Kingdom does not transfer to Germany unchanged. The vocabulary transfers, the procedure does not.

The two German routes side by side

Teams used to a named patient vocabulary usually want the second column. The word they will hear in Germany is not named patient but Einzelimport, single import.

The three conditions of § 73(3) AMG

The German Medicines Act sets three conditions that must be met together. If one fails, the route fails.

1. The medicines are ordered by pharmacies on an existing order from individual persons, in small quantity, and dispensed by those pharmacies within their existing pharmacy operating licence.
2. They may lawfully be placed on the market in the state from which they are brought into the German territory.
3. No medicines identical in active substance and comparable in strength are available in Germany for the indication concerned.

Condition three is the one that fails in practice, and rarely on the merits. It is negative evidence, and it is time bound: not available means not available at the moment of ordering. Anyone asked to prove this two months later needs a dated record, not a recollection.

One more provision matters for non-European supply. Where the product is obtained from outside the European Union and the European Economic Area, both the order and the dispensing require a medical or dental prescription. This is explicit in the act, not a matter of interpretation.

What each route requires as evidence

The first row is where most international requests stall. Trade names differ between countries, and the same brand can carry a different strength or form. The reliable anchor is the combination of active substance, strength and pharmaceutical form, resolved into the national product code of the target market.

Discontinued is not the same as unlicensed

Two situations are often merged and should not be. A product can be authorised in Germany and simply withdrawn from the market, or it can never have been authorised at all. The routes differ.

Checking which of the three applies takes one field, the German distribution status. Skipping that check is the most common reason a request enters the wrong route.

Which data supports this

pharmazie.com is the consolidated pharmaceutical data platform by DACON Datenbank Consulting GmbH, on the market since 1989. It unifies 25+ pharmaceutical databases in a single search, the Eisbergsuche®. Its audience is exclusively healthcare professionals. The focus is DACH, with product data covering 50+ countries. The data is updated daily.

For this use case three parts matter. The German article master supplies the distribution status that decides which of the three situations above applies. The shortage data, updated daily, supplies the dated evidence for condition three. The international product data covering 50+ countries supplies identity and lawful marketing status in the source country. Structured substance dossiers cover 63,589 active and excipient substances.

One boundary, stated plainly: price data covers DACH and some further EU countries, not the entire EU. Further countries will follow in the coming months. Identity and availability are therefore covered more widely than price.

Where the limits are

Three of them. First, availability abroad is not legal admissibility; that a product is lawfully marketed somewhere does not settle whether your specific constellation is permitted. Second, no data source replaces the clinical justification, which is made by the treating physician. Third, German reimbursement is a separate question from regulatory admissibility, and a permitted import is not automatically a reimbursed one.

Conclusion

Start with the routing question, not the product search. Ask whether you need cohort access or an individual supply, then check the German distribution status to see whether the product is unauthorised, discontinued or merely unavailable. Only then does the search for a source begin. Teams that reverse this order spend their effort on a route that will not carry the request.

Related reading: pharmaceutical import into Germany for the commercial import context, EU active ingredient registration and PZN mapping for the identity question, and discontinued products for the withdrawal case.

To check which countries and fields your use case needs, book a 30 minute demo or get in touch.

Sources

• § 73 German Medicines Act (Arzneimittelgesetz), gesetze-im-internet.de
• § 21 German Medicines Act, marketing authorisation requirement
• European Medicines Agency, compassionate use
• EUPATI Open Classroom, early access and named patient basis
• GMP Journal, compassionate use and other managed access concepts